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.

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 (<24hrs) of contact with tissue and blood.

The HPR45i is designed to be used in combination with a radiofrequency generator (MedRF4000 (K210077) manufactured by F Care Systems USA LLC) for the application of haemostasis of soft tissue. The RF signal, which is generated by the generator, passes through the HPR45i, and is applied on the soft tissue by means of the HPR45i tip. When contact is made with tissue, the RF signal is converted into heat resulting in the bleeding to stop and haemostasis to appear. The HPR45i has no power regulating function, and it does not contain a diagnostic or monitoring function.

AI/ML Overview

The provided text is a 510(k) summary for the HPR45i electrosurgical electrode. It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical and a lack of clinical study data.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria in a table format with corresponding device performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating compliance with recognized standards and passing various non-clinical performance tests.

Acceptance Criterion Type	Specific Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance Testing
ESU Testing	Defined performance specifications for electrosurgical units (details not provided).	Pass
Active Components/Accessories Testing	Defined performance specifications for active components/accessories (details not provided).	Pass
Neutral Electrode Testing	Defined performance specifications for neutral electrodes (details not provided).	Pass
Miscellaneous Components/Accessories Testing	Defined performance specifications for miscellaneous components/accessories (details not provided).	Pass
Capacitive Coupling Testing	Verification that capacitive coupling is within acceptable limits (details not provided).	Pass
Electrical Safety and Electromagnetic Compatibility	Compliance with IEC 60601-1 and IEC 60601-1-2 standards.	Pass
Thermal Effect on Tissue	Acceptable thermal effects on tissue, indicating proper function for coagulation (details not provided).	Pass
Sterilization & Packaging
Sterility Assurance Level (SAL)	10^-6 in accordance with ISO 11135.	Validated to SAL 10^-6
Packaging Integrity	Maintenance of sterile barrier and physical integrity (details not provided).	Performed and supports proposed shelf life.
Accelerated Aging Test	Demonstration that device maintains performance over its projected shelf life (details not provided).	Performed and supports proposed shelf life.
Biocompatibility	Compliance with various ISO 10993 standards (1, 3, 4, 5, 10, 11, 18).	All relevant biocompatibility tests were performed and passed (implied by "All non-clinical tests met the acceptance criteria specified in the standards").
Substantial Equivalence	Device is as safe and effective as the predicate device (E-Z Clean Electrosurgical Electrode, K081791) regarding intended use, technology, and performance.	Determined to be Substantially Equivalent (SE).

2. Sample Size Used for the Test Set and the Data Provenance

The provided document describes non-clinical performance tests only. It does not refer to a "test set" in the context of clinical data or diagnostic accuracy. Therefore, there is no information on:

Sample size used for the test set.
Data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since no clinical "test set" was used for diagnostic accuracy, there is no information on the number or qualifications of experts used to establish ground truth. The non-clinical tests rely on established engineering and safety standards.

4. Adjudication Method for the Test Set

As no clinical "test set" was used for diagnostic accuracy, there is no information on any adjudication method.

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 MRMC comparative effectiveness study was done or reported. The device is an electrosurgical electrode, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This device is a medical instrument used by a human surgeon, not an independent algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" implicitly refers to:

Compliance with international and FDA-recognized consensus standards: such as IEC 60601-2-2, IEC 60601-1, IEC 60601-1-2, and various ISO 10993 standards.
Engineering specifications and validated processes: for electrosurgical unit performance, component testing, and sterilization.

There is no clinical ground truth (e.g., expert consensus, pathology, outcomes data) presented as no clinical studies were performed.

8. The Sample Size for the Training Set

Not Applicable. This device is an electrosurgical electrode and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See point 8).

Summary

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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:

OfficialCorrespondent (USAgent):	Shilpa GampaFreyr 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
LegalManufacturer:	F Care Systems USA LLC11098 Biscayne BlvdSuite 301Miami 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 andaccessories

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 ElectrosurgicalElectrode	Megadyne MedicalProducts, Inc

Table 2 Predicate Device

4. Device Description

Compatible device:

MEDRF 4000 ●
No accessories are required to achieve the intended purpose of the HPR45i.

5. Intended Use/Indications for Use

6. Substantial Equivalence Comparison

The substantial equivalence comparison table is provided in Table 3.

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Characteristic / Feature	E-ZCLEANElectrosurgical Electrode(Predicate Device)	HPR45i (Subject device)	Comments
Device Name	E-Z CLEAN ElectrosurgicalElectrode	HPR45i Electrode	N/A
Manufacturer Name	Megadyne MedicalProducts, Inc.	F Care Systems	N/A
510(K) Number	K081791	K220725	N/A
Classification Name	Electrosurgical cutting andcoagulation device andaccessories	Electrosurgical cutting andcoagulation device andaccessories	Same
Product code	GEI	GEI	Same
Regulation Number	21 CFR 878.4400	21 CFR 878.4400	Same
Panel	General & Plastic Surgery	General & Plastic Surgery	Same
Class	Class II	Class II	Same
Indications for Use	E-Z Clean electrosurgicalelectrodes are intended toconduct radio frequency(RF) current for cutting andcoagulation from the RFelectrosurgical generator totarget soft tissue in a broadrange of surgical proceduresrequiring the use of electrosurgery for cutting andcauterization.Some tip configurationshave a specific geometry thatminimizes blanching andthermal damage in skinincisions when used inconjunction with thegenerator's AdvancedCutting Effect (ACE) mode.	HPR45i electrosurgicalelectrode is intended to conductradio frequency (RF) current forcoagulation from the RFelectrosurgical generator totarget soft tissue in a broad rangeof surgical procedures. Thedevice is a prescription use (Rx)device.	Similar. ReferJustification 1
Mode of Action	Thermocoagulation (RF) oftissue by administration ofhigh frequency energy	Thermocoagulation (RF) oftissue by administration of highfrequency energy	Same
Characteristic / Feature	E-ZElectrosurgical(Predicate Device)	CLEANElectrode	HPR45i (Subject device)	Comments
Components		Electrosurgical Generator, active electrode, return electrode, foot pedal.	Electrosurgical Generator was approved along with the neutral electrode, active electrode, foot pedal,	Same
Output Energy type		Radio Frequency	Radio Frequency	Same
Mode of delivery		Disposable Electrode	Disposable Electrode	Same
Modality		Monopolar	Monopolar	Same
Rx or OTC		Prescription Use	Prescription Use	Same
Maximum power		300 watts	25 Watts	Different. Referjustification 2.
Maximum Voltage		≤10.8 KV	800 v	Different. Referjustification 3.
Maximum Frequency		510 kHz	4MHZ	Different. Referjustification 4.
Tip HeadDimensions	Tiplength ofBladeElectrode	21 mm	N/A	Thisconfiguration isnot available insubject device.
	Tiplength ofBallElectrode	5.3 mm	N/A	Thisconfiguration isnot available insubject device.
	Tiplength ofNeedleElectrode	4.2 mm	10 mm	Different. Referjustification 5.
Tissue/Tiphead surface-contactingarea	Bladeelectrode	53mm²	44mm²	Similar
	Ballelectrode	56mm²
	Needleelectrode	5.8mm²
Electrode Material		300 series stainless steel	Stainless steel, AISI316L	Same
PatientContactingMaterial		SS, Polyolefin, PTFE, vinyl, and Silicone	AISI316L Stainless steel and PTFE	Same
Insulation Material		Polyolefin and PTFE	PTFE	Similar. ReferJustification 6.
Characteristic / Feature	E-Z Electrosurgical Electrode (Predicate Device)	CLEAN	HPR45i (Subject device)	Comments
Sterilization	Radiation GammaEO	EO		Same
Single use	Yes	Yes		Same
Coating Material	PTFE	PTFE		Same

Table 3 Comparison of Technological Characteristics between subject and predicate device

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Justification 1: The minor difference in the intended use of the device is that HPR45i is intended only for coagulation not for cutting but the predicate device is intended to be used for both cutting and coagulation. However, this difference will not raise any concern on the safety and effectiveness of the subject device since coagulation is covered under the intended use of predicate device.

Justification 2: The predicate device, E-Z CLEAN Electrosurgical Electrode is used for both cutting and coagulation whereas HPR45i is not used for cutting, only control of hemostasis, therefore the maximum power of HPR45i (25 W) is much lower than the predicate (300 W).

Justification 3: The predicate device, E-Z CLEAN Electrosurgical Electrode is used for both cutting and coagulation whereas HPR45i is not used for cutting, only control of hemostasis, therefore the maximum voltage of HPR45i (800V) is much lower than the predicate (≤10.8 KV).

Justification 4: The predicate device, E-Z Clean Electrosurgical uses a lower frequency (510 kHz), the HPR45i uses a higher frequency (4MHZ). The higher frequency in HPR45i has no effect on efficiency as evidenced by the tissue testing.

Justification 5: The tip length of HPR45i and E-Z Clean Electrosurgical Electrode different. However, tip length of HPR45i (10mm) tip length falls within the tip length (21mm, 5.3mm and 4.2mm) of the different versions of the predicate device, E-Z Clean Electrosurgical Electrode.

Justification 6: The PTFE material was selected as it was more durable material than polyolefin. Therefore, the above difference does not raise any safety or effectives tissue for the subject device

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7. Summary of Non- Clinical Data

The non-clinical performance tests have been executed in line with recommendations of the FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016. The following performance tests were carried out for HPR45i:

S. No	Test Performed	Results
1	ESU Testing	Pass
2	Active Components/ Accessories Testing	Pass
3	Neutral Electrode Testing	Pass
4	Miscellaneous Components/ Accessories Testing	Pass
5	Capacitive Coupling Testing	Pass
6	Electrical safety and Electromagnetic Compatibility	Pass
7	Thermal Effect on Tissue	Pass

Table 4 Non-Clinical Performance Tests

HPR45i comply with the following international and FDA-recognized consensus standards:

. IEC 60601-2-2: 2018 Medical electrical equipment - Part 2-2: Requirements for the safety of high frequency surgical equipment.
IEC 60601-1:2006/A11:2011/A1:2013 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance.
IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment- Part 1-2: General . Requirements for Basic safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
. ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
. 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
10993-4 Third edition 2017-04 Biological Evaluation of Medical Devices Part 4: ● Selection of Tests for interactions with Blood.
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
. ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ISO 10993-18 Second edition 2020-01 Biological Evaluation of Medical Devices Part . 18: Chemical characterization of medical device materials within a risk management process.

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Traditional 510(K) HPR45i

HPR45i Monopolar Electrodes are sterilized by using a validated ethylene oxide cycle. The sterilization cycle has been validated to ensure a sterility level of (SAL) 10-6 in accordance with ISO 11135. Furthermore, the packaging integrity and accelerated aging test were performed on the subject device to support the proposed shelf life.

All non-clinical tests met the acceptance criteria specified in the standards.

8. Summary of Clinical Data

As per FDA's guidance document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" Clinical data are generally not necessary to support 510(k) submissions for electrosurgical devices that are intended for general surgery indications. Moreover, indications for use of HPR45i or device technology or mechamism of action is not significantly different when compared to the predicate device. Therefore, no clinical data was submitted for HPR45i.

9. Conclusion

Based on the comparison and analysis above, the proposed device "HPR45i" is determined to be Substantially Equivalent (SE) to the predicate device "E-Z Clean Electrosurgical Electrode".

Regulation Number and Section

§ 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.