The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

Device Description

The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode.

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

AI/ML Overview

The provided text describes the DANNIK Disposable Monopolar Laparoscopic Instrument, which is a medical device. The document does not describe a study that uses acceptance criteria in the context of an AI/ML powered medical device, but rather provides information related to the 510(k) premarket notification process for a physical medical instrument.

Therefore, many of the requested elements for an AI/ML powered device, such as sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or cannot be extracted from this document.

However, I can extract information about the non-clinical tests performed, which could be considered analogous to "acceptance criteria" in a broad sense for a physical device, and how the device meets them through testing.

Here's the information that can be extracted, framed as closely as possible to your request, with an explicit note where the information is not applicable to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Evaluation Parameters)	Reported Device Performance (Evaluation Method)
Thermal effects on Tissue	Evaluated by Design Engineers through performance and functionality evaluations.
Connection strength	Evaluated by Design Engineers through performance and functionality evaluations.
Clamping performance	Evaluated by Design Engineers through performance and functionality evaluations.
Cable connection	Evaluated by Design Engineers through performance and functionality evaluations.
Open and close performance	Evaluated by Design Engineers through performance and functionality evaluations.
Hardness	Evaluated by Design Engineers through performance and functionality evaluations.
Corrosion resistance	Evaluated by Design Engineers through performance and functionality evaluations.
Outward (likely referring to outward appearance/integrity)	Evaluated by Design Engineers through performance and functionality evaluations.
Biocompatibility	Conforms to ISO 10993.
Sterilization	Achieved by Ethylene Oxide (ETO) according to ISO 11135-1.

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

Not applicable. This document pertains to the 510(k) clearance of a physical medical instrument, not an AI/ML powered device. The "tests" mentioned are non-clinical engineering evaluations, not studies with test sets in the AI/ML context.

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

Not applicable. The evaluations were performed by "Design Engineers." Specific numbers or detailed qualifications are not provided beyond this title. Ground truth in the AI/ML sense (e.g., expert consensus on image interpretation) is not relevant here.

4. Adjudication method for the test set

Not applicable. This concept (e.g., 2+1, 3+1) is for reconciling discrepancies in expert opinions for AI/ML ground truth, which is not relevant to the non-clinical engineering evaluations described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML powered device, and no MRMC study was conducted or reported.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is implied to be engineering specifications, performance standards (like ISO 10993, ISO 11135-1), and functionality requirements validated through direct testing by design engineers. There is no "ground truth" as typically defined for AI/ML models (e.g., pathology, expert consensus).

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

Summary

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March 4, 2020

DANNIK Olga Haberland Regulatory Compliance 941 W Morse Blvd., Suite 100 Winter Park, Florida 32789

Re: K193019

Trade/Device Name: DANNIK Disposable Monopolar Laparoscopic Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 18, 2020 Received: February 24, 2020

Dear Olga Haberland:

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) K193019

Device Name

DANNIK Disposable Monopolar Laparoscopic Instrument

Indications for Use (Describe)

The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

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)

| 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

Contact Information DANNIK 941 West Morse Blvd. Suite #100 Winter Park, Florida 32789 Phone: (407) 745-1698 Olga Haberland, Regulatory Compliance January 30, 2020

1. Device Name
- Trade Name DANNIK Disposable Monopolar Laparoscopic . Instrument
- Common Name: Disposable Monopolar Laparoscopic Instrument .
- Classification Name : Electrosurgical, Cutting & Coagulation Device . and Accessories
- Classification: Class II General and Plastic Surgery Devices GEI, 21 . CFR878.4400

Performance Standards: Devices are manufactured according to Good Manufacturing Practices (G.M.P.), Association for Advancement of Medical Instrumentation (A.AM.I.) and American Society for Testing and Materials (A.S.T.M.) requirements and applicable Harmonized Standards ISO 13485.

1. Substantially Equivalent Device
- Legally Marketed (unmodified Devices): .
- Ethicon Endo-Surgery Endopath Endoscopic Instrument FDA 510K . (K984240)

005 1

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K193019

1. Device Description
  The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode.

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

Biocompatibility Conforms to ISO 10993 Prescription Only Yes Sterilized by ETO ( Ethelyn Oxide )

1. Intended Use
  The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
1. Technological Characteristics of the Subject Device Compared to the Predicate Device
  Comparison of Technological Characteristics: DANNIK Disposable Monopolar Laparoscopic Instrument is substantially equivalent to the predicate device.

There are no new technologies being added to this device from the predicate, in terms of finished device functions. The device has the same intended use and application as the predicate device.

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Device	Dannik Disposable MonopolarLaparoscopic Instrument	Ethicon Endo-Surgery EndopathEndoscopic Instrument FDA 510K(K984240)
Intended use	The DANNIK DisposableMonopolar LaparoscopicInstrument have application in avariety of minimally invasiveprocedures to facilitate grasping,mobilization, dissection andtransection of tissue.	Same
Product Picture	Image: Dannik Disposable Monopolar Laparoscopic Instrument	Image: Ethicon Endo-Surgery Endopath Endoscopic Instrument
Device Description	The DANNIK Disposable MonopolarLaparoscopic Instrument consists ofHandle which activates theinstruments jaws and scissor blades,Rotator knob that provides 360degrees rotation to shaft; bothhandle and rotation knob are madeof ABS thermoplastic, and a Shaft5mm in diameter with a workinglength of 33cm made from Medicalgrade Stainless Steel and insulatedwith high-density polyethylene PE.5mm in diameter with a workinglength of 33cm. RF Post forelectrosurgery when attached to anapproved electrosurgical generatorto provide coagulation of tissuewhen used with appropriate groundelectrode.	Same/Equivalent"The Instruments have a rotatinginsulated shaft with a diameter of3mm, 5mm or 10mm. The Rotationknob located on the handle rotatesthe shaft 260 degrees in eitherdirection. The ring handles arecompressed and released to activatethe instrument jaws or scissorblades. Each of the curved scissorsand dissectors has a monopolarcautery connector that extendsfrom the top of the handle. Theconnector is used for electrosurgerywhen properly attached to astandard cautery cable and propergenerator
Classification	Class II General and Plastic SurgeryDevices GEI, 21 CFR878.4400	Same
Diameter	5mm x 33cm	Same ( also offers additional diameters)
Materials	Non-Patient Contact:• ABS Thermoplastic-Patient Contact:• Stainless Steel• PE (Polyethylene)	Unknown
Sterilization	Ethylene Oxide ( ETO)I.S.O 11135-1	Unknown
Prescription Only	Yes	Yes
Biocompatibility	Conforms to ISO 10993	Unknown

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7. Non-Clinical Tests

DANNIK Disposable Monopolar Laparoscopic Instrument has been evaluated by Design Engineers, through performance and functionality evaluations that include Thermal effects on Tissue Connection strength, clamping performance , cable connection, open and close performance, Hardness , corrosion resistance and outward.

1. Clinical Tests
  No Clinical trials performed on the DANNIK Disposable Monopolar Laparoscopic Instrument
1. Conclusions
  The subject device has equivalent indications for use as the predicate device. There are no new technologies being added to this device from the predicate, in terms of finished device functions. The device has the same intended use and application as the predicate device.

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.