(87 days)
For the Peeling and Vertical Cutting of Preretinal Membranes.
The PVRS - Peregrine Vitreoretinal Scissor is vertical cutting, provided sterile and consists of the following: A 6' length of (pneumatical) tubing with a luer connector at the proximal end to fit into a surgical console. A Delrin handpiece with a 20 GA stainless steel shaft and scissor tip at the distal end.
The provided text describes a 510(k) submission for the PVRS - Peregrine Vitreoretinal Scissor, a medical device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The document primarily focuses on:
- Device Description: What the device is and what it does (vertical cutting, preretinal membranes).
- Substantial Equivalence Comparison: Comparing the PVRS to predicate devices (Grieshaber MPC and Sutherland Instruments) based on features like cutting type, drive mechanism, shaft size, and insertion method.
- Sterility Validation: Mentioning ETO sterilization and the AAMI Overkill Method for validation.
- FDA Communication: The FDA's letter of substantial equivalence.
- Indications for Use: Explicitly stating "For the Peeling and Vertical Cutting of Preretinal Membranes."
Therefore, I cannot provide the requested information in the format you specified, as the source material does not contain it.
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APR 3 0 1998
January 29, 1998
980400
Premarket Notification [510(k)] Summary
Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901 Phone: (215) 348-0456 (215) 348-5526 Fax:
Official Correspondent: Amy Hessenthaler
Trade Name: PVRS - Peregrine Vitreoretinal Scissor
Common Name: Vitreoretinal Scissor
Registration Number: 2529392
Classification: Class II
Class Name: Not Known
Panel: Ophthalmic
Product Code: 86 HAF HQE
Device Description: The PVRS - Peregrine Vitreoretinal Scissor is vertical cutting, provided sterile and consists of the following: A 6' length of (pneumatical) tubing with a luer connector at the proximal end to fit into a surgical console. A Delrin handpiece with a 20 GA stainless steel shaft and scissor tip at the distal end. (see Appendix B)
Statement of indications for use. - For the Peeling and Vertical Cutting of Preretinal Membranes.
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Substantial Equivalence Comparison
| PeregrinePVRS - Peregrine Vitreo-Retina Scissor | GrieshaberMPC - Membrane Peeler Cutter | GrieshaberSutherland Instruments |
|---|---|---|
| Application for 510(K)Product #505.10 | Manufactured by GrieshaberProduct #625.12 | Manufactured by GrieshaberProduct #612.25 |
| Posterior Cutting | Posterior Cutting | Posterior Cutting |
| pneumatic driven handpiece | electromagnet driven handpiece | manual driven handpiece |
| vertical cutting action | vertical cutting action | vertical cutting action |
| 20 GA stainless steel shaft | 20 GA stainless steel shaft | 20 GA stainless steel shaft |
| insertion through 1mm incision | insertion through 1mm incision | insertion through 1mm incision |
| equipped with cleaning port | equipped with cleaning port | equipped with cleaning port |
| reusable | reusable | reusable |
ﺮ ﺍ
Sterility
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The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one above the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Mr. Todd Richmond Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901
Re: K980400
Trade Name: PVRS - Peregrine Vitreoretinal Scissor Regulatory Class: II Product Code: 86 HQE Dated: January 29, 1998 Received: February 2, 1998
Dear Mr. Richmond:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Todd Richmond
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorenttal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510K Number (if known): K980400
Device Name: PVRS - Peregrine Vitreoretinal Scissor
Indications for Use:
For the Peeling and Vertical Cutting of Preretinal Membranes.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
Er Beam
XX
Division of Ophthalm 510(k) Number.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.