For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation during ophthalmic surgery. This device delivers 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 Straight 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 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 is a 510(k) Premarket Notification summary for the Peregrine Straight Laser Probe. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on manufacturing and materials rather than performance data from a clinical study. Therefore, the document does not contain the information required to populate the acceptance criteria and study details as requested. This type of submission typically focuses on demonstrating equivalence to an already approved device through design, materials, and intended use, rather than presenting novel performance data from human or extensive animal studies.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, or the nature of any test sets.
- Information about experts, ground truth establishment, or adjudication methods for performance evaluation.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone (algorithm-only) performance data.
- Details on the type of ground truth used for performance evaluation, beyond inferring that the probe is intended to achieve photocoagulation.
- Information on training set sample sizes or how their ground truth was established, as this is not an AI/ML device submission.
The closest relevant information is about sterility, where it states:
- Acceptance Criteria (Implied): The device will be ETO Sterilized to achieve sterility.
- Study (Method): The method used to validate the sterilization cycle is the AAMI Overkill Method. This is a standard validation method for sterilization, but no specific performance data (e.g., sterility assurance level achieved) is reported in this summary.
In summary, the provided text describes a medical device in the context of a 510(k) submission, which focuses on device description, indications for use, and substantial equivalence to predicate devices. It does not contain the detailed performance study data requested in your prompt.
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MAR 0 7 2003
Image /page/0/Picture/1 description: The image shows a black silhouette of a bird of prey, possibly a falcon or hawk, in profile. The bird is depicted with its wings swept back and its head facing to the right. The sharp beak and streamlined body suggest a focus on speed and hunting prowess. The image is simple yet striking, conveying a sense of power and agility.
Peregrine Surgical Ltd. 51 Britain Drive New Britain, PA 18901
KO 24061
December 5, 2002
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 Straight 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: HQE
Device Description: The Peregrine Straight 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 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 during ophthalmic surgery. To be used with (specified equipment).
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Substantial Equivalence Comparison
| Application for 510KProduct PD600.00Peregrine Straight Laser Probe | Substantial Equivalence to:EndoOcular Laser Probe510K K954307Manufactured by Gamp & Assoc. | B&L Endo Illuminator 25gaFamilied under 510K K980797Manufactured by Peregrine |
|---|---|---|
| Light transmission forphotocoagulation | Light transmission forphotocoagulation | Light transmission |
| 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 |
| PVC Jacket | Teflon Jacket | Teflon Jacket |
:
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 U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the head and wings of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 7 2003
Mr. Todd Richmond Peregrine Surgical Ltd. 51 Britain Drive New Britain, Pennsylvania 18901
Re: K024061
Trade/Device Name: Peregrine Straight Laser Probe Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, HQF Dated: December 5, 2002 Received: December 9, 2002
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 (QS) 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,
Miriam C. Provost
ted 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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Image /page/4/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K024061'. The characters are written in black ink on a white background.
Indications for Use:
For photocoagulation during ophthalmic surgery. This device delivers 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)
Prescription Use xx_______________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K02406/
Page 3
December 5, 2002
Premarket Notification [510(k)] Summary
Submitter: Peregrine Surgical Ltd. 51 Britain Drive
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.