The LiNA Loop is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectorny. It is used with standard electrosurgical generators.

Device Description

The LiNA Loop is a 5 mm laparoscopic instrument. It is available with two different loop dimensions; 160mm x 80mm and 200mm x 100mm. The outer 15mm on each side of the loop are not insulated i.e. the monopolar cutting area length is totally 30mm. The device is sterile for single use and is compatible with all standard electrosurgical generators that have a monopolar outlet.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "LiNA Loop." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the document explicitly states: "No clinical tests have been performed." This means there is no study described that proves the device meets acceptance criteria in the way a clinical trial would for novel, high-risk devices or software. The acceptance criteria and "device performance" in this context refer to the electrical and safety testing conducted to show the device functions as intended and is safe under those specific conditions, without involving human patients.

Here's a breakdown based on the provided information, addressing your points where applicable but also highlighting what is not available due to the nature of this submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Electrical Safety	Deemed safe under tested conditions

Explanation: The document states "Test data include electrical testing which deems the LiNA Loop to be safe under those conditions." This indicates that the device's electrical properties met the predefined safety standards or criteria for electrosurgical devices. Specific numerical acceptance criteria (e.g., maximum leakage current, impedance ranges) and corresponding measured values are not detailed in this summary, but would have been part of the full submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in a clinical sense, as no clinical tests were performed. For the electrical testing, the "sample size" would refer to the number of devices tested. This information is not provided in the summary.
Data Provenance: Not applicable for clinical data. For the electrical testing, the data would have originated from LiNA Medical ApS (Denmark) as part of their internal validation process. The testing would be prospective in the sense that the new device was manufactured and then tested according to a plan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since no clinical tests were performed, there was no "ground truth" establishment by medical experts in the context of diagnostic or interventional performance on patients. The "ground truth" for the electrical safety testing would be the established engineering and safety standards for electrosurgical devices, evaluated by qualified engineers/technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies when there's a need to resolve discrepancies in expert opinions, especially for subjective assessments. This was not a clinical study.

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

No. This is a medical device (monopolar electrosurgical loop), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.

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

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Electrical Safety Standards/Specifications. The "ground truth" for the non-clinical testing was compliance with established electrical safety standards and the device's own design specifications for safe operation.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device as it is not an AI/machine learning product.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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K070315

OCT 30 2003

5. 510(k) Summary

[As required by 21 CFR 807.92]

Submitted by	LiNA Medical ApSFormervangen 52600 GlostrupDenmarkPhone: +45 4329 6666Fax: +45 4329 6699
Contact person	Jane Kudsk, QA Manager
Date Prepared	January 25, 2007
Device trade name	LiNA Loop
Common name	Monopolar Endoscopic Loop
Classification name	Coagulator-Cutter, Endoscopic, Unipolar (And accessories)21 CFR 884.4160, Product code KNFClass II

Intended Use

Description of Device

Substantial Equivalence

The LiNA Loop is substantial equivalent to the Omnitech Resectoscope Cutting Loop Electrode (K981464) and the Cook Ireland Sonnet Polypectomy Snare (K050294) with respect to technical and design features. The submitted devices pose the same type of questions about safety or effectiveness as the existing devices.

Test Data

Test data include electrical testing which deems the LiNA Loop to be safe under those conditions. No clinical tests have been performed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2007

LiNA Medical ApS % Mr. Walt Brittle Vice President FDA Compliance Help Desk, Inc. 1289 N. Fordham Blvd., Suite A-128 CHAPEL HILL NC 27517

Re: K070315

Trade Name: LiNA Loop Regulation Number: 21 CFR 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: KNF Dated: October 20, 2007 Received: October 22, 2007

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, Orug, and Cosmetic act (Act) that do not require approval of a premarket approval application (MAA), You may, therefore, market the device, subject to the general controls provisions of the (ct. The general controls provisions of the Act include requirements for annual registration, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your it it wire 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological 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): K070315

Device Name: LiNA Loop

Indications for Use:

x Prescription Use (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)


(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number	K070315
	Page 1 of

Jan. 25, 2007 LiNA Loop Submission to FDA

Page 4-1

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).