PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10

K980400 · Peregrine Surgical , Ltd. · HQE · Apr 30, 1998 · Ophthalmic

Device Facts

• Record ID: K980400
• Device Name: PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
• Applicant: Peregrine Surgical , Ltd.
• Product Code: HQE · Ophthalmic
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the Peeling and Vertical Cutting of Preretinal Membranes.

Device Story

PVRS - Peregrine Vitreoretinal Scissor is a surgical instrument for posterior segment ophthalmic procedures. Device consists of a Delrin handpiece, 20 GA stainless steel shaft, and scissor tip; connected via 6-foot pneumatic tubing to a surgical console. Operated by ophthalmologists in an OR setting. Pneumatic drive provides vertical cutting action for peeling and cutting preretinal membranes. Device is reusable and includes a cleaning port. Benefits include precise membrane manipulation during vitreoretinal surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Delrin handpiece, 20 GA stainless steel shaft. Energy source: Pneumatic. Form factor: Handheld surgical instrument with 6-foot tubing. Sterilization: ETO (AAMI Overkill Method).

Indications for Use

Indicated for the peeling and vertical cutting of preretinal membranes in patients undergoing vitreoretinal surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Grieshaber MPC - Membrane Peeler Cutter (Product #625.12)
• Grieshaber Sutherland Instruments (Product #612.25)

Submission Summary (Full Text)

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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: [phone] [phone] 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

| Peregrine<br>PVRS - Peregrine Vitreo-<br>Retina Scissor | Grieshaber<br>MPC - Membrane Peeler Cutter | Grieshaber<br>Sutherland Instruments |
|---------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Application for 510(K)<br>Product #505.10 | Manufactured by Grieshaber<br>Product #625.12 | Manufactured by Grieshaber<br>Product #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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.