HG Innovations Ltd.'s Electrical Surqical Instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, bipolar forceps (various lengths and designs), with preattached cables are designed to grasp, manipulate and coagulate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current.

AI/ML Overview

This FDA 510(k) summary provides information for a Single Use Bipolar Forceps (K230432).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Important Note: This document is a 510(k) Summary for a medical device (bipolar forceps), not a diagnostic AI software. Therefore, many of the typical AI/ML study components like multi-reader multi-case (MRMC) studies, expert ground truth adjudication for complex interpretations, and training set details are not applicable here. The "acceptance criteria" discussed are largely related to engineering performance and biological safety, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria/Test	Acceptance Criteria (Implied/Defined)	Reported Device Performance/Result
Biocompatibility (ISO 10993-1)
Cytotoxicity (ISO 10993-5)	Non-Cytotoxic	Non-Cytotoxic (Same as predicate)
Irritation (ISO 10993-23)	Non-Irritating	Non-Irritating (Same as predicate)
Sensitization (ISO 10993-10)	Non-Sensitizing	Non-Sensitizing (Same as predicate)
Pyrogenicity (USP151)	<10 EU/sample (Pass)	Pass (Same as predicate)
Systemic Toxicity (ISO 10993-11)	Non-Toxic	Non-Toxic (Same as predicate)
Selection of Tests for Interactions with Blood	(Not required for intended use)	N/A (Not required for intended use)
Electrical Safety (IEC-60601-2-2)
HiPot & Continuity Test (Dielectric strength insulation; insulated safety plug)	Pass performance for dielectric strength and insulation	Pass (Same as predicate)
Compatibility with general electrosurgical generators with 4mm outlets	Compatible	Pass (Same as predicate)
Drop Test	Withstand specified drop conditions without functional impairment	Pass (Same as predicate)
Sterilization Method & SAL	SAL = 10^-6 (Sterility Assurance Level)	Ethylene Oxide (EO), provided sterile to user, SAL= 10^-6 (Equivalent to predicate's steam sterilization in meeting SAL)
Shelf-Life	To demonstrate product integrity for a specified duration	Real-time aging study shows product shelf life up to 3 years
Packaging	Maintain sterility and integrity	Paper/film (Tyvek/Film) pouch (Equivalent to predicate's packaging in meeting requirements for package integrity)
Operating Parameters	Frequency range: 300 kHz-1,000 kHz; Maximum generator operating voltage: 600Vp	The device is intended to be operated within these parameters, and its design is evaluated based on its consistency with these parameters. The performance tests (electrical safety) confirm its suitability for these conditions.
Tip Sizes	Within a range equivalent to the predicate device (0.2mm-2mm)	0.5mm-2mm (Range falls within predicate's range)
Lengths	Within a range equivalent to the predicate device (89mm-273mm)	102mm-240mm (Range falls within predicate's range)

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

For a medical device like this, the "test set" refers to the physical units of the device that underwent various engineering, electrical, and biological safety tests.
The exact sample sizes for each specific test (e.g., how many devices were subjected to the drop test, how many samples for cytotoxicity) are not explicitly stated in this 510(k) summary. These details would typically be found in the full test reports referenced in the submission.
Data Provenance: The tests are standard performance and safety tests for medical devices, performed by the manufacturer (HG Innovations Ltd.) or contracted testing facilities. The provenance is internal to the manufacturer's quality system and likely conducted in the UK where the manufacturer is located, or by certified labs. These are prospective tests performed on newly manufactured devices.

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

This question is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic AI typically refers to an expert interpretation of medical images or data.
For the performance tests described, "ground truth" is established by standard engineering principles, calibrated instruments, and internationally recognized test methods. The "experts" involved are likely engineers, quality assurance personnel, and certified lab technicians who conduct and interpret the results of these physical and chemical tests, rather than clinical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing a "ground truth" for diagnostic studies.
For engineering and safety tests, the outcome is typically objective (e.g., pass/fail based on a measurement against a defined tolerance).

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:

This question is not applicable. This device is a surgical instrument, not an AI diagnostic tool. No human reader involvement or AI assistance is relevant to its direct function, nor were MRMC studies performed.

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

This question is not applicable. This device is a physical surgical instrument and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this device, the "ground truth" for its performance and safety is derived from:
- International Standards: e.g., ISO 10993 series for biocompatibility, IEC 60601-2-2 for electrical safety.
- Engineering Specifications: The device's design specifications (e.g., tip sizes, lengths, materials) are compared against functional requirements and predicate device characteristics.
- Regulatory Requirements: Adherence to FDA regulations and guidance.
There's no "expert consensus" on diagnostic findings, pathology, or outcomes data in the context of this device's performance demonstration.

8. The sample size for the training set:

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as above; there is no training set for a physical medical device.

Summary

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May 18, 2023

HG Innovations Ltd % Wondwossen Tekolla Associate Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738

Re: K230432

Trade/Device Name: Single Use Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 17, 2023 Received: February 17, 2023

Dear Wondwossen Tekolla:

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

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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 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 (QS) 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 medical devices and radiation-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,

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.05.1811:13:23 -04'00'
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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) K230432

Device Name Single Use Bipolar Forceps

Indications for Use (Describe)

Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current.

The bipolar forceps must be operated with the following parameters:

-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.

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- K230432

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

SUBMITTER:	HG Innovations Ltd.5 Elder Court,Lions Drive Shadsworth Business Park,Blackburn Lancashire, BB1 2EQ UK
Contact Person:Phone No:	Dr. M. Umran Rafiq+44 7702195623
Date Prepared:	May 17 2023

DEVICE ll.

Device Trade Name:	Single Use Bipolar Forceps
Classification Name:	Electrosurgical Cutting & Coagulation Device andAccessories
Regulation:	21 CFR §878.4400
Regulatory Class:	Class II
Device Panel:	General & Plastic Surgery
Product Classification Code:	GEI

. PREDICATE DEVICE

Predicate Manufacturer:	Titan Manufacturing Inc.
Predicate Trade Name:	Titan Manufacturing Bipolar Forceps
Predicate 510(k):	K213386

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

-Frequency range between 300 kHz-1,000 kHZ;

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-Maximum generator operating voltage 600Vp.

INDICATIONS FOR USE V.

Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current.

The bipolar forceps must be operated with the following parameters:

-Frequency range between 300 kHz-1,000 kHZ;

-Maximum generator operating voltage 600Vp.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE & PERFORMANCE DATA

Feature	Subject Device	Predicate Device	Justification For Differences
	Single-use BipolarForceps with cable(Multiple models withdifferent designs andsizes)	Titan ManufacturingBipolar Forceps –K213386(Multiple modelswith differentdesigns and sizes)
Manufacturer	HG Innovations Ltd.	Titan Manufacturing, Inc.	--------
Regulation	878.4400	878.4400	Same
Classification 21	Class II	Class II	Same
Product Code	GEI	GEI	Same
Electrode Type	Bipolar	Bipolar	Same
Cable included	Yes	No	Different
Principles of Operation	The blood vessel ortissue is graspedbetween the forcepstines or tips, each ofwhich acts as anelectrode, and currentpasses to desiccateand coagulate thetissue. Bipolarforceps areconnected through asuitable bipolar cablewith the bipolaroutput of anelectrosurgicalgenerator. Bipolarforceps must only beused with bipolarcoagulation current.	Bipolar forceps aredesigned to grasp,manipulate, andcoagulate selectedtissue. They are tobe connectedthrough a bipolarcable with thebipolar output of anelectrosurgicalgenerator.Coagulation isachieved usingelectrosurgicalenergy generatedby theelectrosurgicalgenerator unit(ESU) and activatedby a footswitch.Bipolar cables, ESUand footswitch arenot part of thesubjectdevice.	The wording forprinciples ofoperation aredifferent, but theprinciples ofoperation areequivalent.
Indications for use	Single-use, bipolarforceps are intended forbipolar coagulation toremove tissue andcontrol bleeding by use	Titan ManufacturingBipolar Forceps areintended to removetissue and controlbleeding by use of	Subject deviceincludes “bipolarcoagulation” whichis how bleeding iscontrolled. The
	electrical current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp.	high frequency electrical current.	operating parameters were also added to the indications of the subject device.
Rx/ OTC	Rx	Rx	Same
Design	Straight	Straight	Same
	Jeweler	N/A	Similar to predicate (materials, components)
	Angled	Angled	Same
	Adson	N/A	Similar to predicate (materials, components)
	McPherson	N/A	Similar to predicate (materials, components)
	McPherson, Angled	N/A	Similar to predicate (materials, components)
	Bayonet	N/A	Similar to predicate (materials, components)
	N/A	Curved	N/A
	N/A	Coaptation	N/A
	Insulated	Insulated/noninsulated	Same
	N/A	Insulating/ Irrigating	N/A
	N/A	Non-insulating/Irrigating	N/A
Energy Source	Generator	Generator	Same
Single Use	Yes	Reusable	Disposable use of subject device eliminates risk of reuse.
Tip Sizes	0.5-2mm	0.2mm-2mm	Range of tip sizes falls within range of predicate device.
Lengths	102-240mm	89mm-273mm	Range of lengths falls within range of predicate device.
Component Materials
Forceps' Tip(s)	Stainless Steel AISI 420	Stainless Steel or titanium	Subject device is equivalent to the stainless steel
			model of the
			predicate.
Arm Material	Stainless Steel AISI420	Stainless Steel ortitanium	Subject device isequivalent to thestainless steelmodel of thepredicate.
Adhesive	None	Epoxy	N/A. Subject devicelegs are over-molded to footinstead of usingadhesives.
Outer Cap	Polypropylene,SABIC® PP107M90T + MasterColor, Black	N/A	Used for shippingpurposes only,because subjectdevice is shippedsterile.
Cable	Polyvinyl Chloride(PVC), 2/16 core,Copper Wires	Not included	Cable wires used insubject device ismade of equivalentmaterials topredicate wires.
Solder	Tin	N/A	N/A
Powder Coating	Polyamide 11	PolyvinylideneFluoride (PVDF)	Equivalent, both arethermoplastics.
Colorant	Pigment Blue 15:3UN8632	Kynar (blue)	Both colorants arenon-patientcontacting.
Forging Blank	Stainless Steel AISI420	N/A	N/A
Inner Cap	Polypropylene,SABIC® PP107M90T + MasterColor, Black	N/A	N/A
Banana Pin	Chrome-plated, Gold-plated spring, Brass	N/A	N/A
Internal Plug Body	Polypropylene,SABIC® PP107M90T + MasterColor, Black	N/A	N/A
Outer Plug Body	Polyvinyl Chloride(PVC)	N/A	Both are made ofplastic
Sterilization Method &SAL	Ethylene Oxide (EO),provided sterile touserSAL= 10-6	Provided non-sterileto user for pre-vacuum sterilization(steam).SAL= 10-6	Equivalent. Bothmeet requirementfor sterile products.
Shelf-Life Testing	Real-time aging study shows product shelf life up to 3 years	N/A	N/A
Packaging	Paper/film (Tyvek/Film) pouch	Bipolar forcep in a propionate clear hard plastic tube with foam insets at both ends packaged in an instrument sturdy box with packaging material to protect the instrument (bipolar forcep)	Equivalent. Both meet requirements for package integrity.
Performance TestingBiocompatibility (ISO 10993-1)
Cytotoxicity (ISO 10993-5)	Non-Cytotoxic	Non-Cytotoxic	Same
Irritation (ISO 10993-23)	Non-Irritating	Non-Irritating	Same
Sensitization (ISO 10993-10)	Non-Sensitizing	Non-Sensitizing	Same
Pyrogenicity (USP151)	<10 EU/ sample (Pass)	Pass	Same
Systemic Toxicity (ISO 10993-11)	Non-Toxic	Non-Toxic	Same
Selection of Tests for Interactions with Blood (ISO 10993-4)	N/A	Pass	Not required for intended use.
Electrical Safety IEC-60601-2-2
HiPot & Continuity Test Dielectric strength insulation; insulated safety plug;	Pass	Pass	Same
Compatible with general electrosurgical generators with 4mm outlets	Pass	Pass	Same
Drop Test	Pass	Pass	Same

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VII. CONCLUSION

HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and construction material of the tips. The tip-size range of the subject device also completely overlaps with that of the predicate device. There is a difference in the specific arm/body coatings used between the subject device and the predicate device.

Based on the indications for use, comparison of technological characteristics with the predicate device, and results of performance testing, the subject device is substantially equivalent to the predicate for the proposed indications for use.

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.