ACMI DUR-HL LASER SYSTEMS

K060752 · Acmi Corporation · GEX · May 25, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060752
• Device Name: ACMI DUR-HL LASER SYSTEMS
• Applicant: Acmi Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.

Device Story

Pulsed solid-state Holmium YAG laser (2080 nm wavelength); 400 um penetration depth. System includes laser console, control/display panel, fiber port, microprocessor control electronics, and footswitch. Used with fiber optic delivery accessories. Operated by clinicians in surgical settings (OR/endoscopic suites). Laser energy absorbed by water in tissue to perform ablation, vaporization, excision, incision, and coagulation. Enables minimally invasive endoscopic surgery and lithotripsy. Provides precise tissue interaction for various surgical specialties.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pulsed solid-state Holmium YAG laser; 2080 nm wavelength; Class IV laser (21 CFR 1040); microprocessor-controlled; fiber optic delivery system; console with control/display panel.

Indications for Use

Indicated for patients requiring surgical stone fragmentation, tissue cutting, ablation, vaporization, excision, incision, or coagulation across specialties including Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, and General Surgery. Used in open and endoscopic procedures.

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

• WaveLight Auriga Laser (K051399)
• Dornier Medilas H Laser Systems (K983963)

Submission Summary (Full Text)

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ACMI® DUR-HL Laser Systems ACMI Corporation 136 Turnpike Road Southborough, MA 01772

510(k) Notification

K 060752

# 510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® DUR-HL Laser Systems

MAY 2 5 2006

#### General Information

Manufacturer: ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104 Contact Person: Lorraine Calzetta Regulatory Affairs Tel. #: [phone] Fax #: [phone] Date Prepared: March 16, 2006 Device Description Classification Name: Class II ( 21 CR 878. 4810)

Laser surgical instrument for use in general and plastic surgery and in dermatology

ACMI® DUR-HL Laser Systems

Laser, Holmium YAG, Surgical

Trade Name:

Generic/Common Name:

#### Predicate Devices

WaveLight Auriga Laser Dornier Medilas H Laser Systems

K051399 K983963

#### Intended Uses

The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecol ogy, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.

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# Product Description

The ACMI® DUR-HL Laser Systems are pulsed solid-state Holmium YAG Lasers with a wavelength of approximately 2080 nm (2.1um). This wavelength is absorbed primarily by water, whereby an average penetration depth of approx. 400 um (0.4 mm). The lasers are Class IV lasers pursuant to 21CFR 1040 and designed to comply with the requirements outlined in 21 CFR 1040. The ACMI® DUR-HL Laser Systems are comprised of the following components:

- Laser Unit, which includes Laser console, control and display panel .
- . Fiber port for delivery systems
- System microprocessor control electronics .
- Covered footswitch .
- . Operating software
- (For use with) a variety of fiber optic delivery devices/accessories. .

# Technological Characteristics and Substantial Equivalence

The ACMI® DUR-HL Laser Systems utilize features such as indications for use, design, materials, technological characteristics, and operational characteristics incorporated into the following legally marketed predicate devices:

## WaveLight Auriga cleared under K051399 Dornier Medilas H Laser Systems cleared under K983963

In summary, the ACMI® DUR-HL Laser Systems are substantially equivalent to the predicate devices and present no new questions of safety or efficacy.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

ACMI Corporation. % Ms. Lorraine Calzetta Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104

Re: K060752

Trade/Device Name: ACMI® DUR-HL Laser Systems 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: March 16, 2006 Received: March 21, 2006

Dear Ms. Calzetta:

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. Lorraine Calzetta

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct 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

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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510(k) Notification

ACMI® DUR-HL Laser Systems ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Device Name: ACMI® DUR-HL Laser Systems

510(k) Number: K060752

Indications for use:

The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery

_ Prescription Use: __ X

OR Over-the-Counter Use: _

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.mQ

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

510(k) Number. Koso752

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