(224 days)
Not Found
No
The description focuses on mechanical cutting and resection tools and does not mention any computational or data-driven features.
No
The device is described as an instrument for cutting and resection of tissues and bone during surgical procedures, which is an operative function, not a therapeutic one.
No
The device description indicates its purpose is for "cutting and resection of soft tissue, cartilage and bone" during surgical procedures, not for identifying, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a powered instrument made of stainless steel with a hollow shaft, distal blade or bur, and cannula, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and resection of soft tissue, cartilage and bone during arthroscopic and endoscopic procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a powered surgical instrument with blades and burs for physical cutting and shaping of tissue and bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is used for surgical intervention on the body.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
HRX, NUJ
Device Description
Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue, cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrument consist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannula with outer diameters ranging from 2 to 6 mm. Devices are designed for use only with compatible driver systems with continuous irrigation and aspiration of fluids through the inner shaft during use. Depending upon the aggressiveness required for cutting, shavers are designed with different serrated and non-serrated blades and angles, and burs have varying shapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burs have identical technological characteristics as the predicate devices, i.e. device component materials, dimensions and system compatibility are unchanged during reprocessing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing of devices following the maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices.
SureTek cleaning process is validated to be effective for decontamination of grossly contaminated instruments under worst case operational conditions.
Product packaging conforms to all relevant requirements of ISO 11607 Packaging for terminally sterilized medical devices, with performance qualifications tested according to EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02.
Product sterility and process validation conform to the relevant requirements of ISO 11135 Medical Devices – Validation and routine control of ethylene oxide sterilization.
Products conform to the relevant requirements of ISO 10993 Biological Evaluation of Medical Devices for ethylene oxide residuals and biocompatibility of device materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K953695, K941333, K990524, K010667, K012346, K012667
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
SureTek Medical 510(k) Summary
... : 一、一、
| Submitter | SureTek Medical 25-B Maple Creek Cir Greenville, SC 29607 | ||
|---|---|---|---|
| Contact | Mike Sammon, Ph.D. Phone 864-299-9743 | ||
| Date | 9/25/05 | ||
| Product | Reprocessed Arthroscopic Shavers and Burs | ||
| Classification | Code:HRX Regulation: 21 CFR 888.1100 | ||
| Manufacturer/Reprocessor | 510(k) | ||
| Predicate | |||
| Devices | Dyonics (Smith & Nephew) | K953695 | |
| Stryker Corp | K941333 | ||
| Linvatec | K990524 | ||
| Xomed (Medtronic) | K010667 | ||
| Vanguard Medical Concepts | K012346 | ||
| MediSISS | K012667 | ||
| Device | |||
| Description | Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue, | ||
| cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrument | |||
| consist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannula | |||
| with outer diameters ranging from 2 to 6 mm. Devices are designed for use only with | |||
| compatible driver systems with continuous irrigation and aspiration of fluids through the | |||
| inner shaft during use. Depending upon the aggressiveness required for cutting, shavers are | |||
| designed with different serrated and non-serrated blades and angles, and burs have varying | |||
| shapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burs | |||
| have identical technological characteristics as the predicate devices, i.e. device component | |||
| materials, dimensions and system compatibility are unchanged during reprocessing. | |||
| 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). | |||
| Testing and | |||
| Standards | • Bench testing of devices following the maximum number of use and reprocessing cycles | ||
| found their performance to be substantially equivalent to new, unused devices. | |||
| • SureTek cleaning process is validated to be effective for decontamination of grossly | |||
| contaminated instruments under worst case operational conditions. | |||
| • Product packaging conforms to all relevant requirements of ISO 11607 Packaging for | |||
| terminally sterilized medical devices, with performance qualifications tested according to | |||
| EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02. | |||
| • Product sterility and process validation conform to the relevant requirements of ISO | |||
| 11135 Medical Devices – Validation and routine control of ethylene oxide sterilization. | |||
| • Products conform to the relevant requirements of ISO 10993 Biological Evaluation of | |||
| Medical Devices for ethylene oxide residuals and biocompatibility of device materials. | |||
| Substantial | |||
| Equivalence | Product testing and comparisons of specifications determines that SureTek Reprocessed | ||
| Arthroscopic Shavers and Burs are substantially equivalent to their predicate devices with | |||
| respect to device intended use and performance, as well as product packaging, labeling, | |||
| sterility and safety. |
1
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
2
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 (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 (800) 638-2041 or (301) 443-6597 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
3
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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
4
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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
vision Sign-Off)
vision of General, Restorative
and Neurological Devices
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Number K052695
6
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Milliken
ision Sign-Off) ision of General, Restorative A Neurological Devices