TITANIUM HEMOSTATIC CLIP

K981645 · Vitalitec Int'L., Inc. · FZP · Oct 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981645
• Device Name: TITANIUM HEMOSTATIC CLIP
• Applicant: Vitalitec Int'L., Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Oct 13, 1998
• 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 clips; used for ligation/occlusion of blood vessels during surgery. Clips supplied sterile in various sizes (mini-micro to large) on disposable polycarbonate holders. Material is Grade I titanium (ASTM F-67 95, ISO 5832-2-93). Device applied by surgeon to tissue; clips remain in vivo as biologically inert implants. Design features include mechanism to prevent slippage once applied. Benefits include effective hemostatic control and radiographic visibility.

Clinical Evidence

No clinical data. Safety and efficacy established through material biocompatibility (ASTM/ISO standards) and historical clinical acceptance of titanium hemostatic clips.

Technological Characteristics

Material: Grade I Titanium (ASTM F-67 95, ISO 5832-2-93). Holder: Polycarbonate plastic. Form factor: Various sizes (mini-micro, micro, small/medium, medium/large, large). Sterilization: Sterile. Energy source: None (mechanical).

Indications for Use

Indicated for the occlusion of blood vessels in surgical applications where ligation is required or radiographic marking is necessary.

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

• EISNER USA Titanium Hemoclip (K972745)
• Baxter Healthcare Vitaclip (K953258)
• Edward Weck & Company Pre-Amendment Hemoclip Surgical Occluding System (K800079)
• 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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OCT 1 3 1998

510(k) Summarv / Statement VITALITEC INTERNATIONAL, Inc. Submitters Name: 15 Caswell Lane, 3rd. Fl. Plymouth, MA 02360 Fax: [phone] 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.

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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.

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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,

(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

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\$10(k) Number (if known):

Implantable Titanium Hemostatic Clip Device Name:

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Indications For Use:

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(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)