The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site

Device Description

The system consists of a hand piece equipped with two trumpet style valves, a probe and connecting lines of tubing, one set designated to attach to supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

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 document is a 510(k) summary for the DANNIK Laparoscopic Suction Irrigation System. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or study details in the format requested for AI/algorithm performance evaluation.

This document describes a medical device (a physical instrument), not an AI/software device. Therefore, many of the requested fields, such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable in this context.

Based on the document, here's what can be extracted and what cannot:

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

Acceptance Criteria (from predicate device's established performance)	Reported Device Performance (DANNIK Laparoscopic Suction Irrigation System)
Functional Equivalence:
- Deliver sterile irrigation fluids.	- Designed to deliver sterile irrigation fluids.
- Evacuate blood and tissue debris.	- Designed to evacuate blood and tissue debris.
- Controlled irrigation and aspiration.	- Valves allow controlled irrigation and aspiration.
Physical Characteristics Equivalence:
- Handpiece design (Trumpet Valve Assembly).	- Trumpet Valve Assembly. (Same as predicate)
- Probe Length (e.g., 33cm/330mm).	- 33cm (330mm). (Same as predicate; predicate also offers additional lengths).
Safety & Biocompatibility:
- Sterilization (e.g., Ethylene Oxide, ISO 11135-1).	- Ethylene Oxide, ISO 11135-1.
- Biocompatibility (e.g., Conforms to ISO 10993).	- Conforms to ISO 10993.
Performance Testing:
- Appropriate fluid flow rates (implicitly from predicate).	- Performance studies and bench testing included determining and verifying appropriate fluid flow rates.
- Valve seal integrity (implicitly from predicate).	- Performance studies and bench testing included verifying valve seal integrity.
Regulatory:
- Prescription use.	- Yes. (Same as predicate)

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not a software or AI product that uses test sets of data. The "test set" here refers to the device itself being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a physical device is its manufacturing specifications and performance standards, established through engineering design and testing, not expert consensus on medical images or patient data. The document mentions evaluation by a "Design Engineer."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in medical imaging or clinical data for AI models.

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 a physical surgical tool and does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is defined by established engineering and manufacturing standards, and the performance of the predicate device. This is confirmed through bench testing rather than clinical outcomes or pathological analysis.

8. The sample size for the training set: Not applicable. There is no "training set" for a physical device in this context.

9. How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

November 19, 2019

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

Re: K192643

Trade/Device Name: DANNIK Laparoscopic Suction Irrigation System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 11, 2019 Received: October 17, 2019

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.

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

{1}------------------------------------------------

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 (OS) 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192643

Device Name

DANNIK Laparoscopic Suction Irrigation System

Indications for Use (Describe)

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)

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 the word "DANNIK" in blue, block letters. Above the word is a curved line, also in blue, with a thinner, curved line in purple inside of it. The logo is simple and modern, with the curved lines adding a touch of elegance.

K192643

510(k) / Summary

1. Contact Information DANNIK 941 West Morse Blvd. Suite #100 Winter Park, Florida 32789 Phone: (407) 745-1698 Olga Haberland, Regulatory Compliance September 15, 2019
1. Device Name
- Trade Name DANNIK Laparoscopic Suction Irrigation System ●
- Common Name: laparoscopic Suction Irrigation System ●
- Classification Name Endoscope and Accessories (21 CFR 876.1500, . Product Code GCJ)
1. Substantially Equivalent Device
- · Legally Marketed (unmodified Devices): The Unimax Suction Irrigation Set FDA 510K (K103509)
1. Device Description

008_1

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for "DANNIK". The logo is in blue and has a curved line above the text. The curved line is also blue, but has a purple line inside of it.

K192643

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

1. Intended Use
  The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site.
1. Technological Characteristics of the Subject Device Compared to the Predicate Device

AREA	DANNIKK192643	UnimaxK103509
Intended Use	Laparoscopic Surgery	Same
Handpiece Design	Trumpet Valve Assembly	Same
Probe Length	33cm (330mm)	SameUnimax alsooffersadditionalprobelengths.
Materials	Probes: Medical Grade Stainless Steel	Unknown
	Handpiece: Poly Carbonate	Unknown
	Seals: Silicone	Unknown
		008_

{5}------------------------------------------------

K192643

Image /page/5/Picture/1 description: The image shows the word "DANNIK" in blue, block letters. Above the word is a curved line that is blue on the outside and purple on the inside. The word is in all caps and is the main focus of the image. The background is white.

www.dannik.us

	Tubing: PVC	Unknown
PerformanceTesting	There are no US FDA performance standardsfor these products.	Same
Sterilization	Ethelene OxideI.S.O. 11135-1	Unknown
Prescription Only	Yes	Same
Biocompatibility	Conforms to ISO 10993	Unknown

Dannik will NOT be offering electrical probes as offered by 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.

7. Non-Clinical Tests

The DANNIK Laparoscopic Suction Irrigation System has been evaluated by our Design Engineer, through performance studies and bench testing which included determining and verifying appropriate fluid flow rates and valve seal integrity. Testing showed that the devices met the same requirements as the predicate device.

1. Clinical Tests
  There were no clinical trials performed on the DANNIK Laparoscopic Suction Irrigation System

{6}------------------------------------------------

www.dannik.us

Image /page/6/Picture/1 description: The image shows the logo for "DANNIK" in blue font. Above the text is a curved line, also in blue, with a smaller curved line in purple underneath it. The logo is simple and modern, with a clean font and color scheme.

K192643

1. Conclusions
  The subject device has equivalent indications for use as the predicate device. The technological characteristics, non-clinical testing and performance and bench testing of the DANNIK Laparoscopic Suction Irrigation Device show that the device is as safe, as effective, and meets the same performance standard. Therefore, the proposed DANNIK Laparoscopic Suction Irrigation Device is substantially equivalent to the predicate.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.