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.

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.

AI/ML Overview

Based on the provided text, the SlendAir 4000 Compression System is a medical device, and the information is from a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance in terms of clinical outcomes (e.g., reduction in edema, healing of leg ulcers) are provided. The "performance" described refers to compliance with voluntary engineering standards and a comparative safety and performance study for substantial equivalence determination.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of clinical efficacy or quantitative performance metrics for the device's intended use.	The device complies with IEC 60601-1 (and amendments), IEC 60601-1-2, EN-1441, and applicable parts of Mil-Std-810E. A comparative study on safety and performance was conducted to demonstrate substantial equivalence to predicate devices: Talley TM300, TM500, and Multipulse Sequential Compression Systems.

2. Sample size used for the test set and the data provenance

Not available. The document mentions "a series of safety and performance testing including a comparative study," but it does not specify the sample size, the type of data (e.g., patient data, engineering data), or the provenance (country of origin, retrospective/prospective nature) of this test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not available. The document does not describe the establishment of a "ground truth" in the context of a clinical test set, as its focus is on substantial equivalence through engineering and comparative performance.

4. Adjudication method for the test set

Not available.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pneumatic compression system, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study and AI improvement effect size are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not available. The concept of "ground truth" in a clinical diagnostic sense is not discussed. The "ground truth" for demonstrating equivalence would likely be meeting the performance specifications of the predicate devices or relevant engineering standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of available information regarding the study:

The document states:

"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."

This indicates that a comparative study was performed to demonstrate substantial equivalence to predicate devices (Talley TM300, TM500, and Multipulse Sequential Compression Systems) in terms of safety and performance. However, specific details about the methodology, sample sizes, or results of this study are not provided in this 510(k) summary. The summary focuses on regulatory compliance and the device's basic operational description rather than detailed clinical trial data.

Summary

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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.

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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. 1. 1

Acute pulmonary edema ●
Acute thrombophlebitis ●
Acute congestive cardiac failure .
Deep vein thrombosis
. Episodes of pulmonary embolism
. Acute infections.

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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.

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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.

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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

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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)

Over the Counter Use

8-7

Regulation Number and Section

§ 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).