REPROCESSED MULTIPLE CLIP APPLIERS

K033579 · Clearmedical, Inc. · NMJ · Jul 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K033579
• Device Name: REPROCESSED MULTIPLE CLIP APPLIERS
• Applicant: Clearmedical, Inc.
• Product Code: NMJ · General, Plastic Surgery
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed multiple clip appliers are intended for the ligation of vessels or other tubular structures.

Device Story

Reprocessed multiple clip appliers are automatic ligating clip appliers preloaded with at least 10 titanium clips. The device functions by advancing a clip after each application to ligate vessels or tubular structures. These are previously used devices that undergo cleaning, inspection, functional testing, packaging, and sterilization for single-patient reuse. Used by surgeons in clinical settings to facilitate vessel ligation during surgical procedures.

Clinical Evidence

Bench testing only. Validation included cleaning, performance, packaging, sterilization, and biocompatibility testing to demonstrate that reprocessed devices perform as intended and are safe and effective.

Technological Characteristics

Manual surgical instrument; titanium ligating clips; preloaded mechanism; reprocessed via cleaning, inspection, and sterilization for single-patient use. No changes to original design or materials.

Indications for Use

Indicated for the ligation of vessels or other tubular structures in patients requiring surgical intervention.

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

• Ethicon Ligaclip MCA clip appliers (K771412)

Submission Summary (Full Text)

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## JUL 1 1 2005

## 510(k) Summary

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| Submitter: | ClearMedical, Inc.<br>1776 136th Place NE<br>Bellevue, WA 98005 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gene Lim<br>Ph: [phone]<br>Fax: [phone] |
| Trade name: | ClearMedical Reprocessed Multiple Clip Appliers |
| Common name: | Non-reloadable Multiple Clip Appliers |
| Classification name: | Manual surgical instrument for general use (21 CFR 878.4800) |
| Product code: | GDO - Applier, Surgical, Clip |
| Predicate device: | K771412 - Ethicon Ligaclip MCA clip appliers |
| Device description: | The reprocessed multiple clip applier is an automatic ligating clip<br>applier. The device is preloaded with a minimum of 10 titanium<br>ligating clips that individually advance after each clip application. |
| Intended use: | Reprocessed multiple clip appliers are intended for the ligation of<br>vessels or other tubular structures. |
| Technological<br>characteristics: | Reprocessed multiple clip appliers are used devices that are<br>cleaned, inspected, tested, packaged, and sterilized for an<br>additional single patient use. The technological characteristics of<br>design, material, and functional performance of reprocessed<br>multiple clip appliers are unchanged and remain equivalent to the<br>predicate devices. |
| Test data: | Validation of cleaning, performance, packaging, and sterilization<br>together with biocompatibility testing demonstrate reprocessed clip<br>appliers perform as intended and are safe and effective. |
| Conclusion: | Based on information provided in this submission, ClearMedical<br>Reprocessed Clip Appliers are substantially equivalent to the<br>identified predicate devices and are safe and effective for their<br>intended use. |

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OCT 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clear Medical Corporation % Mr. Mike Kovacs 1776 136th Place Northeast Bellevue, Washington 98005

Re: K033579

Trade/Device Name: Reprocessed Multiple Clip Appliers Models, MCL20, MCM20, MCM30, MCS20 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NMJ Dated: July 11, 2005 Received: May 31, 2005

Dear Mr. Kovacs:

This letter corrects our substantially equivalent letter of July 11, 2005.

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 (PMA). 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 (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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mike Kovacs

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Pue Dally

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K033579

Ethicon Ligaclip Multiple Clip Appliers Device Name:

Indications for Use:

The Ethicon Ligaclip Multiple Clip Appliers are instruments used for ligation of tubular structures and vessels.

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

of Device Evaluation (ODE) Concurrence of CDRH, Off.

De of

Division of General, Restorative, and Neurological Devices

510(k) Number K033575

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Device Listing:

MCL20 MCM20 MCM30 MCS20