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

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.

AI/ML Overview

This FDA 510(k) summary describes the "Single Use Non-Stick Bipolar Forceps sterile/non-sterile" and "Single Use Non-Stick Bipolar Irrigating forceps sterile/non-sterile" and their substantial equivalence to predicate devices. However, the document does not provide acceptance criteria in a tabular format with reported device performance for specific clinical metrics. Instead, it focuses on demonstrating safety and efficacy through non-clinical performance tests and comparison to a predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria and reported device performance in a formal table with specific numerical metrics commonly associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating compliance with recognized standards and successful completion of engineering tests.

The general "acceptance criterion" implicit throughout the document is that the subject device performs as safely and effectively as the predicate devices and meets relevant electrical safety and mechanical strength standards.

Acceptance Criteria Category	Reported Device Performance
Mechanical Strength (Drop Test)	Passed without damage; outer packaging remained in transportable condition. Demonstrated suitability of the packaging system.
Electrical Safety (DIN EN IEC 60601-2-2)	Completed entire test cycles without changes or impairments to insulation, mechanics, or function. Complies with the standard.
Performance (Mechanical Strength, Electrical Performance, Thermal Effects on Tissue)	All test results met pre-defined acceptance criteria. Products with irrigation function achieved same results, and in some cases better results (with maximum power setting) than products without irrigation function. Provided safe and appropriate results for intended use.
Biocompatibility (ISO 10993-1)	Manufactured from identical material using identical processes and procedures as the primary predicate device (K101080). Safety for use of materials proven in past and monitored by Post Market Surveillance.

2. Sample size used for the test set and the data provenance

The document describes non-clinical performance testing.

Sample Size: The document does not specify general "sample sizes" in terms of number of devices tested for each performance test. For the thermal effects on tissue, it states "three different types of tissue (liver, kidney and muscle) were coagulated." This refers to the tissue types, not the number of devices or test repetitions.
Data Provenance: The tests are described as in vitro or bench tests conducted "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." The location of these tests or the "country of origin of the data" is not explicitly stated, but the manufacturer is based in Germany, and European standards (DIN EN IEC) are cited. These are non-clinical, controlled tests, not derived from clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The device is a medical instrument (electrosurgical forceps), not an AI/ML device that generates diagnoses or interpretations requiring human expert "ground truth." The performance is evaluated based on objective physical, electrical, and thermal properties as per engineering standards and guidance.

4. Adjudication method for the test set

This information is not applicable. As stated above, this is not an AI/ML device evaluating clinical cases requiring expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

For this electrosurgical device, "ground truth" is established by:

Compliance with recognized international standards for electrical safety (DIN EN IEC 60601-2-2) and biocompatibility (ISO 10993-1).
Demonstration of mechanical integrity through drop testing.
Demonstration of appropriate thermal effects on tissue, tested on "three different types of tissue (liver, kidney and muscle)" in comparison to a predicate device and meeting "pre-defined acceptance criteria." This could be considered a form of "bench test ground truth" where expected thermal effects are the standard.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/ML device and does not have a "training set."

In summary, the provided document describes a device submission for an electrosurgical instrument, not an AI/ML-driven device. Therefore, many of the requested details regarding AI/ML device evaluation (like expert ground truth, MRMC studies, training sets) are not relevant to this specific K182773 submission.

Summary

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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)

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 sterileSingle 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
PrimaryPredicate Device	Egon FaulhaberBipolar, Non-StickBipolar and MonopolarForceps	K101080	GEI Electrosurgical, Cutting &Coagulation & AccessoriesClass II

3.2 Reference device

	Device Owner/Trade Name	510(k) #	Product Code
ReferenceDevice	Olsen MedicalSingle Use BayonetBipolar Irrigating Forceps	K080187	GEI Electrosurgical, Cutting &Coagulation & AccessoriesClass 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

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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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 DeviceK182773Single Use BipolarForceps (sterile and non-sterile)Faulhaber PinzettenOHG	Primary PredicateDevice K101080Bipolar, Non-StickBipolar and MonopolarForcepsEGON FAULHABERPinzetten	Reference DeviceK080187Single Use BayonetBipolar Irrigating ForcepsOlsen Medical
510(k)number	K182773	K101080	K080187
510(k)submitter/holder	Faulhaber PinzettenOHG	EGON FAULHABERPinzetten	Olsen Medical
Product Code	GEI	GEI	GEI
Indications forUse/ IntendedUse	Faulhaber Single UseNon-Stick BipolarForceps and Single UseNon-Stick BipolarIrrigating Forceps areintended for use by aphysician familar withelectrosurgery for bipolarcoagulation and irrigationof tissue for generalsurgery. The bipolarforceps are used with thebipolar output forstandard electrosurgicalgenerators.The products areintended for single useand are provided sterileas well as non-sterile.Products supplied non-sterile must be cleaned,disinfected and sterilizedprior to their use by thevalidated cleaning,disinfection andsterilization process.The bipolar forceps havenot been shown to beeffective for tubalsterilization or tubalcoagulation forsterilization proceduresand should not be used	The EGONFAULHABER Bipolar,Non-Stick Bipolar andMonopolar Forceps areintended for use by aphysician familar withelectrosurgery in bipolarand monopolarcoagulation for generalsurgery wherecoagulation of soft tissueis needed. The BipolarForceps are used withthe bipolar and theMonopolar Forceps areused with themonopolar output forstandard electrosurgicalgenerators.The EGONFAULHABER Bipolar,Non-Stick Bipolar andMonopolar Forceps havenot been shown to beeffective for tubalsterilization or tubalcoagulation forsterilization proceduresand should not be usedfor this procedures.The types of surgeryintended are	The Olsen MedicalSingle Use BayonetBipolar IrrigatingForceps is a single useproduct sold sterile andis intended for use inelectro surgery forcoagulation and irrigationof tissue. This device isintended for use with theOLSEN MEDICALIntegrated IrrigationTubing and Bipolar CordSet or similar design ofBipolar Cord andIrrigation Tubing.
	Subject DeviceK182773Single Use BipolarForceps (sterile and non-sterile)Faulhaber Pinzetten	Primary PredicateDevice K101080Bipolar, Non-StickBipolar and MonopolarForcepsEGON FAULHABER	Reference DeviceK080187Single Use BayonetBipolar Irrigating ForcepsOlsen Medical
	OHG	Pinzetten
	for these procedures.The types of surgeryintended are- General surgery- Laryngeal coagulation- Orthopedic coagulation- Thoracic coagulation- Neurosurgicalcoagulation- Gynecologicalcoagulation (except foruse in femalesterilization)- Urological coagulation- Ear-, Nose-, and Throatcoagulation	- Laryngeal coagulation- Orthopedic coagulation- Thoracic coagulation- Neurosurgicalcoagulation- Gynecologicalcoagulation (except foruse in femalesterilization)- Urological coagulation- Ear-, Nose-, and Throatcoagulation
Product life	Single use	Reusable	Single use
ApplicationTechnology	Bipolar	Bipolar and monopolar	Bipolar
Tipdimensions/Tip material	0.5 mm – 1.5 mmSterling silver	0.25 mm – 2.0 mmSterling silver	0.5 mm – 1.5 mmNon-Stick Cermet(Ceramic Metal) Coating
Shaft style/Shaft	Bayonet	Straight/ Angled/Bayonet	Bayonet
dimensions/Shaftmaterials	203 mm – 300 mmCoated Stainless steel	110 mm – 250 mmCoated Stainless steel	180 mm – 267 mmInsulated stainless steelbody
Cableconnectortype	US-Pin	US-Pin	Twin Pin
Irrigationconnectortype	Female luer to beconnected with male luerof irrigation tubing	not applicable	Female luer for use withthe Olsen medicalIntegrated IrrigationTubing and Bipolar CordSet or similar design ofBipolar Cord andIrrigation Tubing
Body contactmaterial	- Stainless steel acc. ISO7153-1- Sterling silver	- Stainless steel acc.ISO 7153-1- Sterling silver	- Stainless steel bodywith nylon insulation- Non-stick Cermet
	Subject DeviceK182773Single Use BipolarForceps (sterile and non-sterile)Faulhaber PinzettenOHG	Primary PredicateDevice K101080Bipolar, Non-StickBipolar and MonopolarForcepsEGON FAULHABERPinzetten	Reference DeviceK080187Single Use BayonetBipolar Irrigating ForcepsOlsen Medical
	- Rilsan® (Nylon)Coating	- Rilsan® (Nylon)Coating	(Ceramic Metal) coating
Deliverystatus	Sterile and non-sterile	Non sterile	Sterile
Sterilizationmethod forproductsprovidedsterile	Gamma irradiation	not applicable	Ethylene Oxide (EtO)
Packaging forproductsprovidedsterile	Cleerpeel® Foil Pouch	not applicable	Tyvek® Pouch
Sterilizationmethod forinitialtreatment/reprocessing	Steam sterilization	Steam sterilization	not applicable
Packaging forproductsprovided non-sterile	foil bag with cardboardbox	foil bag with cardboardbox	not applicable
MaximumPeak Voltage	≤ 500 Vp	≤ 500 Vp	Information not available
Tissuetemperaturerange	~ 60°C - ~ 100°C	~ 60°C - ~ 100°C	Information not available
Method ofoperation	mechanical activation,no switch	both, mechanicalactivation (bipolar) andhandle with switch(monopolar)	mechanical activation,no switch
Accessories	No	No	Olsen medical IntegratedIrrigation Tubing andBipolar Cord Set orsimilar design of BipolarCord and IrrigationTubing
Safetyfeatures	Dielectric strengthinsulation acc. IEC60601-2-2; insulatedsafety plug	Dielectric strengthinsulation acc. IEC60601-2-2; insulatedsafety plug	Insulated

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510 (k) Summary

K182773

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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 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.

Regulation Number and Section

§ 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.