(196 days)
Not Found
No
The device description details a pneumatic compression system controlled by solenoid valves and pressure sensors with software-based pressure limits. There is no mention of AI or ML algorithms for decision-making, pattern recognition, or adaptive control based on data. The operation modes are fixed and based on user selection.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by patients and medical professionals in treating many conditions". This clearly indicates a therapeutic purpose.
No
The ProAir 3000 is described as a prescriptive device that induces controlled compression for treatment, not for diagnosing conditions. Its intended uses are for prevention and treatment of various conditions like DVT and edema, which are therapeutic rather than diagnostic actions.
No
The device description explicitly lists hardware components: Portable pneumatic control unit, Pair of cuffs, Pneumatic connecting tubes, and Electrical transformer. While it mentions a "software-based protection," the device is clearly a physical system with software controlling its operation, not a software-only device.
Based on the provided information, the ProAir 3000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as inducing controlled compression of the calf and/or foot to treat various conditions like DVT prevention, enhancing blood circulation, and reducing swelling. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a pneumatic compression device that applies pressure to the lower limb. This mechanism is physical and external to the body, not involving the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ProAir 3000 does not fit this definition.
N/A
Intended Use / Indications for Use
The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.
The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as:
- prevention of deep vein thrombosis (DVT) .
- . enhancement of blood circulation
- reduction of post-operative pain and swelling .
- . reduction of wound-healing time
- stasis dermatitis .
- treatment and assist healing of cutaneous ulceration .
- venous stasis ulcers .
- . leg ulcers
- chronic venous insufficiencies .
- . reduction of edema
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The ProAir 3000 is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The device is composed of four components:
- Portable pneumatic control unit ●
- Pair of cuffs (calf and/or foot-ware) ●
- Pneumatic connecting tubes. .
- . Electrical transformer
During the compression cycle the solenoid valves are activated to insert air into one cuff and then other valves are activated for the other cuff. After inflating the cells in one cuff, the solenoid valves are deactivated and, simultaneously, the second cuff is inflated. Following a complete cycle for both legs there is a relaxation period. A software-based protection limits the pressure in all cuff cells using pressure sensors. In addition, a mechanical valve has been included in the air system for releasing air in case of over pressure in one of the cells. The ProAir 3000 has three operation modes: calf cuff mode, foot cuff mode and combined mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calf, foot, lower limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients and medical professionals
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)
Not Found
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.
K942664, K915092, K921562, K981311
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
MAY 1 9 2000
510(K) SUMMARY
ProAir 3000 Compression System
510(k) Number K_______________________________________________________________________________________________________________________________________________________________
Applicant's Name:
Medical Compression Systems (DBN) Ltd. 9 Harugei Malhut st. Tel-Aviv 69714, Israel Tel.: 972-3-647-1615 Fax: 972-3-647-0293
Contact Person:
Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131
Date Prepared:
October, 1999
Trade Name:
ProAir 3000 Compression System
Classification Name:
Compressible Limb Sleeve
Classification:
The FDA has classified compressible limb sleeves as class II devices (product code JOW, Regulation No. 870.5800) and they are reviewed by the Cardiovascular Panel.
1
Predicate Device:
- · Kendall Model 6325 SCD Sequel Compression System (Kendall Co.), cleared under K942664
- · Talley TM300 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915092
- · Jobst Extremity Pump System 7500 (Jobst Institute, Inc.) cleared under K921562
- · Cowboy XV [PlexiPulse®] (KCI New Technologies, Inc.) cleared under K981311
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the ProAir 3000 complies with the following voluntary standards: IEC 60601-1 (and amendments), IEC 60601-1-2. EN-1441, and applicable parts of Mil-Std-810E.
Indications:
The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.
The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as:
- prevention of deep vein thrombosis (DVT) .
- . enhancement of blood circulation
- reduction of post-operative pain and swelling .
- . reduction of wound-healing time
- stasis dermatitis .
- treatment and assist healing of cutaneous ulceration .
- venous stasis ulcers .
- . leg ulcers
- chronic venous insufficiencies .
- . reduction of edema
Contraindications:
The ProAir 3000 compression system should not be used in the following cases: Gangrene, recent skin graft, severe arteriosclerosis or other ischemic vascular disease, congestive cardiac failure, massive edema, pulmonary edema, existing DVT, acute thrombophlebitis, acute infections, and during episodes of pulmonary embolism.
2
Device Description:
The ProAir 3000 is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The device is composed of four components:
- Portable pneumatic control unit ●
- Pair of cuffs (calf and/or foot-ware) ●
- Pneumatic connecting tubes. .
- . Electrical transformer
During the compression cycle the solenoid valves are activated to insert air into one cuff and then other valves are activated for the other cuff. After inflating the cells in one cuff, the solenoid valves are deactivated and, simultaneously, the second cuff is inflated. Following a complete cycle for both legs there is a relaxation period. A software-based protection limits the pressure in all cuff cells using pressure sensors. In addition, a mechanical valve has been included in the air system for releasing air in case of over pressure in one of the cells. The ProAir 3000 has three operation modes: calf cuff mode, foot cuff mode and combined mode.
Substantial Equivalence:
Based on a series of safety and performance testing including a comparative study, Medical Compression Systems (DBN) Ltd. believes that the ProAir 3000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2000
Ms. Shoshana Friedman Medical Compression Systems Ltd. C/O Push-med Ltd. 117 Ahuza Street Ra'ananna 43373 Israel
Re: K993758 ProAir 3000 Compression System Requlatory Class: II Product Code: JOW Dated: March 5, 2000 Received: March 7, 2000
Dear Ms. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the bubbancearly of analy marketed predicate devices marketed in interstate encrobare) 80 rogal 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
4
Page 2 - Ms. Shoshana Friedman
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Brim E. Haneym
James E. Dillard III
Director
Division of Cardiovascular and
Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
ProAir 3000 Compression System Device Name:
Indications for Use:
The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both.
The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as:
- prevention of deep vein thrombosis (DVT) .
- enhancement of blood circulation .
- reduction of post-operative pain and swelling .
- reduction of wound-healing time .
- stasis dermatitis .
- treatment and assist healing of cutaneous ulceration .
- venous stasis ulcers .
- leg ulcers .
- . chronic venous insufficiencies
- reduction of edema .
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
M. Loree K. Buxerle