(407 days)
-
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. -
Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. -
Single Use Hand Switch Monopolar Forceps (CD956)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. -
Single Use Hand Switch Bipolar Forceps (CD957)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957.
The provided document is a 510(k) premarket notification from the FDA for Monopolar and Bipolar Forceps. It details the device's characteristics and its substantial equivalence to previously cleared predicate devices. Crucially, this document is for electrosurgical cutting and coagulation devices and accessories, not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI models, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information, are not applicable to this submission.
The document focuses on demonstrating that the new device is as safe and effective as its predicate devices, primarily through comparative performance testing data (physical, electrical, and biological properties) rather than algorithmic performance.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria in a formal table with quantitative targets for "performance" as one might expect for an AI/ML model (e.g., accuracy, sensitivity, specificity). Instead, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" is the demonstration that these characteristics are equivalent, or that any differences do not raise new safety or effectiveness concerns.
The tables (e.g., Table 1, Table 2) present a Side-by-Side Comparison (Subject-Predicate Comparison) for different models of the proposed device against their respective predicate devices. The "Result" column indicates "Equivalent" or "Not Equivalent." For items marked "Not Equivalent," an explanation is provided to argue why this difference does not impact safety or effectiveness.
Examples from the tables:
| Compared Items | Proposed Device (K210315) Performance | Predicate Device Performance | Result | Comments on difference/equivalent evidence |
|---|---|---|---|---|
| Classification Name | Electrosurgical, Cutting and Coagulation Accessories | Electrosurgical, Cutting and Coagulation Accessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | Equivalent | |
| Intended use | The device is intended to be used as active electrosurgical devices where monopolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue. | The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue. | Equivalent | Evidence: IFU (Indications for Use). The slight difference in wording ("cut or coagulate" vs. "coagulate") is addressed by demonstrating the proposed device still falls within the established use of similar devices. |
| Sterility | ETO | Irradiation (Predicate K032327), or ETO (Predicate K200372) | Equivalent | ETO sterilization validation have been done for this device. Evidence: EO validation report number R-EO2011; Evidence: IFU. (The document states ETO validation for the proposed device and compares it to both ETO and Irradiation from predicates, concluding equivalence based on validated process.) |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence: Material Technical Data Sheet. |
| Size (distal tips) | 0.1-1.2mm | 0.5-1.5mm (K130669)0.5-2.0mm (K032327) | Not Equivalent | Tip Size doesn't increase any risk for the product. Evidence: Simulation test report 956MVPE1N-2111123R; Evidence: IFU. (This is a key example of a difference being justified.) |
| Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence: DSS_GZES200802563702-IEC 60601-2-2. (Demonstrates compliance with relevant electrical safety standards). |
| Functionality | With smoke evacuation (for specific models) | Without smoke evacuation (K032327) | Not Equivalent | The smoke evacuation is a feature that be added to the forceps to increase convenience of functionality, without altering the intended use or risk profile (relative to a predicate) of the proposed device. Instead, smoke evacuation functionality. Evidence: Simulation test report. 955MVPE1N-2111121F. (Another key example of a new feature being justified as not raising new safety/effectiveness concerns). |
| Shelf life | 3 years | 3 years | Equivalent | Evidence: Labeling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of an AI/ML model with a specific sample size of cases (e.g., images). Instead, it refers to performance testing on the physical device:
- "Performance Testing included comparative device use on porcine tissue: kidney, liver and muscle for both Cut mode and Coagulation mode..."
- This indicates prospective in-vitro/ex-vivo testing rather than data from human subjects.
- The origin of the tissue (e.g., country) is not specified.
- The "sample size" would likely refer to the number of porcine tissue samples or the number of tests performed, which is not numerically detailed but implied to be sufficient for the required validation per the referenced FDA guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this type of device submission. Ground truth for an electrosurgical device typically comes from:
- Engineering specifications and measurements: e.g., electrical safety tests, material properties.
- Established biological models: e.g., the observed effect of electrosurgical current on porcine tissue.
- Compliance with recognized consensus standards: e.g., ISO, IEC standards for sterility, biocompatibility, electrical safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no human interpretation or subjective assessment of "cases" that would require an adjudication method. The performance tests are objective measurements (e.g., resistance levels, temperature, visible coagulation effects that meet predefined criteria).
5. 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. This is a medical device, not an AI/ML-driven diagnostic or assistive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no standalone algorithm. The device is a physical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established through:
- Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, ISO 11135:2014/AMD 1:2018 for sterility, ISO 10993 series for biocompatibility.
- Comparative functional testing: Performance tests on porcine tissue to demonstrate similar coagulation/cutting effects as the predicate devices.
- Material and design specifications: Data sheets for materials, design drawings, and manufacturing processes ensure the device is constructed as intended and is equivalent to predicates.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth for it to establish.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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.
March 17, 2022
Modern Medical Equipment Manufacturing, LTD. Mr. Philip Hung QA Manager / Management Representative Unit A, 10/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street. Kwai Chung, N.T., Hong Kong, China
Re: K210315
Trade/Device Name: Monopolar and Bipolar Forceps (with and without Smoke Evacuation). Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI
Dated: January 04, 2022 Received: January 26, 2022
Dear Mr. Hung:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210315
Device Name
Monopolar and Bipolar Forceps ( with and without Smoke Evacuation)
Indications for Use (Describe)
- Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
-
Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
-
Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
-
Single Use Hand Switch Bipolar Forceps (CD957)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| 1. 510(k) OwnerName: | Modern Medical Equipment Manufacturing Limited | |
|---|---|---|
| Address: | Modern Medical Equipment Mfg., Ltd.Unit A, 10/F., Mai Wah Ind. Bldg.,1-7 Wah Sing Street,Kwai Chung, N.T., Hong Kong, China. | |
| Telephone: | (852) 2420 9068 | |
| Fax: | (852) 2481 1234 | |
| Contact person: | Mr. Philip Hung | |
| Position: | Quality Assurance Manager / Management Representative | |
| Email Address: | philip_hung@modernmedical.com.hk | |
| Date of preparation: | Feb14, 2022 | |
| 2. Device | ||
| Device Trade name: | Monopolar and Bipolar Forceps( with and without Smoke Evacuation) | |
| Common or usual name: | Single Use Hand Switch Monopolar and Bipolar ForcepsSingle Use Hand Switch Monopolar and Bipolar Forcepswith Smoke Evacuation. | |
| Classification name: | Electrosurgical Cutting & CoagulationDevice & Accessories | |
| Classification number: | 21 CFR 878.4400 | |
| Classification Panel: | General & Plastic Surgery | |
| Product Code: | GEI | |
| Class: | II |
3. Predicate device
3.1 Olsen Medical SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS with 510(k) number K130669, cleared Dec 06,2013.
{4}------------------------------------------------
3.2 Modern Medical Smoke Evacuation Fingerswitch, Smoke Evacuation System With Electrosurgical
Pencil with 510(k) number K200372, cleared Nov 30, 2020.
3.3 Modern Medical Bipolar Forceps with 510(k) number K032327
4. Device description
Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957. Please refer it to the item 6, for the detail of these four models.
5. Intended use
The device is intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue.
6. Indication for use
- 6.1 Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coaqulation in electrosurgical procedure, with the additional function to facilitate the removal of surqical smoke generated by electrosurgery
6.2 Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
6.3 Single Use Hand Switch Monopolar Forceps (CD956)
The device delivers electrosurqical current to target tissue for coaqulation in electrosurgical procedure.
- 6.4 Single Use Hand Switch Bipolar Forceps (CD957)
{5}------------------------------------------------
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
7. Technological characteristics
Single Use Hand Switch Forceps has substantially equivalent construction and performance as the predicate devices.
8. Substantial Equivalence
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent.
1. Table 1: Subject-Predicate Comparison
Proposed device: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation_(CD954)
| ComparedItems | ProposedDevice(K210315) | PredicateDevice(K130669) | PredicateDevice(K200372) | Result | Commentson difference/equivalentevidence |
|---|---|---|---|---|---|
| Predicate device: K130669 and K200372 | |||||
| Single UseHand SwitchMonopolarForceps withSmokeEvacuation | Olsen MedicalBipolar andMonopolarForceps | Single UseSmokeEvacuationFingerswitch/ Pencil | |||
| ClassificationName | Electrosurgical, CuttingandCoagulationAccessories | Electrosurgical, CuttingandCoagulationAccessories | Electrosurgical, CuttingandCoagulationAccessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | 878.4400 | Equivalent | |
| CommonName | Single UseHand SwitchMonopolarForceps withSmokeEvacuation | Single UseBipolar andMonopolarForcepsMultiple-UseBipolar andMonopolarForceps | Single UseSmokeEvacuationFingerswitch /Pencil | Equivalent | |
| Product Code | GEI | GEI | GEI | Equivalent | |
| Intended use | The device isintended to beused asactiveelectrosurgical deviceswheremonopolarelectrosurgical coagulationis desiredduringsurgery andare intendedto grasp,manipulatecoagulateselected softtissue. | The OLSENMedicalElectrosurgical Monopolarand BipolarForceps areintended to beused asactiveelectrosurgical deviceswheremonopolar orbipolarelectrosurgical cutting andcoagulation isdesired duringsurgery andare intendedto grasp,manipulatecut orcoagulateselected softtissue. | Monopolarcutting andcoagulation inelectrosurgical procedure,with theadditionalfunction tofacilitate theremoval ofsurgicalsmokegenerated byelectrosurgery. | Equivalent | Evidence: IFU |
| Prescriptionor OTC | PrescriptionUse | PrescriptionUse | PrescriptionUse | Equivalent | |
| Indication foruse | The devicedeliverselectrosurgical current totarget tissueforcoagulation inelectrosurgical procedure,with theadditionalfunction tofacilitate theremoval ofsurgicalsmokegenerated byelectrosurgery. | OLSENMedical®Electrosurgical Monopolarand BipolarForceps havebeendesigned asactiveelectrosurgical instrumentsto grasp,manipulate,cut orcoagulateselected softtissue. Thesestainless steelforceps areconnectedthrough asuitable activeelectrosurgical cable(bipolar ormonopolar) tothe specified | Monopolarelectrosurgical pencil whichdeliverselectrosurgical current totarget tissuefor cutting andcoagulation inelectrosurgical procedure,with theadditionalfunction tofacilitate theremoval ofsurgicalsmokegenerated byelectrosurgery. | Equivalent | Evidence: IFU |
| outputterminal of anelectrosurgicaI generator.Irradiation | |||||
| Sterility | ETO | ETO | Equivalent | ETOsterilizationvalidationhave done forthis device.Evidence: EOvalidationreport numberR-EO2011Evidence: IFU | |
| Usage | Single Use | Disposableand reusable | Single Use | Equivalent | Evidence: IFU |
| Tip Material | StainlessSteel | StainlessSteel | StainlessSteel | Equivalent | Evidence:MaterialTechnicalData Sheet |
| Size (distaltips) | 0.1-1.2mm | 0.5-1.5mm | 0.5mm | NotEquivalent | Tip Sizedoesn'tincrease anyrisk for theproduct.Evidence:Simulationtest report956MVPE1N-2111123R.Evidence: IFU |
| Packaging | Tyvek Pouch | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| ElectricalSafetyTesting | IEC60601-2-2 | IEC60601-2-2 | IEC60601-2-2 | Equivalent | Evidence:DSS_GZES200802563702-IEC60601-2-2 |
| Energydelivery | MonopolarelectrosurgicaI Forcepswhich deliverselectrosurgicaI current totarget tissue. | Monopolar orbipolarelectrosurgicaI Forcepswhich deliverselectrosurgicaI current totarget tissue. | MonopolarelectrosurgicaI Forcepswhich deliverselectrosurgicaI current totarget tissue. | Equivalent | Evidence: testreport number954MVPE2N-2012196R |
| RatedAccessoryVoltage | 2.0kVp | The bipolarforceps areintended forusewith amaximumvoltage of 500volts while themonopolarforceps havea | 4.5kVp | Equivalent | Evidence:Acceleratedaging testreport |
| maximumvoltage of2000 volts. | |||||
| Biocompatibility | Non irritant,non sensitiveto skin, nontoxic to cells | Non irritant,non sensitiveto skin, nontoxic to cells | Non irritant,non sensitiveto skin, nontoxic to cells | Equivalent | Evidence:Biocompatibility test report |
| Shelf life | 3 years | 3 years | 3 years | Equivalent | Evidence:Labeling |
| Targetpopulation | All patients,no specificrestriction | All patients,no specificrestriction | All patients,no specificrestriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Hospitals | Equivalent | Evidence: IFU |
Predicate device: K130669 and K200372
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
Table 2: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Bipolar Forceps with Smoke Evacuation_(CD955)
Predicate device: K032327
| ComparedItems | ProposedDevice(K210315)Single UseHand SwitchBipolar Forcepswith SmokeEvacuation | Predicate Device(K032327)Modern MedicalBipolar Forceps | Result | Comments ondifference/ equivalentevidence |
|---|---|---|---|---|
| ClassificationName | Electrosurgical,Cutting andCoagulationAccessories | Electrosurgical,Cutting andCoagulationAccessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | Equivalent | |
| CommonName | Single UseHand SwitchBipolar Forcepswith SmokeEvacuation | Modern MedicalBipolar Forceps | Equivalent | |
| Product Code | GEI | GEI | Equivalent | |
| Intended use | The device isintended to beused as activeelectrosurgicaldevices wherebipolarelectrosurgicalcoagulation isdesired duringsurgery and areintended tograsp,manipulate rcoagulateselected softtissue. | The device isintended to beused as activeelectrosurgicaldevices wherebipolarelectrosurgicalcoagulation isdesired duringsurgery and areintended tograsp,manipulate rcoagulateselected softtissue. | Equivalent | Evidence: IFU |
| Prescription orOTC | PrescriptionUse | Prescription Use | Equivalent | |
| Indication foruse | The devicedeliverselectrosurgicalcurrent to targettissue forcoagulation inelectrosurgicalprocedure, withthe additionalfunction tofacilitate theremoval ofsurgical smokegenerated byelectrosurgery. | The devicedeliverselectrosurgicalcurrent to targettissue forcoagulation inelectrosurgicalprocedure, withthe additionalfunction tofacilitate theremoval ofsurgical smokegenerated byelectrosurgery. | Equivalent | Evidence: IFU |
| Sterility | ETO | Irradiation | Equivalent | ETO sterilizationvalidation have done forthis device. Evidence:EO validation reportnumber R-EO2011Evidence: IFU |
| Usage | Single Use | Disposable andreusable | Equivalent | Evidence: IFU |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence: MaterialTechnical Data Sheet |
| Size (distaltips) | 0.1-1.2mm | 0.5-2.0mm | Not equivalent | Tip Size doesn'tincrease any risk for theproduct.Evidence: |
| 955MVPE1N-2111122R | ||||
| Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| ElectricalSafetyTesting | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence:DSS_GZES200802563702-IEC 60601-2-2 |
| Energy delivery | BipolarelectrosurgicalForceps whichdeliverselectrosurgicalcurrent to targettissue. | Monopolar orbipolarelectrosurgicalForceps whichdeliverselectrosurgicalcurrent to targettissue. | Equivalent | Evidence: test reportnumber954MVPE2N-2012196R |
| RatedAccessoryVoltage | 2.0kVp | The bipolarforceps areintended for usewith a maximumvoltage of 500volts while themonopolarforceps have amaximumvoltage of 2000volts. | Equivalent | Evidence: Acceleratedaging test report |
| Biocompatibility | Non irritant, nonsensitive toskin, non toxicto cells | Non irritant, nonsensitive to skin,non toxic to cells | Equivalent | Evidence:Biocompatibility testreport |
| Shelf life | 3 years | 3 years | Equivalent | Evidence: Labeling |
| Targetpopulation | All patients, nospecificrestriction | All patients, nospecificrestriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU |
| Functionality | With smokeevacuation | Without smokeevacuation | Not equivalent | The smoke evacuationis a features that beadded to the forceps toincrease convenienceof functionality,without altering theintended use or riskprofile (relative to apredicate) of theproposed device.Instead, smokeevacuationfunctionality. |
| Evidence: Simulationtest report.955MVPE1N-2111121F |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
Table 3: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Monopolar Forceps_(CD956) Predicate device: K130669
| Compared Items | Proposed Device(K210315)Single Use Hand SwitchMonopolar Forceps | Predicate Device(K130669)Olsen MedicalBipolar andMonopolar Forceps | Result | Comments ondifference/equivalentevidence |
|---|---|---|---|---|
| ClassificationName | Electrosurgical,Cutting andCoagulationAccessories | Electrosurgical,Cutting andCoagulationAccessories | Equivalent | |
| RegulationCommonName | 878.4400Single Use Hand SwitchMonopolarForceps | 878.4400Single UseBipolar andMonopolarForcepsMultiple-UseBipolar andMonopolarForceps | Equivalent | |
| Product CodeIntended use | GEIThe device isintended to beused as activeelectrosurgicaldevices wheremonopolarelectrosurgicalcoagulation isdesired duringsurgery and areintended tograsp,manipulatecoagulateselected softtissue. | GEIThe OLSENMedicalElectrosurgicalMonopolar andBipolar Forcepsare intended tobe used as activeelectrosurgicaldevices wheremonopolar orbipolarelectrosurgicalcutting andcoagulation isdesired duringsurgery and areintended tograsp,manipulate cut orcoagulateselected softtissue. | Equivalent | Evidence: IFU |
| Prescription orOTC | Prescription Use | Prescription Use | Equivalent | |
| Indication for use | OLSENMedical® | Equivalent | Evidence: IFU | |
| The devicedeliverselectrosurgicalcurrent to targettissue for andcoagulation inelectrosurgicalprocedure. | ElectrosurgicalMonopolar andBipolar Forcepshave beendesigned asactiveelectrosurgicalinstruments tograsp,manipulate, cutor coagulateselected softtissue. Thesestainless steelforceps areconnectedthrough asuitable activeelectrosurgicalcable (bipolar ormonopolar) to thespecified outputterminal of anelectrosurgicalgenerator. | Equivalent | ||
| Sterility | ETO | Irradiation | Equivalent | ETO sterilizationvalidation havedone for thisdevice. Evidence:EO validationreport numberR-EO2011Evidence: IFU |
| Usage | Single Use | Disposable andreusable | Equivalent | Evidence: IFU |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence:MaterialTechnical DataSheet |
| Size (distaltips) | 0.1-1.2mm | 0.5-1.5mm | Not Equivalent | Tip Size doesn'tincrease any riskfor the product.Evidence:Simulation testreport956MVPE1N-2111123R. |
| Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| ElectricalSafetyTesting | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence:DSS_GZES200802563702-IEC60601-2-2 |
| Energy delivery | MonopolarelectrosurgicalForceps whichdeliverselectrosurgicalcurrent to targettissue. | Monopolar orbipolarelectrosurgicalForceps whichdeliverselectrosurgicalcurrent to targettissue. | Equivalent | Evidence: testreport number954MVPE2N-2012196R |
| Rated AccessoryVoltage | 2.0kVp | The bipolarforceps areintended for usewith a maximumvoltage of 500volts while themonopolarforceps have amaximum voltageof 2000 volts. | Equivalent | Evidence:Acceleratedaging test report |
| Biocompatibility | Non irritant, nonsensitive to skin,non toxic to cells | Non irritant, nonsensitive to skin,non toxic to cells | Equivalent | Evidence:Biocompatibilitytest report |
| Shelf life | 3 years | 3 years | Equivalent | Evidence:Labeling |
| Target population | All patients, nospecificrestriction | All patients, nospecificrestriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU |
{12}------------------------------------------------
{13}------------------------------------------------
Table 4: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Bipolar Forceps_(CD957) Predicate device K130669
| Compared Items | ProposedDevice(K210315)Single Use HandSwitchMonopolarForceps withSmokeEvacuation | Predicate Device(K130669)Olsen MedicalBipolar andMonopolarForceps | Result | Comments ondifference/equivalentevidence |
|---|---|---|---|---|
| ClassificationName | Electrosurgical,Cutting andCoagulationAccessories | Electrosurgical,Cutting andCoagulationAccessories | Equivalent | |
| Regulation | 878.4400 | 878.4400 | Equivalent | |
| CommonName | Single Use HandSwitch BipolarForceps | Single UseBipolar andMonopolarForcepsMultiple-UseBipolar and | Equivalent |
{14}------------------------------------------------
| Product Code | MonopolarForceps | |||
|---|---|---|---|---|
| Intended use | GEI | Equivalent | Evidence: IFU | |
| GEI | The OLSENMedicalElectrosurgicalMonopolar andBipolar Forcepsare intended tobe used as activeelectrosurgicaldevices wheremonopolar orbipolarelectrosurgicalcutting andcoagulation isdesired duringsurgery and areintended tograsp,manipulate cut orcoagulateselected softtissue. | Equivalent | ||
| Prescription orOTC | Prescription Use | Equivalent | ||
| Indication for use | The devicedeliverselectrosurgicalcurrent to targettissue forcoagulation inelectrosurgicalprocedure. | OLSENMedical®ElectrosurgicalMonopolar andBipolar Forcepshave beendesigned asactiveelectrosurgicalinstruments tograsp,manipulate, cutor coagulateselected softtissue. Thesestainless steelforceps areconnectedthrough asuitable activeelectrosurgicalcable (bipolar ormonopolar) to thespecified outputterminal of an | Evidence: IFU |
{15}------------------------------------------------
| Sterility | ETO | Irradiation | Equivalent | ETO sterilizationvalidation havedone for thisdevice. Evidence:EO validationreport numberR-EO2011 |
|---|---|---|---|---|
| Usage | Single Use | Disposable andreusable | Equivalent | Evidence: IFU |
| Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence:MaterialTechnical DataSheet |
| Size (distaltips) | 0.1-1.2mm | 0.5-1.5mm | Not Equivalent | Tip Size doesn'tincrease any riskfor the product.Evidence:955MVPE1N-2111122R. |
| Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU |
| ElectricalSafetyTesting | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence:DSS GZES200802563702-IEC60601-2-2 |
| Energy delivery | MonopolarelectrosurgicalForceps whichdeliverselectrosurgicalcurrent to targettissue. | Monopolar orbipolarelectrosurgicalForceps whichdeliverselectrosurgicalcurrent to targettissue. | Equivalent | Evidence: testreport number954MVPE2N-2012196R |
| Rated AccessoryVoltage | 2.0kVp | The bipolarforceps areintended for usewith a maximumvoltage of 500volts while themonopolarforceps have amaximum voltageof 2000 volts. | Equivalent | Evidence:Acceleratedaging test report |
| Biocompatibility | Non irritant, nonsensitive to skin,non toxic to cells | Non irritant, nonsensitive to skin,non toxic to cells | Equivalent | Evidence:Biocompatibilitytest report |
| Shelf life | 3 years | 3 years | Equivalent | Evidence:Labeling |
| Target population | All patients, nospecificrestriction | All patients, nospecificrestriction | Equivalent | Evidence: IFU |
| Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU |
{16}------------------------------------------------
We conclude that proposal devices are substantial equivalence to predicate devices.
9. Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with
ISO11135:2014/AMD 1:2018 Sterilization of health-care products - Ethylene oxide - Requirement s for the development, validation and routine control of a sterilization process for medical devices
Performance Testing included comparative device use on porcine tissue: kidney, liver and muscle for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016.
10. Safety and Biocompatibility testing data
Electrical Safety complies with
IEC 60601-1:2005+AMD1:2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential perfor mance
IEC 60601-1-2:2014
Medical electrical equipment - Part 1 -2: General requirements for basic safety and essential perf ormance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2:2017
Medical electrical equipment - Part 2- 2: Particular requirements for the basic safety and essentia I performance of high frequency surgical equipment and high frequency surgical accessories
The proposed devices are an external device that contacts tissue/bone/dentin for limited contact duration (less than 24 hours). No biologically significant effect was observed in tests conducted in accordance with following ISO 10993 standards for Cytotoxicity, Sensitization, Intracutaneous reactivity, Material-mediated pyrogenicity and Acutesystemic toxicity.
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
{17}------------------------------------------------
ISO 10993-11:2017
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
11. Conclusion
The proposed Modern Medical Monopolar and Bipolar Forceps is similar in design as its predicates. The Modern Medical Forceps are sterilized using equivalent material and processes as its predicates. The subject devices also have same intended use and performance characteristics as their predicates. No new technological characteristics were introduced and as such, the proposed forceps do not raise new types of safety and effectiveness issues as compared to the predicates.
§ 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.