(49 days)
Not Found
No
The summary describes a mechanical compression system and explicitly states that AI, DNN, or ML were not found in the description.
Yes.
The device is intended to prevent deep vein thrombosis and pulmonary embolism, diminish post-operative pain and swelling, enhance blood circulation, and reduce wound healing time, all of which are therapeutic purposes.
No
The device is a compression sleeve intended to prevent deep vein thrombosis and pulmonary embolism by applying pressure, not to diagnose a condition.
No
The device description explicitly states that the system consists of a control unit, inflatable limb sleeves, and conduit tubing, indicating hardware components beyond just software. 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a system of compression sleeves worn on the lower extremities of a patient. It applies external pressure to simulate muscle contractions and aid blood circulation.
- Intended Use: The intended use is to prevent deep vein thrombosis and pulmonary embolism, diminish pain and swelling, enhance blood circulation, and reduce wound healing time. These are all therapeutic or preventative actions performed directly on the patient's body, not diagnostic tests on samples.
The device is an external compression system, which falls under the category of medical devices used for treatment and prevention, not in vitro diagnosis.
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 (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (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
§ 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
FEB 2 4 2006
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: | October 25, 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
K040511 | Device Description
SCD Express Portable 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
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 seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2006
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044
Re: K060049
Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: December 28, 2005 Received: January 6, 2006
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to regists the Medical Device Amendments, or to conninered prior to May 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 devices that have been recuire in asse e approval of a premarket approval application (PMA). and Cosmetic (110) the (110) that the device, subject to the general controls provisions of the Act. The r ou may, arorerere, mans 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 may be subject to basil adable in Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning 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 Please be advised that FDA s issualite of a substition with other requirements of the Act
that FDA has made a determination that your device also accomples . You must that FDA has made a determination that your arres by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21
comply with all the Act's requirements, including, but not manirements as set comply with all the Act s requirements, monamas manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if englicable, the electronic CFR Part 807); labeling (21 CFR Part 801); good manaxasing (2008); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 11 CFF) 1000, forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scctions 31 device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a leval This letter will allow you to begin harkemig your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalse and thus, p premarket notification. The FDA inding of substantial equivaliation wour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the regulation and 1100 m 11 comments on any more the regulation entitled If you desire specific advice for your de not on an a more the regulation entitled,
contact the Office of Compliance at (240) 276-0120. ↑ Also, please note the may obtain contact the Office of Complance at (210) 276-6100 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premanse notificansity of the Act from the Division of Sm?!
other general information on your responsibilities under the Act from the 4800 638, 2 other general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Abolance area consideralindustry/support/index.html.
Sincerely yours,
Dmn R. Lachner
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): K060049
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications For Use: When coupled with an appropriate inflation system, compressions in Indications I of OSE. Vinch outplou man an uppopramating deep very of healing time devices are intended for use in preventing doop for and reducing wound healing time.
Prescription Use _ × (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)
Duna R. Le Jones
Devices
510(K) Number K66(0044
CONFIDENTIAL
Alliance Medical Corporation Traditional 510(k)
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