K Number
K024061
Device Name
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
Date Cleared
2003-03-07

(88 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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."
More Information

No
The summary describes a simple laser probe that delivers energy from an external source and does not mention any computational or algorithmic processing, let alone AI/ML.

Yes
The device is described as delivering laser energy to target tissue, causing coagulation for photocoagulation during ophthalmic surgery, which is a therapeutic intervention.

No.
The device is described as an ophthalmic laser delivery device used for photocoagulation during ophthalmic surgery, which is a therapeutic rather than diagnostic function. It delivers laser energy to target tissue to cause coagulation, and there is no mention of it being used to identify or analyze a condition.

No

The device description clearly states it is a physical ophthalmic laser delivery device consisting of a connector, glass fiber, handpiece, and needle. It is not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "For photocoagulation during ophthalmic surgery." This describes a surgical procedure performed directly on a patient's eye.
  • Device Description: The device is a laser delivery probe used to apply laser energy to tissue. It's a surgical tool.
  • Lack of IVD Characteristics: An IVD is a medical device used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.

The device is clearly intended for use in vivo (within a living organism) during surgery, not in vitro (in a test tube or lab setting) for diagnostic purposes.

N/A

Intended Use / Indications for Use

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.

Product codes

HQE, GEX, HQF

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."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K954307

Reference Device(s)

K980797

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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).

1

Substantial Equivalence Comparison

| Application for 510K
Product PD600.00
Peregrine Straight Laser Probe | Substantial Equivalence to:
EndoOcular Laser Probe
510K K954307
Manufactured by Gamp & Assoc. | B&L Endo Illuminator 25ga
Familied under 510K K980797
Manufactured by Peregrine |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Light transmission for
photocoagulation | Light transmission for
photocoagulation | 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.

2

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.

3

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