TITANIUM HEMOSTATIC CLIP

K972745 · Eisner USA, Inc. · MCH · Oct 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972745
• Device Name: TITANIUM HEMOSTATIC CLIP
• Applicant: Eisner USA, Inc.
• Product Code: MCH · General, Plastic Surgery
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An implantable Hemostatic clip intended for the ligation of blood vessels.

Device Story

Implantable titanium hemostatic clip; used for ligation of blood vessels during surgical procedures; provides hemostasis and radiographic marking. Device consists of Grade I titanium clips supplied in small, medium/large, and large sizes; housed in disposable polycarbonate holders. Applied by surgeons during surgery; clip design ensures occlusion and prevents slippage. Material is biologically inert; low magnetic susceptibility allows use in MRI environments; produces minimal artifacts in CT scanning. Benefits include effective hemostatic control and compatibility with diagnostic imaging.

Clinical Evidence

No clinical data provided. Safety and efficacy are supported by bench testing, adherence to cGMP, AAMI, and ASTM standards, and the established clinical history of titanium hemostatic clips since 1963.

Technological Characteristics

Material: ASTM F-67 95 Grade I Titanium. Holder: Polycarbonate plastic. Form factor: Implantable clips in small, medium/large, and large sizes. Standards: cGMP, AAMI, ASTM, ISO 9002/EN 46002. Non-magnetic, low artifact in CT.

Indications for Use

Indicated for ligation of blood vessels in surgical procedures requiring hemostasis or radiographic marking. Suitable for patients requiring vessel occlusion. Contraindicated if tissue size exceeds clip capacity.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Baxter Healthcare Vitaclip (K953258)
• Edward Weck & Company Hemoclin Surgical Occluding System
• Edward Weck & Company Hemoclip Surgical Occluding Clip Stainless Steel (K800079)
• United States Surgical Corporation Auto Suture Titanium Hemostatic Clip (K853650)
• United States Surgical Corporation Axiom Auto-Clip (K771021)

Submission Summary (Full Text)

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K92745

| 510(k) Summary / Statement | |
|----------------------------|------------------------------------------------------------------------------------------------------------|
| Submitters Name: | EISNER USA<br>15 Caswell Lane/Boat Yard Square<br>Plymouth, MA 02360<br>Ph: 508-747-6006 Fax: [phone] |
| 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)