(317 days)
Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.
The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study plan with the granularity required to fill out all the fields in your request for the "BiCOAG Coagulating Forceps" or the "Tubal Sterilization device".
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance testing has been submitted to support the safety and functional performance of the submitted devices." and "Clinical studies evaluating histological results have been conducted using the same Wolf Bipolar generator to demonstrate equivalent effectiveness to the currently available Tubal sterilization Wolf Kleppinger Forceps."
While specific quantitative acceptance criteria are not detailed, the primary performance criterion appears to be equivalent effectiveness to the predicate device, the "Tubal sterilization Wolf Kleppinger Forceps," as demonstrated by histological results.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalent effectiveness in tubal sterilization (based on histological results) to predicate device | Equivalent effectiveness demonstrated through clinical studies and histological results when used with the Wolf Bipolar generator. |
| Safety and functional performance | Supported by submitted performance testing. |
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 explicitly stated. The document only mentions "Clinical studies evaluating histological results have been conducted."
- Data Provenance: Not explicitly stated. We don't know the country of origin or if the studies were retrospective or prospective.
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)
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: This is a Class III medical device (tubal sterilization forceps), not an AI-powered diagnostic device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context. The study focuses on the device's physical performance in a surgical procedure, not its interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: This is a surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device's performance is inherently tied to its use by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The document explicitly states "Clinical studies evaluating histological results have been conducted." This indicates that histology/pathology was the primary method for determining the effectiveness (e.g., successful tubal occlusion).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would involve engineering design, prototyping, and testing, not data-driven machine learning.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable (as explained in point 8).
In Summary:
The provided 510(k) summary focuses on establishing substantial equivalence for a surgical instrument (tubal sterilization forceps). The key evidence presented revolves around performance testing for safety and functional performance, and clinical studies using histological results to demonstrate equivalent effectiveness to a predicate device. The information is very high-level and lacks the granular details typically found in summaries for diagnostic devices or AI algorithms regarding study designs, sample sizes, and expert evaluations.
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MARAR | 29,998
K971565
PI91
4/30/97
510(k) Summary of Safetv & Effectiveness
This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps. Performance testing has been submitted to support the safety and functional performance of the submitted devices. Clinical studies evaluating histological results have been conducted using the same Wolf Bipolar generator to demonstrate equivalent effectiveness to the currently available Tubal sterilization Wolf Kleppinger Forceps.
CONTACT PERSON: David J. Parins
Vice President, Engineering, Requlatory Affairs, and Quality Assurance Everest Medical Corp. 13755 First Ave. N. Minneapolis, MN 55340
Tel. No. (612) 473-6262 FAX. No. (612) 473-6465
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Image /page/1/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1998
Mr. David J. Parins Everest Medical® 13755 First Avenue North Minneapolis, Minnesota 55441-5454 Re: K971565 BiCOAG Coagulating Forceps Dated: January 8, 1998 Received: January 12, 1998 Regulatory Class: III 21 CFR 884.4150/Procode: 85 HIN
Dear Mr. Parins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K971565
BiCOAG Coagulating Forceps Device Name:
Indications For Use:
Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. baparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971565
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.