(274 days)
The compression limb sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
The devices that are the subject of this submission are used with a pump system to apply sequential compression to the lower limbs. They are made of a variety of materials and come in various sizes. Some are leg wraps and some are foot wraps. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, testing, packaging, and sterilization. It allows the compression limb sleeves to be used several times rather than just once.
The provided 510(k) summary for Surgical Instruments Servicing & Savings, Inc. regarding "Reprocessed Compression Limb Sleeves" indicates that no comparative performance testing or clinical evaluations were conducted as part of this submission. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for novel devices or those with significant performance claims.
Here's a breakdown based on the information provided in the document, and where details are missing:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated for comparative performance or clinical efficacy) | (Not explicitly stated for comparative performance or clinical efficacy) |
| Functionality during reprocessing | "Each compression limb sleeve is tested for functionality during reprocessing." (Pass/Fail criteria not detailed, but implies successful reprocessing) |
| Sterility | "Validation testing of the sterility protocols have also been completed." (Implies successful validation, but specific sterility assurance levels or criteria are not detailed) |
| Materials and dimensions identical to original | "The materials and dimensions are identical." (Met by design) |
| Technical characteristics, method of use, and compatibility with pump systems identical to original | "The technical characteristics, method of use, and compatibility with pump systems are also identical." (Met by design) |
Missing Information: The document explicitly states that "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This means there are no acceptance criteria related to clinical effectiveness, user performance, or comparative performance against the original single-use devices, nor are there any reported performance metrics for such criteria. The acceptance is based on demonstrating substantial equivalence through material and functional identity, and successful reprocessing/sterilization validation.
2. Sample size used for the test set and the data provenance
- For functionality testing during reprocessing: Not specified. This typically would involve testing a sample from each reprocessing batch.
- For sterility validation: Not specified. Sterility validation usually involves a defined sample size and method (e.g., sterilization overkill method, bioburden reduction validation), but details are absent.
- For comparative performance/clinical effectiveness: N/A (no such testing was reported).
Data Provenance: N/A for comparative performance/clinical effectiveness studies, as none were conducted. For internal "functionality during reprocessing" and "sterility validation," the data would originate internally from the reprocessor (Surgical Instruments Servicing & Savings, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Given that no comparative performance or clinical effectiveness studies were conducted, there was no need for expert ground truth establishment for such purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. No comparative performance or clinical effectiveness studies were conducted that would require an adjudication method.
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
N/A. This device is a medical accessory (compression limb sleeve), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a medical accessory, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. No clinical or comparative performance studies were conducted that would require a ground truth of this nature. The "ground truth" for the submission's claims revolves around the physical and functional identity to the predicate device and the successful execution of reprocessing and sterilization.
8. The sample size for the training set
N/A. This device is a reprocessed physical medical accessory, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
N/A. As stated above, there is no "training set" for this device.
{0}------------------------------------------------
MAY 14 2002
16012658
510(k) SUMMARY
Submitter's name: Surgical Instruments Servicing & Savings, Inc. 723 Curtis Court Sisters. OR 97759 (541) 549-4164
Date summary prepared: August 10, 2001
Device name:
Proprietary name: Common or usual name: Classification name:
Reprocessed Compression Limb Sleeves Various compression limb sleeves Compressible limb sleeves, 870.5800.
Legally marketed device for substantial equivalence comparison:
The predicate device for each reprocessed compression limb sleeve is the same sleeve as provided by the original manufacturer.
Description of the device:
The devices that are the subject of this submission are used with a pump system to apply sequential compression to the lower limbs. They are made of a variety of materials and come in various sizes. Some are leg wraps and some are foot wraps. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, testing, packaging, and sterilization. It allows the compression limb sleeves to be used several times rather than just once.
Intended use of device:
The compression limb sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
Technological characteristics:
The device features of the reprocessed compression limb sleeves and the single use compression limb sleeves are very similar. The materials and dimensions are identical. The technical characteristics, method of use, and compatibility with pump systems are also identical. There are two differences. First, the reprocessed devices are provided sterile while the original devices are not. Second, the reprocessed products can be used several times, while the original products are sold for single use.
Testing conducted:
Each compression limb sleeve is tested for functionality during reprocessing. Validation testing of the sterility protocols have also been completed.
Performance testing:
Comparative performance testing and clinical evaluations were not included as part of this 510(k).
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2002
Surgical Instruments Service Linda J. Bovard, B.S., RAC c/o R. S. McQuate & Associates, Inc. 29611Simmons Road Eugene, OR 97405
K012658 Re:
Device Name: Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: April 11, 2002 Received: April 12, 2002
Dear Ms. Bovard:
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 - Linda J. Bovard, B.S., RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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, Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular
and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Reprocessed Compression Limb Sleeves 510(k) Notification Page 3
Indications for Use Statement
510(k) Number (if known): __ KO126SD
Device name: Reprocessed Compression Limb Sleeves
Indications for Use: The compression limb sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
(Please do not write below this line)
==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| Prescription Use | X |
| OR | |
| Over-The-Counter Use | _ |
Division of Cardiovascular & Respiratory Devices
510(k) Number K012658
3
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).