DORNIER MEDILAS H30 SOLVO

K122159 · Dornier Medtech America, Inc. · GEX · Feb 1, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K122159
• Device Name: DORNIER MEDILAS H30 SOLVO
• Applicant: Dornier Medtech America, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, 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 Solvo is indicated for use in medicine and surgery, in the following medical specialties: - Arthroscopy - Urology - Lithotripsy - Pulmonology - Gastroenterology - Gynecology - ENT - General Surgery

Device Story

Holmium:YAG laser system; delivers laser energy for soft tissue management. Used in OR/clinical settings by physicians. Operates via contact or non-contact delivery, often with endoscopic accessories. Provides incision, excision, vaporization, ablation, and coagulation. Benefits include precise tissue interaction and versatility across multiple surgical specialties. Modification of predicate Medilas H20.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Holmium:YAG (Ho:YAG) laser system. Class II surgical powered laser instrument (21 CFR 878.4810). Designed for contact/non-contact soft tissue surgery. Compatible with various endoscopic instruments.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, vaporization, ablation, or coagulation across specialties including 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 H20 Laser (K061455)

Submission Summary (Full Text)

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# 510(k) SUMMARY

### Medilas H Solvo

FEB 0 1 2013

#### 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: 07/18/2012

Contact Person: John Hoffer

Phone: [phone]

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

Medilas H Solvo 1155 Roberts Blvd. Kennesaw, GA 30144

#### Common or Usual Name

Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System

#### Classification Name

The General and Plastic Surgery Branch has classified Surgical Powered Laser Instruments (Product Code GEX) as a Class II device pursuant to 21 C.F.R. § 878.4810.

#### Predicate Devices

Dornier Medilas H20 Laser K061455

#### Purpose of the Special 510(k) Notice

The Solvo is a modification to Dornier's Medilas H20 Laser K061455.

#### Intended Use

The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bysteroscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, ablation and coagulation of soft tissue. The Solvo 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

From a clinical perspective and comparing design specifications, the Solvo and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics, design and overall performance of the devices, Dornier MedTech America believes that no significant differences exist between the Solvo and Dornier's Medilas H20 Laser (K061455).

Dornier MedTech America, Inc. believes the minor differences do not raise any concerns regarding the overall safety or effectiveness. Thus, the Solvo is 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three intertwined lines representing the branches of government or aspects of health and human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

FEB 0 1 2013

Dornier MedTech America, Inc. % John S. Hoffer, VP Quality, Regulatory, Clinical 1155 Roberts Boulevard, Suite 100 Kennesaw, Georgia 30144

Re: K122159

Trade/Device Name: Medilas H Solvo Holmium Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgicial instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 31, 2012 Received: January 03, 2013

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 - John S. Hoffer, VP Quality, Regulatory, Clinical

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/ucm 1.15809.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/ReportaProblem/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical 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): ____________________________________________________________________________________________________________________________________________________ K122159

Device Name: Medilas H Solvo

Indications for Use:

The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, 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 Solvo is indicated for use in medicine and surgery, in the following medical specialties:

- Arthroscopy .
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT .
- General Surgery

Prescription Use _ X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 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 Ogden 2013.02.04 ,1 1:05:47 -05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number __K122159