(90 days)
Not Found
No
The description focuses on the material and mechanical function of a hemostatic clip, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a hemostatic clip used for ligating blood vessels during surgical procedures to achieve hemostasis or for radiographic marking. It does not directly treat or diagnose a disease but rather assists in surgical procedures.
No
The device is a hemostatic clip used for ligating blood vessels during surgical procedures to achieve hemostasis or for radiographic marking. It does not perform any diagnostic function.
No
The device is a physical hemostatic clip made of titanium, not a software-only device. The description explicitly details the material and physical form of the clips.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ligating blood vessels" and "hemostasis is required or radiographic marking is necessary" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a physical clip made of titanium, designed to be applied to blood vessels.
- Lack of IVD Characteristics: 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 involve the analysis of biological samples.
The device is a surgical implant/instrument used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The EISNER USA Hemostatic Clip 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.
As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67 95), it has low magnetic susceptibility and is safe for use in the present clinical MRI environment with main Magnetic fields up to 2 read and maximum main field gradients up to 500 gauss per centrimeters care of my systems above 1.5 T.
As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67 95) it also produces less artifact than non-titanium clips in CT Scanning.
Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the jaws of the clip. The tissue to be occluded with undergo free compression without sequela as it is biologically inert.
Product codes (comma separated list FDA assigned to the subject device)
MCH, FZP
Device Description
The clips are composed exclusively of titanium and are supplied sterile in various sizes (small, 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.
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.
Baxter Healthcare Vitaclip® K953258, Edward Weck & Company, Preamendment Hemoclin® 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.
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
K92745
| 510(k) Summary / Statement | |
|---|---|
| Submitters Name: | EISNER USA |
| 15 Caswell Lane/Boat Yard Square | |
| Plymouth, MA 02360 | |
| Ph: 508-747-6006 Fax: 508-747-5118 | |
| Contact Name: | Ellen Henke-Knupp, Official Corespondent |
| Name of Device: | Titanium Hemostatic Clip |
| OCT 21 1997 |
SAFETY & EFFECTIVENESS DATA SUMMARY
Classification Name: Clip, Implantable Common/Usual Name: Titanium Hemostatic Clip Proprietary Name: N/A at this time ;
Classification: Class II Reg. # 878.4300 # 79 FZP = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Implantable Clip
Performance Standards: Devices are manufactured according to cGMP's, AAMI and ASTM requirements, and applicable Harmonized Standards ISO 9002/ EN 46002.
Material Composition: ASTM F-67 95, 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 (small, 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.
Predicate Devices: Baxter Healthcare Vitaclip® K953258, Edward Weck & Company, Preamendment Hemoclin® 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
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 1997
Ms. Ellen J. Henke-Knupp Official Correspondent EISNER USA 15 Caswell Lane Boatyard Square 02332 Plymouth, Massachusetts
Re: K972745 Titanium Hemostatic Clip Trade Name: Requlatory Class: II Product Codes: MCH and FZP Dated: July 17, 1997 Received: July 23, 1997
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 regulations.
2
Page 2 - Ms. Ellen J. Henke-Knupp
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,
Celia M. Witten, Ph.D., M.
Celia 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
Page 1 of 1
510(k) Number (if known): к 972745
Titanium Hemostatic Clip Device Name:
Indications For Use:
The EISNER USA Hemostatic Clip is designed for the intended use The EISNER USA Hemostatic Crip Is deebsnobeen specially designed
of ligating blood vessels. The clip has been any clippage once of ligating blood vessels. "Inc crip went any slippage once to insure occlusion of vessers and in many types of surgical applied. The Clip has applications in many off
procedures where hemostasis is required or radiographic marking is necessary.
As the clip:is made of Commercially Pure - GRADE I, Implant As the clip:is made or Commercially fulc - on.magnetic susceptibility
Titanium (/ASTM Standard r-67 95), it has low magnetic susceptibility Titanium (7ASIM Standard - or 937) clinical MII environment with and is safe for use in the present crimeaximum main field gradients
main Magnetic fields up to 2 main Magnetic Treids up co 2 read and gametic Force will only up to 500 gauss per centrimeters care of my systems above 15 T.
As the clip is made of Commercially Pure - GRADE I, Implant As the Clip is made of Commercially - also produces less artifact Titanium (7ASIM Standard I 87-597) 20 address than non-titanium clips in CT Scanning.
Choose the size of clip to fit the procedure maxing certain the Choose the Size or crip co respectedy within the clip.
tissue to be occluded fits completely within truels of i The CISSUE CO DE OCCInaca free ocmpression in thout 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-Om)
Division of General Restorative Devices K972745
510(k) Number.
Prescription Use
(Pe 1 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)