SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS

K052695 · Suretek Medical · NUJ · May 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052695
• Device Name: SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
• Applicant: Suretek Medical
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SureTek Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5mm).

Device Story

Reprocessed powered arthroscopic instruments (shavers/burs) for cutting soft tissue, cartilage, and bone; used in arthroscopic/endoscopic surgeries. Input: mechanical rotation via compatible driver systems; features continuous irrigation/aspiration through hollow shaft. Output: physical resection of tissue. Used in clinical settings by surgeons. Reprocessing restores used blades/burs to original specifications; identical materials, dimensions, and system compatibility as predicates. Benefits: provides cost-effective, sterile, functional surgical instruments equivalent to new devices.

Clinical Evidence

Bench testing only. Validated cleaning process for decontamination under worst-case conditions. Performance testing after maximum use/reprocessing cycles confirms equivalence to new devices. Packaging and sterility validation per ISO 11607, ISO 11135, and EN868-1. Biocompatibility and ethylene oxide residuals conform to ISO 10993.

Technological Characteristics

Stainless steel hollow shaft instruments with distal blade/bur. Diameters 2-6mm. Features serrated/non-serrated blades and burs (4-12 flutes). Powered by external driver systems. Sterilization via ethylene oxide (ISO 11135). Biocompatibility per ISO 10993. Packaging per ISO 11607.

Indications for Use

Indicated for patients undergoing arthroscopic or endoscopic procedures requiring cutting and resection of soft tissue, cartilage, and bone. Endoscopic sinus surgery restricted to instruments 2-3.5mm diameter.

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

• Dyonics (Smith & Nephew) (K953695)
• Stryker Corp (K941333)
• Linvatec (K990524)
• Xomed (Medtronic) (K010667)
• Vanguard Medical Concepts (K012346)
• MediSISS (K012667)

Submission Summary (Full Text)

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# SureTek Medical 510(k) Summary

... : 一、一、

| Submitter | SureTek Medical 25-B Maple Creek Cir Greenville, SC 29607 | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|
| Contact | Mike Sammon, Ph.D. Phone [phone] | | |
| Date | 9/25/05 | | |
| Product | Reprocessed Arthroscopic Shavers and Burs | | |
| Classification | Code:HRX Regulation: 21 CFR 888.1100 | | |
| | Manufacturer/Reprocessor | 510(k) | |
| Predicate<br>Devices | Dyonics (Smith & Nephew) | K953695 | |
| | Stryker Corp | K941333 | |
| | Linvatec | K990524 | |
| | Xomed (Medtronic) | K010667 | |
| | Vanguard Medical Concepts | K012346 | |
| | MediSISS | K012667 | |
| Device<br>Description | Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue,<br>cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrument<br>consist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannula<br>with outer diameters ranging from 2 to 6 mm. Devices are designed for use only with<br>compatible driver systems with continuous irrigation and aspiration of fluids through the<br>inner shaft during use. Depending upon the aggressiveness required for cutting, shavers are<br>designed with different serrated and non-serrated blades and angles, and burs have varying<br>shapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burs<br>have identical technological characteristics as the predicate devices, i.e. device component<br>materials, dimensions and system compatibility are unchanged during reprocessing. | | |
| Intended Use | SureTek Arthroscopic Blades and Burs are intended for use during arthroscopic and<br>endoscopic procedures for cutting and resection of soft tissue, cartilage and bone.<br>Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5mm). | | |
| Testing and<br>Standards | • Bench testing of devices following the maximum number of use and reprocessing cycles<br>found their performance to be substantially equivalent to new, unused devices.<br>• SureTek cleaning process is validated to be effective for decontamination of grossly<br>contaminated instruments under worst case operational conditions.<br>• Product packaging conforms to all relevant requirements of ISO 11607 Packaging for<br>terminally sterilized medical devices, with performance qualifications tested according to<br>EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02.<br>• Product sterility and process validation conform to the relevant requirements of ISO<br>11135 Medical Devices – Validation and routine control of ethylene oxide sterilization.<br>• Products conform to the relevant requirements of ISO 10993 Biological Evaluation of<br>Medical Devices for ethylene oxide residuals and biocompatibility of device materials. | | |
| Substantial<br>Equivalence | Product testing and comparisons of specifications determines that SureTek Reprocessed<br>Arthroscopic Shavers and Burs are substantially equivalent to their predicate devices with<br>respect to device intended use and performance, as well as product packaging, labeling,<br>sterility and safety. | | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

SureTek Medical c/o Mike Sammon, BME, Ph.D. CEO/President 25-B Maple Creek Circle Greenville, South Carolina 29607

Re: K052695

Trade/Device Name: SureTek Reprocessed Arthroscopic Blades and Burs Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: April 1, 2006 Received: April 5, 2006

Dear Dr. Sammon:

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 - Mike Sammon, BME, Ph.D.

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 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. Millan

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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SureTek Medical

Reprocessed Arthroscopic Blades and Burs found to be substantially equivalent:

Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dvonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dvonics Dyonics Dvonics Dvonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Dyonics Linvatec Linvatec Linvatec Linvatec Linvatec Linvatec Linvatec Linvatec Linvatec Linvatec Linvatec

Cutter Blade Cutter Blade Cutter Blade Full Radius Blade Full Radius Blade Full Radius Blade Full Radius Blade Full Radius Blade Incisor Blade Incisor Blade Incisor Blade Incisor Blade Incisor Blade Incisor Plus Blade Incisor Plus Blade RazorCut Blade RazorCut Blade RazorCut Blade RazorCut Blade Synovator Blade Synovator Blade TurboTrimmer Blade Turbo Whisker Blade TurboWhisker Blade Barrel AcromioBlaster Bur. 12 Flute Barrel AcromioBlaster Bur, 12 Flute Barrel Acromionizer Bur, 12 Flute Barrel Acromionizer Bur, 12 Flute Barrel Abrader Bur, 4 Flute Barrel StoneCutter Bur, 8 Flute Barrel StoneCutter Bur, 4 Flute HeliCut Bur, 6 Flute Round Abrader Bur, 4 Flute Round Abrader Bur, 4 Flute Round Abrader Bur, 8 Flute Round Abrader Bur, 8 Flute Round Notchblaster Bur, 4 Flute Round Notchbiaster Bur, 4 Flute Cuda Blade, Micro Hub Cuda Blade, Micro Hub Cuda Blade, Micro Hub Cuda Blade, Large Hub Cuda Blade, Large Hub Cuda Blade, Large Hub Cuda Blade, Large Hub Dragon End Cutter, Large Hub Dragon End Cutter, Large Hub Dragon End Cutter, Large Hub Full Radius Resector, Micro Hub

2.9mm, Beige, 7.5cm shaft 3.5mm, Red 4.5mm, Blue 2.0mm, Blue, 7.5cm shaft 2.9mm, Red, 7.5cm shaft 3.5mm, Beige 4.5mm, Yellow 5.5mm, Orange 2.9mm, Lime Green, 7.5cm 3.5mm, Turquoise 3.5mm, Medium Grey 4.5mm, Lime Green 5.5mm, Mocha 4.5mm, Violet 5.5mm, Teal 4.5mm, Pink 3.5mm, Pink, 7.5cm shaft 3.5mm. Purple 5.5mm, Lt Pink 4.5mm, Forest Green 5.5mm, Melon Yellow 4.5mm, Powder Blue 2.0mm, Yellow, 7.5cm shaft 2.9mm, Green, 7.5cm shaft 4.0mm, Sage Green 5.5mm, Brick Red 4.0mm. Mauve 5.5mm, Brown 2.9mm, Purple, 7cm shaft 4.0mm, Maroon 5.5mm, Olive 4.5mm, Slate 2.9mm, Orange, 7cm shaft 3.5mm, Aqua, 7cm shaft 4.0mm. Aqua 5.5mm, Black 4.0mm. Lilac 5.5mm, Peach 2.0mm, Magenta, 7.6cm shaft 2.9mm, Magenta, 7.6cm shal 3.5mm, Magenta, 7.6cm shaf 3.5mm, Magenta 4.2mm, Magenta 4.8mm. Magenta 5.5mm, Magenta 3.2mm, Purple 4.2mm, Purple 5.5mm. Purple 2.0mm, Yellow, 7.6cm sha

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SureTek Medical

Reprocessed Arthroscopic Blades and Burs found to be substantially equivalent:

| Linvatec | Full Radius Resector, Micro Hub | 2.9mm, Yellow, 7.6cm shaft |
|----------|------------------------------------|-------------------------------|
| Linvatec | Full Radius Resector, Micro Hub | 3.5mm, Yellow, 7.6cm shaft |
| Linvatec | Full Radius Resector, Large Hub | 3.5mm, Yellow |
| Linvatec | Full Radius Resector, Large Hub | 4.2mm, Yellow |
| Linvatec | Full Radius Resector, Large Hub | 4.8mm, Yellow |
| Linvatec | Full Radius Resector, Large Hub | 5.5mm, Yellow |
| Linvatec | Gator Blade, Micro Hub | 2.0mm, Orange, 7.6cm shaft |
| Linvatec | Gator Blade, Micro Hub | 2.9mm, Orange, 7.6cm shaft |
| Linvatec | Gator Blade, Micro Hub | 3.5mm, Orange, 7.6cm shaft |
| Linvatec | Gator Blade, Large Hub | 3.5mm, Orange |
| Linvatec | Gator Blade, Large Hub | 4.2mm, Orange |
| Linvatec | Gator Blade, Large Hub | 4.8mm, Orange |
| Linvatec | Gator Blade, Large Hub | 5.5mm, Orange |
| Linvatec | Great White Blade, Large Hub | 3.5mm, White |
| Linvatec | Great White Blade, Large Hub | 4.2mm, White |
| Linvatec | Great White Blade, Large Hub | 4.8mm, White |
| Linvatec | Mako Blade, Large Hub | 4.2mm, Green |
| Linvatec | Mako Blade, Large Hub | 5.5mm, Green |
| Linvatec | Slotted Whisker, Micro Hub | 2.9mm, Red, 7.6cm shaft |
| Linvatec | Slotted Whisker, Large Hub | 4.2mm, Red |
| Linvatec | Slotted Whisker, Large Hub | 5.5mm, Red |
| Linvatec | Oval Bur, Large Hub, 6 Flute | 4.0mm, Purple, High Speed |
| Linvatec | Oval Bur, Large Hub, 6 Flute | 6.0mm, Purple, High Speed |
| Linvatec | Vortex Router, Micro Hub, 2 Flute | 2.9mm, Green, 7.6cm shaft |
| Linvatec | Vortex Router, Micro Hub, 2 Flute | 3.5mm, Green, 7.6cm shaft |
| Linvatec | Vortex Router, Large Hub, 5 Flute | 4.5mm, Dk Green, High Speed |
| Linvatec | Vortex Router, Large Hub, 5 Flute | 5.5mm, Dk Green, High Speed |
| Linvatec | Spherical Bur, Micro Hub, 12 Flute | 2.9mm, Blue, 7.6cm shaft |
| Linvatec | Spherical Bur, Micro Hub, 12 Flute | 3.5mm, Blue, 7.6cm shaft |
| Linvatec | Spherical Bur, Large Hub, 12 Flute | 3.5mm, Blue, High Speed |
| Linvatec | Spherical Bur, Large Hub, 12 Flute | 4.0mm, Blue, High Speed |
| Linvatec | Spherical Bur, Large Hub, 12 Flute | 5.5mm, Blue, High Speed |
| Linvatec | Cyclone Bur, Large Hub, 6 Flute | 4.5mm, Lime Green, High Speed |
| Linvatec | Cyclone Bur, Large Hub, 6 Flute | 5.5mm, Lime Green, High Speed |
| Stryker | Aggressive Cutter Blade | 2.0mm, Yellow, 7cm shaft |
| Stryker | Aggressive Cutter Blade | 2.9mm, Yellow, 7cm shaft |
| Stryker | Aggressive Meniscus Cutter Blade | 3.5mm, Yellow/Yellow |
| Stryker | Aggressive Meniscus Cutter Blade | 4.0mm, Red/Red |
| Stryker | Aggressive Meniscus Cutter Blade | 5.0mm, Blue/Blue |
| Stryker | Aggressive Plus Cutter Blade | 3.5mm, Yellow/Blue |
| Stryker | Aggressive Plus Cutter Blade | 4.0mm, Red/Blue |
| Stryker | Aggressive Plus Cutter Blade | 5.5mm, Dark Blue/Blue |
| Stryker | Aggressive Plus Cutter Blade | 6.0mm, Beige/Blue |
| Stryker | Cougar End Cutter Blade | 3.5mm, Yellow/Yellow |
| Stryker | Cougar End Cutter Blade | 4.0mm, Red/Red |
| Stryker | Cougar End Cutter Blade | 5.5mm, Blue/Blue |
| Stryker | End Cutter Blade | 3.5mm, Yellow/Yellow |
| Stryker | End Cutter Blade | 4.0mm, Red/Red |
| Stryker | Full Radius Cutter Blade | 2.0mm, Grey, 7cm shaft |
| Stryker | Full Radius Cutter Blade | 2.9mm, Yellow, 7cm shaft |

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SureTek Medical

Reprocessed Arthroscopic Blades and Burs found to be substantially equivalent:

Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Stryker Xomed Xomed Xomed Xomed

Xomed

Full Radius Cutter Blade Full Radius Cutter Blade Full Radius Cutter Blade Resector Cutter Blade Resector Cutter Blade Resector Cutter Blade Resector Cutter Blade Slotted Whisker Blade Tomcat Cutter Blade Tomcat Cutter Blade Tomcat Cutter Blade Barrel Bur, 6 Flute Barrel Bur, 6 Flute Barrel Bur, 6 Flute Barrel Bur, 6 Flute Barrel Bur, 8 Flute Barrel Bur, 12 Flute Barrel Bur, 12 Flute Round Bur, 6 Flute Round Bur, 6 Flute Round Bur, 6 Flute Round Bur, 8 Flute Round Bur. 8 Flute Round Bur. 12 Flute Round Bur, 12 Flute Inferior Turbinate Blade Inferior Turbinate Blade Serrated Blade Serrated Blade Silver Bullet Blade

3.5mm, Yellow/Yellow 4.0mm, Red/Red 5.0mm, Blue/Blue 3.5mm, Yellow/Black 4.0mm, Red/Black 5.5mm, Blue/Black 6.0mm, Beige/Black 4.0mm, Red/Red 4.0mm, Red/White 5.5mm, Blue/White 6.0mm, Beige/White 2.0mm, Purple, 7.5cm shaft 3.0mm, Orange, 7.5cm shaft 4.0mm, Red/Red 5.0mm, Beige/Beige 5.0mm, Blue/Beige 4.0mm, Red/Red 5.0mm. Beige/Beige 3.5mm, Yellow/Yellow 4.0mm, Red/Red 5.5mm. Beige/Beige 4.0mm, Red/Beige 5.0mm, Blue/Beige 4.0mm, Red/Red 5.5mm. Beige/Beige 2.0mm, White, 11cm shaft 2.9mm, White, 11cm shaft 3.5mm, White, 11cm shaft 4.0mm, White, I 1cm shaft 2.9mm, White, 11cm shaft

Manh

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Number K052695

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## Indications for Use

KOSZ695 510(k) Number (if known):

SureTek Reprocessed Arthroscopic Blades and Burs Device Name:

Indications for Use:

--------

SureTek Reprocessed Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5 mm).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Mark H. Milliken

ision Sign-Off) ision of General, Restorative A Neurological Devices

K052695