(185 days)
These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external intermittent or sequential limb compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.
Reprocessed Compression Sleeves are inflatable devices that are fitted to a patient's foot and/or leg. They are connected to a separate pneumatic compressor, which provides intermittent, graduated pressure. When the sleeve compresses, the veins collapse, forcing blood to flow. When pressure is reduced, the sleeve deflates, allowing the veins to fill with blood. The cycle is then repeated. It should be noted that this submission applies to the compression sleeve only. It does not include any other components in a compression system such as the pneumatic compressor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SterilMed Reprocessed Compression Sleeves:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, the performance is demonstrated through a claim of "substantial equivalence" to predicate devices. The functional and safety testing described aims to show that the reprocessed devices perform as well as or similarly to the original, new devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Characteristics: Appropriate operation, comparable to new devices. | "Representative samples of reprocessed compression sleeves underwent bench testing to demonstrate appropriate functional characteristics." The conclusion states they are "essentially identical to the predicate devices in terms of functional design... and principles of operation." |
| Cleaning Procedures Validation: Effective removal of contaminants. | "Process validation testing was done to validate the cleaning procedures..." |
| Packaging Validation: Maintain sterility/integrity during shipping and storage. | "...as well as the device's packaging." |
| Visual Inspection: Meet quality standards. | "In addition, the manufacturing process includes visual inspection..." |
| Functional Testing (Individual Product): Each produced device functions correctly. | "...and functional testing of all products produced." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states "Representative samples" were used for bench testing and process validation. However, no specific number or size of the test set is provided.
- Data Provenance: The data is generated internally by SterilMed, Inc. during their "bench testing" and "process validation testing." The document does not specify country of origin for the data (beyond SterilMed's location in Minneapolis, MN) nor explicitly state if it's retrospective or prospective. Given it's for a 510(k) submission, it's almost certainly prospective testing conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The testing described (bench testing, process validation, visual inspection, functional testing) does not typically involve expert "ground truth" establishment in the same way clinical studies or diagnostic AI algorithms do. The "truth" here is based on engineering specifications and performance benchmarks against predicate devices.
4. Adjudication Method for the Test Set:
This information is not applicable to the type of testing described. Adjudication methods like 2+1 or 3+1 are used for human review of cases, typically in clinical studies, to establish a consensus ground truth for diagnostic decisions. The described testing is primarily engineering and process validation.
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:
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers. The SterilMed Reprocessed Compression Sleeves are physical medical devices, not AI software, and therefore this type of study is not relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance is inherent to the physical device itself.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is established through engineering specifications and performance characteristics of the predicate devices. The reprocessed devices are compared against these known, legally marketed, and established predicate devices (Kendall Company and Huntleigh Technology Inc. models). The claim of substantial equivalence is based on the reprocessed devices being "essentially identical to the predicate devices in terms of functional design, materials, indications for use, construction, and principles of operation."
8. The Sample Size for the Training Set:
Not applicable. This is a physical reprocessed medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As the device is not an AI/ML model, there is no training set or corresponding ground truth establishment process in this context.
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FEB 1 1 2002
SECTION 2. SUMMARY AND CERTIFICATION
510(K) SUMMARY A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis, MN 55369Phone: 888-856-4870Fax: 763-488-3350 |
| Date Prepared: | August 8, 2001 |
| Trade Name: | SterilMed Reprocessed Compression Sleeves |
| Classification Name:and Number: | Class II, 21 CFR 870.5800 |
| Product Code: | JOW |
| Predicate Device(s): | SterilMed's reprocessed compression sleeves aresubstantially equivalent to the Kendall Company models5329, 5330 (K781357) 5065, 5066, and 5075 (K953648and K951683), and the Huntleigh Technology Inc. modelsGS337M and GS334 (K910188), and to the originalmanufacturers' devices. |
| Device Description: | Reprocessed Compression Sleeves are inflatable devicesthat are fitted to a patient's foot and/or leg. They areconnected to a separate pneumatic compressor, whichprovides intermittent, graduated pressure. When the sleevecompresses, the veins collapse, forcing blood to flow.When pressure is reduced, the sleeve deflates, allowing theveins to fill with blood. The cycle is then repeated.It should be noted that this submission applies to thecompression sleeve only. It does not include any othercomponents in a compression system such as the pneumaticcompressor. |
| Intended Use: | Compression sleeves are designed to provide externalintermittent or sequential limb compression to artificiallyimitate the pumping action of the lower limbs to prevent |
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deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.
Functional and Safety Testing:
Representative samples of reprocessed compression sleeves underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning procedures as well as the device's packaging. In addition, the manufacturing process includes visual inspection and functional testing of all products produced.
The compression sleeves reprocessed by SterilMed are substantially equivalent to the Kendall Company models 5329, 5330 (K781357) 5065,5066, and 5075 (K953648 and K951683), and the Huntleigh Technology Inc. models GS337M and GS334 (K910188), and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, construction, and principles of operation.
Conclusion:
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Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized lines that are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc 11400 73rd Avenue North Minneapolis, MN 55369
Re: K012597
Trade Name: Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. Fleischhacker:
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.
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Page 2 - Mr. Patrick Fleischhacker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backed or a backed on the requirements of the Act
that FDA has made a determination that your device complies with other requireme that IDA has made a decormination administered by other Federal agencies. You must of any Federal Statutes and regulations daminities. So 10 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 607), labeling (21 CFR Part 820); and if applicable, the electronic ford in the quality systems (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) This letter will anow you to oogin mailoung of substantial equivalence of your device to a legally premarket nothcation. The PDA miding of bacasification 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 II you desire specific advice tor your dovices disenostic devices), please contact the Office of additionally 21 CFN Part 607.10 for mirrial creations on the promotion and advertising of Compliance at (301) 594-1016. Ticanal Compliance at (301) 594-4639. Also, please note the your device, prease comate and o thereference to premarket notification" (21CFR Part 807.97). Ingulation chitica, "Misoranang of responsibilities under the Act may be obtained from the Other general information on your responsional 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,
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known): KO12597
Reprocessed Pneumatic Compression Sleeves Device Name:
Indications For Use:
These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external manufacturers (OEM) Compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K612597
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).