The DANNIK Titanium Ligation Clips is designed for the intended use of ligating blood vessels .The Clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.

Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The DANNIK Titanium Ligation, clip can be left in vivo without sequela as it is biologically inert.

Device Description

The DANNIK Titanium Ligation Clips are exclusively made of titanium and supplied in four different sizes: small, medium-large, and large. Packaged in cartridge of six clip units.

The titanium used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".

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 a 510(k) premarket notification for a medical device: the DANNIK Titanium Ligation Clip. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through new clinical trials.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/machine learning performance metrics (e.g., sensitivity, specificity, reader improvement with AI assistance). The "acceptance criteria" and "study" described in the prompt are typical for AI/ML device submissions, but not for a physical device like a ligation clip, where the focus is on material properties, mechanical performance (e.g., clamping force, corrosion resistance), and biocompatibility.

Based on the provided text, here's what can be extracted about the device and its testing:

A table of acceptance criteria and the reported device performance:
The document does not present a formal table of explicit acceptance criteria with quantitative performance metrics for AI/ML. Instead, it states:

Acceptance Criteria (Implied)	Reported Device Performance
Appearance	"PASS"
Dimension	"PASS"
Surface Roughness	"PASS"
Hardness	"PASS"
Toughness	"PASS"
Clamping (Retention) Performance	"PASS"
Corrosion Resistance	"PASS"
Other technical standard requirements of Dannik compared to predicate	"meets"

Sample sizes used for the test set and the data provenance:
The document mentions "performance studies and bench testing" and "non-clinical tests." It does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically physical tests on a sample of manufactured clips.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable in the context of AI/ML ground truth. The tests were evaluated by the "Design Engineer." Qualifications of the Design Engineer are not specified beyond their title.
Adjudication method for the test set:
Not applicable in the context of AI/ML ground truth. The results were simply reported as "PASS."
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic devices, not for a titanium ligation clip.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
The "ground truth" for the performance of the ligation clips appears to be based on physical measurements and material science standards (e.g., ASTM F-67 95, ISO 5832-2-93, ISO 10993) and comparison to the predicate device's known performance characteristics. For biocompatibility, it "Conforms to ISO 10993."
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
Not applicable.

Summary of Device Performance and Equivalence:

The DANNIK Titanium Ligation Clip's safety and effectiveness were demonstrated through:

Substantial Equivalence: Comparison to legally marketed predicate devices (Vitalitec International Inc Implantable Titanium Hemostatic Clip K981645 and Weck Metal Ligating Clips K132658) in terms of:
- Intended Use: Ligation of blood vessels for hemostasis or radiographic marking.
- Device Description: Titanium ligation clips.
- Clip Material: Titanium meeting ASTM F-67 95 Grade I and ISO 5832-2-93 and 10993 standards.
- Sterilization: Ethylene Oxide (ETO) conforming to ISO 11135-1.
- Prescription Only Use: Yes.
- Biocompatibility: Conforms to ISO 10993.
Non-Clinical Bench Testing: Evaluation of physical and mechanical properties including appearance, dimension, surface roughness, hardness, toughness, clamping (retention) performance, and corrosion resistance. All tests resulted in "PASS."
No new technologies: The document states that "There are no new technologies being added to this device from the predicate, in terms of finished device functions."
No Clinical Trials: "No Clinical trials performed on the DANNIK Titanium Ligation Clips." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 20, 2019

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

Re: K192711

Trade/Device Name: Dannik Titanium Ligation Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: September 19, 2019 Received: September 27, 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

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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 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,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K192711

Device Name DANNIK Titanium Ligation Clip

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)

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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 December 16, 2019
1. Device Name
- Trade Name DANNIK Titanium Ligation Clip ●
- Common Name: Titanium Ligation Clip ●
- Classification Name Clip Implantable ●
- Classification: Class II General and Plastic Surgery Devices #79 FZP, ● 21 CFR 878.4300

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.

Material Composition: A.S.T.M F-67 95, Grade I Titanium I.S.O. #5832-2-93, Grade I Titanium

1. Substantially Equivalent Device
- Legally Marketed (unmodified Devices): .
  - o Primary Predicate: Vitalitec International Inc Implantable Titanium Hemostatic Clip FDA 510K (K981645)
  - o Additional Predicate: Weck Metal Ligating Clips (K132658)

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4. Device Description

The DANNIK Titanium Ligation Clips are exclusively made of titanium and supplied in four different sizes: small, medium-large, and large. Packaged in cartridge of six clip units.

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 (Ethylene Oxide)

5. Intended Use

The DANNIK Titanium Ligation Clips is designed for the intended use of ligating blood vessels. The Clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.

1. Technological Characteristics of the Subject Device Compared to the Predicate Device
  Comparison of Technological Characteristics: The titanium clip material and disposable holder material substantially equivalent to the predicate device. In function, the clips are the substantially equivalent to the predicate device as well.

Safety and Efficacy Information: Titanium is well recognized as being safe and effective for long term implantation. Millions of titanium clips are applied yearly and since inception in the 1960's attest to the wide

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acceptance of this method of hemostatic and ligation control.

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.

Device	DANNIK TitaniumLigation Clip	Vitalitec K981645	Weck Metal LigatingClips K132658
Intended use	The DANNIK TitaniumLigation Clips isdesigned for theintended use ofligating blood vessels.The Clip has beenspecially designed toinsure occlusion ofvessels and preventany slippage onceapplied. The clip hasapplications in manytypes of surgicalprocedures wherehemostasis isrequired orradiographic markingis necessary.Choose the size ofclip to fit theprocedure makingcertain the tissue tobe occluded fitscompletely withinthe clip. The DANNIKTitanium Ligation,clip can be left in vivowithout sequela as itis biologically inert.	The VITALITECINTERNATIONAL,INC,. Hemostatic Clipis designed for theintended use ofligating bloodvessels. The clip hasbeen speciallydesigned to insureoccclusion of vesselsand prevent anyslippage onceapplied. The clip hasapplications in manytypes of surgicalprocedures wherehemostasis isrequired orradiographic markingis necessary.Choose the size ofclip to fit theprocedure makingcertain the tissue tobe occluded fitscompletely withinthe clip. TheVITALITECINTERNATIONAL,INC., clip can be leftin vivo withoutsequela as it isbiologically inert.	Weck@ Ligating Clipsare intended for usein proceduresinvolving vessels oranatomic structuresfor which thesurgeon determinesligating clips are thebest choice. Surgeonsshould select thesize, type andmaterial of the clipbased upon theirexperience,judgment and needs.
Device Description	Titanium LigationClips madeexclusively made oftitanium	Same	Weck® Metal LigatingClips aremanufactured frommedical gradetitanium, tantalum orstainless steel alloys
Clip Material	TitaniumThe titanium usedmeets allrequirements forA.S.T.M.specifications F-67 95"Unalloyed Titaniumfor Surgical ImplantApplications", Grade Iand ISO 5832-2-93and 10993 "Implantsfor Surgery - MetallicMaterials - Part 2:Unalloyed Titanium".	Same	Medical GradeTitanium
Sterilization	Ethylene Oxide (ETO)I.S.O 11135-1	Unknown	Unknown
Prescription Only	Yes	Same	Same
Biocompatibility	Conforms to ISO10993	Unknown	Conforms to ISO10993
EnviromentalConditions			Weck® Metal LigatingClips are "MRConditional" up toand including 3-TeslaMR environments.

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K192711

Page 4 of 5

7. Non-Clinical Tests

The DANNIK Titanium Ligation Clips has been evaluated by our Design Engineer and through performance studies and bench testing, as attached in ANNEX F. Testing encompassed appearance, dimension, surface roughness, hardness toughness , clamping( retention) performance and corrosion resistance.

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All the test results were "PASS". The performance of Titanium Clip meets the technical standard requirements of Dannik as compared to the predicate.

1. Clinical Tests No Clinical trials performed on the DANNIK Titanium Ligation Clips .

9. 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 Titanium Ligation Clips show that the device is substantially equivalent to the predicate.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.