Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);

K233346 · Hg Innovations, Ltd. · GEI · Nov 20, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K233346
• Device Name: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010)
• Applicant: Hg Innovations, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp. Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include: -ENT -Gynecology -Urology -General Surgery -Neurosurgery -Laryngeal Surgery -Orthopedic Surgery -Thoracic Surgery Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.

Device Story

Single-use, non-stick bayonet bipolar forceps (with or without irrigation) designed for grasping, manipulating, and coagulating soft tissue. Device inputs: electrical energy from an external electrosurgical generator (300-1,000 kHz; max 600Vp). Operation: physician grasps tissue between forceps tines; tines act as electrodes to deliver bipolar current, desiccating and coagulating tissue. Irrigating models include tubing to deliver fluid to the surgical site. Used in general open surgery (ENT, neuro, etc.) by physicians. Output: thermal coagulation of tissue. Benefits: non-stick tip coating reduces tissue adhesion; bipolar technique limits current flow to the small cross-sectional area between tines, minimizing collateral tissue damage.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Biocompatibility (ISO 10993-1) and electrical safety/EMC (AAMI/ANSI IEC 60601-1, IEC 60601-2-2) testing passed.

Technological Characteristics

Bayonet-style bipolar forceps. Materials: Aluminum arms, silver/rhodium-plated tips, polypropylene caps, PVC/copper cables, nylon/polyamide powder coating. Energy: Bipolar electrosurgical current (300-1,000 kHz, max 600Vp). Connectivity: Wired to electrosurgical generator. Sterilization: Ethylene Oxide (EO). Single-use.

Indications for Use

Indicated for bipolar coagulation and irrigation of soft tissue in general open surgery (ENT, Gynecology, Urology, General, Neurosurgery, Laryngeal, Orthopedic, Thoracic). Contraindicated for tubal sterilization or tubal coagulation procedures. For use by physicians familiar with electrosurgery.

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

• Synergetics Disposable Single Use Dual Irrigating Standard Bipolar Forceps (K110924)
• Sutter Swyng Nonstick Bipolar Forceps- Single Use (K193587)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 20, 2023

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

Re: K233346

Trade/Device Name: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable (HMAL20/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable (HMAL23/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable (HMAL23/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.5mm Tip with Cable (HMAL23/015); Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable & Irrigation Tubing (H Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 15, 2023 Received: September 29, 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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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, 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

{2}------------------------------------------------

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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.20 13:08:27 -05'00'

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

Submission Number (if known)

| Submission Number (if known) | K233346 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable (HMAL20/015);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable (HMAL23/005);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable (HMAL23/010);<br>Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.5mm Tip with Cable (HMAL23/015);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL18/005/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL18/010/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL18/015/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL20/005/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL20/010/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL20/015/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL23/005/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL23/010/IRD);<br>Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL23/015/IRD) |
| Indications for Use (Describe) | Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are |

intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use nonstick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:

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

-Maximum generator operating voltage 600Vp.

{4}------------------------------------------------

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:

-ENT

- -Gynecology
- -Urology
- -General Surgery
- -Neurosurgery
- -Laryngeal Surgery
- -Orthopedic Surgery
- -Thoracic Surgery

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.

HG Innovations, as a manufacturer, does not recommend a specific procedure.

Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

e-Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY

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

| I. SUBMITTER: | Mr. Wondwossen Tekolla |
|----------------------|-----------------------------|
| Company Name: | Medical Device Academy Inc. |
| Address: | 345 Lincoln Hill Rd |
| City, State, Zip USA | Shrewsbury, VT 05738 |
| Tel: | 919-903-0194 |
| Fax: | N/A |

| Contact Person: | Dr. M Umran Rafiq |
|-----------------|-------------------|
| Date Prepared: | August 23, 2023 |

#### DEVICE ll.

| Device Trade Name: | Heinrich Single Use Non-Stick Bipolar Forceps/ Heinrich<br>Single Use Irrigating Non-Stick 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 |

#### lll. PREDICATE DEVICE

| A) Predicate 1: Irrigating forceps. | |
|----------------------------------------|-------------------------------------------------------------------------------|
| Predicate Manufacturer: | Synergetics, Inc. |
| Predicate Trade Name: | Synergetics Disposable Single Use Dual Irrigating Standard<br>Bipolar Forceps |
| Predicate 510(k): | K110924 |
| B) Predicate 2: Non-irrigating forceps | |
| Predicate Manufacturer: | Sutter Medizintechnik GmbH |
| Predicate Trade Name: | Sutter Swyng® Nonstick Bipolar Forceps- Single Use |
| Predicate 510(k): | K193587 |

No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

HG Innovations Ltd.'s electrical surgical 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, non-stick bipolar forceps and non-stick bipolar irrigating forceps (various sizes and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft

{6}------------------------------------------------

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

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

-Maximum generator operating voltage 600Vp.

#### V. INDICATIONS FOR USE

Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich single-use non-stick bipolar forceps and Heinrich singleuse non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp.

Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:

-ENT

- -Gynecology
- -Urology
- -General Surgery
- -Neurosurgery
- -Laryngeal Surgery
- -Orthopedic Surgery
- -Thoracic Surgery

Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.

HG Innovations, as a manufacturer, does not recommend a specific procedure.

Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small crosssectional area of body.

{7}------------------------------------------------

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

Table 1: Comparison of subject device, Heinrich Single Use Non-Stick Irrigating Bipolar Forceps with Cable with predicate device, Synergetics Disposable Single Use Dual Irrigating Standard Bipolar Forceps- K110924

| Irrigating Standard Bipolar Forceps- K110924 | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Subject Device | Predicate Device | Justification For<br>Differences |
| | Heinrich Single Use<br>Non-Stick Irrigating<br>Bipolar Forceps with<br>Cable<br>(one model with<br>different sizes) | Synergetics<br>Disposable Single<br>Use Dual Irrigating<br>Standard Bipolar<br>Forceps K110924 | |
| Manufacturer | HG Innovations Ltd. | Synergetics, Inc | ------- |
| Regulation | 878.4400 | 878.4400 | Same |
| Classification 21 | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Device Description | The Heinrich single-<br>use, non-stick<br>irrigating bipolar<br>forceps (various<br>sizes), with<br>preattached cables<br>are designed to<br>grasp, manipulate,<br>coagulate and irrigate<br>soft tissues and are<br>intended for use by a<br>physician familiar with<br>electrosurgery in<br>bipolar coagulation<br>for general open<br>surgery where<br>coagulation of soft<br>tissue is needed. The<br>blood vessel or tissue<br>is grasped between<br>the forceps tines,<br>each of which acts as<br>an electrode, and<br>current passes to<br>desiccate and<br>coagulate the tissue.<br>Bipolar forceps are<br>connected through a<br>suitable bipolar cable<br>with the bipolar output<br>of an electrosurgical<br>generator. Bipolar | The SynergeticsTm<br>Disposable<br>Spetzlefrm Malis®<br>Standard Bipolar<br>Forceps are sterile<br>single use devices<br>for use in<br>electrosurgery. The<br>forceps are a<br>bayonet style and<br>include a cord at the<br>proximal end which<br>allows for<br>connection to a<br>Malis bipolar<br>electrosurgical<br>generator. | Similar |
| | forceps must only be<br>used with bipolar<br>coagulation current. | | |
| Indications for use | Heinrich single-use<br>non-stick irrigating<br>bipolar forceps are<br>intended for use by<br>a physician familiar<br>with electrosurgery<br>for bipolar<br>coagulation and<br>irrigation of tissue<br>for general open<br>surgery where<br>coagulation of soft<br>tissue is needed.<br>Heinrich single-use<br>non-stick irrigating<br>bipolar forceps<br>must be operated<br>within the following<br>parameters:<br>-Frequency range<br>between 300 kHz-<br>1,000 kHZ;<br>-Maximum<br>generator operating<br>voltage 600Vp.<br>Heinrich single-use<br>non-stick irrigating<br>bipolar forceps<br>have not been<br>shown to be<br>effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization<br>procedures and<br>should not be used<br>for these<br>procedures. The<br>types of surgery<br>intended include: | Sterile, single use,<br>for use in<br>electrosurgery for<br>coagulation and<br>irrigation of tissue. | Same |
| -ENT<br>-Gynecology<br>-Urology<br>-General Surgery<br>-Neurosurgery<br>-Laryngeal Surgery<br>-Orthopedic<br>Surgery<br>-Thoracic Surgery | | | |
| Heinrich single-use<br>non-stick irrigating<br>bipolar forceps are<br>connected through<br>a suitable bipolar<br>cable with the<br>bipolar output of an<br>electrosurgical<br>generator. Heinrich<br>single-use non-stick<br>bipolar forceps and<br>Heinrich single-use<br>non-stick irrigating<br>bipolar forceps<br>must only be used<br>with a bipolar<br>coagulation current. | | | |
| HG Innovations, as<br>a manufacturer,<br>does not<br>recommend a<br>specific procedure. | | | |
| Use of bipolar<br>techniques may be<br>desirable in order to<br>avoid unwanted<br>tissue damage for<br>surgical procedures<br>where HF current<br>could flow through<br>relatively small<br>cross-sectional area<br>of body. | | | |
| | | | |
| For Use with | Electrosurgical<br>generators, irrigation<br>modules and<br>irrigation tubing | Electrosurgical<br>generators, irrigation<br>modules and<br>irrigation tubing | Same |
| Irrigation Tube<br>Connection | Connects to irrigation<br>port that's connected<br>to main housing | Connects to<br>irrigation port that's<br>connected to main<br>housing | Similar |
| Delivery Line to distal<br>end of forceps | Yes | Yes | Same |
| Irrigation Pipe | PVC, silicone | N/A | |
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Yes | Same. Disposable<br>use of subject<br>device reduces risk. |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm, 1mm, 1.5mm | 0.5mm, 1mm,<br>1.5mm | Range of tip sizes is<br>identical. Larger tip<br>will decrease<br>current density and<br>last longer than<br>smaller tips. |
| Lengths | 180mm, 200mm,<br>230mm | 177.8mm-228.6mm<br>** Tip and length<br>sizes obtained from<br>marketing brochure | Range of lengths is<br>similar and largely<br>overlaps with<br>predicate device. |
| Component Materials | | | |
| Forceps' Tip(s) | Silver Plated…