(30 days)
Not Found
No
The summary describes a reprocessed surgical tool (arthroscopic blades and burs) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is used for resection of tissue (removing tissue), which is a surgical tool, not a device intended to treat or prevent disease or restore function.
No
The device is used for resection of tissue within joint spaces, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is composed of physical materials (blades and burs) and is a single-use surgical device, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection of tissue within joint spaces under arthroscopic control." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as "single use surgical devices used for resection of tissue within joint spaces." This further reinforces its role as a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue samples, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / 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.
Medical Device Services intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.
Only disposable, 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 Medical Device Services.
Product codes (comma separated list FDA assigned to the subject device)
HWE
Device Description
Medical Device Services (MDS), intends to market Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs that have been reprocessed. Reprocessing Stryker and Dyonics Disposable Arthroscopic Blades/Burs is performed by MDS protocols. "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).
MDS 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.
MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control.
MDS 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joint spaces
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)
Not Found
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.
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
§ 878.4820 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.
0
SEP 1 8 2002
Medical Device Services, Inc
West Brigham Road, Bldg. E St. George, UT 84790
Tel: (435) 652-3073
Fax: (435) 652-3087
510(k) SUMMARY
Medical Device Services Re: 501(K) Notification: Reprocessed Used Disposable Arthroscopic Blades and Burs 87HWE Powered Surgical Instruments & Accessories/Attachments. Classification Name: Disposable Arthroscopic Bone Shavers Common/Usual Name: Proprietary Name: Reprocessed Used Disposable Arthoscopic Blades and Burs Establishment Reg. No .: 1724309 Class I per 21 CFR 878.482 - Powered Surgical Accessories. Device Classifications:
Medical Device Services (MDS), intends to market Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs that have been reprocessed. Reprocessing Stryker and Dyonics Disposable Arthroscopic Blades/Burs is performed by MDS protocols. "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).
MDS 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.
MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control.
MDS 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
MDS 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.
MDS 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged to suggest a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 8 2002
Medical Device Services c/o Mark Aldana Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404
Re: K022744
Trade/Device Name: Reprocessed Used Disposable Arthroscopic Blades and Burs Regulation Number: 878.4820 Regulation Name: Powered surgical instruments & accessories/attachments Regulatory Class: Class I Product Code: HWE Dated: August 9, 2002 Received: August 19, 2002
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. Iisting 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.
2
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" (21 CFR 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
Sincerely yours,
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
3
K022744 510)k) Number:
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.
Medical Device Services intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.
Only disposable, 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 Medical Device Services.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hert Purle
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use / (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)