LINA XCISE MODEL MOR-1515

K101458 · Lina Medical Aps · HET · Mar 11, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K101458
• Device Name: LINA XCISE MODEL MOR-1515
• Applicant: Lina Medical Aps
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LiNA Xcise Laparoscopic Morcellator is intended for gynaecologic endoscopic use by trained professionals in hospital and surgical clinic environments.

Device Story

LiNA Xcise is a single-use, sterile, disposable laparoscopic morcellator. Device features a pistol-grip housing containing a self-contained motor unit and battery power supply. A trigger controls blade rotation for a rotating cylindrical tube (15mm diameter) with a sharpened distal cutting blade. The trocar housing is manually retractable to expose the blade; includes a duckbill housing with a valve to minimize gas leakage. Operated by trained professionals in hospitals or surgical clinics. During use, a standard tissue grasper is inserted through the cylindrical tube to grasp tissue, which is then pulled through the rotating blade for coring/extraction. The device facilitates tissue removal during gynecologic procedures like hysterectomy and myomectomy, potentially reducing the need for larger incisions.

Clinical Evidence

No clinical data was generated for this submission. Bench testing was performed to validate mechanical and electrical performance, including cutting tube strength, trocar function, motor torque/speed, battery lifetime, and EMC compliance (EN 60601-1-2: 2007). Published literature was provided to support the general safety and effectiveness of morcellation devices in hysterectomy.

Technological Characteristics

Single-use, disposable, battery-powered electromechanical device. Features a 15mm diameter rotating cylindrical cutting tube. Materials include a pistol-grip housing with integrated motor and battery. Connectivity: None. Sterilization: Gamma radiation. Standards: EMC per EN 60601-1-2: 2007 and FCC 47 CFR part 18.

Indications for Use

Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Gynecare laparoscopic Morcellator [GYNECARE X-TRACT Tissue Morcellator] (K993801)
• S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) (K960640)

Submission Summary (Full Text)

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K101458 pe

LiNA eXcise 510(k) Submission to FDA

# 5. 510(k) Summarv

[As required by 21 CFR 807.92]

Submitted by

LiNA Medical ApS Formervangen 5 2600 Glostrup Denmark .. Phone: [phone] Fax: [phone]

Louisa Memborg, Regulatory Affairs Officer

5/27/2010

LiNA Xcise Laparoscopic Morcellator

Soft Tissue Morcellator and Accessories

Laparoscope, Gynecologic (and accessories)

Predicate device(s) name, number, date cleared

(1)Gynecare laparoscopic Morcellator [GYNECARE X-TRACT Tissue Morcellator] K993801, cleared on 02/07/2000 (2) S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) K960640, cleared on 02/14/1997

#### Intended Use

The LiNA Xcise Laparoscopic Morcellator is intended for gynaecologic endoscopic use by trained professionals in hospital and surgical clinic environments.

#### Description of Device

The LiNA Xcise Laparoscopic Morcellator is a single use, fully disposable, device that is supplied sterile. It has a self contained motor-unit and battery power-supply in a pistol grip housing with a trigger to control blade rotation and an integrated adjustable trocar housing containing a rotating cylindrical tube 15mm in diameter sharpened on the distal end to a cutting blade. The trocar housing is manually retractable to expose the cutting blade. The device includes duckbill housing with valve to restrict gas leakage. The morcellator is to be used with standard tissue graspers that are extended through the cylindrical tube to grasp the tissue to be morcellated by pulling it through the rotating

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21458 2331

May 27, 2010

MAR 1 1 2011

**Contact person**

Date Prepared

Device trade name

Common name

Classification name

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blade in a coring action. The device is single packed in blister package with tyvek lid. The package includes an obturator.

### Indications For Use

Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.

## Technological Characteristics

The essential technological characteristics of the device are substantially the same as the predicate devices.

## Performance Data

Testing has been carried out with respect to:

Test of cutting tube

Test of trocar and trocar function

Test of gearing/toothed wheels lifetime

Test of motor, torque, motor-lifetime and morcellation functionality

Test of ergonomics and trigger function

Test of battery lifetime and electronics

Test of battery post gamma sterilization

Test of environment: Heat, vibration and noise

Test of pull strength cutting tube

Test of torque

Test of speed (RPM)

Test of EMC per EN 60601-1-2: 2007 FCC 47 CFR part 18

Test cut rate g/minute

## Clinical Data

No clinical data was deemed necessary to support this premarket notification. However, published literature is provided to demonstrate the safe and effective use of morcellation devices used for tissue removal during hysterectomy.

## Substantial Equivalence Conclusions

The LiNA Xcise Laparoscopic Morcellator device does not raise any new issues of safety, effectiveness, or performance of the product. Based on the 510(k) summaries and information presented herein we have concluded that the LiNA Xcise Laparoscopic Morcellator is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug, and Cosmetic Act.

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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 stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

LiNA Medical ApS c/o Mr. Walter L. Brittle, Jr. Managing Partner FDA Compliance Help Desk, Inc. 1289 N. Fordham Blvd.. Suite A-128 CHAPEL HILL NC 27517

# MAR 1 1 2011

Re: K101458

Trade Name: LiNA Xcise™ Laparoscopic Morcellator Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: February 25, 2011 Received: March 1, 2011

Dear Mr. Brittle:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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

Sincerely yours,

Hubert Lemire MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

#### Enclosure

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# 4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K101458

Device Name: LiNA Xcise™ Laparoscopic Morcellator

Indications for Use:

Indicated for cutting, coring and extracting tissue in operative laparoscopy, including gynaecologic procedures such as hysterectomy and myomectomy.

Prescription Use X
(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)

Page 1 of **__**

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101458