(90 days)
The NTERO HOTROD™ System is intended to coagulate tissue during surgical procedures.
Not Found
The provided text describes a 510(k) submission for the NTERO HOTROD™ System, an electrosurgical device. It outlines the intended use, classification, equivalent devices, and summary of the substantial equivalence determination by the FDA. However, the document does not contain the specific information required to answer your questions about acceptance criteria and a study proving those criteria are met for an AI/device performance study.
Here's why and what information is missing:
- No Acceptance Criteria or Stated Performance: The document states "Results of animal testing demonstrate that the NTERO HOTROD™ System is safe and effective for its intended function," but it does not specify any quantitative acceptance criteria (e.g., specific coagulation depth, time to achieve hemostasis, or a quantifiable measure of "effectiveness" or "safety") or report numerical device performance against such criteria.
- No AI Component: The NTERO HOTROD™ System is an electrosurgical device for tissue coagulation, not an AI-powered diagnostic or therapeutic device. Therefore, questions related to AI performance, such as sample sizes for test/training sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this device description.
- Study Details are Limited: The study mentioned is "animal testing" for safety and effectiveness and "biocompatibility" testing for materials. No detailed methodology, sample sizes, or specific results are provided beyond the general statement of safety and effectiveness.
Based on the provided text, I cannot complete the table or answer the specific questions related to acceptance criteria and an AI-related study. The document is a regulatory filing for a traditional medical device, not an AI-driven one, and lacks the detailed performance metrics you've requested.
However, I can extract and state what is available based on your prompt's structure:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended function (coagulation of tissue during surgical procedures) | Demonstrated through animal testing. |
| Biocompatibility of materials in direct tissue and blood contact | Materials have been shown to be biocompatible. |
Detailed Study Information (Based on available text):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "animal testing."
- Data Provenance: Animal testing. No country of origin is specified. The study type is effectively "prospective experimental" as it involved conducting tests on animals.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was animal testing for a non-AI device. Ground truth establishment by experts in the context of diagnostic image interpretation, for example, is not relevant here. The "ground truth" would be direct physiological outcomes in the animals.
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Adjudication method for the test set: Not applicable. This was animal testing for a non-AI device.
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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. The NTERO HOTROD™ System is an electrosurgical device, not a diagnostic AI system with human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The NTERO HOTROD™ System is an electrosurgical device, not an algorithm.
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The type of ground truth used: Direct physiological and histological observation in animal models and material property testing for biocompatibility.
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The sample size for the training set: Not applicable. No "training set" in the context of machine learning, as this is not an AI device.
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How the ground truth for the training set was established: Not applicable.
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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: December 21, 2001
MAR 2 7 2002
KO1425 510(k) number: _______________________________________________________________________________________________________________________________________________________________
Applicant Information:
NTERO Surgical, Inc. 1137D San Antonio Rd Palo Alto, CA 94303
D. Bommi Bommannan, PhD, JD Contact Person: (650) 428-1000 ext. 101 Phone Number: (650) 428-0700 Fax Number:
Device Information:
Classification: Class II Trade Name: NTERO HOTROD™ System Classification Name: Electrosurgical Device and accessories (21 CFR 878.4400)
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the NTERO RF Sleeve (K992572), Valleylab BiSure Laparoscopic Bipolar Forceps (K983743), and VNUS Closure System (K974521).
Intended Use:
The NTERO HOTROD™ System is intended to coagulate tissue during surgical procedures.
Test Results:
Performance
Results of animal testing demonstrate that the NTERO HOTROD™ System is safe and effective for its intended function.
Biocompatibility
The materials in direct tissue and blood contact used in the NTERO HOTROD™ System have been shown to be biocompatible.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
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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 features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
NTERO Surgical, Inc. D. Bommi Bommannan, Ph.D., JD President and CEO 1137D San Antonio Road Palo Alto, California 94303
Re: K014251
Trade Name: NTERO Hotrod System™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI Dated: December 21, 2001 Received: December 26, 2001
Dear Dr. Bommannan:
We have reviewed your Section 510(k) premarket 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) 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.
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 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 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.
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Page 2 - Dr. D. Bommi Bommannan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally promation noticated. 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (30) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
KO14 251
Device Name:
NTERO HOTROD System
Indications for Use:
The NTERO HOTROD System is intended to coagulate tissue during surgical procedures.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0114257
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.