(271 days)
Not Found
No
The summary describes a purely mechanical and electrical electrosurgical device with no mention of AI or ML capabilities, data processing, or performance metrics typically associated with AI/ML.
Yes
The device is used for cutting and removal of soft tissue in gynecological procedures, which is a therapeutic function.
No
The device is an electrosurgical tool for cutting and removing tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a 5mm laparoscopic instrument with physical dimensions and a monopolar cutting area, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- LiNA Loop Function: The LiNA Loop is a surgical instrument used inside the body (in vivo) during gynecological procedures. It directly cuts and removes soft tissue using electrosurgery.
The description clearly states its intended use is for surgical procedures, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
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.
Product codes
KNF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Test data include electrical testing which deems the LiNA Loop to be safe under those conditions. No clinical tests have been performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
OCT 30 2003
5. 510(k) Summary
[As required by 21 CFR 807.92]
| Submitted by | LiNA Medical ApS
Formervangen 5
2600 Glostrup
Denmark
Phone: +45 4329 6666
Fax: +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 KNF
Class II |
Intended Use
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.
Description of Device
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.
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.
1
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.
2
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
3
4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K070315
Device Name: LiNA Loop
Indications for Use:
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.
x Prescription Use (Part 21 CFR 801 Subpart D)
t
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
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