PEREGRINE TAPERED DIFFUSION PROBE

K980025 · Peregrine Surgical , Ltd. · MPA · Mar 31, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980025
• Device Name: PEREGRINE TAPERED DIFFUSION PROBE
• Applicant: Peregrine Surgical , Ltd.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Mar 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

For wide angle illumination of the posterior segment during ophthalmic surgery

Device Story

Peregrine Tapered Diffusion Probe is a single-use fiber optic light guide for ophthalmic surgery. Device consists of a universal aluminum connector, polyethylene jacket, Delrin handpiece, and 20 GA stainless steel needle. Acrylic fiber runs through the jacket, is polished at both ends, and is tapered at the distal tip to achieve wide-angle light diffusion. Device connects to a surgical light source to provide illumination of the posterior segment. Used by surgeons in an operating room setting to facilitate visualization during procedures involving coagulation, irrigation/aspiration, and tissue manipulation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Fiber optic light guide; acrylic fiber with tapered distal end; Delrin handpiece; 20 GA stainless steel needle; polyethylene jacket; aluminum connector. ETO sterilized using AAMI Overkill Method. Single-use.

Indications for Use

Indicated for wide angle illumination of the posterior segment during ophthalmic surgery. Intended for prescription use by clinicians.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Reference Devices

• Peregrine Diffusion Light Pipe
• Peregrine Wide Angle Light Pipe

Submission Summary (Full Text)

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K980025

## Premarket Notification [510(k)] Summary

MAR 3 1 1998

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

Official Correspondent: Amy Hessenthaler

Trade Name: Peregrine Tapered Diffusion Probe

Common Name: Fiber Optic Light Pipe with wide angle dispersion of illuminated field

Registration Number: 2529392

Classification: Class II

Class Name: Not Known

Panel: Ophthalmic

Product Code: MPA

Device Description: The Peregrine Tapered Diffusion Probe is a single use light guide approximately 6' in length consisting of the following: A Universal Aluminum connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic fiber runs. A Delrin Handpiece with a 20 GA Stainless Steel Needle at the distal end. The acrylic fiber, which is polished and affixed at both ends, is tapered and extends past the tip to achieve the diffusion of light.

Statement of indications for use. - For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.

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| Peregrine<br>Peregrine Tapered<br>Diffusion Probe | Peregrine<br>Peregrine Diffusion Light Pipe | Peregrine<br>Peregrine Wide Angle<br>Light Pipe |
|---------------------------------------------------|---------------------------------------------|-------------------------------------------------|
| Application for 510(K) | Manufactured for Grieshaber | Manufactured for Storz |
| Wide Angle Light Diffusion | Wide Angle Light Diffusion | Wide Angle Light Diffusion |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| 20 GA Stainless Steel Needle | 20 GA Stainless Steel Needle | 20 GA Stainless Steel Needle |
| Polyethylene Jacket | Polyethylene Jacket | Teflon Jacket |
| Acrylic Fiber w/Tapered End | Acrylic Fiber w/ Prism Wafer | Acrylic Fiber w/ Sapphire Ball |
| Aluminum Connector | Aluminum Connector | Acetal Connector |
| Single Use | Single Use | Single Use |

## 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown, PA 18901

MAR 3 1 1998

K980025/S1 Re:

> Trade Name: Peregrine Tapered Diffusion Probe Regulatory Class: II Product Code: 86 MPA Dated: December 30, 1997 Received: January 5, 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 OS 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- 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 Rosenthal

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):

Device Name: Peregrine Tapered Diffusion Probe

Indications for Use:

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For wide angle illumination of the posterior segment during ophthalmic surgery

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use_

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Thassha L. Burke kicholors
(Division Sign-Off)

Division of Ophthalmic Devices 510(k) Number. 49,0075