(36 days)
Not Found
No
The document describes a mechanical compression system and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is described as "intended to help prevent deep vein thrombosis and pulmonary embolism" and for "use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time," which are all therapeutic purposes.
No
The device, reprocessed compression sleeves, is intended for therapeutic purposes (preventing DVT, diminishing pain/swelling, enhancing circulation, reducing wound healing time) by applying pressure to the lower extremities. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device description clearly states it consists of a control unit, inflatable limb sleeves, and conduit tubing, which are hardware components. The reprocessing is applied to the physical compression sleeves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to prevent deep vein thrombosis and pulmonary embolism by applying external pressure to the lower extremities. This is a therapeutic and preventative function, not a diagnostic one.
- Device Description: The description details an external compression system that applies pressure to the body. This is consistent with a physical therapy or medical device used for treatment or prevention, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Product codes
JOW
Device Description
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves.
• Biocompatibility
• Function Test(s)
• Validation of Processing
Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Ko60091/
FEB 1 7 2006 1 1 1 2
SECTION B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton
Regulatory Affairs Manager
(480) 763-5350 (o)
(480) 763-5310 (f)
mbarton@alliance-medical.com |
| Date of preparation: | November 2, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression Sleeves
Common or Usual Name: Compression Sleeve
Classification Name: Compressible Limb Sleeve |
| Predicate device: | |
| K Number
K944567
K915092 | Device Description
PlexiPulse Acute Care Unit
Talley TM300 Sequential Multicom Compression System |
| Device description: | Compression sleeves are part of an external compression
system, in which intermittent or sequential compression is
provided using a pump/controller and limb garment. The system
consists of the following three main components: a control unit,
inflatable limb sleeves and conduit tubing with detachable
connections. Only the compression sleeves are reprocessed. |
| Intended use: | Reprocessed Compression Sleeves are intended to help
prevent deep vein thrombosis and pulmonary embolism by
supplying a measured, intermittent pressure into the
compression sleeves worn on the lower extremities of a
recumbent patient, resulting in a gradient, sequential, repetitive
squeezing and relaxing action, simulating normal muscle
contractions. |
| Indications
statement: | When coupled with an appropriate inflation system,
compression devices are intended for use in preventing deep
vein thrombosis (DVT), diminishing post-operative pain and
swelling, enhancing blood circulation, and reducing wound
healing time. |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Compression Sleeves are identical to the predicate devices.
The mechanism of action of Reprocessed Compression Sleeves |
| | Alliance Medical Corporation
Reprocessed Medline Compression Sleeves
Traditional 510(k) 9 of 200 |
| | is identical to the predicate devices in that the same standard
mechanical design, materials and sizes are utilized. There are
no changes to the claims, intended use, clinical applications,
patient population, performance specifications, or method of
operation. |
| | Alliance Medical Corporation's reprocessing of compression
sleeves includes removal of adherent visible soil and
decontamination. Each individual compression sleeve is tested
for appropriate function of its components prior to packaging,
labeling, and EO exposure operations. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate
performance (safety and effectiveness) of Reprocessed
Compression Sleeves. |
| | • Biocompatibility
• Function Test(s)
• Validation of Processing |
| | Performance testing demonstrates that Reprocessed
Compression Sleeves perform as originally intended. |
| Conclusion: | Alliance Medical Corporation concludes that the modified
devices (Reprocessed Compression Sleeves) are safe, effective
and substantially equivalent to the predicate devices as
described herein. |
1
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044
Re: K060091
Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 10, 2006 Received: January 12, 2006
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 9 ro(x) premaince is substantially equivalent (for the indications felerenced above and nave determined have and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and ment date of the Medical Device American proc commerce prior to May 26, 1776, the enastinent with the provisions of the Federal Food. Drug, devices that have been reclassince in accessaries was a premarket approval application (PMA). and Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merclore, market the devices, boojes to annual registration, listing of general controls provisions of the line, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can Inay be subject to suen additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous overning your device in the Federal Register.
3
Page 2 - Ms. Moira Barton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that 1 Dris and over device complies with other requirements of the Act that I Dri has made a doted regulations administered by other Federal agencies. You must or any I cut all the Act's requirements ancluding, but not limited to: registration and listing (21 Configity with an the 11et 3 requirements, as a manufacturing practice requirements as set CFN i art 607); adomig (21 OFR Part 820); and if applicable, the electronic forul in the quanty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (overiens (overies as described in your Section 510(k) This icter will anow you to ocgin mading of substantial equivalence of your device to a legally prematics notification. The PDF interest on 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 11 you desire specific acries ion your 240) 276-0120. Also, please note the regulation entitled, Connation of Collied of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
unma R. Jochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement 1.
510(k) Number (if known): K060091
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications For Use: When coupled with an appropriate inflation system, compression Indications For USe. When Coupleting deep vein thrombosis (DVT), diminishing postdevices are intended for use in preventing deep von thrombols ( = 1), and reducing wound healing time.
Prescription Use X (per 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 if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Vochner
(Division Sign Off)
Cardiovascular Devices
(Division S
vision of Cardiovascular Devices
් ((x) Number_
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Medline Compression Sleeves Traditional 510(k)
13 of 200