(107 days)
Not Found
No
The document describes a standard bipolar electrocautery device with a temperature monitor. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is described as being used for the "treatment of symptomatic Grade I and Grade II internal hemorrhoids," indicating a therapeutic purpose.
No
Explanation: The device is intended for grasping, manipulating, and coagulating soft tissue, and treating Grade I and II internal hemorrhoids. While it displays temperature, this is for monitoring the treatment, not for diagnosing a condition.
No
The device description clearly outlines hardware components including bipolar forceps, an integrated bipolar cable, and an accessory monitor with a temperature sensor and LED light source.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "grasping, manipulating and coagulating soft tissue during general surgery" and "treatment of symptomatic Grade I and Grade II internal hemorrhoids." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bipolar electrocautery forceps and monitor used with an electrosurgical generator. It applies energy to tissue for coagulation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens.
The device is used in vivo (within the living body) for surgical treatment, not in vitro (in glass or outside the body) for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
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 Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Systems HET™ Bipolar Electrocautery Forceps and Monitor may be used with any Bipolar Electrosurgical generator in the coagulation mode with an output power set at 10 W and a maximum voltage of 1250v.
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)
Testing was conducted to characterize the device's performance when used in conjunction with eight FDA cleared, commercially available, bipolar electrosurgical generators. The studies evaluated to zone of thermal injury and confirmed that the treatment time was acceptable to allow safe treatment.
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 the same, the information reported for the predicate HET device is applicable.
Biocompatibility Testing: Testing was previously conducted, and reported in the 510(k) Notice for the predicate, to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity and hemocompatibility.
Clinical Testing: The 510(k) Notice for the predicate also contains reports of 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 an additional predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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JUN 0 5 2014
K140422
Page 1 of 3
510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
| Name: | HET Systems, LLC |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 200 Middlesex Turnpike - Suite 304 |
| Iselin, NJ 08830 | |
| Telephone: | (609) 924 - 9510 |
| Fax: | (732) 683 - 9476 |
| Date Prepared | April 29, 2014 |
| General Device Information | |
| Product Name: | HETTM Bipolar Electrocautery Forceps and Monitor |
| Classification: | "Electrosurgical cutting and coagulation device and accessories" |
| Product code: GEI - Class II |
Predicate Device
HET Systems, LLC - HET™ Bipolar Electrocautery Forceps and Monitor - 510(k) Number K121085
Description
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.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Systems HET™ Bipolar Electrocautery Forceps and Monitor may be used with any Bipolar Electrosurgical generator in the coagulation mode with an output power set at 10 W and a maximum voltage of 1250v.
The monitor displays the temperature at the forceps-tissue interface. The HET" Monitor does not generate RF energy.
1
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 Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
Substantial Equivalence
This submission supports the position that the HET™ Bipolar Electrocautery Forceps and Monitor is substantially equivalent to a previously cleared device, specifically, the HET Bipolar Electrocautery Forceps and Monitor (K121085).
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) K121085. The purpose of this submission is to demonstrate that the HET Bipolar Electrocautery Forceps and Monitor may be used with any bipolar electrosurgical generator that can be operated at 10W output power and a maximum voltage of 1250. The materials, software, and treatment mechanism (i.e., bipolar energy used to produce heat) are unchanged. Both the predicate system and the subject device use thermal energy to achieve the treatment effect (tissue coagulation). The predicate device is indicated for the treatment of internal hemorrhoids.
The 510(k) Notice contains reports of a series of studies (in an ex vivo tissue model model) that were conducted to evaluate the performance and thermal 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 the same, the information reported for the predicate HET device is applicable.
Performance Testing
Testing was conducted to characterize the device's performance when used in conjunction with eight FDA cleared, commercially available, bipolar electrosurgical generators. The studies evaluated to zone of thermal injury and confirmed that the treatment time was acceptable to allow safe treatment.
2
Biocompatibility Testing
Testing was previously conducted, and reported in the 510(k) Notice for the predicate, to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity and hemocompatibility.
Clinical Testing
The 510(k) Notice for the predicate also contains reports of 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 an additional predicate device.
Conclusions
HET Systems, LLC believes that the information provided establishes that similar leqally marketed devices have been used for the same clinical applications as the indications for the HET™ Bipolar Electrocautery Forceps and Monitor. The materials from which the HET Systems device is fabricated have 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2014
HET Systems, LLC % Mr. Howard L. Schrayer Regulatory Affairs Consultant 200 Middlesex Turnpike, Suite 304 Iselin, New Jersey 08830
Re: K140422
Trade/Device Name: HET" Bipolar Electrocautery Forceps and Monitor Regulation Number: 21 CFR 878.4000 Regulation Name: Electrosurgical, cutting & coagulation device & accessories Regulatory Class: Class II Product Code: GEI Dated: April 30, 2014 Received: May 1, 2014
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: CDRFI 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
4
Page 2 - Mr. Howard L. Schrayer
device-related adverse events) (21 CFR 803); 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 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.hum.
Sincerely yours,
David Krause -S
l'or
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K140422
INDICATIONS FOR USE
510(k) Number (if known): K140422
Device Name: HET™ Bipolar Electrocautery Forceps and Monitor
Indications For Use:
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 Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
lan P. Broverman -S 5. cn=lan P. Broverman -S
Digitally signed by lan P. Broverman -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=200079294 Date: 2014.06.04 15:38:11 -04'00'
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