(84 days)
No
The summary describes a purely mechanical device (titanium ligation clips) and contains no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as titanium ligation clips designed for occluding blood vessels and is used in surgical procedures for hemostasis or radiographic marking. It is an implantable device used within the body but is not intended to treat, mitigate, prevent, or cure a disease or condition, which is a key characteristic of a therapeutic device. It serves a mechanical function (ligation) rather than a therapeutic one.
No
The device is designed for ligating blood vessels and is described as an implantable clip used in surgical procedures for hemostasis or radiographic marking. These functions are therapeutic or interventional, not diagnostic.
No
The device description explicitly states the device is made of titanium and is a physical clip used for ligating blood vessels. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to ligate blood vessels during surgical procedures. This is a direct intervention on the patient's body for hemostasis (stopping bleeding) or radiographic marking.
- Device Description: The device is a physical clip made of titanium, designed to be implanted in the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with specimens in this way.
- Anatomical Site: The device is applied directly to blood vessels within the body.
The DANNIK Titanium Ligation Clips are a surgical implant used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
FZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. All the test results were "PASS". The performance of Titanium Clip meets the technical standard requirements of Dannik as compared to the predicate.
Clinical Tests: No Clinical trials performed on the DANNIK Titanium Ligation Clips.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K192711
Device Name DANNIK Titanium Ligation Clip
Indications for Use (Describe)
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.
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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3
510(k) /Summary
-
- Contact Information DANNIK 941 West Morse Blvd. Suite #100 Winter Park, Florida 32789 Phone: (407) 745-1698 Olga Haberland, Regulatory Compliance December 16, 2019
-
- 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
-
- Substantially Equivalent Device
4
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.
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.
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.
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
-
- 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.
- Technological Characteristics of the Subject Device Compared to the Predicate Device
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
5
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 Titanium
Ligation Clip | Vitalitec K981645 | Weck Metal Ligating
Clips K132658 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
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. | The VITALITEC
INTERNATIONAL,
INC,. Hemostatic Clip
is designed for the
intended use of
ligating blood
vessels. The clip has
been specially
designed to insure
occclusion 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
VITALITEC
INTERNATIONAL,
INC., clip can be left
in vivo without
sequela as it is
biologically inert. | Weck@ Ligating Clips
are intended for use
in procedures
involving vessels or
anatomic structures
for which the
surgeon determines
ligating clips are the
best choice. Surgeons
should select the
size, type and
material of the clip
based upon their
experience,
judgment and needs. |
| Device Description | Titanium Ligation
Clips made
exclusively made of
titanium | Same | Weck® Metal Ligating
Clips are
manufactured from
medical grade
titanium, tantalum or
stainless steel alloys |
| Clip Material | Titanium
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". | Same | Medical Grade
Titanium |
| Sterilization | Ethylene Oxide (
ETO)
I.S.O 11135-1 | Unknown | Unknown |
| Prescription Only | Yes | Same | Same |
| Biocompatibility | Conforms to ISO
10993 | Unknown | Conforms to ISO
10993 |
| Enviromental
Conditions | | | Weck® Metal Ligating
Clips are "MR
Conditional" up to
and including 3-Tesla
MR environments. |
6
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.
7
All the test results were "PASS". The performance of Titanium Clip meets the technical standard requirements of Dannik as compared to the predicate.
-
- 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.