The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

Device Description

The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.

The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors.

The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Disposable Monopolar Laparoscopic Tips and Reusable Handles). It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the document does not contain information about:

Acceptance criteria for a study, beyond the general statement that nonclinical testing "met all design specifications and are substantially equivalent to the predicate device."
A study proving the device meets acceptance criteria in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). The "study" mentioned here is nonclinical testing to ensure electrical performance and thermal spread are comparable to the predicate device, not a diagnostic accuracy study.
Sample sizes for test sets (in the context of algorithm evaluation).
Data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. These questions are highly relevant to the evaluation of AI/ML-based medical devices, which this product is not.

The document describes a traditional medical device (electrosurgical instruments) and demonstrates substantial equivalence through nonclinical testing, primarily focused on electrical safety, biocompatibility, sterilization, and basic performance parameters like thermal spread in tissue. It explicitly states, "There were no clinical trials performed on these devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I answer the specific questions related to the study design for such a device, as this information is not present in the provided text.

The information that is provided regarding "tests" can be summarized as:

Nonclinical Tests Performed:

Biocompatibility Testing: Conforms to ISO 10993 standards (Parts 1, 5, 7, 10, 11).
Medical Electrical Equipment Safety Testing: Conforms to IEC 60601 series standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18).
Aging Study
Autoclave Sterilization Validation
Ethylene Oxide Sterilization: Per ISO 11135:2014.
Performance Studies: Designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy, and thermal effects on tissue.
Electrical Performance: Followed FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," requiring testing on three different tissue types (e.g., Kidney, Muscle as shown in tables) at minimum, default, and maximum generator power to simulate thermal spread.

Table 1 & 3: Thermal Damage Results (Example provided for Kidney and Muscle Tissue)

Tissue Type	Power Level	Thermal Damage Width ( $$\overline{X}$$ ±SD, mm)	Thermal Damage Depth ( $$\overline{X}$$ ±SD, mm)
Kidney	30W	0.42 ±0.26	3.05 ±2.10
	50W	0.28 ±0.30	2.69 ±0.47
	90W	0.47 ±0.36	4.43 ±1.42
Muscle	30W	1.28 ±0.58	2.62 ±0.20
	50W	1.51 ±0.65	3.26 ±0.32
	90W	1.20 ±0.85	2.82 ±0.37

Summary and Limitations based on the provided text:

Acceptance Criteria and Reported Device Performance: General statement that "Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings" compared to the predicate. The thermal damage tables provide measured performance for the subject device. Specific numerical acceptance criteria (e.g., "thermal spread must be <= X mm") are not explicitly stated, but the implication is that the subject device's performance aligns with that of the predicate device.
Sample Size and Data Provenance: Not applicable for an AI/ML algorithm. For the nonclinical thermal spread tests, the sample size (N instances of measurement) per tissue type and power setting is not specified, nor is the "provenance" in terms of human subjects or data collection methods as would be relevant for an AI study.
Number of Experts/Qualifications: Not applicable. These were nonclinical bench tests.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Explicitly stated "There were no clinical trials performed on these devices."
Standalone Performance: Not applicable as this is not an AI/ML algorithm.
Type of Ground Truth: For the thermal spread testing, the "ground truth" would be the physically measured thermal damage width and depth on tissue samples, measured "under magnification." This is a direct physical measurement, not an expert consensus or pathology report in the diagnostic sense.
Sample Size for Training Set: Not applicable, as there's no AI/ML model.
How Ground Truth for Training Set was Established: Not applicable.

Summary

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October 28, 2021

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

Re: K211019

Trade/Device Name: Disposable Monopolar Laparoscopic Tips and Reusable Handles Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 27, 2021 Received: October 1, 2021

Dear Olga Haberland:

We have reviewed vour 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.

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

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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

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Indications for Use

510(k) Number (if known) K211019

Device Name

Disposable Monopolar Laparoscopic Tips and Reusable Handles

Indications for Use (Describe)

The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

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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K211019 510(k) Summary

1. SUBMITTER'S CONTACT INFORMATION

Company: DANNIK Address: 941 West Morse Blvd. Suite #100 Winter Park, FL 32789 Contact Person: Mrs. Olga Haberland, President & Requlatory Compliance Phone: (407) 927-1743

2. DEVICE NAME

Trade Name – Disposable Monopolar Laparoscopic Tips and Reusable Handles Common Name - Monopolar Laparoscopic Instruments Regulation Number - 21 CFR 878.4400 Classification Name - Electrosurgical, Cutting & Coaqulation Device and Accessories Product Code - GEI Device Classification - Class II Classification Panel - General and Plastic Surgery

3. PREDICATE DEVICE

The Disposable Monopolar Laparoscopic Tips and Reusable Handles claim Substantial Equivalence to Hunan Handlike Minimally Invasive Surgery Co. Endoscopic Surgical Instruments cleared under 510(k) K171825.

4. DEVICE DESCRIPTION

The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors.

5. INDICATIONS FOR USE

The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut. dissect, manipulate and/or cauterize various tissues during endoscopic, general surgical procedures.

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6. SUBSTANTIAL EQUIVALENCE TABLE

Device	Disposable Monopolar Laparoscopic Tips andReusable Handles (510(k) TBD)	Hunan Handlike Minimally Invasive Surgery Co.Endoscopic Surgical Instruments (510(k) K171825)
Intended Use	The Disposable Monopolar Laparoscopic Tips and Reusable Handlesare intended to cut, dissect, manipulate and/or cauterize varioustissues during endoscopic/laparoscopic, general surgical procedures.	Same
Product Picture	Image: Disposable tip and reusable handle & shaft	Image: Disposable tip and reusable handle & shaft
Design	The Disposable Monopolar Laparoscopic Tips and Reusable Handlesare sterile single use monopolar attachments intended for use incombination with the Reusable Handle. These devices are made frombiocompatible plastic and stainless steel. The handle activates theinstrument jaws and scissor blades. The rotation knob provides 360degrees of rotation for the instrument shaft and jaws. The shaftincludes an external insulation that runs from the rotation knob to theinstrument jaws and is provided in working diameters of 5 mm andlength of 34 cm. The handle includes an RF Post for electrosurgerywhen attached to an approved electrosurgical generator to providecoagulation of tissue when used with an appropriate ground (neutral)electrode.	Endoscopic Surgical Instruments Tip-Detachable Type: Disposabletip and reusable shaft/handle can be disassembled but shaft cannotbe disassembled from handle. Handles have ratchet and non-ratchet.Tips have 14 different models available. This product is monopolarhigh frequency electrode as the applied part to be used with amatching HF surgical generator with peak output voltage 3800V andfrequency 0.3MHz-2MHz and neutral electrode.
Diameter	5 mm	Same
Length	34 cm	Same
Power Settings	Maximum Peak Voltage = 3800 Vp	Maximum Peak Voltage = 3800 Vp
	Operating Frequency = 300 to 2000 kHz	Operating Frequency = 300 to 2000 kHz
	Operating Current = 0.8 Arms	Operating Current = 0.8 Arms
Biocompatibility	Conforms to ISO 10993	Same
Sterilization	Sterilized using Ethylene Oxide for single patient usein accordance with ISO 11135 to an SAL of 10^-6.	Ethylene Oxide
Electrical Safety	IEC 60601-1IEC 60601-1-2IEC 60601-2-18IEC 60601-2-2	Same
Prescription Use	Yes	Yes

7. NONCLINICAL TESTS

Nonclinical testing has been conducted to verify that the Disposable Monopolar Laparoscopic Tips and Reusable Handles met all design specifications and are substantially equivalent to the predicate device. Testing included the following:

. Biocompatibility Testing performed in accordance with the following:
- ISO 10993-1: 2018 Biological evaluation of medical devices -Part 1: Evaluation and O testing within a risk management process (Recognition No. 2-258)
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity (Recognition No. 2-245)
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide o sterilization residuals (Recognition No. 14-408)
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for о irritation and skin sensitization (Recognition No. 2-174)

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ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for o systemic toxicity (Recognition No. 2-255)
Medical Electrical Equipment Safety Testing performed in accordance with the following:
- o ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (Recognition No. 19-4)
- ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition No. 19-8)
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements о for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Recognition No. 6-389)
- IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular o requirements for the basic safety and essential performance of endoscopic equipment (Recognition No. 9-114)
Aging Study ●
Autoclave Sterilization Validation ●
Ethylene Oxide Sterilization per ISO 11135:2014 Sterilization of health-care . products - Ethylene Oxide (Recognition No. 14-529)

In addition, The Disposable Monopolar Laparoscopic Tips and Reusable Handles have been compared to the predicate device through various performance studies designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy and thermal effects on tissue.

Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This requires testing on three different tissue types at minimum, default, and maximum generator power in order to simulate thermal spread across different tissue types. The spread is then measured under magnification, and recorded to be compared with the predicate product. Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings. Summary results are shown below.

Power Level	Thermal Damage Width( $$\overline{X}$$ ±SD, mm)	Thermal Damage Depth( $$\overline{X}$$ ±SD, mm)
30W	0.42 ±0.26	3.05 ±2.10
50W	0.28 ±0.30	2.69 ±0.47
90W	0.47 ±0.36	4.43 ±1.42

Table 1 – Thermal Damage on Kidney Tissue

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Power Level	Thermal Damage Width(X ±SD, mm)	Thermal Damage Depth(X ±SD, mm)
30W	1.28 ±0.58	2.62 ±0.20
50W	1.51 ±0.65	3.26 ±0.32
90W	1.20 ±0.85	2.82 ±0.37

Table 3 – Thermal Damage on Muscle Tissue

8. CLINICAL TESTS

There were no clinical trials performed on these devices.

9. 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.