(371 days)
No
The device description focuses on the physical components and function of an electrosurgical electrode, which conducts RF current. There is no mention of AI, ML, image processing, or any data processing/analysis capabilities that would suggest the use of these technologies. The device is described as having "no power regulating function" and not containing a "diagnostic or monitoring function," further indicating a lack of AI/ML integration.
Yes
The device is intended to conduct radio frequency (RF) current for coagulation and to remove tissue and control bleeding, which are therapeutic actions.
No
Explanation: The "Device Description" explicitly states, "The HPR45i has no power regulating function, and it does not contain a diagnostic or monitoring function."
No
The device description clearly states it is a physical electrosurgical electrode consisting of a handle, cable, and stainless-steel tube with a tip, intended to conduct RF current. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures." This describes a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a device used to apply RF current directly to tissue for haemostasis (stopping bleeding). This is a surgical tool.
- Lack of Diagnostic Function: The description explicitly states, "The HPR45i has no power regulating function, and it does not contain a diagnostic or monitoring function." IVDs are designed to diagnose or monitor conditions.
- Method of Operation: The device works by converting RF energy into heat to achieve haemostasis, which is a physical effect on tissue, not a chemical or biological analysis of a sample.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient's tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The device is a prescription use (Rx) device.
Product codes
GEI
Device Description
HPR45i is a monopolar electrosurgical electrode intended to remove tissue and control bleeding using radio frequency electrical current. It is a prescription use device which is intended to be used by a licensed doctors or specialist in the healthcare facility/ hospital.
The HPR45i is supplied sterile (Sterilized by EO Sterilization) and is not intended to be reused. It consists of 3 different parts such as HPR45i handle, output cable and stainless-steel tube. The stainless-steel tube is insulated over most of its exposed length, and it is connected to the stainless steel (AISI316L) tip at the end. The material of insulation is PTFE. The stainless steel (AISI316L) tip and PTFE insulation are the direct patient contacting parts of the device. It is an external communicating device with limited duration (
§ 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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March 20, 2023
F Care Systems USA LLC % Shilpa Gampa Delivery Manager and US Agent-MDV Freyr, Inc. 150 College Rd W, #102 Princeton, New Jersey 08540
Re: K220725
Trade/Device Name: HPR45i Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 18, 2023 Received: January 20, 2023
Dear Shilpa Gampa:
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 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 requirements,
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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) 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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 DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe assistance/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,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.03.20
12:13:51 -04'00'
Mark Trumbore, 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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Indications for Use
510(k) Number (if known) K220725
Device Name HPR45i
Indications for Use (Describe)
HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft issue in a broad range of surgical procedures. The device is a prescription use (Rx) device.
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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510(K) Summary
This 510(K) summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: March 14, 2023
1. Submitter Information:
| Official
Correspondent (US
Agent): | Shilpa Gampa
Freyr Inc.
150 College Rd W #102, Princeton, NJ 08540 |
|------------------------------------------|------------------------------------------------------------------------------|
| Phone: | +1 908-483-7958 Ext 1780
+1 760-583-4401 |
| E-mail: | usagent@freyrsolutions.com |
| Legal
Manufacturer: | F Care Systems USA LLC
11098 Biscayne Blvd
Suite 301
Miami FL 33161 |
| Phone: | 786 288 0740 |
| Contact Person: | Patrick Danciu |
| E-mail: | pdanciu@fcaresystems.us |
| Fax Number: | +32 3 451 51 39 |
| Date Prepared: | 03-March-2022 |
2. Device Identification:
| Device Trade Name: | HPR45i |
|---|---|
| Common Name: | Electrosurgical electrode |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories |
Table 1 Device Identification
| Regulation Number | Product Code | Device Class |
|---|---|---|
| 878.4400 | GEI | Class II |
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3. Legally Marketed Equivalent Device:
| 510(k) Number | Device Name | Manufacturer |
|---|---|---|
| K081791 | E-Z Clean Electrosurgical | |
| Electrode | Megadyne Medical | |
| Products, Inc |
Table 2 Predicate Device
4. Device Description
HPR45i is a monopolar electrosurgical electrode intended to remove tissue and control bleeding using radio frequency electrical current. It is a prescription use device which is intended to be used by a licensed doctors or specialist in the healthcare facility/ hospital.
The HPR45i is supplied sterile (Sterilized by EO Sterilization) and is not intended to be reused. It consists of 3 different parts such as HPR45i handle, output cable and stainless-steel tube. The stainless-steel tube is insulated over most of its exposed length, and it is connected to the stainless steel (AISI316L) tip at the end. The material of insulation is PTFE. The stainless steel (AISI316L) tip and PTFE insulation are the direct patient contacting parts of the device. It is an external communicating device with limited duration (