REPROCESSED SCISSOR TIPS

K073613 · Sterilmed, Inc. · NUJ · Feb 12, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073613
• Device Name: REPROCESSED SCISSOR TIPS
• Applicant: Sterilmed, Inc.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Feb 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting of tissue.

Device Story

Reprocessed scissor tips are laparoscopic electrosurgical accessories designed for insertion into reusable hand pieces. Used in minimally invasive and open surgical procedures by surgeons to facilitate tissue coagulation, preparation, mobilization, and cutting. Devices are monopolar, featuring a cautery connector on the handle or a connector cable. The device functions as a mechanical cutting tool with integrated electrosurgical capability. SterilMed reprocesses these tips, originally manufactured by Aesculap, Encision, Microline, and Snowden Pencer. The reprocessed tips are provided sterile. The healthcare provider uses the device by attaching it to a compatible hand piece and generator; the output is the physical cutting and cauterization of tissue, which aids in surgical efficiency and patient management during procedures.

Clinical Evidence

Bench testing only. Functional and safety testing performed on representative samples. Process validation conducted for cleaning, sterilization, and packaging. Manufacturing process includes visual and validated functional testing of all products.

Technological Characteristics

Monopolar electrosurgical scissor tips for laparoscopic/open surgery. Materials and construction methods are consistent with original predicate devices. Connectivity via cautery connector or cable to external generator/hand piece. Sterilization process validated for reprocessed units.

Indications for Use

Indicated for use in minimally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue in patients requiring such surgical intervention.

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

• Snowden Pencer Switchblade®
• Microline Eversharp®
• Aesculap Disposable Scissor Insert
• Encision AEM® Scissor Insert

Submission Summary (Full Text)

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

## FEB 1 2 2008 510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 20, 2007

For Reprocessed Scissor Tips (Laparoscopic Electric Instrument Accessories)

### II. SUMMARY AND CERTIFICATION

### A. 510(k) Summary

| Submitter: | SterilMed, Inc. |
|------------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joshua Clarin<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 763-488-3483<br>Fax: [phone] |
| Date Prepared: | December 17, 2007 |
| Trade Name: | Reprocessed Scissor Tips |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NUJ |

| Predicate<br>Devices: | The reprocessed scissor tips are substantially equivalent to Snowden Pencer Switchblade®,<br>Microline Eversharp®, Aesculap Disposable Scissor Insert, and Encision AEM® Scissor Insert<br>sterile electrosurgical scissors. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed's reprocessed scissor tips are laparoscopic electric devices that are inserted into a<br>reusable hand piece and are designed to be used in laparoscopic and open surgical procedures<br>to facilitate coagulation, preparation, mobilization and cutting of tissue. The devices are<br>monopolar and have a cautery connector on the handle or a connector cable. These devices<br>were originally manufactured by Aesculap (Braun), Encision, Microline, and Snowden Pencer.<br>Note: Only the scissor tip is the subject of this submission, the reusable hand piece, the cautery<br>cable and the generator are not included in the scope of this submission. |
| Intended Use: | The reprocessed scissor tips are intended to be used with a reusable hand piece and are<br>designed for use in minimally invasive and open surgical procedures to facilitate coagulation,<br>preparation, mobilization, and cutting of tissue. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed scissor tips were tested to demonstrate appropriate<br>functional characteristics. Process validation testing was performed to validate the cleaning and<br>sterilization procedures as well as device packaging. In addition, the manufacturing process<br>includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed Scissor Tips are substantially equivalent to Snowden Pencer Switchblade®,<br>Microline Eversharp®, Aesculap Disposable Scissor Insert, and Encision AEM® Scissor Insert<br>sterile electrosurgical scissors.<br>This conclusion is based upon the devices' similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2008

SterilMed, Inc. % Mr. Joshua Clarin Senior Regulatory Affairs Specialist 11400 73td Avenue North, Suite 100 Maple Grove, Minnesota 55369

Re: K073613

Trade/Device Name: Reprocessed Scissor Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: December 20, 2007 Received: December 21, 2007

Dear Mr. Clarin:

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 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

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Page 2 – Mr. Joshua Clarin

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 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 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 acre ventures (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 Assistances of 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 M. Millman

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

510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 20, 2007

For Reprocessed Scissor Tips (Laparoscopic Electric Instrument Accessories)

K0 73613

# Indications for Use

510(k) Number (if known):

Device Name: Reprocessed Scissor Tips

Indications for Use:

The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in mininally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization and coagulation 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)

Division of General Restorative. and Neurological Devices

510(k) Number L073613

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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| Manufacturer | Model # | Description |
|---------------------|-------------------------------------------|----------------------------------------------------------|
| Aesculap<br>(Braun) | PO886 | Hook Scissor Tip, 5mm diameter,<br>31 cm long |
| | PO887 | Mini-Metzenbaum Scissor Tip,<br>5mm diameter, 31 cm long |
| | PO888 | Metzenbaum Scissor Tip, 5mm<br>diameter, 31 cm long |
| | PO889 | Metzenbaum Scissor Tip, 5mm<br>diameter, 42 cm long |
| Encision | ES0101 | Curved Scissor Tip ½", 35cm long |
| | ES0102 | Curved Scissor Tip ¾, 35cm long |
| | ES0110 | Hook Scissor Tip. 35cm long |
| Microline | 3112 | Scissor Tip Metzenbaum 13.46 mm long |
| | 3122 | Scissor Tip Micro 9.4 mm long |
| | 3132 | Scissor Tip Hook 12.7 mm long |
| | 3142 | Scissor Tip Endocut 16.51 mm long |
| 3152 | Scissor Tip Mini Endocut 11.42<br>mm long | |
| Snowden<br>Pencer | 89-5100 | Scissor Tip Curved |
| | 89-5200 | Scissor Tip Hook |
| | 89-5300 | Scissor Tip Curved Mini-<br>Metzenbaum Micro |

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The following table displays the list of the fifteen (15) Reprocessed Scissors included in this subject K073613 submission: Tips

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