(52 days)
McPherson 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. Single-use non-stick 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.
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.
The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate 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 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.
The provided document describes the FDA's "Substantial Equivalence" determination for a device, not a study to prove acceptance criteria for a new AI/software medical device.
The document discusses various performance tests and comparisons to predicate devices for Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Irrigating Bipolar Forceps, which are mechanical electrosurgical accessories.
Therefore, the requested information about acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), and training set details for an AI/software device cannot be extracted from this document, as it pertains to a different type of medical device and a different regulatory review process.
The document consistently states "N/A" for "Software Verification and Validation Testing," "Animal Study," and "Human Clinical Performance Testing," further confirming that this is not an AI/software medical device submission requiring such studies.
However, I can provide a summary of the performance criteria and reported performance for the mechanical device as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Feature | Acceptance Criteria (Implied by "Pass" or "Same") | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility (ISO10993-1) | Demonstrably non-cytotoxic, non-irritating, systemically non-toxic, non-sensitizing, and passes pyrogenicity testing (as inferred from the justification for differences between subject and predicate where predicate did not report these tests, implying these are required for substantial equivalence). Meets the requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation & Sensitization), USP151 (Pyrogenicity), and ISO 10993-11 (Systemic Toxicity). | Pass |
| Electrical Safety & EMC (AAMI/ANSI IEC 60601-1, IEC 60601-2-2) | Meets the specified standards for high-frequency leakage current. | Pass |
| High-frequency dielectric strength | Meets the specified standards for high-frequency dielectric strength. | Pass |
| Mains frequency dielectric strength | Meets the specified standards for mains frequency dielectric strength. | Pass |
| Active Accessory Insulation (for irrigating forceps) | Meets the specified standards for active accessory insulation. | Pass |
| Mechanical Testing | Meets the specified standards for mechanical performance. | Pass |
| Sterility Testing (ISO-10993-7) | Sterilized by Ethylene Oxide (EO) and meeting the requirements of ISO-10993-7 for sterility. (Implied by the method used and regulatory acceptance of EO sterilization). | Ethylene Oxide (EO) |
| Shelf-Life Testing | Demonstrates a product shelf life of at least 3 years through real-time aging studies. | Shows product shelf life up to 3 years |
Study Proving Acceptance Criteria (General):
The document indicates that the device's performance was evaluated through various bench performance tests. These tests covered biocompatibility, electrical safety and electromagnetic compatibility (EMC), mechanical testing, sterility testing, and shelf-life testing. The report concludes that "HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary," implying that the performance data from these bench tests demonstrated substantial equivalence to the predicate devices. The details of these studies are not provided in this summary, but the results are reported as "Pass" for the relevant tests.
Information NOT Applicable/Available (as per the document's content for AI/Software specific questions):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device. The document mentions "bench performance testing" which are laboratory-based physical tests, not data-driven tests on patient sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are irrelevant for this type of mechanical device testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/software device.
- How the ground truth for the training set was established: Not applicable.
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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 % Wondwossem Tekolla Associate Regulatory Consultant Medical Device Academy 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K233351
Trade/Device Name: Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150A); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 0.5mm Tip with Cable (HNSAG-5150S); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 0.5mm Tip with Cable (HNSAG-5160S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 1.0mm Tip with Cable (HNSAG-1160S); Single Use Non-Stick Straight Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HNSAG-5180S); Single Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 29, 2023 Received: September 29, 2023
Dear Wondwossem 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 (the 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
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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 QS 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 (OS) 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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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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
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.11.20
13:04:01 -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)
Irrigation Tubing (HNSAG-2220S/IRS);
K233351
Device Name
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M): Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150A); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 0.5mm Tip with Cable (HNSAG-5150S); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 0.5mm Tip with Cable (HNSAG-5160S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 1.0mm Tip with Cable (HNSAG-1160S); Single Use Non-Stick Straight Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HNSAG-5180S); Single Use Non-Stick Straight Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HNSAG-1180S); Single Use Non-Stick Straight Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HNSAG-1200S); Single Use Non-Stick Straight Bipolar Forceps, 200mm, Angled 1.0mm Tip with Cable (HNSAG-1200SA): Single Use Non-Stick Bayonet Bipolar Forceps, 165mm, 1.0mm Tip with Cable (HNSAG-1165B); Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HNSAG-1200B); Single Use Non-Stick Bayonet Bipolar Forceps, 220mm, 1.0mm Tip with Cable (HNSAG-1220B); Single Use Non-Stick Bayonet Bipolar Forceps, 240mm, 1.0mm Tip with Cable (HNSAG-1240B); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 150mm, 0.5mm Tip with Cable & Irrigation Tubing (HNSAG-5150S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 150mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1150S/IRS): Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 160mm, 0.5mm Tip with Cable & Irrigation Tubing (HNSAG-5160S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 160mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1160S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 180mm, 0.5mm Tip with Cable & Irrigation Tubing (HNSAG-5180S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 180mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1180S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1200S/IRS): Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2200S/IRS): Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, Angled 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1200SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, Angled 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2200SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1220S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, 2.0mm Tip with Cable &
{4}------------------------------------------------
Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, Angled 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1220SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, Angled 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2220SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1240S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2240S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, Angled 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1240SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, Angled 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2240SA/IRS); Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 165mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1165B/IRS): Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1200B/IRS): Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 220mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1220B/IRS); Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 240mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1240B/IRS) ndications for Use (Describe)
McPherson 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. Single-use non-stick 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.
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.
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Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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{6}------------------------------------------------
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| 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/ HeinrichSingle Use Irrigating Non-Stick Bipolar Forceps |
|---|---|
| Classification Name: | Electrosurgical Cutting & Coagulation Device andAccessories |
| Requlation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Device Panel: | General & Plastic Surgery |
| Product Classification Code: | GEI |
PREDICATE DEVICE lll.
| A) Predicate 1: Irrigating forceps. | |
|---|---|
| Predicate Manufacturer: | Adeor Medical AG |
| Predicate Trade Name: | Adeor Medical nxt™ Non-stick Bipolar ForcepsAdeor Medical nxt™ Single-Use Non-stick Bipolar Forceps |
| Predicate 510(k): | K191847 |
B) Predicate 2: Non-irrigating forceps
| Predicate Manufacturer: | Faulhaber by Pinzetten OHG |
|---|---|
| Predicate Trade Name: | Single Use Non-Stick Bipolar Forceps sterile/non sterile,Single Use Non-Stick Bipolar Irrigating Forceps sterile/ nonsterile |
| Predicate 510(k): | K182773 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for
{7}------------------------------------------------
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
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. Single-use non-stick 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.
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 crosssectional area of body.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE & PERFORMANCE DATA
Table 1: Comparison of subject device, Heinrich Single Use Non-Stick Bipolar Forceps with Cable – and Predicate Device, Adeor Medical nxt™ Non-stick Bipolar Forceps Adeor Medical nxt™ Single-Use Non-stick Bipolar Forceps- K191847
| Feature | Subject Device | Predicate Device | Justification ForDifferences |
|---|---|---|---|
| Heinrich Single UseNon-Stick BipolarForceps with Cable –(Multiple models withdifferent sizes) | Adeor Medical nxt™Non-stick BipolarForceps/ AdeorMedical nxt™Single-Use Non-stick BipolarForceps K191847 | ||
| Manufacturer | HG Innovations Ltd. | Adeor Medical AG | ---------- |
| Regulation | 878.4400 | 878.4400 | Same |
| Classification 21 | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Device Description | The product family“Single Use BipolarForceps”, includingHeinrich Single Use,Non-Stick BipolarForceps (varioussizes, designs and tipconfigurations), withPre-Attached Cableare designed tograsp, manipulate,coagulate and irrigatesoft tissues and areintended for use by aphysician familiar withelectrosurgery inbipolar coagulationfor general opensurgery wherecoagulation of softtissue is needed. Theblood vessel or tissueis grasped betweenthe forceps tines,each of which acts asan electrode, andcurrent passes todesiccate andcoagulate the tissue.Bipolar forceps arecoppected through a | The Adeor MedicalAG Bipolar Forcepsare electrosurgicalinstruments used tograsp, manipulate,cut orcoagulate tissue.Bipolar forceps havevarious lengths andtip configurations, aswell as irrigation andsuctiontechnologies. Bothreusable and single-use forceps areavailable, with flatplug or two pin plugconfigurations.Bipolar forceps areconnected through asuitable bipolarcable with thebipolar output of ahigh frequencygenerator and maybe used only withbipolar coagulationcurrent. Adeorbipolar forcepsmust be operatedwith the following | Similar |
| suitable bipolar cablewith the bipolar outputof an electrosurgicalgenerator. Bipolarforceps must only beused with bipolarcoagulation current.The Single Use, Non-Stick Bipolar Forcepsare single useproducts and mustnot be reused. | parameters:Frequency rangebetween 300 kHzand 1,000 kHz:maximum generatoroperating voltage600Vp. | ||
| Indications for use | |||
| Heinrich Single-usenon-stick bipolarforceps are intendedfor use by a physicianfamiliar withelectrosurgery forbipolar coagulationand irrigation of tissuefor general opensurgery wherecoagulation of softtissue is needed.Single-use non-stickbipolar forceps mustbe operated withinthe followingparameters:-Frequency rangebetween 300 kHz-1,000 kHZ;-Maximum generatoroperating voltage600Vp.Single-use non-stickbipolar forceps havenot been shown to beeffective for tubalsterilization or tubalcoagulation forsterilizationprocedures andshould not be usedfor these procedures.The types of surgeryintended include: | The Adeor MedicalNon-stick BipolarForceps areintended for use bya physician familiarwithelectrosurgery inbipolar coagulationfor general opensurgery wherecoagulation of softtissue isneeded. Adeorbipolar forceps mustbe operated with thefollowingparameters:Frequency rangebetween 300 kHzand 1,000 kHZ;maximum generatoroperating voltage600Vp.The Adeor MedicalNon-stick BipolarForceps have notbeen shown to beeffective for tubalsterilization or tubalcoagulation forsterilizationprocedures andshould not be usedfor theseprocedures.The types of surgery | Same | |
| -ENT-Gynecology-Urology-General Surgery-Neurosurgery-Laryngeal Surgery-Orthopedic Surgery-Thoracic SurgerySingle-use non-stickbipolar forceps andare connectedthrough a suitablebipolar cable with thebipolar output of anelectrosurgicalgenerator. Single-usenon-stick bipolarforceps must only beused with a bipolarcoagulation current.HG Innovations, as amanufacturer, doesnot recommend aspecific procedure.Use of bipolartechniques may bedesirable in order toavoid unwantedtissue damage forsurgical procedureswhere HF currentcould flow throughrelatively small cross-sectional area ofbody. - ThoracicSurgery | -ENT-Gynecology (exceptfor use in femalesterilization)-Urology-General Surgery-Neurosurgery-Laryngeal Surgery-Orthopedic Surgery-Thoracic Surgery | ||
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| Mcpherson | N/A | N/A | |
| Jeweller | N/A | N/A | |
| Adson | N/A | N/A | |
| Straight | N/A | N/A | |
| Irrigating Bayonet | N/A | N/A | |
| Irrigating Straight | N/A | N/A | |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Both single use andmultiuse | Subject device issingle use,predicate devicehas both single useand multiusedevices. Disposableuse of subjectdevice reduces risk. |
| Maximum Peak Voltage | 600 Vp | 600Vp | Same |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm-1.5mm | 0.2mm-1.5mm | Range of tip sizesfor predicate devicecompletely overlapthat of the subjectdevice. Larger tipwill decreasecurrent density andlast longer thansmaller tips. |
| Lengths | 110mm-240mm | 127mm-254mm | Range of lengths issimilar and largelyoverlaps withpredicate device. |
| Component Materials | |||
| Forceps' Tip(s) | Ag800 (80% puresilver) | Ag800 (80% puresilver) | Forceps tipmaterials areidentical for theintended use of thesingle-use subjectdevice |
| Arm Material | Stainless steel AISI420 | Stainless Steel | Forceps armmaterials areidentical |
| Outer Cap | Polypropylene,SABIC® PP107M90T + MasterColour, Black | N/A | N/A |
| Cable | Polyvinyl Cholride(PVC), 2/16 core,Copper Wires | N/A | Both are made ofplastic |
| Solder | Tin | N/A | N/A |
| Powder Coating | Nylon Powder,Polyamide 11 | Polyamide | Both are made ofplastic and are nonpatient contacting |
| Colorant | Pigment Blue 15:3UN8632 | N/A | N/A |
| Forging Blank | Stainless steel AISI420 | N/A | N/A |
| Inner Cap | Polypropylene,SABIC® PP107M90T + MasterColour, Black | N/A | N/A |
| Banana Pin | Chrome-plated, Goldplated spring, Brass | N/A | N/A |
| Internal Plug Body | Polypropylene,SABIC® PP107M90T + MasterColour, Black | N/A | N/A |
| Outer Plug Body | Polyvinyl Chloride(PVC) | N/A | Both are made ofplastic |
| Sterility Testing (ISO-10993-7) | Ethylene Oxide (EO) | Gamma Irradiation/Steam | Both are recognizedsterility methods. |
| Shelf-Life Testing | Real-time aging studyshows product shelflife up to 3 years | N/A | N/A |
| Packaging | Paper/Film PouchTyvek/Film Pouch | PETG Tray/ Tyveklid | Similar |
| Performance Testing | |||
| Biocompatibility(ISO10993-1)Cytotoxicity (ISO-10993-5)Irritation (ISO-10993-10Sensitization (ISO-10993-10)Pyrogenicity (USP151)Systemic Toxicity (ISO-10993-11) | Pass | N/A | Subject devices isdemonstrably non-cytotoxic, non-irritating,systemically nontoxic, non-sensitizing andpasses pyrogenicitytesting. Predicatedevice has notreportedbiocompatibilitytesting. |
| Electrical Safety &EMC (AAMI/ANSI IEC60601-1, IEC 60601-2-2) | |||
| High-frequency leakagecurrent | Pass | Pass | Same |
| High-frequencydielectric strength | Pass | Pass | Same |
| Mains frequencydielectric strength | Pass | Pass | Same |
| Mechanical Testing | Pass | Pass | Same |
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Table 1: Comparison of subject device, Heinrich Single Use Non-Stick Irrigating Bipolar Forceps with Cable, and Predicate Device, Faulhaber Single Use Non-Stick Bipolar Forceps sterile/non sterile, Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non sterile-K182773
| Feature | Subject Device | Predicate Device | Justification For Differences |
|---|---|---|---|
| Heinrich Single UseNon-Stick IrrigatingBipolar Forceps withCable(Multiple models withdifferent sizes) | Single Use Non-Stick BipolarForceps sterile/nonsterile,Single Use Non-Stick BipolarIrrigating Forcepssterile/ non sterile-K182773 | ||
| Manufacturer | HG Innovations Ltd. | Faulhaber byPinzetten OHG | |
| Regulation | 878.4400 | 878.4400 | |
| Classification 21 | Class II | Class II | |
| Product Code | GEI | GEI | |
| Device Description | The product family"Single Use BipolarForceps", includingHeinrich Single Use,Non-Stick IrrigatingBipolar Forceps(various sizes,designs and tipconfigurations), withPre-Attached Cablesare designed tograsp, manipulate,coagulate and irrigatesoft tissues and areintended for use by aphysician familiar withelectrosurgery inbipolar coagulationfor general opensurgery wherecoagulation of softtissue is needed. Theblood vessel or tissueis grasped betweenthe forceps tines | The product family"Single Use BipolarForceps", includingFaulhaber SingleUse Non-StickBipolar Forceps andSingle Use Non-Stick BipolarIrrigating Forceps,are intended to beused for bipolarcoagulation andirrigation of tissue byphysicians familiarwith bipolarcoagulation inmedical practicesand clinics.The Single UseBipolar Forceps aresingle use productsand must not bereused. They areprovided sterile aswell as non-sterile |
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| each of which acts asan electrode, andcurrent passes todesiccate andcoagulate the tissue.Bipolar forceps areconnected through asuitable bipolar cablewith the bipolar outputof an electrosurgicalgenerator. Bipolarforceps must only beused with bipolarcoagulation current.The Single Use, Non-Stick Bipolar IrrigatingForceps are singleuse products andmust not be reused.The Single Use, Non-Stick Bipolar IrrigatingForceps are withirrigation function.The irrigation functionworks via a drainrunning along theforceps tines from tipto handle. At handleheight, the drain isconnected by Luer-Lock via an irrigationtubing with anirrigation pump. | Products deliverednon sterile must becleaned,disinfected andsterilized before use.For the applicationthe Single UseBipolar Forcepshave to beconnected byappropriatebipolar cable to thebipolar output of anHF generator.Bipolar cables andESU are not partof the subjectdevice.The Single UseBipolar Forceps areprovided in bayonetdesign with non-stick tips and areidentical in design,construction,materials andmanufacturing to thereusable deviceEGONFAULHABERBipolar Non-StickForceps (K101080).The principles ofoperation andmechanism of actionare identical as well.In addition to thecleared and legallymarketed EGONFAULHABERdevices, theproductsare with irrigationfunction available.The irrigationfunction works via adrain running alongthe forceps tinesfrom tip to handle. AtThe principles ofoperation andmechanism of actionare identical as well. |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Indications for use | |||
|---|---|---|---|
| Heinrich single-usenon-stick irrigatingbipolar forceps areintended for use by aphysician familiar withelectrosurgery forbipolar coagulationand irrigation of tissuefor general opensurgery wherecoagulation of softtissue is needed.Single-use non-stickirrigating bipolarforceps must beoperated within thefollowing parameters:-Frequency rangebetween 300 kHz-1,000 kHZ;-Maximum generatoroperating voltage600Vp.Single-use non-stickirrigating bipolarforceps have notbeen shown to beeffective for tubalsterilization or tubalcoagulation forsterilizationprocedures andshould not be usedfor these procedures.The types of surgeryintended include:-ENT-Gynecology-Urology-General Surgery | handle height, thedrain is connectedby Luer-Lockvia an irrigationtubing with anirrigation pump.Faulhaber SingleUse Non-StickBipolar Forcepssterile/ non-sterileand Single Use Non-Stick IrrigatingForceps sterile/ non-sterile are intendedfor use by aphysician familiarwithelectrosurgery forbipolar coagulationand irrigation oftissue for generalsurgery. Thebipolar forceps areused with the bipolaroutput for standardelectrosurgicalgenerators.The products areintended for singleuse and areprovided sterile aswell as non sterile.Products suppliednon sterile must becleaned, disinfectedand sterilized priorto their useby the validatedcleaning,disinfection andsterilization process.The bipolar forcepshave not beenshown to beeffective for tubalsterilization or tubalcoagulation forsterilization | Same | |
| -Laryngeal Surgery-Orthopedic Surgery-Thoracic SurgerySingle-use non-stickirrigating bipolarforceps areconnected through asuitable bipolar cablewith the bipolar outputof an electrosurgicalgenerator. Single-usenon-stick irrigatingbipolar forceps mustonly be used with abipolar coagulationcurrent.HG Innovations, as amanufacturer, doesnot recommend aspecific procedure.Use of bipolartechniques may bedesirable in order toavoid unwantedtissue damage forsurgical procedureswhere HF currentcould flow throughrelatively small cross-sectional area ofbody. | should not be usedfor theseprocedures.The types of surgeryintended are- General surgery- Laryngealcoagulation- Orthopediccoagulation- Thoraciccoagulation- Neurosurgicalcoagulation- Gynecologicalcoagulation (exceptfor use in femalesterilization)- Urologicalcoagulation- Ear-, Nose- andThroat coagulation | ||
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| Straight | N/A | N/A | |
| N/A | N/A | ||
| N/A | N/A | ||
| Irrigation feature | Yes | Yes | Same |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Yes | Same. Disposableuse of subjectdevice reduces risk. |
| Maximum Peak Voltage | 600 Vp | <500Vp | Similar |
| Method of Operation | mechanicalactivation,no switch | mechanicalactivation,no switch | |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm-1.5mm | 0.5mm-1.5mm | Range of tip sizesfor predicate devicecompletely overlapthat of the subjectdevice. Larger tipwill decreasecurrent density andlast longer thansmaller tips. |
| Lengths | 150mm-240mm | 203mm-300mm | Range of lengths issimilar and largelyoverlaps withpredicate device. |
| Component Materials | |||
| Forceps' Tip(s) | Sterling silver | Sterling Silver | Forceps tipmaterials areidentical for theintended use of thesingle-use subjectdevice |
| Arm Material | Coated Stainlesssteel AISI 420 | Coated StainlessSteel | Forceps armmaterials areidentical |
| Outer Cap | Polypropylene,SABIC® PP107M90T + MasterColour, Black | N/A | N/A |
| Cable | Polyvinyl Cholride(PVC), 2/16 core,Copper Wires | N/A | Both are made ofplastic |
| Solder | Tin | N/A | N/A |
| Powder Coating | Nylon Powder,Polyamide 11 | Rilsan® (Nylon)Coating | Similar materialsused for coating. |
| Colorant | Pigment Blue 15:3UN8632 | N/A | N/A |
| Forging Blank | Stainless steel AISI420 | N/A | N/A |
| Inner Cap | Polypropylene,SABIC® PP107M90T + MasterColour, Black | N/A | N/A |
| Banana Pin | Chrome-plated, Goldplated spring, Brass | N/A | N/A |
| Internal Plug Body | Polypropylene,SABIC® PP | N/A | N/A |
| 107M90T + MasterColour, Black | |||
| Outer Plug Body | Polyvinyl Chloride(PVC) | N/A | Both are made ofplastic |
| Irrigation Pipe | PVC, Silicone | N/A | Both are made ofplastic |
| Irrigation TubeConnection | Female luer locatedon the forceps nearthe main housing tobe connected withmale luerof irrigation tubing | Female luer locatedon the forceps nearthe main housing tobe connected withmale luerof irrigation tubing | Same |
| Sterility | Sterile | Sterile and non-sterile | Single use, steriledevices pose lessrisk. |
| Sterility Testing (ISO-10993-7) | Ethylene Oxide (EO) | Steam Sterilization | Both are recognizedsterility methods. |
| Shelf-Life Testing | Real-time aging studyshows product shelflife up to 3 years | N/A | N/A |
| Packaging | Paper/Film PouchTyvek/Film Pouch | Sterile : Cleerpeel®Foil PouchNon-sterile : foil bagwith cardboard box | Different. Packagingdifference does notaffect safety ofsubject device. |
| Performance Testing | |||
| Biocompatibility(ISO10993-1)Cytotoxicity (ISO-10993-5)Irritation (ISO-10993-10Sensitization (ISO-10993-10)Pyrogenicity (USP151)Systemic Toxicity (ISO-10993-11) | Pass | pass | Subject devices isdemonstrably non-cytotoxic, non-irritating,systemically nontoxic, non-sensitizing andpasses pyrogenicitytesting. Predicatedevice has notreportedbiocompatibilitytesting. |
| Electrical Safety &EMC (AAMI/ANSI IEC60601-1, IEC 60601-2-2) | |||
| High-frequency leakagecurrent | Pass | Pass | Same |
| High-frequency | Pass | Pass | Same |
| Mains frequencydielectric strength | Pass | Pass | Same |
| Active AccessoryInsulation | Pass | Pass | Same |
| Mechanical Testing | Pass | Pass | Same |
| Drop Test | N/A | Pass | N/A |
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Bench Performance Testing System Testing
HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary.
Software Verification and Validation Testing N/A
Mechanical and acoustic Testing N/A
Animal Study
N/A
Human Clinical Performance Testing N/A
VII. CONCLUSION
Based on the indications for use, technological characteristics and comparison with the predicate devices, the subject devices have demonstrated substantial equivalence.
§ 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.