PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20

K980399 · Peregrine Surgical , Ltd. · HQE · Apr 30, 1998 · Ophthalmic

Device Facts

• Record ID: K980399
• Device Name: PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
• 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 removal of vitreous and vitreal membranes during ophthalmic surgery.

Device Story

Peregrine OptiPort Vitrectomy Probe is a single-use, 20 GA guillotine-style cutter for ophthalmic surgery. Device consists of a Delrin handpiece with a 20 GA stainless steel needle, connected to dual PVC tubing with luer connectors for aspiration and pneumatic activation. Operated pneumatically by a surgeon during ophthalmic procedures to remove vitreous and vitreal membranes. Mechanical guillotine action at the distal tip allows for precise tissue resection through a 1mm incision. Single-use design ensures sterility and eliminates cross-contamination risks.

Clinical Evidence

Bench testing only.

Technological Characteristics

20 GA stainless steel needle; Delrin handpiece; dual PVC tubing; pneumatic energy source; 6-inch length; .035mm distal port; ETO sterilization (AAMI Overkill Method).

Indications for Use

Indicated for the removal of vitreous and vitreal membranes during ophthalmic 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

• H.S. International Shapiro Cutter Vitrectomy Probe (Product# HS32-803)

Submission Summary (Full Text)

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## APR 3 0 1998

January 30, 1998

# K9803999

### Premarket Notification [510(k)] Summary

Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Dovlestown, PA 18901 Phone: [phone] [phone] Fax:

Official Correspondent: Amy Hessenthaler

Trade Name: Peregrine OptiPort Vitrectomy Probe

Common Name: Vitrectomy Guillotine Cutter

Registration Number: 2529392

Classification: Class II

Class Name: Not Known

Panel: Ophthalmic

Product Code: 86 HQE

Device Description: The Peregrine OptiPort Vitrectomy Probe is a single use, 20 GA guillotine style cutter for use during ophthalmic surgery. Approximately 6' in length and provided sterile, it consists of the following. At the proximal end, a female and male luer connector attached to the resective ends of dual PVC tubing. A colored stripe is added to one of the tubes to establish it as the half used for aspiration. A Delrin Handpiece with a 20 GA stainless steel needle at the distal end. The mechanics to operate the vitrectomy probe extend through the inner lumen of the stainless shaft and may be activated pneumatically. (see Appendix B)

Statement of indications for use. - For removal of vitreous and vitreal membranes during opthalmic surgery.

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#### Substantial Equivalence Comparison

| Peregrine<br>OptiPort Vitrectomy Probe | H.S. International<br>Shapiro Cutter Vitrectomy<br>Probe |
|-------------------------------------------|----------------------------------------------------------|
| Application for 510(K)<br>Product# 505.10 | Manufactured by H.S. International<br>Product# HS32-803 |
| Vitreous Removal | Vitreous Removal |
| pneumatic driver | pneumatic driver |
| guillotine cutting action | guillotine cutting action |
| 20 GA stainless steel shaft | 20 GA stainless steel shaft |
| .035mm port at distal tip | .034mm port at distal tip |
| insertion through 1mm incision | insertion through 1mm incision |
| single use | single use |
| ergonomic handle | ergonomic handle |
| | |
| | |
| | |

The Peregrine OptiPort Vitrectomy Probe is identical in principle to the ophthalmic guillotine cutters marketed today. The materials used in its manufacture are similar, if not in most comparisons identical.

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#### Sterility

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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird, with three stylized human profiles incorporated into the design.

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: K980399

> Trade Name: Peregrine OptiPort Vitrectomy Probe Regulatory Class: II Product Code: 86 HQE Dated: January 30, 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 forentthal

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): K980399

Device Name: Peregrine OptiPort Vitrectorny Probe

Indications for Use:

For removal of vitreous and vitreal membranes dering ophthalmic surgery.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _______xx

ાર

Over-The-Counter Use

Everett T. Boom

(Division Sign-Off) Division of Ophthalmic D 510(k) Number

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