LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE

K130305 · Lina Medical Aps · HIN · Jul 24, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K130305
• Device Name: LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
• Applicant: Lina Medical Aps
• Product Code: HIN · Obstetrics/Gynecology
• Decision Date: Jul 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.

Device Story

LiNA Bipolar Loop is 5mm single-use laparoscopic electrosurgical instrument; utilizes bipolar energy for tissue cutting/coagulation. Device consists of gold-plated stainless steel wire loop with zirconia ceramic tip; compatible with standard bipolar electrosurgical generators. Operated by surgeons in clinical/OR settings during gynecological procedures. Surgeon controls energy delivery via generator; loop amputates mobilized uterus or resects pedunculated myomas. Provides precise tissue cutting; benefits include reduced surgical time and effective hemostasis during laparoscopic hysterectomy/myomectomy. Device is sterile, single-use, and disposable.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including efficacy and functionality studies in simulated tissue (pork/beef muscle). Cutting quality and time were evaluated against predicate devices, demonstrating equivalent performance within acceptable limits.

Technological Characteristics

5mm bipolar electrosurgical loop. Materials: gold-plated stainless steel wire, zirconia ceramic tip, FEP/Kynar insulation, vinyl ether resin/fiberglass cannula, ABS handle. Energy: bipolar electrosurgical (requires external generator). Connectivity: standard bipolar outlet. Sterilization: Ethylene Oxide (SAL 10^-6). Compliance: ISO 10993-1, IEC 60601.

Indications for Use

Indicated for patients undergoing laparoscopic supracervical (subtotal) hysterectomy for uterine amputation or resection of devasculated subserosal pedunculated myomas.

Regulatory Classification

Identification

A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),” (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,” (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.

Predicate Devices

• LiNA Loop (K070315)
• PKS BiLL (K111059)

Submission Summary (Full Text)

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LiNA Medical ApS Traditional 510(k) Premarket Submission LiNA Bipolar Loop

# EMERGO GROUP

## Section 5 - 510(k) Summary

#### 1. Submission Sponsor

# JUL 2 4 2013

- LiNA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: [phone] Fax: [phone] Contact: Louisa Memborg, Regulatory Affairs Officer
#### 2. Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] . Contact: Richard Gillis, Ph.D., Senior Consultant Email: [e-mail]

### 3. Date Prepared

27 JAN 2013

#### Device Identification 4.

| Trade/Proprietary Name: | LiNA Bipolar Loop |
|----------------------------|------------------------------------------------------|
| Common/Usual Name: | Bipolar electrosurgical Loop |
| Classification Name: | Bipolar Endoscopic coagulator-cutter and accessories |
| Classification Regulation: | 21 CFR 884.4150 |
| Product Code: | HIN |
| Device Class: | Class II |
| Classification Panel: | Obstetrics and Gynecology Panel |

#### 5. Predicate Devices

- 1. LiNA Loop (K070315)
- 2. PKS BiLL (K111059)

#### 6. Device Description

The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length

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totals 30mm. 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 Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.

### 8. Comparison of Technological Characteristics

The following table compares the LiNA Bipolar Loop to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | LiNA Medical ApS<br>Formervangen 5<br>2600 Glostrup<br>Denmark | LiNA Medical ApS<br>Formervangen 5<br>2600 Glostrup<br>Denmark | Gyrus ACMI, Inc<br>136 Turnpike Rd.<br>Southborough, MA<br>01772-2104 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | LINA Bipolar Loop | LINA Loop | PKS BILL |
| 510(k) Number | TBD | K070315 | K111059 |
| Product Code | HIN | KNF | HIN |
| Regulation<br>Number | 21 CFR 884.4150 | 21 CFR 884.4160 | 21 CFR 884.4150 |
| Regulation Name | Bipolar endoscopic<br>coagulator-cutter and<br>accessories | Coagulator-cutter,<br>endoscopic, unipolar<br>(and accessories) | Bipolar endoscopic<br>coagulator-cutter and<br>accessories |
| Indications for<br>Use | The LiNA Bipolar Loop is<br>a 5mm bipolar<br>electrosurgical device<br>intended for amputating<br>the mobilized uterus<br>during laparoscopic<br>supracervical (subtotal)<br>hysterectomy and<br>resection of<br>devasculated subserosal<br>pedunculated myomas.<br>To be used with an<br>electrosurgical generator<br>that provides a bipolar<br>outlet. | The LiNA Loop is a<br>5mm monopolar<br>electrosurgical device<br>intended for<br>sectoring the<br>mobilized uterus<br>during Laparoscopic<br>supracervical<br>hysterectomy. To be<br>used with an<br>electrosurgical<br>generator | The PKS BILL is a 5mm<br>bipolar electrosurgical<br>device intended for<br>sectoring the mobilized<br>uterus during<br>Laparoscopic<br>supracervical<br>hysterectomy and the<br>resection of<br>devasculated subserosal<br>pedunculated myomas.<br>Working in conjunction<br>with Gyrus ACMI<br>generator |
| Material | 1. Gold plated stainless<br>steel wire with<br>molded zirconia<br>ceramic tin and | 1. Stainless steel wire | According to PKS BILL<br>510(k), K111059<br>summary "Uses<br>materials that are well |

#### Table 5A - Comparison of Characteristics

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# EMERGO GROUP

| Manufacturer | LiNA Medical ApS | LiNA Medical ApS | Gyrus ACMI, Inc |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | Formervangen 5<br>2600 Glostrup<br>Denmark | Formervangen 5<br>2600 Glostrup<br>Denmark | 136 Turnpike Rd.<br>Southborough, MA<br>01772-2104 |
| Trade Name | LiNA Bipolar Loop | LiNA Loop | PKS BILL<br>established". |
| | polyamide cap.<br>2. Shrink tube: FEP<br>(Teflon)<br>3. Funnel: Black<br>polyamide<br>4. Cannula/Fibre tube:<br>Vinyl ether resin with<br>fiberglass<br>reinforcement<br>5. Inner cannula Tube:<br>Kynar®<br>6. Handle: ABS<br>7. Cable: Thermoplastic<br>polyurethane with<br>brass connector. | 2. Shrink tube:<br>Kynar®(PVDF)<br>3. Funnel: Black<br>polyamide<br>4. Fibre tube: Vinyl<br>ether resin with<br>fiberglass<br>reinforcement<br>5. Inner cannula<br>Tube: Kynar®<br>6. Handle: ABS<br>7. Cable: PVC with<br>brass connector. | |
| Sterile | Sterile packed.<br>Ethylene Oxide Gas<br>SAL 10-6 | Sterile packed.<br>Ethylene Oxide Gas<br>SAL 10-6 | Sterile packed.<br>Gamma Irradiation.<br>SAL 10-6 |
| Single-Use | Intended for single use<br>only. | Intended for single<br>use only. | Intended for single use<br>only. |
| Shelf Life | 3 years | 3 years | Unknown |
| Battery Operated | N/A | N/A | N/A |
| AC Powered | N/A | N/A | N/A |
| Complies with ISO<br>10993-1 | Yes | Yes | Yes |
| Electrical Safety<br>Testing Passed | IEC 60601 | IEC 60601 | IEC 60601 |

#### Non-Clinical Performance Data 9.

The following testing has been performed to support substantial equivalence:

- Efficacy and Functionality Test The LiNA Loop and the LiNA Bipolar Loop had similar . cutting quality in simulated tissue study using pork and beef muscle. Cutting quality was assessed on a scale of 1-9, with 5 being the acceptance criteria. 200mm sized loops were selected as this represented the mid-size loop for both the Bipolar Loop and Loop. The loops were assessed for cutting quality at high and low power settings. Both devices were qualitatively scored as a 5. Furthermore, cutting time was assessed, with an average deviation time between cuts of 0.85 seconds. Cutting time was assessed at the respective high and low power settings using three different generators and found to be within acceptable limits (±4 seconds). Therefore, the cutting time and quality were equivalent between the LiNA Loop and the LiNA Bipolar Loop.

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As part of demonstrating the safety and effectiveness of the LINA Bipolar Loop and in showing substantial equivalence the predicate devices that are subject to this 510(k) submission, LiNA Medical ApS completed a number of tests. The LiNA Bipolar Loop meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The LiNA Bipolar Loop passed all testing stated above as shown by the acceptable results obtained.

The LiNA Bipolar Loop complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

#### 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

lt has been shown in this 510(k) submission that the difference between the LiNA Bipolar Loop and the predicate devices do not raise any questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the LiNA Bipolar Loop is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. The LiNA Bipolar Loop, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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Public Health Service

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

July 24, 2013

LiNA Medical ApS % Richard Gillis, Ph.D. Senior Regulatory Consultant Emergo Group, Inc. 611 West 5th Street, Third Floor Austin, TX 78701

Re: K130305

Trade/Device Name: LiNA Bipolar Loop Regulation Number: 21 CFR 884.4150 Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: Class II Product Code: HIN Dated: June 07, 2013 Received: June 10, 2013

Dear Richard Gillis, Ph.D.,

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 cither 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

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## Page 2 - Richard Gillis, Ph.D.

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its to!!-free 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,

# Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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## Section 4 - Indications for Use Statement

510(k) Number (if known): Not Assigned K130305

Device Name: LiNA Bipolar Loop

Indications for Use:

The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgicol generator that provides a bipolar outlet.

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)

# Herbert P. Lerner -S

K130305