Single Use Bipolar Forceps

K230432 · Hg Innovations, Ltd. · GEI · May 18, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230432
• Device Name: Single Use Bipolar Forceps
• Applicant: Hg Innovations, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use bipolar forceps designed for grasping, manipulating, and coagulating soft tissue during open surgery. Device consists of forceps with pre-attached cables; tines act as electrodes. Operated by physician; connects to standard electrosurgical generator (ESU) via bipolar cable. Current passes between tines to desiccate and coagulate tissue. Single-use design eliminates reuse-related risks. Output is thermal coagulation of tissue; aids in bleeding control. Device provided sterile (EO).

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 (cytotoxicity, irritation, sensitization, systemic toxicity) and pyrogenicity (USP 151) passed. Electrical safety testing per IEC 60601-2-2 (HiPot, continuity, dielectric strength) passed. Mechanical performance verified via drop testing.

Technological Characteristics

Bipolar forceps; stainless steel AISI 420 tips/arms. Polyamide 11 powder coating. Polypropylene/PVC components. Energy source: external electrosurgical generator (300-1,000 kHz, max 600Vp). Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: 4mm standard generator outlet. Single-use.

Indications for Use

Indicated for bipolar coagulation to remove tissue and control bleeding in general open surgery. For use by physicians familiar with electrosurgery. Requires bipolar coagulation current (300-1,000 kHz; max 600Vp).

Regulatory Classification

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.

Predicate Devices

• Titan Manufacturing Bipolar Forceps (K213386)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

| Mark<br>Trumbore -S | Digitally signed by<br>Mark Trumbore -S<br>Date: 2023.05.18<br>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) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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.<br>5 Elder Court,<br>Lions Drive Shadsworth Business Park,<br>Blackburn Lancashire, BB1 2EQ UK |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Phone No: | Dr. M. Umran Rafiq<br>[phone] |
| Date Prepared: | May 17 2023 |

#### DEVICE ll.

| Device Trade Name: | Single Use Bipolar Forceps |
|------------------------------|-----------------------------------------------------------------|
| Classification Name: | Electrosurgical Cutting & Coagulation Device and<br>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<br>Forceps with cable<br>(Multiple models with<br>different designs and<br>sizes) | Titan Manufacturing<br>Bipolar Forceps –<br><i>K213386</i><br>(Multiple models<br>with different<br>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<br>tissue is grasped<br>between the forceps<br>tines or tips, each of<br>which acts as an<br>electrode, and current<br>passes to desiccate<br>and coagulate the<br>tissue. Bipolar<br>forceps are<br>connected through a<br>suitable bipolar cable<br>with the bipolar<br>output of an<br>electrosurgical<br>generator. Bipolar<br>forceps must only be<br>used with bipolar<br>coagulation current. | Bipolar forceps are<br>designed to grasp,<br>manipulate, and<br>coagulate selected<br>tissue. They are to<br>be connected<br>through a bipolar<br>cable with the<br>bipolar output of an<br>electrosurgical<br>generator.<br>Coagulation is<br>achieved using<br>electrosurgical<br>energy generated<br>by the<br>electrosurgical<br>generator unit<br>(ESU) and activated<br>by a footswitch.<br><br>Bipolar cables, ESU<br>and footswitch are<br>not part of the<br>subject<br>device. | The wording for<br>principles of<br>operation are<br>different, but the<br>principles of<br>operation are<br>equivalent. |
| Indications for use | Single-use, bipolar<br>forceps are intended for<br>bipolar coagulation to<br>remove tissue and<br>control bleeding by use | Titan Manufacturing<br>Bipolar Forceps are<br>intended to remove<br>tissue and control<br>bleeding by use of | Subject device<br>includes “bipolar<br>coagulation” which<br>is how bleeding is<br>controlled. 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 AISI<br>420 | Stainless Steel or<br>titanium | Subject device is<br>equivalent to the<br>stainless steel<br>model of the<br>predicate. |
| Adhesive | None | Epoxy | N/A. Subject device<br>legs are over-<br>molded to foot<br>instead of using<br>adhesives. |
| Outer Cap | Polypropylene,<br>SABIC® PP<br>107M90T + Master<br>Color, Black | N/A | Used for shipping<br>purposes only,<br>because subject<br>device is shipped<br>sterile. |
| Cable | Polyvinyl Chloride<br>(PVC), 2/16 core,<br>Copper Wires | Not included | Cable wires used in<br>subject device is<br>made of equivalent<br>materials to<br>predicate wires. |
| Solder | Tin | N/A | N/A |
| Powder Coating | Polyamide 11 | Polyvinylidene<br>Fluoride (PVDF) | Equivalent, both are<br>thermoplastics. |
| Colorant | Pigment Blue 15:3<br>UN8632 | Kynar (blue) | Both colorants are<br>non-patient<br>contacting. |
| Forging Blank | Stainless Steel AISI<br>420 | N/A | N/A |
| Inner Cap | Polypropylene,<br>SABIC® PP<br>107M90T + Master<br>Color, Black | N/A | N/A |
| Banana Pin | Chrome-plated, Gold-<br>plated spring, Brass | N/A | N/A |
| Internal Plug Body | Polypropylene,<br>SABIC® PP<br>107M90T + Master<br>Color, Black | N/A | N/A |
| Outer Plug Body | Polyvinyl Chloride<br>(PVC) | N/A | Both are made of<br>plastic |
| Sterilization Method &<br>SAL | Ethylene Oxide (EO),<br>provided sterile to<br>user<br>SAL= 10-6 | Provided non-sterile<br>to user for pre-<br>vacuum sterilization<br>(steam).<br>SAL= 10-6 | Equivalent. Both<br>meet requirement<br>for 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 Testing<br>Biocompatibility (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.