The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp.

The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended include:

ENT
Gynecology (except for use in female sterilization)
Urology
General surgery
Neurosurgery
Laryngeal Surgery
Orthopedic Surgery
Thoracic Surgery

Device Description

The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn.

AI/ML Overview

This FDA 510(k) summary for the "Adeor Medical nxt Non-stick Bipolar Forceps" focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this document does not contain data related to these aspects for an AI/ML product.

The document primarily discusses the physical characteristics, intended use, and non-clinical testing (electrical safety, wear, function (drop testing)) of surgical forceps, comparing them to legally marketed predicate devices to establish substantial equivalence.

The information provided in the document is about a traditional medical device (bipolar forceps), not an AI/ML device.

Summary

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May 22, 2020

Adeor Medical AG % Cassie Sopko, Regulatory Engineer JALEX Medical 30311 Clemens Rd, Suite 5D Westlake, Ohio 44145

Re: K191847

Trade/Device Name: Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 15, 2020 Received: April 20, 2020

Dear Cassie Sopko:

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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 mediation-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) K191847

Device Name

Adeor Medical AG nxt™ Non-stick Bipolar Forceps Adeor Medical AG nxt™ Single-Use Non-stick Bipolar Forceps

Indications for Use (Describe)

The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended include:

- ENT

Gynecology (except for use in female sterilization)
Urology
General surgery
Neurosurgery
Laryngeal Surgery
Orthopedic Surgery
Thoracic Surgery

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the logo for Adeor Medical. On the left side of the logo is a blue image of a brain. To the right of the brain is the word "adeor" in black, with the word "MEDICAL" in smaller black letters underneath.

510(k) Summary

Submitted By:	Adeor Medical AGBiberger Str. 9382008 UnterhachingGermany
Date:	February 27, 2020
Contact Person:	Cassie Sopko, Regulatory Engineer
Contact Telephone:	(440) 541-0060
Contact Fax:	(440) 933-7839
Device Trade Name:	Adeor Medical nxt ™ Non-stick Bipolar ForcepsAdeor Medical nxt ™ Single-Use Non-stick Bipolar Forceps
Device Classification Name:	Electrosurgical, Cutting and Coagulation Accessories
Device Classification:	II
Reviewing Panel:	General and Plastic Surgery
Product Code:	GEI
Predicate Device:	K182773 Falhaber Pinzetten OHG Non-Stick Bipolar Forceps (neversubject to recall)
Reference Predicates:	K101080- Faulhaber Non-Stick Bipolar ForcepsK162469- CODMAN VersaTru Non-Stick Bipolar ForcepsK130669- Olsen Medical Electrosurgical Monopolar and BipolarForceps (subject to recall Z-1944-2018 and Z-1945-2018 for packagingrisks)

Device Description:

Intended Use:

The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended include:

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Image /page/4/Picture/2 description: The image contains the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the text "adeor" in black. Below "adeor" is the word "MEDICAL" in smaller, black letters.

ENT
Gynecology (except for use in female sterilization) ●
Urology ●
General Surgery
Neurosurgery
Laryngeal Surgery
Orthopedic Surgery ●
. Thoracic Surgery

Summary of Technological Characteristics:

The Adeor Medical Bipolar Forceps are identical to the predicate in that they are both intended to grasp, manipulate and coagulate soft tissue. The subject device's component materials, fundamental scientific technology, and mode of action are identical to that of the predicate device. See Table 1 for a more detailed comparison of the subject, predicate and reference devices.

Item	Adeor Medical	Faulhaber Pinzetten	CODMANVersaTru	OLSENMedical®	Comparisonto Predicate
ClassificationName	Electrosurgical,Cutting andCoagulationAccessories	Electrosurgical,Cutting andCoagulationAccessories	Electrosurgical,Cutting andCoagulationAccessories	Electrosurgical,Cutting andCoagulationAccessories	Equivalent
Regulation	878.4400	878.4400	878.4400	878.4400	Equivalent
CommonName	Single-Use andReusable BipolarForceps	Non-stick BipolarForceps	DisposableBipolar Forceps	Single UseBipolar andMonopolarForcepsMultiple-UseBipolar andMonopolarForceps	Equivalent
Product Code	GEI	GEI	GEI	GEI	Equivalent
Intended Use	The Adeor Medical	Faulhaber Single Use	Intended for use	Active	Equivalent-
	Non-stick Bipolar	Non-Stick Bipolar	in electrosurgery	electrosurgical	Subject device
	Forceps are	Forceps sterile/ non-	for coagulation of	devices where	includes
	intended for use by	sterile and Single Use	tissue.	monopolar or	specific
	a physician familiar	NonStick Irrigating		bipolar	information
	with electrosurgery	Forceps sterile/ non-		electrosurgical	such as
	in bipolar	sterile are intended for		cutting and	operational
	coagulation for	use by a physician		coagulation is	frequency
	general open	familiar with		desired during	range
	surgery where	electrosurgery for		surgery and are
	coagulation of soft	bipolar coagulation		intended to grasp,
	tissue is needed.	and irrigation of tissue		manipulate cur or
	Adeor bipolar	for general surgery.		coagulate selected
	forceps must be	The bipolar forceps		soft tissue.
	operated with the	are used with the
	following	bipolar output for
	parameters:	standard
	Frequency range	electrosurgical
	between 300 kHz	generators. The
	and 1,000 kHZ;	products are intended
	maximum generator	for single use and are
	operating voltage	provided sterile as
	600Vp.	well as non sterile.
		Products supplied non
	The Adeor Medical	sterile must be
	Non-stick Bipolar	cleaned, disinfected
	Forceps have not	and sterilized prior to
	been shown to be	their use by the
	effective for tubal	validated cleaning,
	sterilization or tubal	disinfection and
	coagulation for	sterilization process.
	sterilization	The bipolar forceps
	procedures and	have not been shown
	should not be used	to be effective for
	for these	tubal sterilization or
	procedures.	tubal coagulation for
	The types of	sterilization
	surgery intended	procedures and should
	include:	not be used for these
	ENT	procedures. The types
	Gynecology	of surgery intended are
	Urology	- General surgery -
	General Surgery	Laryngeal coagulation
	Neurosurgery	- Orthopedic
		coagulation - Thoracic
		coagulation -
		Neurosurgical
		coagulation -
		Gynecological
Item	Adeor Medical	Faulhaber Pinzetten	CODMANVersaTru	OLSENMedical®	Comparisonto Predicate
	• LaryngealSurgery• OrthopedicSurgery• ThoracicSurgery	coagulation (exceptfor use in femalesterilization) -Urological coagulation- Ear-, Nose- andThroat coagulation.
Sterility	Gamma Irradiation/Steam	Gamma Irradiation/Steam	GammaIrradiation	Irradiation	Equivalent
Usage	Single-Use andReusable	Single use (K182773)and Reusable(K101080)	Single- Use	Single andReusable	Equivalent
Tip Material	Ag 800 (80% puresilver)	Sterling Silver	Plated aluminum	Stainless Steel	Equivalent
Arm Material	Stainless Steel (ISO7153)	Stainless Steel	Stainless Steeland Titanium	Stainless Steel	Equivalent
Arm Coating	Polyamide	Nylon	Polyamide	Ceramic-Metallic	Equivalent
Size (overalllength)	5-10"	8-12"	7-9"	7-9"	Equivalent
Size (distaltips)	0.2-1.5mm	0.5-1.5mm	0.5-1.5mm	0.5-1.5mm	Equivalent
Packaging	PETG Tray, TyvekLid	Foil pouch	PETG Tray,Tyvek Lid	Tyvek/film pouch	Equivalent
ElectricalSafetyTesting	IEC 60601-2-2	IEC 60601-2-2	IEC 60601-1-2IEC 60601-2-2	IEC 60601-2-2	Equivalent

Table 1: Subject-Predicate Comparison

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K191847

Image /page/5/Picture/2 description: The image shows the logo for Adeor Medical. On the left is a blue image of a brain. To the right of the brain is the word "adeor" in black, lowercase letters. Below the word "adeor" is the word "MEDICAL" in smaller, black, uppercase letters.

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K191847

Image /page/6/Picture/2 description: The image shows the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the word "adeor" in black lowercase letters. Below "adeor" is the word "MEDICAL" in smaller black uppercase letters. The brain graphic is made up of interconnected lines, giving it a modern and technological feel.

Non-Clinical Testing:

Electrical Safety

Electrical Safety Testing was performed on the Adeor Bipolar Forceps per IEC 60601-2-2: 2017 Medical Electrical Equipment- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. Isolation of active accessories, high-frequency leakage currents, high-frequency dielectric strength, and mains frequency dielectric strength testing was performed. Instruments did not show any signs of impairment or loss of mechanical function; therefore, testing was successfully completed.

Non-Clinical

Wear

The device is not manufactured from a novel material and does not contain articulating components. There is no concern for wear or debris.

Function

Drop testing was performed on the bipolar forceps to ensure that dropping the device will not cause damage to the device nor loss of functionality. Forceps were dropped multiple times and inspected for grasping capabilities, frequency output, and visual damage. All test articles met the acceptance criteria.

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Image /page/7/Picture/2 description: The image shows the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the word "adeor" in black, sans-serif font. Below "adeor" is the word "MEDICAL" in smaller, sans-serif font, also in black.

Mechanical Strength

Due to the high strength of the material and the low forces that the device may be subject to, there is no concern for mechanical strength of the forceps. Testing specific to the strength of the device is not necessary.

System Testing

The Adeor forceps are identical to the predicate in design, materials, manufacturing, manufacturer and function. No further performance testing is required.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

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.