Speculite
by Trylon Corp. 510(k)
Active
510(k) K963391
Overview
The Speculite is a speculum designed for obstetrics and gynecology, classified under the Chemiluminescent Light device type (Product Code: MPU). It is intended for use in cervical screening procedures, providing enhanced visualization of the cervical area during pelvic examinations. This device aids in adjunctive diagnostic support alongside Pap smear testing, ensuring clearer assessment of cervical tissue.
Supplied as a reusable medical instrument, the Speculite is intended for use in clinical settings such as obstetrics and gynecology offices or outpatient care facilities. It is regulated under FDA 510(k) clearance (K963391) as a Class II device, with no explicit sterility or single-use requirements stated in the data. The device is not referenced as MRI-safe or unsafe in the provided specifications. Storage and handling follow standard medical instrument protocols for reusable diagnostic tools.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963391 | Date12 Dec 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0977-03
Lights split, spilling contents when bent to activate.
Specification
- 510(k) Number
- FDA Product Code
- MPU
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Trylon Corp.
Questions
What is the Speculite designed for in clinical practice?
The Speculite is specifically engineered for obstetrics and gynecology to improve visualization of the cervical area during pelvic examinations. Its chemiluminescent light feature helps clinicians obtain clearer views of cervical tissue, supporting adjunctive diagnostic assessments alongside Pap smear testing. This makes it particularly useful in settings like outpatient clinics or gynecological offices where detailed cervical screening is required.
Is the Speculite a single-use or reusable device?
The Speculite is supplied as a reusable medical instrument. Unlike disposable devices, it is intended for repeated use in clinical settings, provided it adheres to standard medical instrument protocols for cleaning, sterilization, and maintenance. This design aligns with its classification as a reusable diagnostic tool in obstetrics and gynecology.
What regulatory pathway does the Speculite follow?
The Speculite is regulated under the FDA’s 510(k) clearance process, specifically classified as a Class II device with the product code MPU (Chemiluminescent Light). It was granted clearance under the traditional review pathway by the Obstetrics/Gynecology Advisory Committee in 1997, with the clearance number K963391. This pathway ensures it meets FDA standards for safety and effectiveness as a diagnostic aid in cervical screening.
How should the Speculite be stored and handled?
The Speculite follows standard medical instrument protocols for reusable diagnostic tools. Proper storage involves keeping it in a clean, dry environment to prevent contamination or damage. Handling should include adherence to clinical decontamination procedures—such as cleaning, disinfection, and sterilization—to maintain its functionality and ensure patient safety. Always refer to manufacturer guidelines for specific cleaning and maintenance instructions.
Does the Speculite have any special considerations for use in imaging or MRI environments?
The provided specifications do not explicitly state whether the Speculite is MRI-safe or unsafe. If used in environments where MRI compatibility is a concern—such as facilities with magnetic resonance imaging—clinicians should verify compatibility with their specific MRI system or consult the manufacturer for guidance. Standard reusable medical instruments may pose risks in MRI environments unless certified otherwise.