CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES

K072814 · Covidien · KDD · Apr 16, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072814
• Device Name: CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
• Applicant: Covidien
• Product Code: KDD · General, Plastic Surgery
• Decision Date: Apr 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.

Device Story

Convenience kit containing various configurations of laparoscopic instruments; used for laparoscopic access, tissue dissection, tissue manipulation, hemostasis, and specimen collection. Used in clinical settings by surgeons during laparoscopic procedures. Kit components are identical to previously cleared predicate devices. Output is the physical performance of the instruments during surgery to facilitate the procedure.

Clinical Evidence

No clinical data; reliance on relevant clinical literature to support the intended use of the convenience kit configuration.

Technological Characteristics

Convenience kit containing various laparoscopic instruments for access, dissection, manipulation, hemostasis, and specimen collection. Materials of construction are unchanged from predicate devices. No electronic or software components.

Indications for Use

Indicated for patients undergoing Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Endo Clip 5mm Clip Applier (K883018)
• Roticulator Endo Dissect 5mm, Endo Grasp 5mm, & Endo Mini-Shears 5mm (K914753)
• AcuClip Right Angle Clip Applier (K920599)
• Endo Catch Gold (K922123)
• Roticulator Endo Sciz 5mm Hook Scissors (K951589)
• Dexide 5mm Threaded Trocar (K981941)
• VersaStep Plus 12mm Trocar (K012539)

Submission Summary (Full Text)

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## Surgical Devices, a global business unit of Tyco Healthcare Group, LP (d/b/a Covidien)

### 5. 510(K) SUMMARY:

510(k) Summary of Safcty and Effectiveness:

| SUBMITTER: | Surgical Devices, a global business unit of<br>Tyco Healthcare Group LP (d/b/a Covidien)<br>60 Middletown Avenue<br>North Haven, CT 06473 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Robert Zott<br>Program Director, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | September 21, 2007 |
| TRADE/PROPRIETARY NAME: | To Be Determined |
| COMMON/USUAL NAME: | Convenience Kit |
| CLASSIFICATION NAME: | Convenience Kit |
| PREDICATE DEVICE(S): | K883018: Endo Clip* 5mm Clip Applier |
| | K914753: Roticulator Endo Dissect* 5mm,<br>Endo Grasp* 5mm, & Endo Mini-Shears* 5mm |
| | K920599: AcuClip* Right Angle Clip Applier |
| | K922123: Endo Catch* Gold |
| | K951589: Roticulator Endo Sciz* 5mm<br>Hook Scissors |
| | K981941: Dexide* 5mm Threaded Trocar |
| | K012539: VersaStep* Plus 12mm Trocar |
| | All predicate devices manufactured by<br>Surgical Devices, a global business of<br>Tyco Healthcare Group LP (d/b/a/ Covidien) |

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## 072414

# Surgical Devices, a global business unit of Tyco Healthcare Group, LP (d/b/a Covidien)

| DEVICE DESCRIPTION: | Convenience kit of laparoscopic instruments. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | "Single-Incision Laparoscopic Surgery and other<br>advanced laparoscopic procedures." |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The convenience kit contains various<br>configurations of tools for the performance of<br>laparoscopic procedures. These tools provide<br>laparoscopic access, tissue dissection and<br>manipulation, hemostasis, and specimen collection. |
| MATERIALS: | Unchanged from predicate devices. |
| PERFORMANCE DATA: | Relevant clinical literature has been cited in<br>support of the intended use of this convenience kit. |

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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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2008

Covidien % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K072814

Trade/Device Name: Convenience Kit for "Single-Incision Laparoscopic Surgery and and other advanced laparoscopic procedures." Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 20, 2008 Received: March 21, 2008

Dear Mr. Zott:

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 Federal agencies. You must or uny I vith 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

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Page 2 - Mr. Robert Zott

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.

This letter will allow you to begin marketing your device as described in your Scction 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

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

Enclosure

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Attachment l

## Indications for Use

| 510(k) Number (if known): | K072814 |
|---------------------------|-----------------------------------------------------------------------------------------------------------|
| Device Name: | Convenience Kit for "Single-Incision Laparoscopic Surgery<br>and other advanced laparoscopic procedures." |
| Indications for Use: | For Single-Incision Laparoscopic Surgery and other<br>advanced laparoscopic procedures. |

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for MXM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K072814

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