SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS

K040602 · Design Standards Corp. · FZP · May 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040602
• Device Name: SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
• Applicant: Design Standards Corp.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sureline™ Laparoscopic Clip Applier with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.

Device Story

Sureline™ Laparoscopic Clip Applier is a surgical instrument for vessel ligation during laparoscopic procedures. Available as disposable single-patient-use or reusable applier with disposable 20-clip titanium cartridges. Device inserted through 10 mm cannula; jaws placed around vessel or tubular structure. Trigger actuation drives internal mechanism to close cartridge jaws, forming titanium clip securely around target tissue. Release of trigger opens jaws; automatic feeding mechanism advances next clip. Used by surgeons in clinical/OR settings. Provides mechanical occlusion of vessels to assist in surgical hemostasis or structure management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices.

Technological Characteristics

Constructed from biocompatible stainless steel and medical-grade polymers. Mechanical actuation via trigger-driven jaw closure and automatic clip feeding. Form factor: 10 mm cannula compatibility. Non-powered, manual surgical instrument.

Indications for Use

Indicated for use in laparoscopic procedures to occlude blood vessels and other tubular structures. Tissue ligated must be consistent with clip size.

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

• Vitalitec International (K981645)
• Microsurge Sureline (964109)
• United States Surgical Corporation (K883081, K890941)
• Ethicon Endosurgery (K920387)
• Pilling Weck (K851251, K905837)

Submission Summary (Full Text)

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**MAY 1 0 2004**

K044602 Page 1/1

Design Standards Corporation

510(k) March 2004

# 510 (k) SUMMARY: Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips

- Design Standards Corporation (1) 182 CEDA Rd. Charlestown, NH 03603 [phone]
Contact Person: Michele Lucey Date Summary Prepared: September 2, 2003

Trade or Proprietary Name: Sureline™ Laparoscopic Clip Applier (2) with Implantable Titanium Clips

Laparoscopic Clip Applier with Implantable Common Name: Titanium Clips

Implantable Clip (74FZP), 21 CFR Classified Name: 878.4300, Class II

- (3) Predicates:
Vitalitec International (k981645) Microsurge Sureline (964109) United States Surgical Corporation (K883081, K890941) Ethicon Endosurgery (K920387) Pilling Weck (K851251, K905837))

(4) Description of Device:

The Sureline TM Laparoscopic Clip Applier with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The product is also available as a reusable clip applier and disposable clip cartridge. The disposable clip applier and disposable clip cartridge contain 20 titanium clips. The clip cartridge is attached to the clip applier handle via

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K040602 page 2/2

#### Design Standards Corporation

510(k) March 2004

March 2004
a lock/release mechanism, and inserted through a trocar to gain a lockrelease moonamamic clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. 13 placed around the clip applier handle/trigger drives a Actuation/oomproom.com/close the cartridge jaws, thereby mechanism within the ourinessel. Release/decompression of forming the clip securely around the jaws of the cartridge to open and the clip applici nandio.ingger all.ge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application.

The cartridge is sized to fit through a 10 mm cannula. The overall shaft The cartridge is sized to in through andle is approximately 33 mm, consistent with other endoscopic instruments.

#### (5) Intended Use:

tended 030.
The Sureline™ Laparoscopic Clip Applier with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.

- (6) Technological Characteristics:
connologiour offaratoscopic Clip Applier with implantable titanium clips i The Ourchino - Euparosophal characteristics as the predicate devices in that they are comprised of similar design, materials, and are intended for that they are comprove structures during laparoscopic surgery.

### (7) Conclusion:

onolori.
The new device has the same intended use and the same basic technology as the predicates identified in the premarket notification technology as the new device contains in some combination similar/same Submission materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 1 0 2004

Ms. Michele Lucey Director of Regulatory Affairs and Quality Assurance Design Standards Corporation 182 Ceda Road P.O. Box 1620 Charlestown, New Hampshire 03603

Re: K040602

Trade/Device Name: Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: March 1, 2004 Received: March 8, 2004

Dear Ms. Lucey:

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 application (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 such 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 Foderal 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 - Ms. Michele Lucey

This letter will allow you to begin 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 [phone]. 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.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040602

Device Name: Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips

Indications For Use:

The Sureline Laparoscopic Clip Applier with Implantable Titanium clips is intended for use in a variety of laparoscopic procedures to occures to occures and blood vessels. The tissue being ligated should be consistent with the size of the clip.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K040602

Prescription Use
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Concurrence of CORH, Office of Device Evaluation (ODE)

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