Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
Device Facts
| Record ID | K182773 |
|---|---|
| Device Name | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps |
| Applicant | Faulhaber Pinzetten Ohg |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Oct 8, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Faulhaber Single Use Non-Stick Bipolar Forceps sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile. Products supplied non-sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.
Device Story
Single-use bipolar forceps (with or without irrigation) used for tissue coagulation in general surgery. Device connects to standard electrosurgical generators via bipolar cable. Irrigation models feature a drain along the tines connected to an irrigation pump via Luer-Lock. Operated by physicians in clinics/hospitals. Provides mechanical tissue grasping and electrical coagulation. Benefits include non-stick tips to reduce tissue adhesion and irrigation to manage thermal effects. Substantially equivalent to reusable Egon Faulhaber forceps (K101080) in design/materials, adapted for single-use and irrigation.
Clinical Evidence
Bench testing only. No clinical data. Testing included drop tests (ISO 2248), electrical safety (IEC 60601-2-2), mechanical strength, and thermal effects on tissue (liver, kidney, muscle) compared to reusable predicate. All results met pre-defined acceptance criteria.
Technological Characteristics
Materials: Stainless steel (ISO 7153-1), sterling silver, Rilsan (nylon) coating. Bipolar electrosurgical principle. Bayonet form factor. Connectivity: US-Pin bipolar connector, Luer-Lock irrigation port. Sterilization: Gamma irradiation (sterile units) or steam sterilization (non-sterile units). Electrical safety per IEC 60601-2-2.
Indications for Use
Indicated for bipolar coagulation and irrigation of tissue in general surgery, including laryngeal, orthopedic, thoracic, neurosurgical, gynecological (excluding female sterilization), urological, and ENT procedures. Intended for use by physicians familiar with electrosurgery.
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Predicate Devices
- Egon Faulhaber Bipolar, Non-Stick Bipolar and Monopolar Forceps (K101080)
Reference Devices
- Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (K080187)
Related Devices
- K233351 — 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 Force · Hg Innovations, Ltd. · Nov 20, 2023
- K102752 — STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS · Stingray Surgical Products, Inc. · Nov 9, 2011
- K233346 — 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); · Hg Innovations, Ltd. · Nov 20, 2023
- K123172 — KOGENT BIPOLAR FORCEPS · Katalyst Surgical, LLC · Dec 21, 2012
- K110924 — DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS · Synergetics, Inc. · Dec 7, 2011
Submission Summary (Full Text)
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October 8, 2019
Faulhaber Pinzetten OHG Ms. Dorothea Faulhaber General Manager Daimlerstr. 1 D-78665 Frittlingen Germany
Re: K182773
Trade/Device Name: Single-Use Non-Stick Bipolar Forceps sterile/non-sterile Single-Use Non-Stick Bipolar Irrigating forceps sterile/non-sterile
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 5, 2019 Received: August 8, 2019
Dear Dorothea Faulhaber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
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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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
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# Indications for Use
510(k) Number (if known) K182773
#### Device Name
Single Use Non-Stick Bipolar Forceps sterile/ non-sterile Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile
#### Indications for Use (Describe)
Faulhaber Single Use Non-Stick Bipolar Forceps sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile.
Products supplied non-sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.
The bipolar forceps have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.
The types of surgery intended are
- General surgery
- Laryngeal coagulation
- Orthopedic coagulation
- Thoracic coagulation
- Neurosurgical coagulation
- Gynecological coagulation (except for use in female sterilization)
- Urological coagulation
- Ear-, Nose-, Throat coagulation
| 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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# 510 (k) Summary
### 1. Submitter's Contract Information
| FAULHABER PINZETTEN OHG | |
|-------------------------|----------------------------------------|
| Daimlerstr. 1 | |
| D – 78665 Frittlingen | |
| Telephone: | 00497426 - 96 38 53-0 |
| Fax: | 00497426 – 96 38 53-30 |
| Contact Person: | Ms. Dorothea Faulhaber, CEO |
| Contact Person: | Ms. Patricia Pfaff, Quality Management |
| Date prepared: | 06/Oct/2019 |
### 2. Device name and classification
| Trade name: | Single Use Non-Stick Bipolar Forceps sterile/ non sterile<br>Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non sterile |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Single Use Bipolar Forceps |
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Product code: | GEI |
| Regulation number: | 878.4400 |
| Classification: | Class II |
| Predicate Device: | K101080 Egon Faulhaber Pinzetten |
| Reference Devices: | K080187 Olsen Medical |
#### 3. Predicate devices
#### 3.1 Primary predicate device
| | Device Owner/<br>Trade Name | 510(k) # | Product Code |
|-----------------------------|--------------------------------------------------------------------------|----------|-------------------------------------------------------------------------|
| Primary<br>Predicate Device | Egon Faulhaber<br>Bipolar, Non-Stick<br>Bipolar and Monopolar<br>Forceps | K101080 | GEI Electrosurgical, Cutting &<br>Coagulation & Accessories<br>Class II |
#### 3.2 Reference device
| | Device Owner/<br>Trade Name | 510(k) # | Product Code |
|---------------------|-------------------------------------------------------------------|----------|-------------------------------------------------------------------------|
| Reference<br>Device | Olsen Medical<br>Single Use Bayonet<br>Bipolar Irrigating Forceps | K080187 | GEI Electrosurgical, Cutting &<br>Coagulation & Accessories<br>Class II |
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Image /page/4/Picture/1 description: The image shows a logo with a gold-colored design inside a diamond shape. The design appears to be two stylized letters, possibly 'T' and 'E', mirrored and joined together in the center. The logo has a symmetrical and geometric appearance, with sharp lines and angles that create a modern and abstract look.
#### 4. Device Description
The product family "Single Use Bipolar Forceps", including Faulhaber Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Bipolar Irrigating Forceps, are intended to be used for bipolar coagulation and irrigation of tissue by physicians familiar with bipolar coagulation in medical practices and clinics.
The Single Use Bipolar Forceps are single use products and must not be reused. They are provided sterile as well as non-sterile. Products delivered non sterile must be cleaned, disinfected and sterilized before use.
For the application the Single Use Bipolar Forceps have to be connected by appropriate bipolar cable to the bipolar output of an HF generator. Bipolar cables and ESU are not part of the subject device.
The Single Use Bipolar Forceps are provided in bayonet design with non-stick tips and are identical in design, construction, materials and manufacturing to the reusable device EGON FAULHABER Bipolar Non-Stick Forceps (K101080). The principles of operation and mechanism of action are identical as well.
In addition to the cleared and leqally marketed EGON FAULHABER devices, the products are with irrigation function available. The irrigation function works via a drain running along the forceps tines from tip to handle height, the drain is connected by Luer-Lock via an irrigation tubing with an irrigation pump.
#### 5. Intended Use/ Indications for use
Faulhaber Single Use Non-Stick Bipolar Forceps sterile and Single Use Non-Stick Irrigating Forceps sterile are intended for use by a physician familiar with electrosurgery for bipolar coaqulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non sterile. Products supplied non sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.
The bipolar forceps have not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures and should not be used for these procedures.
The types of surgery intended are
- General surgery -
- -Laryngeal coagulation
- -Orthopedic coaqulation
- Thoracic coagulation -
- -Neurosurgical coagulation
- -Gynecological coaqulation (except for use in female sterilization)
- -Urological coaqulation
- Ear-, Nose- and Throat coagulation -
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## 6. Substantial Equivalence discussion
| | Subject Device<br>K182773<br>Single Use Bipolar<br>Forceps (sterile and non-<br>sterile)<br>Faulhaber Pinzetten<br>OHG | Primary Predicate<br>Device K101080<br>Bipolar, Non-Stick<br>Bipolar and Monopolar<br>Forceps<br>EGON FAULHABER<br>Pinzetten | Reference Device<br>K080187<br>Single Use Bayonet<br>Bipolar Irrigating Forceps<br>Olsen Medical | |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k)<br>number | K182773 | K101080 | K080187 | |
| 510(k)<br>submitter/hold<br>er | Faulhaber Pinzetten<br>OHG | EGON FAULHABER<br>Pinzetten | Olsen Medical | |
| Product Code | GEI | GEI | GEI | |
| Indications for<br>Use/ Intended<br>Use | Faulhaber Single Use<br>Non-Stick Bipolar<br>Forceps and Single Use<br>Non-Stick Bipolar<br>Irrigating Forceps are<br>intended for use by a<br>physician familar with<br>electrosurgery for bipolar<br>coagulation and irrigation<br>of tissue for general<br>surgery. The bipolar<br>forceps are used with the<br>bipolar output for<br>standard electrosurgical<br>generators.<br>The products are<br>intended for single use<br>and are provided sterile<br>as well as non-sterile.<br>Products supplied non-<br>sterile must be cleaned,<br>disinfected and sterilized<br>prior to their use by the<br>validated cleaning,<br>disinfection and<br>sterilization process.<br>The bipolar forceps have<br>not been shown to be<br>effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures<br>and should not be used | The EGON<br>FAULHABER Bipolar,<br>Non-Stick Bipolar and<br>Monopolar Forceps are<br>intended for use by a<br>physician familar with<br>electrosurgery in bipolar<br>and monopolar<br>coagulation for general<br>surgery where<br>coagulation of soft tissue<br>is needed. The Bipolar<br>Forceps are used with<br>the bipolar and the<br>Monopolar Forceps are<br>used with the<br>monopolar output for<br>standard electrosurgical<br>generators.<br>The EGON<br>FAULHABER Bipolar,<br>Non-Stick Bipolar and<br>Monopolar Forceps have<br>not been shown to be<br>effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures<br>and should not be used<br>for this procedures.<br>The types of surgery<br>intended are | The Olsen Medical<br>Single Use Bayonet<br>Bipolar Irrigating<br>Forceps is a single use<br>product sold sterile and<br>is intended for use in<br>electro surgery for<br>coagulation and irrigation<br>of tissue. This device is<br>intended for use with the<br>OLSEN MEDICAL<br>Integrated Irrigation<br>Tubing and Bipolar Cord<br>Set or similar design of<br>Bipolar Cord and<br>Irrigation Tubing. | |
| | Subject Device<br>K182773<br>Single Use Bipolar<br>Forceps (sterile and non-<br>sterile)<br>Faulhaber Pinzetten | Primary Predicate<br>Device K101080<br>Bipolar, Non-Stick<br>Bipolar and Monopolar<br>Forceps<br>EGON FAULHABER | Reference Device<br>K080187<br>Single Use Bayonet<br>Bipolar Irrigating Forceps<br>Olsen Medical | |
| | OHG | Pinzetten | | |
| | for these procedures.<br>The types of surgery<br>intended are<br>- General surgery<br>- Laryngeal coagulation<br>- Orthopedic coagulation<br>- Thoracic coagulation<br>- Neurosurgical<br>coagulation<br>- Gynecological<br>coagulation (except for<br>use in female<br>sterilization)<br>- Urological coagulation<br>- Ear-, Nose-, and Throat<br>coagulation | - Laryngeal coagulation<br>- Orthopedic coagulation<br>- Thoracic coagulation<br>- Neurosurgical<br>coagulation<br>- Gynecological<br>coagulation (except for<br>use in female<br>sterilization)<br>- Urological coagulation<br>- Ear-, Nose-, and Throat<br>coagulation | | |
| Product life | Single use | Reusable | Single use | |
| Application<br>Technology | Bipolar | Bipolar and monopolar | Bipolar | |
| Tip<br>dimensions/<br>Tip material | 0.5 mm – 1.5 mm<br>Sterling silver | 0.25 mm – 2.0 mm<br>Sterling silver | 0.5 mm – 1.5 mm<br>Non-Stick Cermet<br>(Ceramic Metal) Coating | |
| Shaft style/<br>Shaft | Bayonet | Straight/ Angled/<br>Bayonet | Bayonet | |
| dimensions/<br>Shaft<br>materials | 203 mm – 300 mm<br>Coated Stainless steel | 110 mm – 250 mm<br>Coated Stainless steel | 180 mm – 267 mm<br>Insulated stainless steel<br>body | |
| Cable<br>connector<br>type | US-Pin | US-Pin | Twin Pin | |
| Irrigation<br>connector<br>type | Female luer to be<br>connected with male luer<br>of irrigation tubing | not applicable | Female luer for use with<br>the Olsen medical<br>Integrated Irrigation<br>Tubing and Bipolar Cord<br>Set or similar design of<br>Bipolar Cord and<br>Irrigation Tubing | |
| Body contact<br>material | - Stainless steel acc. ISO<br>7153-1<br>- Sterling silver | - Stainless steel acc.<br>ISO 7153-1<br>- Sterling silver | - Stainless steel body<br>with nylon insulation<br>- Non-stick Cermet | |
| | Subject Device<br>K182773<br>Single Use Bipolar<br>Forceps (sterile and non-<br>sterile)<br>Faulhaber Pinzetten<br>OHG | Primary Predicate<br>Device K101080<br>Bipolar, Non-Stick<br>Bipolar and Monopolar<br>Forceps<br>EGON FAULHABER<br>Pinzetten | Reference Device<br>K080187<br>Single Use Bayonet<br>Bipolar Irrigating Forceps<br>Olsen Medical | |
| | - Rilsan® (Nylon)<br>Coating | - Rilsan® (Nylon)<br>Coating | (Ceramic Metal) coating | |
| Delivery<br>status | Sterile and non-sterile | Non sterile | Sterile | |
| Sterilization<br>method for<br>products<br>provided<br>sterile | Gamma irradiation | not applicable | Ethylene Oxide (EtO) | |
| Packaging for<br>products<br>provided<br>sterile | Cleerpeel® Foil Pouch | not applicable | Tyvek® Pouch | |
| Sterilization<br>method for<br>initial<br>treatment/<br>reprocessing | Steam sterilization | Steam sterilization | not applicable | |
| Packaging for<br>products<br>provided non-<br>sterile | foil bag with cardboard<br>box | foil bag with cardboard<br>box | not applicable | |
| Maximum<br>Peak Voltage | ≤ 500 Vp | ≤ 500 Vp | Information not available | |
| Tissue<br>temperature<br>range | ~ 60°C - ~ 100°C | ~ 60°C - ~ 100°C | Information not available | |
| Method of<br>operation | mechanical activation,<br>no switch | both, mechanical<br>activation (bipolar) and<br>handle with switch<br>(monopolar) | mechanical activation,<br>no switch | |
| Accessories | No | No | Olsen medical Integrated<br>Irrigation Tubing and<br>Bipolar Cord Set or<br>similar design of Bipolar<br>Cord and Irrigation<br>Tubing | |
| Safety<br>features | Dielectric strength<br>insulation acc. IEC<br>60601-2-2; insulated<br>safety plug | Dielectric strength<br>insulation acc. IEC<br>60601-2-2; insulated<br>safety plug | Insulated | |
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# 510 (k) Summary
K182773
Image /page/6/Picture/1 description: The image shows a logo with a diamond shape as the background. Inside the diamond, there is a stylized design that resembles the letters 'AE' or a symmetrical arrow-like figure. The color of the logo and the design is a golden hue, which gives it a premium or elegant feel. The design is simple, yet distinctive, making it easily recognizable.
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# 510 (k) Summary
K182773
Image /page/7/Picture/1 description: The image shows a golden emblem. The emblem is diamond-shaped with a stylized design inside. The design appears to be a symmetrical arrangement of lines and shapes, possibly resembling letters or abstract symbols. The color is a consistent gold tone, giving the emblem a sense of value and importance.
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Image /page/8/Picture/1 description: The image shows a logo with a gold-colored design inside a diamond shape. The design appears to be an abstract representation of the letters 'T' and 'E' intertwined. The logo has a symmetrical appearance, with the 'T' shape in the center and the 'E' shape forming the outer edges of the design.
This submission supports the position that the Faulhaber Pinzetten OHG forceps is substantially equivalent to a number of previously cleared devices, including Olsen Medical Single Use Bayonet Irrigating Bipolar Forceps.
#### 7. Performance data:
Performance testing of the product family Single Use Bipolar Forceps was determined by the application of a risk management process acc. ISO 14971:2013-04.
As a result of the risk analysis and regarding the applicable FDA quidance documents, the following tests have been identified as essential.
The indicated performance tests were derived and have been projected. The performance data were provided in support of the substantial equivalence determination.
#### 7.1 Drop Test acc. DIN EN 22248:1993-02 (ISO 2248:1985) "Packaging; complete, filled transport packages; vertical impact test by dropping"
The vertical impact test was conducted on Faulhaber Single Use Bipolar Forceps acc. to DIN EN 22248:1993-02 (ISO 2248:1985).
The products in their primary and outer packaging have passed the tests without damage. The outer packaging is in a transportable condition.
The test of the packaging system has been successfully completed, the vertical impact test demonstrated the suitability of the packaging system successfully.
The test results are sufficient to support substantial equivalence of the subject device with the predicate devices.
#### 7.2 Electrical safety acc. DIN EN IEC 60601-2-2:2018-12 (IEC 60601-2-2:2017)
Electrical safety testing was conducted on Faulhaber Single Use Bipolar Forceps. The instruments have completed the entire test cycles without changes or impairments, in particular to insulation, but also in terms of mechanics and function.
The testing of the instruments for dielectric strength therefore have been completed successfully.
The system complies with the DIN EN IEC 60601-2-2:2018-12 (IEC 60601-2-2:2017) standards for electrical safety.
The test results are sufficient to support substantial equivalence of the subject device with the predicate devices.
#### 7.3 Performance Tests "Mechanical strength/ Electrical performance with all components and accessories as a system/ Thermal effects on tissue"
Performance tests regarding mechanical strength, electrical performance with all components and accessories as a system and thermal effects on tissue have been conducted on Faulhaber Single Use Bipolar Forceps.
The test procedures correspond to the FDA Guidance document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff", issued August 15, 2016.
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Image /page/9/Picture/1 description: The image shows a golden emblem. The emblem is a diamond shape with a stylized design inside. The design appears to be a combination of geometric shapes and lines, possibly representing a stylized letter or symbol. The color of the emblem is a warm, golden hue, which contrasts with the white background.
For the test performance regarding thermal effects on tissue, three different types of tissue (liver, kidney and muscle) were coagulated with the Single Use Non-Stick Bipolar Forceps with irrigation function and without irrigation function at different settings. For comparison, all tests were carried out with the product "Faulhaber Pinzetten OHG Non-Stick Bipolar Forceps bavonet, reusable".
The tests were carried out in accordance with the Guidance for industry and food and drug administration staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" from August 15, 2016.
All test results met the pre-defined acceptance criteria.
The evaluation of the results also included a comparison between products with irrigation function and products without irrigation function. This comparison allows the conclusion that products with irrigation function achieve the same results, with maximum power setting even better result than the products without irrigation function.
The performance test showed that the products of the product family "Single Use Bipolar Forceps" are able to provide, with or without irrigation of tissue during coagulation, safe and appropriate results for the intended use.
The test results are sufficient to support substantial equivalence of the subject device with the predicate devices.
#### 8. Biocompatibility:
The Biological Evaluation of the Single Use Bipolar Forceps was conducted in accordance with use of International Standard ISO-10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.
Based on the risk management it was proven, that the Single Use Bipolar Forceps are manufactured from identical material using identical processes and procedures as the primary predicate device K101080. Identical machines and equipment as well as identical operating- and auxiliary materials are used in production processes. Therefore, additional clinical tests are not necessary, because the safety for use of the materials has been proved in the past and will continue to be monitored by Post Marke…
