SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS

K052690 · Suretek Medical · NUJ · May 12, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052690
• Device Name: SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
• Applicant: Suretek Medical
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.

Device Story

Suretek Reprocessed Laparoscopic Instruments consist of various surgical tools, including dissectors, scissors, shears, and forceps, designed for use in general and laparoscopic surgical procedures. These devices are reprocessed single-use instruments originally manufactured by companies such as AutoSuture, ConMed, Ethicon, and Gyrus. The instruments function by providing mechanical cutting, grasping, and dissection capabilities, as well as delivering monopolar or bipolar electrosurgical energy for tissue coagulation. They are operated by surgeons in an operating room environment. The devices are intended to perform the same clinical functions as their original, non-reprocessed counterparts, facilitating surgical access and tissue management during minimally invasive procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence was determined based on supplemental validation data submitted for reprocessed single-use devices.

Technological Characteristics

Devices include monopolar and bipolar electrosurgical instruments (dissectors, scissors, shears, forceps) in 5mm and 10mm diameters and various lengths (15cm to 33cm). Energy source is external electrosurgical generator. Construction materials are consistent with original predicate devices. Reprocessing involves cleaning, inspection, and sterilization protocols to restore functionality for single-use application.

Indications for Use

Indicated for use in general and laparoscopic surgery for cutting, grasping, dissection, and electrocautery of tissue in patients requiring such surgical interventions.

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

• AUTOSUTURE ENDO DISSECT 5mm
• AUTOSUTURE ENDO SCIZ 5mm
• AUTOSUTURE ENDO SHEARS 5mm
• CONMED Curved Metzenbaum 5mm
• CONMED Curved Metzenbaum Narrow Tip 5mm
• CONMED Curved Metzenbaum Mini 5mm
• CONMED Maryland Dissector 5mm
• ETHICON Dissector 5mm
• ETHICON Scissors 5mm
• GYRUS Bipolar Cutting Forceps 5mm
• GYRUS Bipolar Cutting Forceps 10mm
• GYRUS Bipolar Needle Electrode 5mm

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 6 2006

SureTek Medical % Mike Sammon, BME, Ph.D. CEO/President 44 Bellwood Farms Greenville, South Carolina 29607

Re: K052690 - Supplemental Validation Submission Trade/Device Name: 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: January 3, 2006 Received: January 6, 2006

Dear Dr. Sammon:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 12, 2006. 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 (2) CFR

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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.

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,

[signature]

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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## Indications for Use

510 (k) Number (if known) : K052690

Suretek Reprocessed Laparoscopic Instruments Device Name:

Indications For Use:

Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.

Prescription Use AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**
Division of General, Restorative,
and Neurological Devices and Neurological Devices
Page 1 of

5100 Number

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1. And 1998

:

Reprocessed Laparoscopic Instruments found to be substantially equivalent:

| AUTOSUTURE | ENDO DISSECT 5mm | Monopolar, 33cm Length |
|------------|------------------------------------|------------------------|
| AUTOSUTURE | ENDO SCIZ 5mm | Monopolar, 33cm Length |
| AUTOSUTURE | ENDO SHEARS 5mm | Monopolar, 33cm Length |
| CONMED | Curved Metzenbaum, 5mm | Monopolar, 32cm Length |
| CONMED | Curved Metzenbaum, Narrow Tip, 5mm | Monopolar, 32cm Length |
| CONMED | Curved Metzenbaum, Mini, 5mm | Monopolar, 32cm Length |
| CONMED | Maryland Dissector, 5mm | Monopolar, 32cm Length |
| ETHICON | Dissector, 5mm | Monopolar, 33cm Length |
| ETHICON | Scissors, 5mm | Monopolar, 33cm Length |
| GYRUS | Bipolar Cutting Forceps, 5mm | 24cm Length |
| GYRUS | Bipolar Cutting Forceps, 5mm | 33cm Length |
| GYRUS | Bipolar Cutting Forceps, 10mm | 15cm Length |
| GYRUS | Bipolar Cutting Forceps, 10mm | 33cm Length |
| GYRUS | Bipolar Needle Electrode, 5mm | 33cm Length |

:

1000 - 1000

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: