(88 days)
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
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."
The provided text describes a 510(k) premarket notification for a medical device (Peregrine Illuminated Laser Probe). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).
The document details:
- Device Description: What the device is composed of and its function.
- Intended Use: For photocoagulation and illumination during ophthalmic surgery.
- Substantial Equivalence Comparison: A comparison of the Peregrine Illuminated Laser Probe to two predicate devices, highlighting similarities and differences in components and specifications. This is a regulatory comparison to justify substantial equivalence, not a performance study.
- Sterility Information: States the device will be ETO sterilized and the validation method (AAMI Overkill Method).
- FDA Clearance Letter: Confirms substantial equivalence to predicate devices and allows marketing.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Aviation
Peregrine Surgical Ltd. 51 Britain Drive ew Britain, PA 18901
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: (215) 348-0456 (215) 348-5526 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:Product PD600.00K024061Peregrine Straight Laser Probe | Substantial Equivalence to:HGM Illuminating Laser Probe510K K931784Manufactured by Gamp & Assoc. | Application for 510KPeregrine IlluminatedLaser ProbeManufactured by Peregrine |
|---|---|---|
| Light transmission forphotocoagulation | Illumination and Lighttransmission forphotocoagulation | Illumination and Lighttransmission forphotocoagulation |
| 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 fiberconnector | Aluminum illumination fiberconnector |
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 (301) 594-4659. 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" (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 (800) 638-2041 or (301) 443-6597 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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§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.