(106 days)
No
The device description focuses on electrosurgical technology and temperature monitoring, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the treatment of symptomatic grade I and grade II internal hemorrhoids, indicating a therapeutic purpose.
No
The device description and intended use clearly state that it is used for the treatment of internal hemorrhoids, specifically for electrosurgical applications (electrocautery). It delivers energy to tissue for therapeutic effect, not for diagnostic purposes like identifying or characterizing a condition.
No
The device description clearly outlines hardware components including bipolar forceps, an integrated bipolar cable, an accessory monitor, a temperature sensor, and an LED light source. It also connects to an electrosurgical generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of symptomatic grade I and grade II internal hemorrhoids. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bipolar forceps used with an electrosurgical generator to apply energy to tissue. This is a surgical tool used for treatment, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used for direct treatment of a condition.
N/A
Intended Use / Indications for Use
The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.
Product codes
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 displays the temperature at the forceps-tissue interface and provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET™ Bipolar Electrocautery Forceps and Monitor do not generate RF energy themselves and may be used with any Bipolar Electrosurgical generator in the coagulation power setting with an output power set at 10 W and a maximum voltage of 1250V.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance testing was conducted and reported in the 510(k) Notice for the predicate device K140422. 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. Because the two devices are identical, the labeling updates provide clarifications and consistency with the revised indication for use and do not change the intended use of the device, user population or patient population. The information reported for the predicate device is applicable to the subject device. Additional testing was provided to support conformance to the latest revision of IEC 60601-1-2:2014.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 7, 2020
Covidien, LLC Liron Bar Yaakov Senior Manager Regulatory Affairs 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K200146
Trade/Device Name: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery 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 2, 2020 Received: April 3, 2020
Dear Liron Yaakov:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200146
Device Name
Device Name
HET™ Bipolar Electrocautery Forceps and Monitor
Indications for Use (Describe)
The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary - K200146
Date Prepared: May 5th, 2020
Submitter's Name and Address:
Covidien Ilc 15 Hampshire Street Mansfield, MA 02048
Contact Person:
Liron Bar Yaakov Senior Manager, regulatory Affairs Phone: (720) 422-9135 Fax: (408) 328-7310
Name of Device:
Proprietary Name: HET™ Bipolar Electrocautery Forceps and Monitor Common/Usual Name: Electrosurgical Instrument Classification Panel: General & Plastic Surgery Device Regulation: 21 CFR 878.4400, Class II Product Code: GEI
Establishment Registration Number, Owner/Operator Number:
Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 The HET™ Bipolar System is manufactured by a contract manufacturer, Contract Medical Manufacturing, LLC (CMM). The CMM facility is located at: 1 Jacks Hill Road - Unit 3e Oxford, CT 06478 The CMM facility has been assigned establishment registration number 3006183537 and Owner/Operator number 10042275.
Predicate Device(s):
K140422 HET™ Bipolar Electrocautery Forceps and Monitor
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 displays the temperature at the forceps-tissue interface and provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET™ Bipolar Electrocautery Forceps and Monitor do not generate RF energy themselves and may be used with any Bipolar Electrosurgical generator in the coagulation power setting with an output power set at 10 W and a maximum voltage of 1250V.
Indications for Use:
The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.
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Technological Characteristics of the Device Compared to Predicate Device
The technological characteristics of the device are unchanged (i.e. are exactly the same) as compared to the characteristics of the predicate device that was cleared under 510(k) K140422. The purpose of this submission is to limit the indication within the previously cleared indications to treatment of symptomatic grade I and grade II internal hemorrhoids and to clarify that the action performed by the HET Bipolar Electrocautery Forceps and Monitor is considered as tissue ligation. The materials, software, and treatment mechanism (i.e., bipolar energy used to produce heat) are unchanged. Both the predicate device and the subject device use thermal energy delivered during forceps tissue clamping/compression to achieve the treatment effect, on the same target tissue and patient population. Both the subject device and the predicate device are indicated for the treatment of internal hemorrhoids.
As the subject device is identical to the predicate device, biocompatibility studies, software validations, and electrical safety studies previously reported and cleared for the predicate device remain applicable to the subject device.
Performance Data
Performance testing was conducted and reported in the 510(k) Notice for the predicate device K140422. 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. Because the two devices are identical, the labeling updates provide clarifications and consistency with the revised indication for use and do not change the intended use of the device, user population or patient population. The information reported for the predicate device is applicable to the subject device. Additional testing was provided to support conformance to the latest revision of IEC 60601-1-2:2014.
Biocompatibility
Testing was previously conducted, and reported in the 510(k) K121085, 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.
Sterilization
The HET™ Bipolar Forceps are sterilized with EtO to a sterility level of 10-6.
Conclusion
The subject device has the same intended use and the identical design as the legally marketed predicate device. The labeling changes made to the subject device do not raise different kinds of safety and effectiveness questions. Therefore, Covidien llc considers the subject device, the HET™ Bipolar Electrocautery Forceps and Monitor, to be substantially equivalent to the legally marketed predicate device, the HET™ Bipolar Electrocautery Forceps and Monitor (K140422).