ACCUTECH ENDOLITE PROBE

K061025 · Accutech Medical Technologies, Inc. · FFS · May 31, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061025
• Device Name: ACCUTECH ENDOLITE PROBE
• Applicant: Accutech Medical Technologies, Inc.
• Product Code: FFS · Gastroenterology, Urology
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology. The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.

Device Story

Accutech EndoLite Probe is a sterile, single-use fiber optic delivery system for 532-659 nm laser energy; used for ocular photocoagulation of anterior and posterior segments. Device consists of glass fiber optic protected by stainless steel needle/handle and plastic jacket; features universal SMA laser connector for attachment to compatible laser systems. Operated by clinicians in ocular surgical settings. Device delivers laser energy to target ocular tissue; clinical effect depends on the specific laser system used. Benefits include precise delivery of therapeutic laser energy for treatment of ocular pathology.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and functional characteristics.

Technological Characteristics

Fiber optic delivery system; stainless steel needle/handle; plastic jacket; universal SMA connector. Compatible with 532-659 nm laser systems. Sterile, single-use.

Indications for Use

Indicated for patients requiring ocular photocoagulation of the anterior and posterior segment for conditions cleared for use with compatible 532-659 nm laser systems.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Lumenis EndoOcular Probes (K052526, K931072, K990174, K022181)
• CeramOptec/BioLitec EndoProbe (K964751)
• CeramOptec MegaBeam Fiber Optic Delivery System (K980389, K943445)

Submission Summary (Full Text)

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

## MAY 3 1 2006

## Section 5 - 510(k) Summary or 510(k) Statement

# KO61025

#### I. General Information

Submitter:

Accutech Medical Technologies, Inc. 13-550 Trillium Drive Kitchener, Ontario N2R 1K3 Canada

Contact Person:

.

David Stiles Director of Regulatory Affairs and Quality Assurance

Summary Preparation Date: April 10, 2006

#### II. Names

Device Names: Accutech EndoLite Probe

Primary Classification Names: Accessory for, Laser Powered Surgical Instruments

#### III. Predicate Devices

- Lumenis EndoOcular Probes (K052526, K931072, K990174, K022181) .
- CeramOptec/BioLitec EndoProbe (K964751) .
- CeramOptec MegaBeam Fiber Optic Delivery System (K980389, K943445) .

#### IV. Product Description

The Accutech EndoLite Probe is comprised of the following main components:

- A glass fiber optic protected by a medical grade stainless steel needle and handle at . the distal (patient contact) end and by a plastic jacket at the proximal (laser connection) end; and
- . A universal SMA laser connector.

The Accutech EndoLite Probe is provided as a sterile, single use 532-659 nm laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the compatible 532-659 nm laser system with universal SMA compatibility that has been qualified by Accutech Medical Technologies, Inc. for use with the Accutech EndoLite Probe.

#### V. Indications for Use

The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology.

The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 m I aser system(s) with which it is compatible for use.

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

#### VI. Rationale for Substantial Equivalence

The Accutech EndoLite Probe shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

#### VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Accutech EndoLite Probe is substantially equivalent to the predicate devices.

## VIII. Conclusion

The Accutech EndoLite Probe was found to be substantially equivalent to the predicate devices.

The Accutech EndoLite Probe shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 3 1 2006

Accutech Medical Technologies, Inc. % AL Voss Associates Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566

Re: K061025

Trade/Device Name: Accutech EndoLite 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 Dated: April 10, 2006 Received: April 13, 2006

Dear Ms. Worden:

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

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

## Page 2 - Ms. Anne Worden

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. 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,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

### Indications for Use Statement

| 510(k) Number (if known): | K06 2061025 |
|---------------------------|-------------------------|
| Device Name: | Accutech EndoLite Probe |

Indications for Use:

The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology.

The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.

Prescription Use __ > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_Ko61025

Page 1 of l