REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

K012603 · Alliance Medical Corp. · NUJ · Nov 7, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012603
• Device Name: REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
• Applicant: Alliance Medical Corp.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Nov 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.

Device Story

Reprocessed single-use unipolar laparoscopic/endoscopic instruments (scissors, dissectors, graspers) used in minimally invasive surgery. Devices function as electrosurgical cutting and coagulation tools. Operated by surgeons in clinical/OR settings. Instruments manipulate soft tissue; provide cauterization/coagulation via electrosurgical energy. Reprocessing restores device functionality to original manufacturer specifications, allowing reuse in subsequent procedures. Benefits include cost-effective access to surgical instrumentation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrosurgical cutting and coagulation instruments. Reprocessed single-use laparoscopic/endoscopic tools (scissors, dissectors, graspers). Materials and design specifications are identical to the original manufacturer's predicate devices. Sterilization is performed as part of the reprocessing cycle.

Indications for Use

Indicated for patients requiring minimally invasive surgical procedures for manipulation and management of internal soft tissue via grasping, cutting, dissecting, cauterizing, or coagulating.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the text "Public Health Service" in bold, black font. The text is horizontally oriented and appears to be a title or heading. The background is plain white, providing a clear contrast for the text.

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "HUMAN SERVICES USA" are arranged in an arc at the top of the logo, and the words "DEPARTMENT OF" are arranged in an arc at the bottom.

AUG - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Renken Regulatory Affairs Specialist Alliance Medical Corporation 10232 South 51" Street Phoenix, Arizona 85044

KO12603 Supplemental Validation Submission Re: Trade/Device Name: Alliance Medical Corporation Reprocessed Unipolar Laparoscopic/Endoscopic Instruments (See Enclosed List) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: March 14,2005 Received: March 15,2005

Dear Ms. Renken:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 7.2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

{1}------------------------------------------------

Page 2 - Ms. Elizabeth Renken

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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.

Styfe Rlwd

Mark N. Melkerson Acting Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## KO12603

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

· ·· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

・・

| Manufacturer | Description | Model |
|--------------|------------------------------------|--------|
| US Surgical | Autosuture ® Endo Mini-shears | 174301 |
| US Surgical | Autosuture ® Endo Shear Short | 174501 |
| US Surgical | Autosuture® Endo Shear Long | 174601 |
| US Surgical | Autosuture® Endo Mini-shears short | 174503 |
| US Surgical | Autosuture® Endo Shears | 176643 |
| US Surgical | Autosuture® Endo Dissect | 176645 |
| US Surgical | Autosuture® Endo Dissect, Short | 174505 |

Stypt Rurla

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

510(k) Number___KO42602_

{3}------------------------------------------------

## NOV 0 7 2001 II. Indications for Use Statement

510(k) Number (if known):

K012603

Device Name: Alliance Medical Corporation Reprocessed Unipolar Laparoscopic/Endoscopic Instruments

Indications for Use: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.

| Manufacturer | Description | Model |
|--------------|------------------------------------|--------|
| US Surgical | Autosuture ® Endo Mini-shears | 174301 |
| US Surgical | Autosuture® Endo Shear Short | 174501 |
| US Surgical | (Autosuture® Endo Shear Long | 174601 |
| US Surgical | Autosuture® Endo Mini-shears short | 174503 |
| US Surgical | Autosuture® Endo Shears | 176643 |
| US Surgical | Autosuture® Endo Dissect | 176645 |
| US Surgical | Autosuture Endo Dissect. Short | 174505 |

Concurrence of CDRH, Office of Device Evaluation (ODE)

t Prescription Use (per 21 CFR801.109)

or

Over-the-counter Use _

Susan Walker, MD

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

CONFIDENTIAL

510(k) Number K01240
Alliance Medical Corporation
Reprocessed Laparoscopic/Endoscopic Instruments
Traditional 510(k)

12