(94 days)
Not Found
No
The description details a pneumatic compression device with mechanical controls and predetermined waveforms, with no mention of AI or ML capabilities.
Yes
The device is intended for use in treating various conditions such as lymphedema, edema, and venous insufficiencies, indicating its therapeutic purpose.
No.
The device applies pneumatic compression for treating conditions like lymphedema and edema; it does not diagnose medical conditions.
No
The device description explicitly lists hardware components: a pneumatic control unit, cuffs, connecting tubes, and an electrical transformer.
Based on the provided information, the SlendAir 4000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The SlendAir 4000 is a pneumatic compression device that applies external pressure to a limb. It treats conditions by physically manipulating the body, not by analyzing biological samples.
The description clearly states its function is to induce controlled compression of the leg or arm for therapeutic purposes. This falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SlendAir 4000 is a prescriptive device that induces controlled compression of the leg or the arm. The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as:
- Primary lymphoedema
- Post mastectomy edema
- Leg ulcers
- Edema following trauma and sport injuries
- Post immobilization edema
- Venous insufficiencies
- Lymphoedema
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
The SlendAir 4000 is a prescriptive, pneumatic compression device designed to apply peristaltic compression to a limb. The device is composed of four components:
- Light and portable pneumatic control unit .
- . Calf, foot, full leg, or full arm cuff composes of 1-12 cells.
- . Pneumatic connecting tubes.
- Electrical transformer ●
The SlendAir enables different treatment pressures (30-90mmHg) and treatment times (15-60 minutes) that should be used according to physician discretion. When activated, air flows into the cuff cells in a continues, predetermined peristaltic waveform. A mechanical valve has been included in the air system for releasing air in case of over pressure in one of the compartments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg or the arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients at home
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)
Based on a series of safety and performance testing including a comparative. study, Medical Compression Systems (DBN) Ltd. believes that the SlendAir 4000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.
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
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
pg. 1/3
510(K) SUMMARY
SlendAir 4000 Compression System 510(k) Number K 994067
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:
November, 1999
Trade Name:
SlendAir 4000 Compression System
Classification Name:
Massager, Powered Inflatable Tube
Classification:
The FDA has classified compressible limb sleeves as class II devices (product code IRP, Regulation No. 890.5650) and they are reviewed by the Physical Medicine Panel.
1
fz 2-33
Predicate Device:
- · Talley TM300 Sequential Multicom Compression System (Progressive Medical Technology, Inc.), cleared under K915092;
- · Talley TM500 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915637.
- · Talley Multipulse Sequential Compression Unit (Progressive Medical Technology, Inc.) cleared under K914774.
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the SlendAir 4000 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 SlendAir 4000 is a prescriptive device that induces controlled compression of the leg or the arm.
The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as:
- · Primary lymphoedema
- · Post mastectomy edema
X · Leg ulcers
- · Edema following trauma and sport injuries
- · Post immobilization edema
- · Venous insufficiencies
- · Lymphoedema
Contraindications:
The SlendAir 4000 compression system should not be used in the following cases:
-
-
- 1
-
- Acute pulmonary edema ●
- Acute thrombophlebitis ●
- Acute congestive cardiac failure .
- Deep vein thrombosis
- . Episodes of pulmonary embolism
- . Acute infections.
2
K99405?
pg. 3 of 3
Device Description:
The SlendAir 4000 is a prescriptive, pneumatic compression device designed to apply peristaltic compression to a limb. The device is composed of four components:
- Light and portable pneumatic control unit .
- . Calf, foot, full leg, or full arm cuff composes of 1-12 cells.
- . Pneumatic connecting tubes.
- Electrical transformer ●
The SlendAir enables different treatment pressures (30-90mmHg) and treatment times (15-60 minutes) that should be used according to physician discretion. When activated, air flows into the cuff cells in a continues, predetermined peristaltic waveform. A mechanical valve has been included in the air system for releasing air in case of over pressure in one of the compartments.
Substantial Equivalence:
Based on a series of safety and performance testing including a comparative. study, Medical Compression Systems (DBN) Ltd. believes that the SlendAir 4000 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2000
Ms. Shoshana Friedman, RAC MCS Consultant Medical Compression Systems C/O Push-Med LTD. 117 Ahuzah Street RA'ANANNA, Israel
Re: K994057/S1
Trade Name: SlendAir 4000 Compression System Regulatory Class: II Product Code: IRP Dated: February 8, 2000 Received: February 14, 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 enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Federal Register. Please note: this response to your premarket 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 regulations.
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.
4
Page 2 - Ms. Shoshana Friedman, RAC
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) 594-4595. 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" (21 CFR 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/dsmamain.html".
Sincerely yours.
Neil R. Ogden
James E. Dillard III for
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SlendAir 4000 Compression System Device Name:
Indications for Use: The SlendAir 4000 is a prescriptive device that induces controlled compression of the calf, the leg or the arm.
The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as:
- Primary lymphoedema .
- Post mastectomy edema .
- September 2018 .
- Edema following trauma and sport injuries .
- Post immobilization edema
- Venous insufficiencies
- Lymphoedema
Nro for JZD
(Division Sign-Off)
Division of General Restorative Devices K994057
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number K994059
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
8-7