(78 days)
For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
The Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to minipulate tissue, irrigate and aspirate, and coagulate blood. It consists of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running through the handprece and outer stainless needle, protruding beyond the tip approximately 2.5mm. Electrical connection for RF current is made via fine insulated wires from the inner and outer needles to the solderless connectors which attach to the coagulator. A 30" length of silicone tubing with a luer connector at the proximal end of the handpiece. The luer connector may be attached to a syringe for irrigation asperation The 2.5mm extension may be used for tissue manipulation.
This document is a 510(k) Premarket Notification for the Peregrine Fiber Optic Multi-Function Manipulator, indicating it's a submission for clearance to market a medical device, not a study reporting on the device's performance against acceptance criteria.
The provided text does not contain acceptance criteria or detailed information about a study proving the device meets specific performance metrics. It's a regulatory submission document for market clearance based on substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. This information is typically found in design verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) summary.
The document primarily states:
- Device Description: Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to manipulate tissue, irrigate and aspirate, and coagulate blood.
- Indications for Use: For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
- Predicate Device: Grieshaber & Co. 3-Function Manipulator. The document presents a comparison of features between the two devices but no performance data.
- Sterilization: The device will be ETO sterilized using the AAMI Overkill Method for validation.
- Regulatory Status: The FDA found the device substantially equivalent to pre-amendment devices for its stated indications for use.
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Rere Zunner
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Peregrine Surgical Lid. 4050D Skyron Drive Doylestown, PA 18901
MAY 1 9 1998
May 11, 1998
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: Peregrine Fiber Optic Multi-Function Manipulator
Common Name: Fiber Optic Light Pipe with Pick, Coagulation, and Irrigation/Aspiration
Registration Number: 2529392
Classification: Class II
Class Name: Not Known
Panel: Ophthalmic
Product Code: 86 MPA
Device Description: The Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to minipulate tissue, irrigate and aspirate, and coagulate blood. It consists of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running through the handprece and outer stainless needle, protruding beyond the tip approximately 2.5mm. Electrical connection for RF current is made via fine insulated wires from the inner and outer needles to the solderless connectors which attach to the coagulator. A 30" length of silicone tubing with a luer connector at the proximal end of the handpiece. The luer connector may be attached to a syringe for irrigation asperation The 2.5mm extension may be used for tissue manipulation.
Statement of indications for use. - For Illumination, coagulation irrigation, and Itssue manipulation during ophthalmic surgery.
..............................................................................................................................................................................
- 215-348-0456 Fax: 215-348-5526
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| Peregrine Fiber OpticMulti-Function Manipulator | Grieshaber & Co.3-Function Manipulator |
|---|---|
| Application for 510(K)Product# 100.14 | Manufactured by Grieshaber & Co.Product# 149.89 |
| coagulation | coagulation |
| pick manipulation | infusion/aspiration |
| polyethylene jacket | polyethylene jacket |
| 20 GA stainless steel needle | 20 GA stainless steel needle |
| Delrin Handpiece | Delrin Handpiece |
| insertion through 1mm incision | insertion through 1mm incision |
| 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 logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of several curved lines that create the shape of the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 1998
Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown, PA 18901
K980797 Re:
Trade Name: Peregrine Fiber Optic Multi-Function Manipulator Regulatory Class: II Product Code: 86 MPA Dated: February 27, 1998 Received: March 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. Ralph 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 Fiber Optic Multi-Function Manipulator
Indications for Use:
For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during 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 V
OR
Over-The-Counter Use_
liasha L. Burke kiokio
(Division Sign Off)
ision of Ophthalmic Devices
Page 5
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.