The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: 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, Prevent pooling of fluids in limbs, Lymphedema

Device Description

IPC-Boot is actually a very similar version of C-Boot's legally marketed device, cleared under 510(k) number K041659. Similarly to the legally marketed device, it is made of the same materials and has the same design, technology and performances. The only modification that was made to the predicate device is the addition of external electric pump that can activate the device electrically when the patient is immobile. This modification provides a solution for such patients. The patient may choose whether the device will be used mechanically (self powered), by walking (as the original device) or electrically as the modified new device: IPC-Boot, when patient is immobile. The IPC-Boot is a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph disorders patients. The IPC-Boot contains boot legging with inflatable sleeves from the patient's foot up to the knee. The IPC-Boot uses an external electric pump. The pump is generated the air to inflate the sleeves through the control system for producing intermittent compression to the lower limb. C-Boot's solution integrates the technological advantages of dynamic compression pumps that enable preset sequential pressure control which is identical to the pressure level of the preamended device (predicate). This enables the patient to individualize treatment regimes, with the mobility benefit of static compression stockings that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return, The modified device covers both self-powered and electrical compression devices and creates one integrated device.

AI/ML Overview

This 510(k) summary describes a device, the IPC-Boot, which is an electrical lymph and venous-insufficiency system. The submission focuses on demonstrating substantial equivalence to a predicate device (C-Boot, K041659) by highlighting that the new device is a very similar version with the primary modification being the addition of an external electric pump for electrical activation when the patient is immobile. The submission asserts that this modification does not affect the device's intended use or alter its fundamental scientific technology.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., pressure output ranges, cycle times, safety thresholds) for the IPC-Boot, nor does it present detailed study results against such criteria.

Instead, the submission states:

Acceptance Criterion	Reported Device Performance
Safety and Effectiveness	"New device verification and validation tests showed that it is as safe and as effective as the predicate device."
	"The evaluation of C-Boot non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device (thanks to the electrical operation addition)."
Compliance with Predicate Device Specifications	"The modified device was tested with accordance to C-Boot's legally marketed device specification and all acceptance criteria were met."
Labeling Claims Support	"Tests results are supporting all labeling claims and substantial equivalency."

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include any information regarding the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The tests mentioned are "non-clinical" and seem to be engineering verification and validation rather than clinical studies with human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Given that the document refers to "non-clinical tests" and "legally marketed device specification," it is highly unlikely that "experts" (like radiologists) were used to establish ground truth in the way medical imaging or diagnostic devices would require. The tests appear to be related to engineering specifications and performance, which would likely be assessed by engineers or technicians. No specific information on experts or their qualifications is provided.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant to clinical studies involving human interpretation or assessment, especially in cases of disagreement among experts. Since the tests described are non-clinical and focus on device specifications, an adjudication method in this sense is not applicable and not mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. The submission is focused on demonstrating substantial equivalence through non-clinical testing of the modified device against the predicate's specifications, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The IPC-Boot is a physical medical device (pneumatic compression boot), not an algorithm or an AI-driven system. Therefore, the concept of a "standalone" algorithmic performance study does not apply to this device. The evaluation would be on the device's mechanical and electrical performance as a standalone unit.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be the legally marketed device's (predicate device's) specifications and performance characteristics. The modified device was evaluated against these established benchmarks. The text indicates: "The modified device was tested with accordance to C-Boot's legally marketed device specification and all acceptance criteria were met." This implies that the 'ground truth' was a set of engineering and performance standards derived from the predicate device.

8. Sample Size for the Training Set

Since the IPC-Boot is a physical medical device and not an AI/machine learning system, a "training set" in the context of algorithm development is not applicable and not mentioned. The device itself is manufactured, not "trained."

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device, the method of establishing its ground truth is not applicable. The reference points for performance were the predicate device's specifications.

Summary

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Special 510k Summary 13.

FOR ELECTRICAL LYMPH AND VENOUS-INSUFFICIENCY SYSTEM (IPC-BOOT, model C-9000)

Date Prepared: DECEMBER 20, 2006

1. 510(K) OWNER NAME: C-Boot Ltd. Kibbutz Yiron, Merom Hagalil, 13855, Israel

SUBMITTER PERSON NAME: Mr. Avi Abraham - Avnet Engineering -8 Marva st., Carmiel 21691, Israel Phone: +972-50-4949699 Fax: +972-4-9589111 Email: avi_abraham@yahoo.com

C-BOOT LTD. U.S AGENT: 20845 Ramita Trail, Boca Raton, FL 33433, USA

Contact Person: David Furshpan Phone: 561-487-6332, Fax: 561-558-1313, Email: dfurshpan@adelphia.net

2. DEVICE NAME

Common/Usual Name: ICP-Boot Proprietary/Trade name: IPC-Boot

Classification: ICP-Boot has been classified as Class II devices under the following classification names:

Name	ProductCode	21 CFR Ref.	Panel
Compressible Limb Sleeve	JOW	870.5800	Cardiovascular

3. PREDICATE DEVICES

C-Boot's new device (IPC-Boot) is substantially equivalent to C-Boot™, cleared under 510(k) number: K041659

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4. DEVICE DESCRIPTION

K070329
Page 2 of 3
IPC-Boot is actually a very similar version

Modified Device and change Description: C-Boot's IPC-Boot is actually a very similar version of C-Boot's legally marketed device, cleared under 510(k) number K041659. Similarly to the legally marketed device, it is made of the same materials and has the same design, technology and performances.

The only modification that was made to the predicate device is the addition of external electric pump that can activate the device electrically when the patient is immobile. This modification provides a solution for such patients.

The patient may choose whether the device will be used mechanically (self powered), by walking (as the original device) or electrically as the modified new device: IPC-Boot, when patient is immobile.

The IPC-Boot is a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph disorders patients.

The IPC-Boot contains boot legging with inflatable sleeves from the patient's foot up to the knee. The IPC-Boot uses an external electric pump. The pump is generated the air to inflate the sleeves through the control system for producing intermittent compression to the lower limb.

C-Boot's solution integrates the technological advantages of dynamic compression pumps that enable preset sequential pressure control which is identical to the pressure level of the preamended device (predicate).

This enables the patient to individualize treatment regimes, with the mobility benefit of static compression stockings that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return,

The modified device covers both self-powered and electrical compression devices and creates one integrated device.

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5. INTENDED USE

K070324
Page 3 of 3

The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both.

The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including:

Prevention of deep vein thrombosis (DVT) 1.
1. Enhancement of blood circulation
1. Reduction of post-operative pain and swelling
1. Reduction of wound-healing time
న్. Stasis dermatitis
1. Treatment and assist healing of cutaneous ulceration
1. Venous stasis ulcers
1. Leg ulcers
の。 Chronic venous insufficiencies
1. Reduction of edema
1. Prevent pooling of fluids in limbs
1. Lymphedema

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

C-Boot's amended device (IPC-Boot) is substantially equivalent to C-Boot's conventional legally marketed device (C-Boot"M), cleared under 510(k) number K041659. C-Boot's new and predicate devices have the same indication for use, same basic shape, characteristics, materials, manufacturing technology and design.

The modified device differs from the predicate device only in the addition of energy source, i.e., the electric pump, transformer and hose.

This modification does not affecting the device's intended use and does not alter the device's fundamental scientific technology.

New device verification and validation tests showed that it is as safe and as effective as the predicate device,

7. NONE CLINICAL PERFORMANCE DATA

Tests results are supporting all labeling claims and substantial equivalency. The modified device was tested with accordance to C-Boot's legally marketed device specification and all acceptance criteria were met.

8. CONCLUSIONS

The evaluation of C-Boot non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device (thanks to the electrical operation addition). Therefore, we believe it is substantially equivalent to C-Boot's legally marketed device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C-BOOT LTD C/O Avent Engineering 8 Marva Street Carmiel Israel 21691 ATTN: Avi Abraham

Re: K070324

Trade/Device Name: IPC-Boot Model C-9000 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 19, 2007 Received: April 3, 2007

Dear Avi Abraham:

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.

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

MAY - 3 2007

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Mr. Avi Abraham - Page 2

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

R. bochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indication For Use Statement

510(k) Number (if known): _K070324

Device Name: Electrical Lymph and Venous-Insufficiency System (IPC-Boot)

Indications for Use: The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both.

The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including:

Prevention of deep vein thrombosis (DVT) 1.
Enhancement of blood circulation 2.
Reduction of post-operative pain and swelling 3.
1. Reduction of wound-healing time
న్. Stasis dermatitis
1. Treatment and assist healing of cutaneous ulceration
1. Venous stasis ulcers
Leg ulcers 8.
Chronic venous insufficiencies の
1. Reduction of edema
1. Prevent pooling of fluids in limbs
1. Lymphedema

Prescription Use	✓
(Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dura R. Holmes

(Posted November 13, 2003)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K070324

Regulation Number and Section

§ 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).