(224 days)
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 3.5mm).
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.
The SureTek Reprocessed Arthroscopic Shavers and Burs received 510(k) clearance based on substantial equivalence to predicate devices, without specific acceptance criteria or a dedicated study explicitly detailing device performance against such criteria in the provided summary. The information focuses on a comparison to new, unused devices through bench testing and compliance with various ISO and ASTM standards.
Here's an analysis of the provided information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The submission does not specify numerical acceptance criteria for performance metrics (like cutting efficiency, blade sharpness, or bur abrasion rate) or reporting device performance against specific targets. Instead, it states that "bench testing of devices following the maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance substantially equivalent to new, unused devices | Bench testing confirmed performance to be substantially equivalent to new, unused devices after maximum use and reprocessing cycles. |
| Effective decontamination for grossly contaminated instruments (Cleaning) | SureTek cleaning process validated to be effective under worst-case operational conditions. |
| Conformance to ISO 11607 for packaging performance | Product packaging conforms to relevant requirements of ISO 11607, with performance qualifications tested according to EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02. |
| Conformance to ISO 11135 for sterility and process validation | Product sterility and process validation conform to relevant requirements of ISO 11135. |
| Conformance to ISO 10993 for biological evaluation (EO residuals, biocompatibility) | Products conform to relevant requirements of ISO 10993 for ethylene oxide residuals and biocompatibility of device materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the bench testing beyond "devices." It also doesn't specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The study appears to be a bench test comparison against new devices, rather than a clinical study requiring expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study described is bench testing and does not involve human adjudication of results in a clinical context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a reprocessed arthroscopic shaver/bur, not an AI-assisted diagnostic or therapeutic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance evaluation, the "ground truth" was implicitly established by the performance characteristics of new, unused devices. For cleaning validation, the "ground truth" would be the absence of viable microorganisms and contaminants as per established standards and methods. For biocompatibility, it would be the absence of adverse biological responses as defined by ISO 10993.
8. The sample size for the training set
This is not applicable. The device is a reprocessed physical instrument and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of device.
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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 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) | ||
| PredicateDevices | Dyonics (Smith & Nephew) | K953695 | |
| Stryker Corp | K941333 | ||
| Linvatec | K990524 | ||
| Xomed (Medtronic) | K010667 | ||
| Vanguard Medical Concepts | K012346 | ||
| MediSISS | K012667 | ||
| DeviceDescription | Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue,cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrumentconsist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannulawith outer diameters ranging from 2 to 6 mm. Devices are designed for use only withcompatible driver systems with continuous irrigation and aspiration of fluids through theinner shaft during use. Depending upon the aggressiveness required for cutting, shavers aredesigned with different serrated and non-serrated blades and angles, and burs have varyingshapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burshave identical technological characteristics as the predicate devices, i.e. device componentmaterials, dimensions and system compatibility are unchanged during reprocessing. | ||
| Intended Use | SureTek Arthroscopic Blades and Burs are intended for use during arthroscopic andendoscopic 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 andStandards | • Bench testing of devices following the maximum number of use and reprocessing cyclesfound their performance to be substantially equivalent to new, unused devices.• SureTek cleaning process is validated to be effective for decontamination of grosslycontaminated instruments under worst case operational conditions.• Product packaging conforms to all relevant requirements of ISO 11607 Packaging forterminally sterilized medical devices, with performance qualifications tested according toEN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02.• Product sterility and process validation conform to the relevant requirements of ISO11135 Medical Devices – Validation and routine control of ethylene oxide sterilization.• Products conform to the relevant requirements of ISO 10993 Biological Evaluation ofMedical Devices for ethylene oxide residuals and biocompatibility of device materials. | ||
| SubstantialEquivalence | Product testing and comparisons of specifications determines that SureTek ReprocessedArthroscopic Shavers and Burs are substantially equivalent to their predicate devices withrespect to device intended use and performance, as well as product packaging, labeling,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 (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
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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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vision of General, Restorative
and Neurological Devices
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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)
(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
§ 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.