(158 days)
Not Found
No
The summary describes a purely mechanical device (hemostatic clips made of titanium) with no mention of software, algorithms, or any computational processing that would indicate the use of AI or ML.
Yes
The device is designed to occlude vessels and remains in vivo, addressing a medical condition or altering the structure/function of the body.
No
The device description clearly states its purpose is for "occlusion of vessels" and "prevent any slippage," indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states the clips are composed exclusively of titanium and are supplied as physical clips, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "figure occlusion of vessels and prevent any slippage once applica." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical clip made of titanium, designed to be implanted in the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
An implantable Hemostatic clip intended for the ligation of blood vessels.
The VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for The VITALITEC INTERNATIONAD, INC. INC. Insures of me clip has been the intended use of figure occlusion of vessels and prevent specially designed to insure books applications in many any sirppage once applica. The cap masters is required or radiographic marking is necessary.
Choose the size of clip to fit the procedure making certain Choose the size of crip co rec crospletely within the clip.
the tissue to be occluded fits completely loft in vive with The the tissue to be occraded fres clip can be left in vivo without sequela as it is biologically inert.
Product codes (comma separated list FDA assigned to the subject device)
FZP, MCH
Device Description
The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K972745, K953258, K800079, K853650, K771021
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 3 1998
510(k) Summarv / Statement VITALITEC INTERNATIONAL, Inc. Submitters Name: 15 Caswell Lane, 3rd. Fl. Plymouth, MA 02360 Fax: 508-747-5118 Ph: 508-747-6033 Ellen Henke-Knupp, Regulatory Director Contact Name:
Titanium Hemostatic Clip Name of Device:
SAFETY & EFFECTIVENESS DATA SUMMARY
Classification Name: Clip, Implantable Common/Usual Name: Titanium Hemostatic Clip Proprietary Name: N/A at this time
| Classification: Class II | |
|---|---|
| Implantable Clip | #79 FZP Reg. # 878.4300 |
| Hemostatic Clip | #79 MCH Reg.# 878.4300 |
Performance Standards: Devices are manufactured according to cGMP's, AAMI and ASTM requirements, and applicable Harmonized Standards ISO 9002/ EN 46002.
ASTM F-67 95, Grade I Titanium. Material Composition: ISO 5832 - 2- 93, Grade I Titanium Intended Use: An implantable Hemostatic clip intended for the ligation of blood vessels.
Device Description: The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".
Predicate Devices: EISNER USA Titanium Hemoclip K972745, Baxter Healthcare Vitaclip @ K953258; Edward Weck & Company, Pre-Amendment Hemoclip ® Surgical Occluding System and Hemoclip® Surgical Occluding Clip-Stainless Steel K800079; United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021.
Comparison of Technological Characteristics: The titanium clip material is identical to the predicate devices. In function, the clips are the same as the predicate devices. The disposable holder is a polycarbonate plastic equivalent to the predicate devices.
Safety and Efficacy Information: The titanium itself is well recognized as being safe and effective for long term implant. The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control.
PAGE 5
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle is blank. In the center of the seal is an abstract image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
Ms. Ellen Henke-Knupp Requlatory Director Vitalitec International, Inc. 15 Caswell Lane 3rd Floor Plymouth, Massachusetts 02360
Re: K981645 Trade Name: Implantable Titanium Hemostatic Clip Requlatory Class: II Product Code: FZP Dated: August 14, 1998 Received: August 17, 1998
Dear Ms. Henke-Knupp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
(S. N. Mr. Whitney Blue Cross-Blue Shield
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows a handwritten string of characters, "K981645". Below this string, the text "Page 1 of 1" is written, indicating that this is page 1 of 1. The handwriting is somewhat stylized, with thick strokes and distinct letterforms.
$10(k) Number (if known):
Implantable Titanium Hemostatic Clip Device Name:
{
Indications For Use:
(P
VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for The The VITALITEC INTERNATIONAD, INC. INC. Insures of me clip has been the intended use of figure occlusion of vessels and prevent specially designed to insure books applications in many any sirppage once applica. The cap masters is required or radiographic marking is necessary.
Choose the size of clip to fit the procedure making certain Choose the size of crip co rec crospletely within the clip.
the tissue to be occluded fits completely loft in vive with The the tissue to be occraded fres clip can be left in vivo without sequela as it is biologically inert.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K981645
510(k) Number
| Prescription Use | X |
|---|---|
| (P 1 CFR 801.109) |
OR
Over-The-Counter Use(Optional Format 1-2-96)