ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES

K090281 · Accutech Medical Technologies, Inc. · GEX · Mar 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090281
• Device Name: ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
• Applicant: Accutech Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

Device Story

Accutech Family of PowerFlex Laser Delivery Devices are fiber optic accessories for surgical lasers. Configurations include bare fibers, sidefire fibers (with glass capillary tip and adjustable handle), and ENT fibers/endoprobes (with stainless steel needle/cannula). Devices connect to KTP, Nd:YAG, Argon, Diode, and Ho:YAG laser systems (488-2100 nm) via SMA connectors to deliver energy to target tissue. Optional RFID connector available for specific diode laser systems. Used by physicians in clinical settings (OR, clinic) for incision, excision, ablation, and hemostasis. Device acts as a conduit for laser energy; clinical decision-making relies on the primary laser system's output and the physician's manual manipulation of the fiber tip. Benefits include precise tissue interaction for various surgical specialties.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Fiber optic delivery system; components include glass fibers, plastic jackets, stainless steel needles/cannulas, glass capillary tubes, and SMA connectors. Optional RFID connector for laser system compatibility. Energy source: external laser systems (KTP, Nd:YAG, Argon, Diode, Ho:YAG).

Indications for Use

Indicated for incision, excision, ablation, and coagulation in patients undergoing procedures in general/cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, dermatology, plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary surgery using compatible laser systems.

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

• Accutech EndoLite Probe (K061025)
• Cook Urological OptiLite™ Holmium Laser Fibers (K073496)
• FiberTech (FT) Fiber Optic Delivery Systems (K050738)
• Technology Delivery Systems MaxiFlex Fiberoptic Energy Delivery System (K013300)

Submission Summary (Full Text)

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

### I. General Information

Submitter:

Accutech Medical Technologies, Inc. 125 Fleming Drive Cambridge, Ontario NIT 2B8 Canada

Contact Person:

Gregory Berzak Regulatory Affairs Officer Tel: [phone], ext. 1901

Summary Preparation Date: February 4. 2009

#### II. Names

Device Names: Accutech Family of PowerFlex Laser Delivery Devices

Primary Classification Names: Accessory for, Laser Powered Surgical Instruments

### III. Predicate Devices

- . Accutech EndoLite Probe (K061025)
- Cook Urological OptiLite™ Holmium Laser Fibers (K073496); .
- FiberTech (FT) Fiber Optic Delivery Systems (K050738); .
- Technology Delivery Systems MaxiFlex Fiberoptic Energy Delivery System . (K013300)

### IV. Product Description

The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type):

Bare Fibers - No Sheaths

- Glass fiber optic with jacket .
- . SMA connector

Bare Fibers - With Sheaths

- Glass fiber optic with jacket .
- Sheath .
- SMA connector .

SideFire Fibers

- Glass fiber optic with jacket with distal (patient contact) fiber tip encased in . glass capillary tube
- SMA connector .
- Adjustable handle (tightens on fiber to allow user to direct laser energy to � desired target site)

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## Endoprobes/ ENT Fibers

- A glass fiber optic protected by a medical grade stainless steel needle/ cannula ● (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end
- SMA connector .

### Additional Accessory(ies)

- Optional Radiofrequency identification (RF ID) connector for use with ● INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)
#### V. Indications for Use

The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

#### VI. Rationale for Substantial Equivalence

The Accutech Family of PowerFlex Laser Delivery Devices 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 Family of PowerFlex Laser Delivery Devices is substantially equivalent to the predicate devices.

# VIII. Conclusion

The Accutech Family of PowerFlex Laser Delivery Devices was found to be substantially equivalent to the predicate devices.

The Accutech Family of PowerFlex Laser Delivery Devices shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

0016

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 2009

Accutech Medical Technologies, Inc. % A L Voss Associates Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566

Re: K090281

Trade/Device Name: Accutech Family of PowerFlex Laser Delivery Devices 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: February 4, 2009 Received: February 5. 2009

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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Anne Worden

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmaties surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmaner, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

f ti mid. for

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

Enclosure

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# Indications for Use Statement

K090 2281 510(k) Number (if known):

Device Name: Accutech Family of PowerFlex Laser Delivery Devices

Indications for Use:

The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

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)

Neil R. Oyler Forman

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

**510(k) Number** K090228

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