(174 days)
Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.
Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.
This is a 510(k) summary for Adven Medical, Inc.'s reprocessed used disposable arthroscopic blades and burs (K012694). This document pertains to the regulatory clearance of a reprocessed medical device, not a new AI-powered diagnostic or treatment device. Therefore, much of the information typically requested for AI/ML device studies (such as diagnostic accuracy metrics, MRMC studies, or training/test set details) is not applicable here.
The core of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device, asserting that the reprocessed devices remain safe and effective for their intended use after reprocessing.
Here's an attempt to address the requested information based on the provided text, noting where specific AI/ML-related questions are not relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this submission are primarily focused on demonstrating that the reprocessed devices:
- Can withstand the necessary cleaning and sterilization process.
- Do not have their physical characteristics or quality adversely affected.
- Remain safe and effective for their intended use.
- Are substantially equivalent to the new, legally marketed predicate device.
The document does not provide a table with quantitative performance metrics typical for new device clearances. Instead, it relies on the assertion that the reprocessed product is substantially equivalent to a cleared predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Remain safe and effective for intended use. | AMI claims that Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely affected, and the device remains safe and effective for its intended use. |
| Material Composition: Composed of the same materials. | AMI Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new. |
| Substantial Equivalence: Equivalent to predicate device. | AMI Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are substantially equivalent to disposable arthroscopic blades/burs marketed by Smith & Nephew Dyonics under 510(k) Number K953695. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of performance data, as would be expected for a diagnostic or AI device. The submission focuses on the reprocessing protocol (Protocol Number 40006) for commercially available devices. The data provenance would relate to the validation of this reprocessing protocol, but specific numbers or details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study assessing the diagnostic accuracy or performance of an AI model with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is not an AI-powered tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this type of submission is the demonstrated safety and effectiveness of the original, new single-use device (the predicate device, Smith & Nephew Dyonics K953695) and the evidence that the reprocessing protocol maintains these characteristics. This is achieved through validation of the cleaning, sterilization, and functional integrity after reprocessing, rather than a diagnostic "ground truth."
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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dven Medical, Inc.
1001 Slaton Hwy. Lubbock, Texas 79404
Tel: (806) 745-7718 Fax: (806) 745-0223
FEB 0 4 2002
510(k) SUMMARY
| Re: | Adven Medical, Inc. |
|---|---|
| 501(K) Notification: | Reprocessed Used Disposable Arthroscopic Blades and Burs |
| Classification Name: | 87HWE Powered Surgical Instruments & Accessories/Attachments |
| Common/Usual Name: | Disposable Arthroscopic Bone Shavers |
| Proprietary Name: | Reprocessed Used Disposable Arthroscopic Blades and Burs |
| Establishment Reg. No.: | 1649663 |
| Device Classifications: | Class I per 21 CFR 878.482 - Powered Surgical Accessories. |
AMI intends to market AMI Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs that have been reprocessed. Reprocessing Stryker and Dyonics Disposable Arthroscopic Blades/Burs is performed by AMI to AMI protocol Number 40006. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals).
AMI believes that reprocessed single-use Stryker and Dyonics Arthroscopic Blades/Burs can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
AMI Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Bursare single use sugery blades for resection of tissue within joint spaces under arthoscopic control.
AMI Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.
AMI Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are substantially equivalent to disposable arthroscopic blades/burs marketed by Smith & Nephew Dyonics under 510(k) Number K953695.
AMI claims that Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
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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 consists of 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 or bird-like figure, with its wings spread and feathers suggested by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2002
Mr. Mark Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404
Re: K012694
Trade/Device Name: Reprocessed Used Disposable Arthroscopic Blades and Burrs Regulation Number: 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: HWE Dated: December 3, 2001 Received: December 5, 2001
Dear Mr. Aldana:
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 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.
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Page 2 - Mr. Mark Aldana
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Miriam C. Provost
Col Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510)k) Number: K012694
Reprocessed Used, Disposable Arthroscopic Blades and Burrs Device Name:
Indications For Use:
Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor.
Arthroscopy blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.
AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.
Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
vision Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K012694
Prescription Use I (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.