(205 days)
The LiNA Gold Loop HC is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectomy. It is used with standard electrosurgical generators.
The LiNA Gold Loop HC is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; EL-160-H (160mm x 80mm), EL-200-H (200mm x 100mm) and EL-240-H (240mm x 120mm), with an uninsulated cutting area of 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a monopolar outlet.
The provided document is a 510(k) premarket notification for a medical device (LiNA Gold Loop HC). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data for the modified device itself. Therefore, a significant portion of the requested information (points 1-9) about a device performance study is not available in the provided text.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The document states that "Testing shows that the modified device complies with the same testing requirements as the predicate device" and "The LiNA Gold Loop HC passed all the testing in accordance with national and international standards." However, it does not list specific quantitative acceptance criteria or the reported device performance values against those criteria. The focus is on compliance with standards rather than presenting a performance study with detailed metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided: The document does not mention sample sizes for any specific performance tests. It also does not specify the origin or nature (retrospective/prospective) of any data beyond stating that testing was performed.
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 / Not Provided: No clinical study involving expert ground truth establishment is described for the modified device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical study or expert review adjudication is mentioned.
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 device is a surgical instrument (electrosurgical loop), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical surgical instrument. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: As no clinical study or expert review for performance was detailed, there's no mention of ground truth types. The document refers to compliance with standards (e.g., ISO10993-1:2009 for biocompatibility, IEC60601-1:2006 for electrical safety, ISO11135-1:2007 for sterilization). The "ground truth" for these would be the specific pass/fail criteria defined within those standards.
8. The sample size for the training set
- Not Applicable: This is not an AI/Machine Learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not applicable.
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LiNA Medical Premarket Notification Special 510(k): LiNA Gold Loop HC
K132135 Page 1 of 2
510(k) Summary
5
- Submission Sponsor LINA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: +45 43 29 66 66 Fax: -45 43 29 66 99 Contact: Louisa Memborg, Regulatory Affairs Officer
2. Submission Correspondent
Christine E. Nichols RAC Boston Biomedical Associates 386 West Main Street. Suite 7 Northborough, MA 01532
-
- Date Prepared July 10, 2013
4. Device Identification
Trade/Proprietary Name:
Common/Usual Name:
Classification Name:
Classification Regulation:
Product Code: Device Class: Classification Panel: LiNA Gold Loop HC
Hand Controlled Loop
coagulator-cutter, endoscopic. unipolar (and accessories) 21 CFR 884.4160
KNF Class II Obstetrics and Gynecology Panel
Predicate Devices to which S.E is claimed: క.
LiNA Loop K070315
6. Device Description
The LiNA Gold Loop HC is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; EL-160-H (160mm x 80mm), EL-200-H (200mm x 100mm) and EL-240-H (240mm x 120mm), with an uninsulated cutting area of 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a monopolar outlet.
Page 18 of 42
JAN 3 1 2014
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7. Intended Use
The intended use has not been changed and is identical to the intended use of the LiNA Loop. The LiNA Gold Loop HC is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynaecological procedures involving endoscopic hysterectorny. It is used with standard electrosurgical generators.
8. Comparison of Technological Characteristics
This special 510(k) is a modification to the LiNA Loop previously cleared by the FDA with the 510(k) number (K070315). The modifications include: the addition of the hand activation switch on the handle of the device; and a material change to the shrink tubing and gold plating on the cutting wire. No changes were made to the intended use, indications for use. energy type, performance specifications, sterilization method or fundamental scientific technology.
9. Non-Clinical Performance Data
Testing shows that the modified device complies with the same testing requirements as the predicate device which includes compliance to 1SO10993-1:2009. IEC60601-1:2006 and ISO11135-1:2007.
The LiNA Gold Loop HC passed all the testing in accordance with national and international standards.
The LiNA Gold Loop HC testing supports the claim of substantial equivalence.
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 LiNA Loop. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
The differences between the LiNA Gold Loop HC and the LiNA Loop do not raise any new questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the LiNA Gold Loop HC is substantially equivalent to the relevant aspects of the predicate device LiNA Loop in terms of design. components, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. LiNA Gold Loop HC. as designed is determined to be substantially equivalent to the referenced predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble a caduceus or a stylized representation of human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
LiNA Medical ApS % Christine Nichols RAC Regulatory Affairs Manager Boston Biomedical Associates 386 West Main Street, Suite 7 Northborough, MA 01532
Re: K132135
Trade/Device Name: LiNA Gold Loop HC Regulation Number: 21 CFR& 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: KNF Dated: January 13, 2014 Received: January 14, 2014
Dear Christine 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.
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Page 2 - Christine Nichols RAC
Sales and Comments of
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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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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LiNA Medical Premarket Notification Special 510(k): LiNA Gold Loop HC
4 Indications for Use Statement
510(k) Number (if known): K132135
Device Name: LiNA Gold Loop HC
Indications for Use:
The LiNA Gold Loop HC is a 5mm monopolar electrosurgical device intended for cutting and removal of soft tissue in gynecological procedures involving endoscopic hysterectomy. It is used with standard electrosurgical generators.
Prescription Use_ X
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(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 2014.01
Page 17 of 42
Confidential and Proprietary to LiNA Medical
§ 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).