(135 days)
HET™ Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.
The HET™ Electrocautery System is comprised of the HET™ Bipolar Electrocautery Forceps and the HET™ Monitor.
The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cabel to the bipolar output of an electrosurqical generator. The HET™ Bipolar Forceps has an integrated illumination and a temperature probe. The HET™ Bipolar Forceps can be connected and used with any commercial bi-polar RF generator which is rated less than 50W.
The HET™ Monitor is an optional accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the time (in seconds) of RF energy delivery and the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
The provided text describes a 510(k) premarket notification for the HET™ Bipolar Electrocautery Forceps and Monitor. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing efficacy through extensive clinical trials with detailed acceptance criteria and performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, and MRMC studies are not typically present in a 510(k) summary for a device like bipolar electrocautery forceps. The focus is on safety and performance comparable to existing devices.
Here's an analysis based on the provided text, Highlighting what is and is not available:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the summary. For a 510(k) submission, "acceptance criteria" are usually demonstrated through equivalence with predicate devices in terms of intended use, technological characteristics, safety (biocompatibility, electrical safety), and in-vivo performance. The summary states:
- "The 510(k) Notice contains summaries of a study that was conducted to evaluate the in vivo performance of the device as compared to predicate devices."
- "In addition, biocompatibility studies and electrical safety studies were conducted to demonstrate that the device was equivalent to predicate bipolar electrocautery forceps."
- "The material from which the HET Systems device is fabricated has an established history of use in medical applications; and devices produced by HET Systems have been tested in accordance with applicable guidelines and standards."
The specific performance metrics and their acceptance thresholds (e.g., coagulation time, tissue impedance ranges, ergonomic feel comparable to predicate) are not detailed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The text only mentions "a study that was conducted to evaluate the in vivo performance."
- Data Provenance: The study was "in vivo," implying animal or human subject testing, but the country of origin or whether it was retrospective/prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Given the nature of a bipolar electrocautery device, "ground truth" would likely be assessed by surgical observation of effective coagulation, minimal thermal spread, and ease of use, rather than a diagnostic 'ground truth' established by multiple expert readers.
4. Adjudication method for the test set
This information is not provided.
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. An MRMC study is completely irrelevant to this device. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument. It does not operate as a standalone algorithm. The "monitor" is an accessory for displaying time and temperature, not an AI or autonomous system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "in vivo performance" study, the "ground truth" would likely be based on:
- Direct observation of surgical outcomes: Effectiveness of grasping, manipulating, and coagulating soft tissue.
- Possibly histological analysis of coagulated tissue to assess thermal damage and coagulation depth, though this is not explicitly stated.
- Comparison to predicate device performance in similar in-vivo settings.
The text does not specify one particular type of ground truth beyond "in vivo performance."
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/ML device that requires a "training set" in the computational sense. The "studies" conducted are for performance and safety validation, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
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K110143 JUN - 2 2011
510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
- Name: HET Systems, LLC Howard Schrayer Contact: Regulatory Affairs Consultant
- 1502 E 14th Street Suite 2 Address: Brooklyn, NY 11230
- (718) 645-6304 Telephone: E-mail: hs.ss@verizon.net
- Date Prepared April 15, 2011
General Device Information
- Product Name: HET™ Bipolar Electrocautery Forceps
- "Electrosurgical cutting and coagulation device and accessories" Classification: Product code: GEI - Class II 21 CFR 878.4400
Predicate Devices
Valleylab, Inc. (now Covidien) Valleylab Bipolar Forceps 510(k) K926414
Link Technology, Inc. (subsequently Silverglide Surgical Technologies currently Stryker) Bipolar Forceps 510(k) K992931 510(k) K093108 (Stryker)
Bissinger GmbH Claris Non-Stick Bipolar Forceps 510(k) K051429
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Predicate Devices (cont'd)
Curon Medical, Inc. (currently Mederi Therapeutics, Inc.) RF electrosurqical generator and accessories [510(k) K014216]
Description
The HET™ Electrocautery System is comprised of the HET™ Bipolar Electrocautery Forceps and the HET™ Monitor.
The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cabel to the bipolar output of an electrosurqical generator. The HET™ Bipolar Forceps has an integrated illumination and a temperature probe. The HET™ Bipolar Forceps can be connected and used with any commercial bi-polar RF generator which is rated less than 50W.
The HET™ Monitor is an optional accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the time (in seconds) of RF energy delivery and the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
Intended Use (Indications)
HET™ Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.
Substantial Equivalence
This submission supports the position that the HET™ Bipolar Electrocautery Forceps is substantially equivalent to a number of previously cleared devices, including the Stryker, Inc., Silveralide® electrocautery forceps.
The 510(k) Notice contains summaries of a study that was conducted to evaluate the in vivo performance of the device as compared to predicate devices. In addition, biocompatibility studies and electrical safety studies were conducted to demonstrate that the device was equivalent to predicate bipolar electrocautery forceps.
The forceps are provided sterile for single-patient-use.
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Conclusions
HET Systems, LLC believes that the information provided establishes that similar legally marketed electrocautery forceps have been used for the same clinical application as the indications for the HET™ Electrocautery forceps. The material from which the HET Systems device is fabricated has an established history of use in medical applications; and devices produced by HET Systems have been tested in accordance with applicable guidelines and standards.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
HET Systems, LLC c/o Howard Schrayer 1502 E 14th St., Suite 2 Brooklyn, NY 11230
JUN - 2 2011
Re: K110143
Trade/Device Name: HET Bipolar Electrocautery Forceps and Monitor Regulation Number: 21 CFR 878,4400 Regulation Name: electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 15, 2011 Received: April 18, 2011
Dear Mr. Schrayer:
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. 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
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Page 2 - Mr. Howard Schraver
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/CDRHQffices/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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K110143
Device Name: HET™ Bipolar Electrocautery Forceps
Indications For Use:
HET™ Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
(Divi (Division Sign-cical, Orthopedic, and Restorative Devices
510(k) Number K110143
§ 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.