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 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 totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.

AI/ML Overview

This describes the acceptance criteria and study for the LiNA Bipolar Loop, an electrosurgical device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Efficacy and Functionality Test
- Cutting Quality (Simulated Tissue)	Qualitatively scored as 5 on a scale of 1-9	Both the LiNA Loop (predicate) and LiNA Bipolar Loop (new device) were qualitatively scored as a 5 in simulated tissue studies using pork and beef muscle.
- Cutting Time (Simulated Tissue)	Within acceptable limits (±4 seconds) average deviation time between cuts compared to predicate device	Average deviation time between cuts was 0.85 seconds, assessed at respective high and low power settings using three different generators. This was found to be within acceptable limits (±4 seconds) compared to the LiNA Loop.
Overall Design	Meets all requirements	The LiNA Bipolar Loop meets all requirements.
Sterilization	Meets all requirements (SAL 10-6)	The LiNA Bipolar Loop meets all requirements and is sterile packed using Ethylene Oxide Gas (SAL 10-6).
Biocompatibility	Meets all requirements (Complies with ISO 10993-1)	The LiNA Bipolar Loop meets all requirements and complies with ISO 10993-1.
Electrical Safety	Meets all requirements (IEC 60601)	The LiNA Bipolar Loop meets all requirements and passed Electrical Safety Testing (IEC 60601).
Other Applicable Voluntary Standards	Passed all testing in accordance with national and international standards	The LiNA Bipolar Loop passed all testing in accordance with national and international standards. This confirms the output meets design inputs and specifications and that the device passed all testing stated.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document specifies that "200mm sized loops were selected as this represented the mid-size loop for both the Bipolar Loop and Loop." It also mentions "pork and beef muscle" for simulated tissue studies and "three different generators" for cutting time assessment. However, the exact number of loops tested, the quantity of tissue samples, or the number of cuts made is not explicitly stated.
Data Provenance: The data is non-clinical performance data from tests conducted by LiNA Medical ApS. The country of origin of the data is not explicitly stated beyond the sponsor being LiNA Medical ApS in Glostrup, Denmark. The study is prospective in the sense that the tests were conducted specifically to support this 510(k) submission for the LiNA Bipolar Loop.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable. For non-clinical performance data like this, "experts" in the sense of clinical reviewers establishing ground truth for a diagnostic output are not mentioned. The assessment of "cutting quality" was "qualitatively scored as a 5," implying an internal assessment based on predefined criteria, likely by engineering or technical personnel. The document does not specify who performed this scoring or their qualifications.

4. Adjudication Method for the Test Set

Not Applicable. There is no mention of an adjudication method as this involves non-clinical performance testing rather than human interpretation of diagnostic data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This submission is for an electrosurgical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is an electrosurgical instrument and does not involve AI algorithms. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical testing was based on predefined performance specifications and industry standards.
- For cutting quality, the ground truth was a qualitative score of '5' on a scale of 1-9.
- For cutting time, the ground truth was an acceptable deviation of ±4 seconds from the predicate device.
- For other aspects like sterilization, biocompatibility, and electrical safety, the ground truth was compliance with relevant national and international standards (e.g., ISO 10993-1, IEC 60601) and meeting internal design requirements.

8. The Sample Size for the Training Set

Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on validating the physical and functional performance of the device against established criteria and a predicate device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set mentioned, the establishment of ground truth for such a set is not relevant.

Summary

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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: +45 4329 6666 Fax: +45 4329 6699 Contact: Louisa Memborg, Regulatory Affairs Officer

2. Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (406) 579-8124 Office Phone: (512) 327.9997 Fax: (512) 327.9998 . Contact: Richard Gillis, Ph.D., Senior Consultant Email: project.management@emergogroup.com

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)
1. PKS BiLL (K111059)

6. Device Description

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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 ApSFormervangen 52600 GlostrupDenmark	LiNA Medical ApSFormervangen 52600 GlostrupDenmark	Gyrus ACMI, Inc136 Turnpike Rd.Southborough, MA01772-2104
Trade Name	LINA Bipolar Loop	LINA Loop	PKS BILL
510(k) Number	TBD	K070315	K111059
Product Code	HIN	KNF	HIN
RegulationNumber	21 CFR 884.4150	21 CFR 884.4160	21 CFR 884.4150
Regulation Name	Bipolar endoscopiccoagulator-cutter andaccessories	Coagulator-cutter,endoscopic, unipolar(and accessories)	Bipolar endoscopiccoagulator-cutter andaccessories
Indications forUse	The LiNA Bipolar Loop isa 5mm bipolarelectrosurgical deviceintended for amputatingthe mobilized uterusduring laparoscopicsupracervical (subtotal)hysterectomy andresection ofdevasculated subserosalpedunculated myomas.To be used with anelectrosurgical generatorthat provides a bipolaroutlet.	The LiNA Loop is a5mm monopolarelectrosurgical deviceintended forsectoring themobilized uterusduring Laparoscopicsupracervicalhysterectomy. To beused with anelectrosurgicalgenerator	The PKS BILL is a 5mmbipolar electrosurgicaldevice intended forsectoring the mobilizeduterus duringLaparoscopicsupracervicalhysterectomy and theresection ofdevasculated subserosalpedunculated myomas.Working in conjunctionwith Gyrus ACMIgenerator
Material	1. Gold plated stainlesssteel wire withmolded zirconiaceramic tin and	1. Stainless steel wire	According to PKS BILL510(k), K111059summary "Usesmaterials 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 52600 GlostrupDenmark	Formervangen 52600 GlostrupDenmark	136 Turnpike Rd.Southborough, MA01772-2104
Trade Name	LiNA Bipolar Loop	LiNA Loop	PKS BILLestablished".
	polyamide cap.2. Shrink tube: FEP(Teflon)3. Funnel: Blackpolyamide4. Cannula/Fibre tube:Vinyl ether resin withfiberglassreinforcement5. Inner cannula Tube:Kynar®6. Handle: ABS7. Cable: Thermoplasticpolyurethane withbrass connector.	2. Shrink tube:Kynar®(PVDF)3. Funnel: Blackpolyamide4. Fibre tube: Vinylether resin withfiberglassreinforcement5. Inner cannulaTube: Kynar®6. Handle: ABS7. Cable: PVC withbrass connector.
Sterile	Sterile packed.Ethylene Oxide GasSAL 10-6	Sterile packed.Ethylene Oxide GasSAL 10-6	Sterile packed.Gamma Irradiation.SAL 10-6
Single-Use	Intended for single useonly.	Intended for singleuse only.	Intended for single useonly.
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 ISO10993-1	Yes	Yes	Yes
Electrical SafetyTesting 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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Image /page/4/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 design featuring three abstract shapes resembling an eagle or bird in flight.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.

(a)
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.(b)
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.