(52 days)
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 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. Heinrich 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 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 cross-sectional area of body.
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 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.
This is not a medical device that utilizes AI and therefore does not have acceptance criteria, study data, or ground truth information as typically found in AI/ML device submissions.
The provided text is a 510(k) summary for Heinrich Single Use Non-Stick Bayonet Bipolar Forceps. This is a traditional medical device (bipolar forceps) and its clearance is based on substantial equivalence to predicate devices, not on performance metrics of an AI/ML algorithm.
Therefore, I cannot provide the requested information. The document focuses on comparing the new device's features and materials to existing cleared devices (predicates) and ensuring it meets safety and effectiveness standards for such devices (e.g., electrical safety, biocompatibility, sterility).
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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
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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);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 (HMAL18/005/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL18/010/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL18/015/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL20/005/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL20/010/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL20/015/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL23/005/IRD);Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL23/010/IRD);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.
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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/ HeinrichSingle Use Irrigating Non-Stick Bipolar Forceps |
|---|---|
| Classification Name: | Electrosurgical Cutting & Coagulation Device andAccessories |
| Regulation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Device Panel: | General & Plastic Surgery |
| Product Classification Code: | GEI |
lll. PREDICATE DEVICE
| A) Predicate 1: Irrigating forceps. | |
|---|---|
| Predicate Manufacturer: | Synergetics, Inc. |
| Predicate Trade Name: | Synergetics Disposable Single Use Dual Irrigating StandardBipolar 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.
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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 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 ForDifferences |
| Heinrich Single UseNon-Stick IrrigatingBipolar Forceps withCable(one model withdifferent sizes) | SynergeticsDisposable SingleUse Dual IrrigatingStandard BipolarForceps 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-use, non-stickirrigating bipolarforceps (varioussizes), withpreattached 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,each of which acts asan electrode, andcurrent passes todesiccate andcoagulate the tissue.Bipolar forceps areconnected through asuitable bipolar cablewith the bipolar outputof an electrosurgicalgenerator. Bipolar | The SynergeticsTmDisposableSpetzlefrm Malis®Standard BipolarForceps are sterilesingle use devicesfor use inelectrosurgery. Theforceps are abayonet style andinclude a cord at theproximal end whichallows forconnection to aMalis bipolarelectrosurgicalgenerator. | Similar |
| forceps must only beused with bipolarcoagulation current. | |||
| Indications for use | Heinrich single-usenon-stick irrigatingbipolar forceps areintended for use bya physician familiarwith electrosurgeryfor bipolarcoagulation andirrigation of tissuefor general opensurgery wherecoagulation of softtissue is needed.Heinrich single-usenon-stick irrigatingbipolar forcepsmust be operatedwithin the followingparameters:-Frequency rangebetween 300 kHz-1,000 kHZ;-Maximumgenerator operatingvoltage 600Vp.Heinrich single-usenon-stick irrigatingbipolar forcepshave not beenshown to beeffective for tubalsterilization or tubalcoagulation forsterilizationprocedures andshould not be usedfor theseprocedures. Thetypes of surgeryintended include: | Sterile, single use,for use inelectrosurgery forcoagulation andirrigation of tissue. | Same |
| -ENT-Gynecology-Urology-General Surgery-Neurosurgery-Laryngeal Surgery-OrthopedicSurgery-Thoracic Surgery | |||
| Heinrich single-usenon-stick irrigatingbipolar forceps areconnected througha suitable bipolarcable with thebipolar output of anelectrosurgicalgenerator. Heinrichsingle-use non-stickbipolar forceps andHeinrich single-usenon-stick irrigatingbipolar forcepsmust only be usedwith a bipolarcoagulation current. | |||
| HG Innovations, asa manufacturer,does notrecommend aspecific procedure. | |||
| Use of bipolartechniques may bedesirable in order toavoid unwantedtissue damage forsurgical procedureswhere HF currentcould flow throughrelatively smallcross-sectional areaof body. | |||
| For Use with | Electrosurgicalgenerators, irrigationmodules andirrigation tubing | Electrosurgicalgenerators, irrigationmodules andirrigation tubing | Same |
| Irrigation TubeConnection | Connects to irrigationport that's connectedto main housing | Connects toirrigation port that'sconnected to mainhousing | Similar |
| Delivery Line to distalend 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. Disposableuse of subjectdevice reduces risk. |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm, 1mm, 1.5mm | 0.5mm, 1mm,1.5mm | Range of tip sizes isidentical. Larger tipwill decreasecurrent density andlast longer thansmaller tips. |
| Lengths | 180mm, 200mm,230mm | 177.8mm-228.6mm** Tip and lengthsizes obtained frommarketing brochure | Range of lengths issimilar and largelyoverlaps withpredicate device. |
| Component Materials | |||
| Forceps' Tip(s) | Silver Plated | Silver Plated | Forceps tipmaterials areidentical |
| Arm Material | Aluminum | Aluminum | 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 | PVDF | Both are made ofplastic and are nonpatient contacting |
| Colorant | Pigment Blue 15:3UN8632 | N/A | N/A |
| Forging Blank | Aluminum | 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) | Ethylene Oxide (EO) | Same. |
| Shelf-Life Testing | Real-time aging studyshows product shelflife up to 3 years | N/A | N/A |
| Performance Testing | |||
| Biocompatibility(ISO10993-1) | 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) | Pass | Pass | Subject device andpredicate deviceboth passedelectromagneticcompatibility testingand electrical safetytesting whichincludes mechanicalstrength andfunctionality testing. |
| Feature | Subject Device | Predicate Device | Justification For Differences |
| Manufacturer | Heinrich Single UseNon-Stick BipolarForceps with Cable –(one model withdifferent sizes) | Sutter Swyng®nonstickbipolar forceps,single-use –K193587 | |
| Manufacturer | HG Innovations Ltd. | SutterMedizintechnikGmbH | ---------- |
| Regulation | 878.4400 | 878.4400 | Same |
| Classification 21 | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Device Description | The Heinrich single-use, non-stick bipolarforceps (various sizes and tipconfigurations), withpreattached cables are designed tograsp, manipulate,coagulate soft tissuesand are intended foruse by a physicianfamiliar 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 areconnected through asuitable bipolar cablewith the bipolar outputof an electrosurgicalgenerator. Bipolarforceps must only be | Sutter Swyng® non-stick bipolar forceps,single-use areelectrosurgicalinstruments. Thebipolar forceps areprovided withbayonet-style handledesign with straightor angled tips anddifferent totallengths. They are tobe connectedthrough anappropriate bipolarcable with thebipolar output of anelectrosurgicalgenerator. Theelectrodes areprovided sterile andare single-useinstruments. | Similar |
| used with bipolarcoagulation current. | |||
| Indications for use | Heinrich Single-usenon-stick bipolarforceps are intendedfor use by a physicianfamiliar withelectrosurgery forbipolar coagulation oftissue for generalopen surgery wherecoagulation of softtissue is needed.Heinrich single-usenon-stick bipolarforceps must beoperated within thefollowing parameters:-Frequency rangebetween 300 kHz-1,000 kHZ;-Maximum generatoroperating voltage600Vp.Heinrich single-usenon-stick 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-Neurosurgery-Laryngeal Surgery-Orthopedic Surgery | Sutter Swyng® non-stick bipolar forceps,single-use areintended for use inelectrosurgery forcoagulation oftissue. | Same |
| Heinrich Single-usenon-stick bipolarforceps areconnected through asuitable bipolar cablewith the bipolar outputof an electrosurgicalgenerator. Heinrichsingle-use non-stickbipolar 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. | |||
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Yes | Same. Disposableuse of subjectdevice reduces risk. |
| Maximum Peak Voltage | 600 Vp | 500 Vp | Although subjectdevice has a slightlyhigher maximumvoltage, it has dulypassed electricalsafety testing andtherefore, the highermax voltage doesnot raise anyquestions of devicesafety. |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm, 1mm, 1.5mm | 0.5mm, 1mm,1.5mm | Range of tip sizes isidentical. Larger tipwill decreasecurrent density andlast longer thansmaller tips. |
| Lengths | 180mm, 200mm,230mm | Different lengths,specifics N/A | N/A |
| Component Materials | |||
| Forceps' Tip(s) | Silver and RhodiumPlated | Silver and RhodiumPlated | Forceps tipmaterials areidentical |
| Arm Material | Aluminum | Aluminum | 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 | Similar |
| Colorant | Pigment Blue 15:3UN8632 | N/A | N/A |
| Forging Blank | Aluminum | 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 | Both are recognizedsterility methods. |
| Shelf-Life Testing | Real-time aging studyshows product shelflife up to 3 years | aging studyestablished productshelf life up to 3years | Identical |
| Performance Testing | |||
| Biocompatibility(ISO10993-1) | Pass | Pass | Subject devices isdemonstrably non-cytotoxic, non-irritating,systemically nontoxic, non-sensitizing andpasses pyrogenicitytesting. Predicatedevice specifics notavailable, but haspassedbiocompatibilitytesting. |
| Electrical Safety &EMC (AAMI/ANSI IEC60601-1, IEC 60601-2-2) | Pass | Pass | Subject device andpredicate deviceboth passedelectromagneticcompatibility testingand electrical safetytesting whichincludes mechanicalstrength andfunctionality testing. |
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Table 2: Comparison of subject device, Single Use Non-Stick Bipolar Forceps with with predicate device, Sutter Swyng® Nonstick Bipolar Forceps, Single-use - K193587
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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.
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§ 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.