INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10

K032703 · Innovatech Surgical, Inc. · GEX · Oct 24, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032703
• Device Name: INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
• Applicant: Innovatech Surgical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Innovatech Straight Laser Probe is an ophthalmic laser delivery device used during surgery. It does not generate or intensify energy; it acts as a conduit for laser energy from an existing external laser source to target ocular tissue. The device consists of an aluminum connector, a glass silica core optical fiber with a PVC jacket, a Delrin handpiece, and a 304 stainless steel 20-gauge needle. Operated by a physician, the probe is used to perform photocoagulation by delivering laser energy to tissue; the spot size is adjusted by varying the distance between the probe tip and the target tissue. The device is provided sterile via ETO sterilization. It benefits patients by enabling precise, targeted coagulation during ophthalmic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: 304 stainless steel needle, Delrin handpiece, silica core glass fiber, PVC jacket, aluminum connector. Energy: Passive laser delivery (up to 1 watt). Dimensions: 20 gauge, 200-micron fiber, 101-inch length. Sterilization: ETO (AAMI Overkill Method). Connectivity: Connects to external laser source.

Indications for Use

Indicated for patients undergoing ophthalmic surgery requiring photocoagulation. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• Peregrine Straight Laser Probe (K024061)
• Endo Ocular Laser Probe (Gamp & Associates) (K954307)

Reference Devices

• Endo Illuminator 25ga. (K980797)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Innovatech Surgical, Inc. The logo is black and white and features a stylized sunburst design on the left. Above the logo is the text "OCT 2 4 2003" and "K032703 1 of 2".

August 25, 2003

# Premarket Notification [510(k)] Summary

Submitter: Innovatech Surgical Inc. 1000 Atlantic Avenue, Suite 514 Camden. NJ 08104 Phone: [phone] Fax:

Official Correspondent: Michael J. McGowan, Sr.

Trade Name Innovatech Straight Laser Probe

Common Name: Ophthalmic Laser Probe

Registration Number: 3003988504

Classification: Class II

- We were unable to find the device listed in the Disposable classification regulations, 21 Class Name: CFR Parts 862-892 [807.87 (c)]
Ophthalmic Panel:

Product Code: GEX, HQF

- Device Description: The Innovatech 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 a 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).

Page 3-1

1000 Atlantic Avenue, Suite 514, Camden, New Jersey 08104 800-240-3123 innovatechsurgical.com

{1}------------------------------------------------

K03 2703 2 of 2

## Substantial Equivalence Comparison

| Application for 510(k) | Substantial Equivalence to: | | |
|-------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Innovatech Straight<br>Laser Probe<br>Product: 420-10 | Peregrine Straight<br>Laser Probe<br>Product: PD600.00 | Endo Ocular Laser<br>Probe (Gamp &<br>Associates)<br>510(k): K954307 | Endo Illuminator 25ga.<br>Manufactured by<br>Peregrine Surgical Ltd<br>Familied under 510(k):<br>K980797 |
| | Manufactured by<br>Peregrine Surgical Ltd | | |
| | 510(k): K024061 | | |
| Light transmission for<br>photocoagulation | Light transmission for<br>photocoagulation | Light transmission for<br>photocoagulation | Light transmission for<br>illumination |
| Aluminum connector | Aluminum connector | Aluminum connector | Delrin connector |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber<br>Glass - Silica Core | Optical Fiber<br>Glass - Silica Core | Optical Fiber<br>Glass- Silica Core | Optical Fiber<br>Glass - Silica Core |
| .008" (200 microns) | .008" (200 microns) | .008" (200 microns) | 400 micron |
| PVC Jacket | PVC Jacket | Teflon Jacket | Teflon Jacket |
| Length 101 inches | Length 101 inches | Length 96 inches | Length 81 inches |
| 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| 20 Gauge | 20 Gauge | 20 Gauge | 25 Gauge |
| Max power output<br>1 watt | Max power output<br>1 watt | Max power output<br>1 watt | N/A |

### Sterility

The Device will be ETO Sterilized.

:二

The method used to validate the sterilization cycle is AAMI Overkill Method.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures representing individuals or populations served by the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2003

Mr. Michael J. McGowan, Sr. Innovatech Surgical, Inc. 1000 Atlantic Avenue, Suite 514 Camden, New Jersey 08104

Re: K032703

Trade/Device Name: Innovatech Straight Laser Probe Regulation Number: 21 CFR 878.4810, 886.4390 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Ophthalmic laser Regulatory Class: II Product Code: GEX, HQF Dated: August 25, 2003 Received: September 2, 2003

Dear Mr. McGowan:

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.

{3}------------------------------------------------

Page 2 - Mr. Michael J. McGowan, Sr.

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 [phone]. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

{4}------------------------------------------------

#### STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K03270 |
|---------------------------|--------|
|---------------------------|--------|

Device Name:

Innovatech Straight Laser Probe

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__________

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032703

Page 3-3