LINA POWERBLADE PLUS

K132837 · Lina Medical Aps · GEI · Dec 19, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132837
• Device Name: LINA POWERBLADE PLUS
• Applicant: Lina Medical Aps
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.

Device Story

LiNA PowerBlade Plus is a 5 mm single-use bipolar forceps instrument; 330mm length; 10mm jaw opening. Device utilizes electrical current from standard electrosurgical generators for tissue coagulation; integrated sharp blade performs tissue transection. Features rotation wheel on handle for jaw positioning. Used in open and laparoscopic surgery by surgeons. Provides mechanical grasping and electrosurgical coagulation/cutting; improves surgical ergonomics and positioning. Benefits include efficient tissue management during procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance testing, including comparative functionality testing (grasping, cutting, coagulation) and compliance with electrical safety (IEC 60601-1, IEC 60601-2-18, IEC 60601-2-2), biocompatibility (ISO 10993-1), and sterilization (ISO 11135-1, ISO 10993-7) standards.

Technological Characteristics

Bipolar electrosurgical forceps; 5mm diameter; 330mm length; 10mm jaw opening. Energy source: external electrosurgical generator (bipolar). Materials: biocompatible per ISO 10993-1. Sterilization: ethylene oxide. Connectivity: standard bipolar electrosurgical generator interface. Mechanical features: rotation wheel for jaw positioning.

Indications for Use

Indicated for use in open and laparoscopic surgery requiring grasping, coagulation, and transection of tissue.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• LiNA PowerBlade (K063025)

Submission Summary (Full Text)

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#### 510(k) Summary 6.

- 1. Submission Sponsor
LiNA Medical ApS

Formervangen 5

2600 Glostrup

Denmark

Phone: [phone]

Fax: [phone]

Contact: Louisa Memborg, Regulatory Affairs Officer

# 2. Submission Correspondent

Christine Nichols RAC Boston Biomedical Associates 386West Main Street Suite 7 Northborough. MA 01532 Phone: [phone] Ext 252 [e-mail]

# 3. Date Prepared

September 9, 2013

### 4. Device Identification

Trade/Proprietary Name: LiNA PowerBlade Plus

Bipolar forceps Common/Usual Name:

Electrosurgical, Cutting and Coagulation device and accessories. Classification Name:

| Class. Regulation: | 21 CFR 878.4400 |
|-----------------------|---------------------------|
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |

REV A

DEC 1 9 2013

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Traditional 510(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus

# 5. Predicate Device

LiNA PowerBlade (K063025)

#### Device Description 6.

The LiNA PowerBlade Plus is a 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The LiNA PowerBlade Plus is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a sharp blade. LiNA PowerBlade Plus includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.

### 7. Intended Use

The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping. coagulating and transecting is indicated.

# 8. Comparison of Technological Characteristics

The LiNA PowerBlade Plus is substantially equivalent to the predicate device with respect to technological characteristics. The devices have similar materials and principal of use, dimensions, as well as the same energy type, performance specifications and fundamental scientific technology.

### 9. Non-Clinical Performance Data

Testing was performed to demonstrate that the LiNA PowerBlade Plus complies with the same testing requirements as the predicate device which includes compliance to IEC60601-1:2006, IEC60601-2-18, and IEC60601-2-2, as well as Biocompatibility and sterilization requirements as shown by compliance to ISO10993-1, ISO1135-1, and ISO10993-7.

In addition, comparative functionality testing was performed which demonstrated that the grasping, cutting and coagulation performance of the proposed device was comparable to the predicate device.

The LiNA PowerBlade Plus testing demonstrates that the proposed and predicate devices are substantially equivalent.

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Traditional 510(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus

# 10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

## 11. Statement of Substantial Equivalence

Performance testing and compliance with voluntary standards, demonstrate that the LiNA PowerBlade Plus is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. The LiNA PowerBlade Plus, as designed and manufactured, is be substantially equivalent to the referenced predicate device.

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Image /page/3/Picture/0 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms, possibly representing care or support.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

LiNA Medical ApS % Ms. Christine E. Nichols Boston Biomedical Associates 386 West Main Street, Suite 7 Northborough, Massachusetts 01532 December 19, 2013

Re: K132837

Trade/Device Name: LiNA PowerBlade Plus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 20, 2013 Received: November 21, 2013

Dear Ms. Nichols:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christine E. Nichols

forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Radiological Health

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and

Enclosure

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Traditional S10(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus

# 5. Indications for Use Statement

510(k) Number (if known): K132837

Device Name: LiNA PowerBlade Plus

#### Indications for Use:

The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-off) Division of Surgical Devices 510 (k) Number: K132837