Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrosurgical bipolar forceps and does not mention any AI or ML capabilities. The performance studies are focused on electrical safety, biocompatibility, and mechanical properties, not algorithmic performance.

Therapeutic

Yes
The device is intended for bipolar coagulation to remove tissue and control bleeding, which aligns with therapeutic purposes.

Diagnostic

No

The device is intended for bipolar coagulation to remove tissue and control bleeding, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device is a physical medical device (bipolar forceps) used in surgery, not a software-only device. The description details hardware components and physical interactions with tissue.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current." This is a surgical procedure performed directly on the patient's body.
Device Description: The device is described as "Electrosurgical forceps and electrodes" used in "general open surgery where coagulation of soft tissue is needed." It works by applying electrical current to tissue.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.

The device is an electrosurgical instrument used for therapeutic purposes during surgery, not for diagnostic testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

GEI

Device Description

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. The bipolar forceps must be operated with the following parameters:

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

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

intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery

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)

Performance Testing
Biocompatibility (ISO 10993-1): Non-Cytotoxic, Non-Irritating, Non-Sensitizing,

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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,

| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.05.18
11:13:23 -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) 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 and
Accessories
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.

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. The bipolar forceps must be operated with the following parameters:

-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 Bipolar
Forceps with cable
(Multiple models with
different designs and
sizes)	Titan Manufacturing
Bipolar Forceps –
K213386
(Multiple models
with different
designs 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 or
tissue is grasped
between the forceps
tines or tips, 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.	Bipolar forceps are
designed to grasp,
manipulate, and
coagulate selected
tissue. They are to
be connected
through a bipolar
cable with the
bipolar output of an
electrosurgical
generator.
Coagulation is
achieved using
electrosurgical
energy generated
by the
electrosurgical
generator unit
(ESU) and activated
by a footswitch.