PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10

K031023 · Peregrine Surgical , Ltd. · HQF · Jun 27, 2003 · Ophthalmic

Device Facts

• Record ID: K031023
• Device Name: PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
• Applicant: Peregrine Surgical , Ltd.
• Product Code: HQF · Ophthalmic
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip

Device Story

The Peregrine Illuminated Laser Probe is an ophthalmic laser delivery device used during surgery. It consists of a connector for an external laser source, a glass fiber for laser delivery, an acrylic fiber for illumination, a PVC jacket, a Delrin handpiece, and a 304 stainless steel needle. The device does not generate or intensify energy; it acts as a conduit for laser energy and light from an existing laser source to target tissue. Operated by a surgeon in a clinical setting, the probe allows for photocoagulation of ocular tissue. The surgeon adjusts the spot size by varying the distance between the probe tip and the target tissue. The device provides illumination to assist the surgeon in visualizing the surgical site during the procedure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: 304 stainless steel needle, Delrin handpiece, glass-silica core optical fiber, acrylic illumination fiber, PVC/Teflon jacket. Energy: Passive delivery of external laser source (max 1 watt). Form factor: 25-gauge probe. Sterilization: ETO (AAMI Overkill Method).

Indications for Use

Indicated for patients undergoing ophthalmic surgery requiring photocoagulation and illumination.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• Peregrine Straight Laser Probe (K024061)
• HGM Illuminating Laser Probe (K931784)

Submission Summary (Full Text)

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Aviation

Peregrine Surgical Ltd. 51 Britain Drive ew Britain, PA 18901

K031023

10FJ

JUN 2 7 2003

March 17, 2003

## Premarket Notification [510(k)] Summary

Submitter: Peregrine Surgical Ltd. 51 Britain Drive New Britain, PA 18901 Phone: [phone] [phone] Fax:

Official Correspondent: Jayne Guthrie

Trade Name: Peregrine Illuminated Laser Probe

Common Name: Ophthalmic Laser Probe

Registration Number: 2529392

Classification: Class II

Class Name: We were unable to find the device listed in the Disposable classification regulations, 21 CFR Parts 862-892 [807.87 (c)]

Panel: Ophthalmic

Product Code: HQF

Device Description: The Peregrine Illuminated Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

Statement of indications for use. - For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip

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K031023
20F2

## Substantial Equivalence Comparison

| Substantial Equivalence to:<br>Product PD600.00<br>K024061<br>Peregrine Straight Laser Probe | Substantial Equivalence to:<br>HGM Illuminating Laser Probe<br>510K K931784<br>Manufactured by Gamp & Assoc. | Application for 510K<br>Peregrine Illuminated<br>Laser Probe<br>Manufactured by Peregrine |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Light transmission for<br>photocoagulation | Illumination and Light<br>transmission for<br>photocoagulation | Illumination and Light<br>transmission for<br>photocoagulation |
| Aluminum connector | Aluminum connector | Delrin connector |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber | Optical Fiber | Optical Fiber |
| Glass - Silica Core | Glass - Silica Core | Glass - Silica Core |
| .008" (200 microns) | .008" (200 microns) | 400 micron |
| PVC Jacket | Teflon Jacket | Teflon Jacket |
| Length 101 inches | Length 96 inches | Length 81 inches |
| 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| 20 Gauge | 20 Gauge | 25 Gauge |
| Max power output | Max power output | |
| 1 watt | 1 watt | |
| No illumination | Illumination | Illumination |
| | Acrylic Optical fiber | Acrylic Optical fiber |
| | Aluminum illumination fiber<br>connector | Aluminum illumination fiber<br>connector |

## Sterility

The Device will be ETO Sterilized.

The method used to validate the sterilization cycle is AAMI Overkill Method.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.

Public Health Service

JUN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Todd Richmond Director of Product Development Peregrine Surgical Ltd. 51 Britain Drive New Britain, Pennsylvania 18901

Re: K031023

Trade/Device Name: Peregrine Illuminated Laser Probe Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: Received:

Dear Mr. Richmond:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Todd Richmond

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely, yours,

Mark N. Millburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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):

Device Name: Peregrine Illuminated Laser Probe

Indications for Use:

For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ XX Restorative and IN 510(k) Num

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