MEDILAS H RFID LASER FIBER

K121938 · Dornier Medtech America, Inc. · GEX · Aug 1, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121938
• Device Name: MEDILAS H RFID LASER FIBER
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 1, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery

Device Story

Dornier Medilas H RFID Laser Fibers are fiber-optic accessories for the Dornier Medilas H Holmium Laser. The fibers transmit laser energy to target soft tissue for incision, excision, vaporization, ablation, or coagulation. The device incorporates RFID technology to interface with the laser system. Used in clinical settings (OR, endoscopy suites) by physicians across multiple specialties (urology, ENT, etc.). The fiber acts as a delivery conduit for laser energy; the RFID tag likely communicates fiber parameters to the laser console to ensure appropriate energy delivery settings. This allows for precise tissue interaction, potentially reducing surgical trauma and improving patient outcomes compared to traditional mechanical methods.

Clinical Evidence

Bench testing only.

Technological Characteristics

Fiber-optic laser delivery accessory; incorporates RFID tag for communication with laser console; compatible with endoscopic and open surgical instruments; intended for use with Holmium laser systems.

Indications for Use

Indicated for patients requiring soft tissue cutting, vaporization, ablation, or coagulation in arthroscopy, urology, lithotripsy, pulmonology, gastroenterology, gynecology, ENT, and general surgery. Used with endoscopic equipment or in open surgery.

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

• Dornier Medilas H Laser Fiber (K022544)
• Accuflex Laser Fibers (K050108)
• Lumenis SlimLine Fibers (K011703)

Submission Summary (Full Text)

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K121938

# 510(k) SUMMARY

# Dornier's Medilas H Laser Fibers

1 2012 AUG

## Submitter's Name. Address, Telephone Number, Contact Person and Date Prepared

Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144

Phone: [phone] Fax: [phone] Date Prepared: June 28, 2012

Contact Person: John Hoffer

Phone: [phone]

#### Name of Device and Name/Address of Sponsor

Medilas H RFID Laser Fibers 1155 Roberts Blvd. Kennesaw, GA 30144

#### Common or Usual Name

Holmium Laser Fibers

## Classification Name

Laser Instrument, (Accessory); Product Code GEX

## Predicate Devices

Dornier Medilas H Laser Fiber K022544 Accuflex Laser Fibers K050108 Lumenis SlimLine Fibers K011703

## Purpose of the Special 510(k) notice.

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H Laser Fiber K022544.

#### Intended Use

Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery

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## Substantial Equivalence

Dornier's Medilas H RFID Laser Fibers has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate devices. The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Dornier Medilas H RFID Laser Fibers are as safe and effective as the listed predicates. Thus, the Dornier Medilas H RFID Laser Fibers are substantially equivalent to its predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

> AUG 1 2012

Dornier Medtech America, Incorporated % Mr. John Hoffer 1155 Roberts Boulevard Kennesaw, Georgia 30144

Re: K121938

Trade/Device Name: Dornier Medilas H RFID Laser Fibers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: June 28, 2012 Received: July 02, 2012

Dear Mr. Hoffer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. John Hoffer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Rar

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K12

Device Name: Dornier Medilas H RFID Laser Fibers

Indications for Use:

Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

Arthroscopy Urology Lithotripsy Pulmonology Gastroenterology Gynecology ENT General Surgery

Prescription Use

(Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C) Mille R.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number 121
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE 'OK' ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)