REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS

K012598 · Sterilmed, Inc. · NUJ · Nov 7, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012598
• Device Name: REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
• Applicant: Sterilmed, Inc.
• 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

Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, mobilization, and dissection of tissue.

Device Story

Reprocessed laparoscopic electric instruments consist of handle, rotating insulated shaft (5mm diameter, 19-33cm length), and distal tip (dissectors, scissors, or cutting forceps). Devices are monopolar or bipolar, featuring cautery connectors or cables. Operated by surgeons in OR settings during minimally invasive or open procedures. Device connects to RF generator; electrical current delivered to distal tip for tissue coagulation, transection, mobilization, and dissection. Reprocessing restores single-use devices to original functional state via validated cleaning and sterilization processes. Benefits include cost-effective access to surgical instrumentation.

Clinical Evidence

Bench testing only. Representative samples underwent functional testing to demonstrate appropriate characteristics. Process validation performed for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional testing.

Technological Characteristics

Monopolar or bipolar electrosurgical instruments. Components: handle, rotating insulated shaft, distal tip (dissectors, scissors, cutting forceps). Energy source: external RF generator. Connectivity: cautery connector or cable. Reprocessing involves validated cleaning and sterilization methods.

Indications for Use

Indicated for use in minimally invasive and open surgical procedures for tissue coagulation, transection, mobilization, and dissection.

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.

Predicate Devices

• BiCoag Forceps (K945975)
• Endopath Endoscopic Instruments (K984240)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2007

SterilMed, Inc. % Mr. Dennis Toussaint Director, Regulatory Affairs 11400 73rd Avenue North Maple Grove, Minnesota 55369

Re: K012598 - Supplemental Validation Submission Trade/Device Name: Reprocessed Electric Instruments (Enclosed List) Regulation Number: 21CFR878.4400 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories Regulatory Class: II Product Code: NUJ Dated: August 8, 2001 Received: August 10, 2001

Dear Mr. Toussaint:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on October 23, 2000. 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.

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 (QS) regulation (21 CFR Part 820); and if

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Page 2 - Mr. Dennis Toussaint

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 [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,
Mark A. Wilkerson

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

Enclosure Intended Use form

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Image /page/2/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in a bold, sans-serif font. Below the company name, it says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The text is black and the background is white.

SVS For 510(K): K012598 Reprocessed Laparoscopic Electric Instruments

## INDICATIONS FOR USE PAGE (K012598)

(Same as currently cleared 510(k))

Device Name: Reprocessed Laparoscopic Electric Instruments

Indications for Use: Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, mobilization, and dissection of tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K012598

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# List of thirteen (13) Reprocessed Laparoscopic Electric Instruments
of the SVS for K012598

| Manufacturer | Model # | Description |
|-----------------|---------|----------------------------------------|
| AutoSuture | 174301 | Endo Mini-Shears, 5mm, Monopolar, 31cm |
| | 174501 | EndoShears, 5mm, Monopolar, 19cm |
| | 174503 | Endo Mini-Shears, 5mm, Monopolar, 19cm |
| | 174505 | Endo Dissect, 5mm Monopolar, 19cm |
| | 176605 | EndoSciz, 5mm, Monopolar, 31cm |
| | 176643 | EndoShears, 5mm, Monopolar, 31cm |
| | 176645 | EndoDissect, 5mm, Monopolar, 31cm |
| Ethicon | 5DCS | Scissors, 5mm, Monopolar, 31cm |
| | 5DCD | Dissector, 5mm, Monopolar, 31 cm |
| Everest (Gyrus) | 3005 | Cutting Forceps, 5mm, Bipolar, 33cm |
| | 3025 | Cutting Forceps, 5mm, Bipolar, 24cm |
| Gyrus | 3005PK | Cutting Forceps, 5mm, Bipolar, 33cm |
| | 3025PK | Cutting Forceps, 5mm, Bipolar, 24cm |

:

:

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### SUPPLEMENTAL VALIDATION SUBMISSION JUNE 27, 2006

For 510(K): K012598 Reprocessed Laparoscopic Electric Instruments

SVS for K012598, Reprocessed Lap. Ele. Instruments

II. SUMMARY AND CERTIFICATION

A. 510(k) Summary

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-----------------------------------------------|
| Submitter: | SterilMed, Inc. |
| Contact Person: | Dennis Toussaint |
| | 11400 73rd Avenue North |
| | Maple Grove, MN 55369 |
| | Ph: 888-856-4870 |
| | Fax: [phone] |
| Date Prepared: | June 28, 2006 |
| Trade Name: | Reprocessed Laparoscopic Electric Instruments |
| Classification Name: | Endoscopic Electrosurgical Accessory |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NUJ |

Predicate
Devices:

Device
Description:

Intended Use:

Functional and
Safety Testing:

Page 1 of 2

The reprocessed laparoscopic electric instruments are substantially
equivalent to BiCoag Forceps (K945975), manufactured by Everest;
Endopath Endoscopic Instruments (K984240) manufactured by
Ethicon; and counterpart devices from other original equipment
manufacturers.

Laparoscopic electric instruments are devices that are designed for use
via laparoscopes or open surgical procedures. The devices have a
handle, a rotating insulated shaft with a diameter of 5mm, a length of
19-33 cm and a distal tip. The distal tip of the devices consists of a
variety of configurations including: dissectors, scissors and cutting
forceps. The devices may be monopolar or bipolar and have a cautery
connector on the handle or a connector cable. The device is connected
via a cautery cable to a RF generator which provides electrical current
to the device.

Laparoscopic electric instruments are designed for use in minimally
invasive procedures and/or open surgical procedures to facilitate
coagulation, transaction, resection, mobilization and dissection of
tissue.

Representative samples of reprocessed laparoscopic electric
instruments underwent functional testing to demonstrate appropriate
functional characteristics. Process validation testing was done to
validate the cleaning and sterilization procedures as well as device
packaging. In addition, the manufacturing process includes visual and
functional testing of all products produced.

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**STERILMED, INC.**
Medical Device Reprocessing
Small Equipment & Instrument Repair

## SUPPLEMENTAL VALIDATIC SUBMIS JUNE 27, 2006

For 510(K): K012598 Reprocessed Laparoscopic Electric Instruments

Conclusion:

The reprocessed laparoscopic electric instruments are substantially equivalent to BiCoag Forceps (K945975), and Endopath Endoscopic Instruments (K984240), manufactured by Ethicon; and counterpart devices from other original equipment manufacturers.

This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.