(252 days)
No
The description focuses on continuous monitoring and precise adjustment based on the physical status of the limb, which is likely achieved through sensors and control algorithms, not AI/ML. There is no mention of AI, ML, or related terms.
Yes
Explanation: The device is intended for the "Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers", "Treatment of chronic venous insufficiency", and "Reducing edema due to venous stasis," all of which are therapeutic uses.
No
The device is described as a therapy device ("Amadeus Adaptive Compression Therapy") used to enhance venous return, reduce healing time for ulcers, and treat conditions like stasis dermatitis and chronic venous insufficiency. It delivers compression and monitors its own operational time for compliance, but it does not diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including a compression sleeve, control unit, sock, and power adaptor/charger.
Based on the provided information, the Amadeus Adaptive Compression Therapy device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly indicate that the Amadeus device applies compression directly to the patient's foot, ankle, and leg. It does not analyze any biological samples.
- The device's function is therapeutic, not diagnostic. Its purpose is to enhance venous return, reduce healing time for ulcers, treat conditions like stasis dermatitis and chronic venous insufficiency, and reduce edema. These are all therapeutic actions, not diagnostic ones.
- There is no mention of analyzing any biological samples or providing diagnostic information. The device monitors and adjusts compression based on the physical status of the limb, not on the analysis of blood, urine, tissue, or other bodily fluids.
Therefore, the Amadeus Adaptive Compression Therapy device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Amadeus Adaptive Compression Therapy provides optimized graduated compression in both sustained and intermittent settings for use in::
- Enhancing venous return
- Reducing venous leg ulcer healing time
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
OR - Treatment of chronic venous insufficiency
- Reducing edema due to venous stasis
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
AMADEUS Adaptive Compression Therapy has been designed to provide accurate, continuously monitored levels of graduated compression to the foot, ankle and leg.
AMADEUS Adaptive Compression Therapy consists of 4 main parts:
- . The compression sleeve consists of 4 chambers that inflate with air to apply compression to the foot, ankle and leg. Its simple wrap-around design with hook and loop fasteners means the compression sleeve can be fitted to many different shaped legs and can be applied and removed with ease.
- The control unit is a small, compact and portable device that fits into the compression sleeve . making the system ideal for ambulant use. The control unit continuously measures and precisely adjusts the delivery of pneumatic sustained graduated compression and intermittent pneumatic compression according to the physical status of the lower limb.
- The sock is designed to absorb perspiration and moisture away from the skin and has . additional padding in key areas to provide additional comfort. The sock also aids in the support and positioning of the compression sleeve.
- . The AC/DC power adaptor/charger is used to power the device directly (in IPC mode) and to recharge the control unit for ambulant use.
The device has 2 modes of operation: Sustained Compression mode and Intermittent Pneumatic Compression (IPC) mode. Sustained compression mode enables the control unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.
AMADEUS Adaptive Compression Therapy features a compliance monitoring feature. An LCD screen is present on the control unit which displays the number of hours the device has been operational in both Sustained and IPC modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle and leg; lower limb
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)
A series of laboratory based tests and clinical investigations, with healthy volunteers and subjects with venous insufficiency, were performed with the AMADEUS Adaptive Compression Therapy to demonstrate that there were no safety concerns.
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.
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
June 29, 2007
MAR - 7 2008
Section 5: 510(K) SUMMARY
- Applicant: ConvaTec A Division of E.R. Squibb and Sons, LLC 200 Headquarters Park Drive Skillman, NJ 08558
- Contact: Marilyn Konicky Associate Director, US and International Regulatory Affairs 908-904-2541 fax: 908-904-2235 email: marilyn.konicky@bms.com
- Device: AMADEUS Adaptive Compression Therapy
- Classification Name: Compressible limb sleeve (21 CFR §870.5800)
- Common Name: Adaptive Compression Therapy
- Product Code: JOW
- Device Class: Class II
PREDICATE DEVICES WITH WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
| Device Name: | Wiz-Air® DVT |
|---|---|
| Company: | Medical Compression Systems (DBN) Ltd. |
| 510(k) Number: | K012994 |
| Classification: | Compressible limb sleeve (21 CFR §870.5800) |
| Device Name: | Extremity Pump® 7500 |
| Company: | Jobst Institute |
| 510(k) Number: | K882683 |
| Classification: | Compressible limb sleeve (21 CFR §870.5800) |
1
| Device Name: | Model SC-3008 Sequential Circulator |
|---|---|
| Company: | Bio Compression Systems, Inc. |
| 510(k) Number: | K043423 |
| Classification: | Compressible limb sleeve (21 CFR §870.5800) |
In addition, a modified version of the Wiz-Air® DVT system (now marketed under the tradename ActiveCare DVT®) has been filed and cleared as ActiveCare ++ device (K060146, cleared March 8, 2006). Labeling was unavailable for the ActiveCare++ device; therefore this submission concentrates on the original Wiz-Air® (marketed as ActiveCare DVT in the U.S.) device.
DEVICE DESCRIPTION
AMADEUS Adaptive Compression Therapy has been designed to provide accurate, continuously monitored levels of graduated compression to the foot, ankle and leg.
AMADEUS Adaptive Compression Therapy consists of 4 main parts:
- . The compression sleeve consists of 4 chambers that inflate with air to apply compression to the foot, ankle and leg. Its simple wrap-around design with hook and loop fasteners means the compression sleeve can be fitted to many different shaped legs and can be applied and removed with ease.
- The control unit is a small, compact and portable device that fits into the compression sleeve . making the system ideal for ambulant use. The control unit continuously measures and precisely adjusts the delivery of pneumatic sustained graduated compression and intermittent pneumatic compression according to the physical status of the lower limb.
- The sock is designed to absorb perspiration and moisture away from the skin and has . additional padding in key areas to provide additional comfort. The sock also aids in the support and positioning of the compression sleeve.
- . The AC/DC power adaptor/charger is used to power the device directly (in IPC mode) and to recharge the control unit for ambulant use.
The device has 2 modes of operation: Sustained Compression mode and Intermittent Pneumatic Compression (IPC) mode. Sustained compression mode enables the control unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.
AMADEUS Adaptive Compression Therapy features a compliance monitoring feature. An LCD screen is present on the control unit which displays the number of hours the device has been operational in both Sustained and IPC modes.
2
INTENDED USE OF THE DEVICE
AMADEUS Adaptive Compression Therapy provides optimized graduated compression in both sustained and intermittent settings for use in:
- Enhancing venous return
- Reducing venous leg ulcer healing time
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Treatment of chronic venous insufficiency
- Reducing edema due to venous stasis
The intended uses and indications of predicate devices and AMADEUS Adaptive Compression Therapy are substantially equivalent.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
AMADEUS Adaptive Compression Therapy consists of a control unit, compression sleeve, socks, medical grade power adaptor/charger and a User Manual. AMADEUS Adaptive Compression Therapy can be powered by the on-board battery for mobile use and the supplied AC/DC power adaptor for IPC use (when non-ambulatory). AMADEUS Adaptive Compression Therapy has two built-in safety mechanisms: software controlled pressure monitoring and control and automatic hardware controlled shutdown and deflation.
AMADEUS Adaptive Compression Therapy is substantially equivalent to predicate devices and exempt traditional compression devices in terms of intended use, modes of operation and performance characteristics.
AMADEUS Adaptive Compression Therapy has been designed with the following features:
- ﮯ dual graduated compression modality (Sustained and IPC modes - are substantially equivalent to the modes of operation of predicate devices and exempt traditional compression devices).
- a chamber in the compression sleeve to provide compression to ankle region
- the tubing (air hosing) is internal to the compression sleeve, !
- the compression sleeve has an integral housing for the control unit.
- there are two automatic shutdown features in the unlikely event of a fault
SUBSTANTIAL EQUIVALENCE BASED ON CLINICAL AND NON-CLINICAL PERFORMANCE DATA
No comparative testing has been performed with either the AMADEUS Adaptive Compression Therapy, Wiz-Air® DVT, Extremity Pump® 7500 or Model SC-3008 Sequential Circulator (as per 807.92(b)(1), (2) & (3)). AMADEUS Adaptive Compression Therapy is substantially equivalent to predicate devices and exempt traditional compression devices in terms of intended use, modes of operation and performance characteristics.
A series of laboratory based tests and clinical investigations, with healthy volunteers and subjects with venous insufficiency, were performed with the AMADEUS Adaptive Compression Therapy to demonstrate that there were no safety concerns.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
ConvaTec c/o Ms. Marilyn Konicky Associate Director, Regulatory Affairs 200 Headquarters Park Dr. Skillman, NJ 08558
Re: K071763
AMADEUS Compression Therapy Regulation Number: 21 CFR 870.5800 Regulation Name: Compression limb sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 8, 2008 Received: February 12, 2008
Dear Ms. Konicky:
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.
4
Page 2 - Ms. Marilyn Konicky
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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
umen R. Vc hum
A Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known > Ko 7176 3
Device Name: AMADEUS Adaptive Compression Therapy
Indications for Use:
Amadeus Adaptive Compression Therapy provides optimized graduated compression in both sustained and intermittent settings for use in::
- Enhancing venous return
- Reducing venous leg ulcer healing time
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
OR
- Treatment of chronic venous insufficiency
- Reducing edema due to venous stasis
Prescription Use X (Per 21CFR 801.109)
Over the Counter Use (Optimal Format 2-96)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
a P. Vacines
(Division Sign-Off)
Division of Cardiovascular Devices
710(k) Number Koz
ConvaTec, A Division of E.R. Squibb and Sons, L.L.C.