(224 days)
Not Found
No
The description focuses on standard electrosurgical technology with temperature monitoring and illumination. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes.
The device is intended for the "treatment of symptomatic Grade I and Grade II internal hemorrhoids," which is a therapeutic purpose.
No
The device is primarily intended for therapeutic purposes (coagulating soft tissue, treating hemorrhoids) and surgical manipulation (grasping, manipulating). While it displays temperature, this is presented as a monitoring feature during a therapeutic procedure, not for diagnosing conditions.
No
The device description clearly outlines hardware components: HET™ Bipolar Electrocautery Forceps and the HET™ Monitor. The monitor provides power and displays temperature, indicating it is a physical device, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "grasping, manipulating and coagulating soft tissue during general surgery" and for the "treatment of symptomatic Grade I and Grade II internal hemorrhoids." These are surgical procedures performed directly on the patient's body.
- Device Description: The description details a bipolar forceps and a monitor used in conjunction with electrosurgical generators. This is a surgical instrument system.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of such specimens.
The device is a surgical tool used for treatment, not a diagnostic tool used for analyzing samples.
N/A
Intended Use / Indications for Use
The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
Product codes
GEI
Device Description
The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar 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 cable to the bipolar output of an electrosurgical generator.
When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an 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 temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, internal hemorrhoids
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 510(k) Notice contains a report of a study (in an animal model) that was conducted to evaluate the in vivo performance and histological effects of the device as compared to the predicate device. Biocompatibility studies, software validations, and electrical safety studies were conducted and reported in the 510(k) Notice for the predicate HET Systems device. Because the two devices are essentially the same, the information reported for the predicate HET device is applicable.
The 510(k) Notice also contains reports of two human clinical evaluations that were conducted to evaluate the clinical performance of the device. These studies demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device.
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
§ 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.
0
NOV 2 0 2012 1
510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
- HET Systems, LLC Name: Howard Schrayer Contact: Regulatory Affairs Consultant
- 113 Laredo Drive Address: Morganville, NJ 07751
- (609) 924-9510 Telephone: hs.ss@verizon.net E-mail:
- November 20, 2012 Date Prepared
General Device Information
HET™ Bipolar Electrocautery Forceps and Monitor Product Name:
"Electrosurgical cutting and coagulation device and Classification: accessories" Product code: GEI - Class II 21 CFR 878.4400
Predicate Devices
HET™ Bipolar Electrocautery Forceps and Monitor HET Systems, Inc. 510(k) K110143
Redfield Infrared Coagulator Redfield, Inc. 510(k) K950836
1
Description
The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar 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 cable to the bipolar output of an electrosurgical generator.
When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an 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 temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
Intended Use (Indications)
The HET™ Bipolar Electrocautery Forceps and Monitor is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery System may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
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 previously cleared HET Bipolar Electrocautery Forceps and Monitor (K110143) and the Redfield Infrared Coagulator (K950836).
The technological characteristics of the device are unchanged (exactly the same as) the characteristics of the predicate HET Systems device that was cleared under 510(k) K110143, with the exception that the timing indicator has been removed from the Monitor. Specifically, the materials, software, and treatment mechanism (i.e., bipolar energy used to produce heat) are unchanged.
2
The technological characteristics of the device differ from those of the Redfield Infrared Coagulator (IRC) predicate that was cleared under 510(k) K950836 in regard to the materials used and energy source. The IRC device uses infrared light to produce heat, instead of high frequency bipolar energy. However, both predicate systems and the subject device use thermal energy to achieve the treatment effect (tissue coagulation). The IRC predicate is indicated for the treatment of internal hemorrhoids.
The 510(k) Notice contains a report of a study (in an animal model) that was conducted to evaluate the in vivo performance and histological effects of the device as compared to the predicate device. Biocompatibility studies, software validations, and electrical safety studies were conducted and reported in the 510(k) Notice for the predicate HET Systems device. Because the two devices are essentially the same, the information reported for the predicate HET device is applicable.
The 510(k) Notice also contains reports of two human clinical evaluations that were conducted to evaluate the clinical performance of the device. These studies demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device.
Conclusions
HET Systems, LLC believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the indications for the HET™ Bipolar Electrocautery Forceps and Monitor. 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.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three curved lines that suggest a person in motion. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 20, 2012
HET Systems, LLC % HET Bipolar Ligator System Mr. Howard Schrayer Regulatory Affairs Consultant 113 Laredo Drive Morganville, NJ 07751
Re: K121085
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: November 09, 2012 Received: November 13, 2012
Dear Mr. Schraver:
We have reviewed vour 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. Iisting 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
4
Page 2 - Mr. Howard Schrayer
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K121085
Device Name: HET™ Bipolar Electrocautery Forceps and Monitor
Indications For Use:
The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
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)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 121085