(372 days)
No
The device description and intended use focus on the mechanical and electrical function of bipolar forceps for coagulation and irrigation. There is no mention of AI or ML in the summary, and the performance studies are based on standard electrical and mechanical testing, not algorithmic performance.
Yes
The device is intended for bipolar coagulation and irrigation of tissue for general surgery, which are therapeutic medical procedures.
No
The device is intended for bipolar coagulation and irrigation of tissue, which are therapeutic rather than diagnostic functions.
No
The device is a physical medical instrument (bipolar forceps) used for electrosurgery and irrigation, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is intended for "bipolar coagulation and irrigation of tissue for general surgery." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for surgical procedures like laryngeal coagulation, orthopedic coagulation, etc., which are all in-vivo applications.
- No Mention of Samples or Testing: The text does not mention any analysis of biological samples or diagnostic testing.
Therefore, the Faulhaber Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Bipolar Irrigating Forceps are surgical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
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
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician familiar with electrosurgery in medical practices and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted by the application of a risk management process according to ISO 14971:2013-04. Tests identified as essential include:
- Drop Test acc. DIN EN 22248:1993-02 (ISO 2248:1985) "Packaging; complete, filled transport packages; vertical impact test by dropping". The products in their primary and outer packaging passed the tests without damage.
- Electrical safety acc. DIN EN IEC 60601-2-2:2018-12 (IEC 60601-2-2:2017). The instruments completed entire test cycles without changes or impairments to insulation, mechanics, or function, and comply with the standards for electrical safety.
- Performance Tests "Mechanical strength/ Electrical performance with all components and accessories as a system/ Thermal effects on tissue". These tests were conducted according 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. For thermal effects, three types of tissue (liver, kidney, muscle) were coagulated with and without irrigation at different settings. All test results met pre-defined acceptance criteria. The comparison showed that products with irrigation achieved results similar to or better than those without irrigation, particularly at maximum power settings. The performance tests showed that the products are able to provide safe and appropriate results for the intended use, with or without irrigation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the full name written out to the right of it.
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
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 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
2
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) |
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
Image /page/3/Picture/1 description: The image shows a golden emblem inside of a diamond shape. The emblem is symmetrical and appears to be made up of two stylized letters that are mirror images of each other. The emblem and the diamond shape have a thin golden outline.
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
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/
Trade Name | 510(k) # | Product Code |
|-----------------------------|--------------------------------------------------------------------------|----------|-------------------------------------------------------------------------|
| Primary
Predicate Device | Egon Faulhaber
Bipolar, Non-Stick
Bipolar and Monopolar
Forceps | K101080 | GEI Electrosurgical, Cutting &
Coagulation & Accessories
Class II |
3.2 Reference device
| | Device Owner/
Trade Name | 510(k) # | Product Code |
|---------------------|-------------------------------------------------------------------|----------|-------------------------------------------------------------------------|
| Reference
Device | Olsen Medical
Single Use Bayonet
Bipolar Irrigating Forceps | K080187 | GEI Electrosurgical, Cutting &
Coagulation & Accessories
Class II |
4
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 -
5
Image /page/5/Picture/1 description: The image shows a gold-colored emblem. The emblem is diamond-shaped and contains a stylized design that resembles two mirrored letter 'T's. The design is symmetrical and has a sharp, modern look.
6. Substantial Equivalence discussion
| | Subject Device
K182773
Single Use Bipolar
Forceps (sterile and non-
sterile)
Faulhaber Pinzetten
OHG | Primary Predicate
Device K101080
Bipolar, Non-Stick
Bipolar and Monopolar
Forceps
EGON FAULHABER
Pinzetten | Reference Device
K080187
Single Use Bayonet
Bipolar Irrigating Forceps
Olsen Medical | |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k)
number | K182773 | K101080 | K080187 | |
| 510(k)
submitter/hold
er | Faulhaber Pinzetten
OHG | EGON FAULHABER
Pinzetten | Olsen Medical | |
| Product Code | GEI | GEI | GEI | |
| Indications for
Use/ Intended
Use | Faulhaber Single Use
Non-Stick Bipolar
Forceps and Single Use
Non-Stick Bipolar
Irrigating Forceps 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
sterilization or tubal
coagulation for
sterilization procedures
and should not be used | The EGON
FAULHABER Bipolar,
Non-Stick Bipolar and
Monopolar Forceps are
intended for use by a
physician familar with
electrosurgery in bipolar
and monopolar
coagulation for general
surgery where
coagulation of soft tissue
is needed. The Bipolar
Forceps are used with
the bipolar and the
Monopolar Forceps are
used with the
monopolar output for
standard electrosurgical
generators.
The EGON
FAULHABER Bipolar,
Non-Stick Bipolar and
Monopolar Forceps have
not been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization procedures
and should not be used
for this procedures.
The types of surgery
intended are | The Olsen Medical
Single Use Bayonet
Bipolar Irrigating
Forceps is a single use
product sold sterile and
is intended for use in
electro surgery for
coagulation and irrigation
of tissue. This device is
intended for use with the
OLSEN MEDICAL
Integrated Irrigation
Tubing and Bipolar Cord
Set or similar design of
Bipolar Cord and
Irrigation Tubing. | |
| | Subject Device
K182773
Single Use Bipolar
Forceps (sterile and non-
sterile)
Faulhaber Pinzetten | Primary Predicate
Device K101080
Bipolar, Non-Stick
Bipolar and Monopolar
Forceps
EGON FAULHABER | Reference Device
K080187
Single Use Bayonet
Bipolar Irrigating Forceps
Olsen Medical | |
| | OHG | Pinzetten | | |
| | 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-, and Throat
coagulation | - Laryngeal coagulation - Orthopedic coagulation
- Thoracic coagulation
- Neurosurgical
coagulation - Gynecological
coagulation (except for
use in female
sterilization) - Urological coagulation
- Ear-, Nose-, and Throat
coagulation | | |
| Product life | Single use | Reusable | Single use | |
| Application
Technology | Bipolar | Bipolar and monopolar | Bipolar | |
| Tip
dimensions/
Tip material | 0.5 mm – 1.5 mm
Sterling silver | 0.25 mm – 2.0 mm
Sterling silver | 0.5 mm – 1.5 mm
Non-Stick Cermet
(Ceramic Metal) Coating | |
| Shaft style/
Shaft | Bayonet | Straight/ Angled/
Bayonet | Bayonet | |
| dimensions/
Shaft
materials | 203 mm – 300 mm
Coated Stainless steel | 110 mm – 250 mm
Coated Stainless steel | 180 mm – 267 mm
Insulated stainless steel
body | |
| Cable
connector
type | US-Pin | US-Pin | Twin Pin | |
| Irrigation
connector
type | Female luer to be
connected with male luer
of irrigation tubing | not applicable | Female luer for use with
the Olsen medical
Integrated Irrigation
Tubing and Bipolar Cord
Set or similar design of
Bipolar Cord and
Irrigation Tubing | |
| Body contact
material | - Stainless steel acc. ISO
7153-1 - Sterling silver | - Stainless steel acc.
ISO 7153-1 - Sterling silver | - Stainless steel body
with nylon insulation - Non-stick Cermet | |
| | Subject Device
K182773
Single Use Bipolar
Forceps (sterile and non-
sterile)
Faulhaber Pinzetten
OHG | Primary Predicate
Device K101080
Bipolar, Non-Stick
Bipolar and Monopolar
Forceps
EGON FAULHABER
Pinzetten | Reference Device
K080187
Single Use Bayonet
Bipolar Irrigating Forceps
Olsen Medical | |
| | - Rilsan® (Nylon)
Coating | - Rilsan® (Nylon)
Coating | (Ceramic Metal) coating | |
| Delivery
status | Sterile and non-sterile | Non sterile | Sterile | |
| Sterilization
method for
products
provided
sterile | Gamma irradiation | not applicable | Ethylene Oxide (EtO) | |
| Packaging for
products
provided
sterile | Cleerpeel® Foil Pouch | not applicable | Tyvek® Pouch | |
| Sterilization
method for
initial
treatment/
reprocessing | Steam sterilization | Steam sterilization | not applicable | |
| Packaging for
products
provided non-
sterile | foil bag with cardboard
box | foil bag with cardboard
box | not applicable | |
| Maximum
Peak Voltage | ≤ 500 Vp | ≤ 500 Vp | Information not available | |
| Tissue
temperature
range | ~ 60°C - ~ 100°C | ~ 60°C - ~ 100°C | Information not available | |
| Method of
operation | mechanical activation,
no switch | both, mechanical
activation (bipolar) and
handle with switch
(monopolar) | mechanical activation,
no switch | |
| Accessories | No | No | Olsen medical Integrated
Irrigation Tubing and
Bipolar Cord Set or
similar design of Bipolar
Cord and Irrigation
Tubing | |
| Safety
features | Dielectric strength
insulation acc. IEC
60601-2-2; insulated
safety plug | Dielectric strength
insulation acc. IEC
60601-2-2; insulated
safety plug | Insulated | |
6
510 (k) Summary
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.
7
510 (k) Summary
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.
8
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.
9
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 Market Surveillance.
The results of the Biological Evaluation are appropriate to support substantial equivalence of the subject device with the predicate device.
9. Conclusion
The subject device is identical in design, material and manufacturing with the primary predicate device. Regarding the deviations from the primary predicate device in single usage, irrigation function and sterile condition, the subject device is similar to the predicate device.
Regarding these aspects, the performance testing has been conducted and successfully passed.
The results of nonclinical testing demonstrate that the subject device is as safe and effective and performs as well as the predicate devices.
For these reasons we conclude that the subject device K182773 is substantially equivalent to the cleared and legally marketed predicate devices K101080 and K080187.