The Mobile External Counter Pulsation System AngioNew-V is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock.

Device Description

The Living Data Technology AngioNew-V system consists of a central control unit and three pairs of inflatable cuffs that are wrapped respectively around a patient's calves, thighs and buttocks. External pressure is applied via the cuffs to the lower extremities of the patient in synchronization with the heartbeat. When the heart is in the relaxed state during diastolic period, pressure is applied sequentially from the distal to proximal extremities to force blood back to the heart, increase coronary perfusion pressure (diastolic augmentation) and, at the same time, increases coronary blood flow and enhances the development of coronary collateral circulation. Just before the heart starts ejecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of the heart, thereby reducing systolic pressure (systolic unloading) and the workload of the heart.

AI/ML Overview

The AngioNew-V device, an external counterpulsation system, underwent non-clinical testing to demonstrate its substantial equivalence to a predicate device, AngioNew-IV. The provided summary focuses on safety and performance testing rather than a comparative effectiveness study involving human readers or a standalone algorithm performance study in the context of medical image analysis.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or specific physiological thresholds). Instead, the acceptance criteria appear to be met by demonstrating compliance with various safety and design specifications, and by showing that the modified features of AngioNew-V do not introduce new questions of safety or effectiveness compared to the predicate device.

The reported device performance is qualitative, indicating that the device "meets all safety and EMC requirement, as well as all design specifications." Specifically, the non-clinical tests covered:

Acceptance Criteria Category	Reported Device Performance
Safety and Electrical/Magnetic Compatibility (EMC)	Meets all safety and EMC requirements (in accordance with IEC 60601-1, EN 60601-1, IEC 60601-1-2, EN 55011, EN 61000-3-2, EN 61000-3-3).
Design Specifications	Meets all design specifications.
R-wave Detection and Heart Rate Calculation	Testing was conducted, and the device is deemed to meet design specifications.
Inflation/Deflation Timing Control and Counterpulsation Effect	Testing was conducted, and the device is deemed to meet design specifications, including a new inflation timing adjustment method for better counterpulsation effect.
Substantial Equivalence to Predicate Device (AngioNew-IV)	"AngioNew-V meets all safety and EMC requirement, as well as all design specifications. Therefore it is substantially equivalent to AngioNew-IV in safety and effect." "no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness."

2. Sample Size for Test Set and Data Provenance

The document describes "non-clinical tests" and "bench testing" but does not specify a "test set" in the context of a dataset of patient cases. This implies a focus on device functionality and safety through engineering and laboratory testing rather than performance on a clinical dataset. Therefore, no sample size for a test set of patient data is provided, nor is data provenance (country of origin, retrospective/prospective) relevant here.

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

Not applicable. This study is not evaluating an AI or diagnostic device that relies on expert interpretation of medical data for ground truth establishment. It's a device safety and performance evaluation.

4. Adjudication Method

Not applicable. As the study does not involve expert interpretation of cases, no adjudication method is relevant.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical and bench testing of the device's technological and functional characteristics, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable in the conventional sense of an algorithm's diagnostic performance. While the device incorporates a "control loop" and "software updates the inflation timing," a standalone study in the context of diagnostic algorithms (e.g., sensitivity, specificity of an AI identifying a condition) was not conducted or reported. The tests focused on the device's operational performance and safety.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been established through engineering specifications, direct measurements, and compliance with recognized safety and performance standards (e.g., IEC, EN standards). For example:

Safety standards: Direct verification that the device components and operation meet defined safety thresholds (e.g., electrical leakage, temperature limits).
Design specifications: Measurement of device outputs (e.g., pressure, timing, heart rate detection accuracy) against predetermined design targets.
Bench test results: Physical measurement of the device's response under various conditions (e.g., inflation/deflation timing accuracy, pressure regulation).

8. Sample Size for the Training Set

Not applicable. This document is for a medical device clearance (510(k)) that focuses on substantial equivalence for an external counterpulsation system, not on an AI algorithm that requires a "training set" for machine learning. The "software updates the inflation timing" suggests an internal algorithm, but the details of its development (and thus, a training set) are not provided in this summary.

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

Not applicable. As a training set for an AI algorithm is not discussed, the method for establishing its ground truth is also not mentioned.

Summary

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Living Data Technology Corp.

Special 510(k) for AngioNew-V

EXHIBIT 1

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 870.92.

The assigned 510(k) number is: _ K033657

Date Summary Prepared 1.

November 19, 2003

2. Submitter's Identification

Living Data Technology Corporation 140 53rd Street Brooklyn, NY 11232

Contact: Dr. Jun Ma (718) 492-7400

Name of the Device 3.

The Mobile External Counter Pulsation System AngioNew-V

Predicate Device Information 4.

K023701. The Mobile External Counter Pulsation System AngioNew-IV Living Data Technology Corporation, Brooklyn, NY

ട. Device Description

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coronary collateral circulation. Just before the heart starts ejecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of the heart, thereby reducing systolic pressure (systolic unloading) and the workload of the heart.

Indications for Use 6.

Comparison to Predicate Device 7.

The modified device AngioNew-V is essentially same in specifications as well as in technological and functional characteristics as the current device AngioNew-IV (cleared under K023701), except for the following technological upgrading:

A control loop is added to the AC drive regulate the compressor motor for . stabilizing the air reservoir pressure.
A finger pulse plethysmography sensor is employed and the original . temporal artery pressure sensor is optional now.
The central control unit CPU is upgraded. The display is also upgraded . from 9" CRT to 8.4" LCD.
The quick connectors between cuffs and valves are improved with . integrated senor to identify cuff connection sequence so that the machine adjusts inflation sequence accordingly, therefore adding an additional safety feature to the device.
A new inflation timing adjustment method for better counter pulsation . effect is used in AngioNew-V. Using a predetermined, heart rate dependent inflation timing as the initial value, the software updates the inflation timing to maximize counterpulsation effect.
A finger oximetry sensor is added to provide measurement and display of . blood oxygen saturation level.
A built-in printer is added to the device to provide real time recording of . ECG and pulse wave, as well as other information such as heart rate, D/S ratios, etc., during ECP treatment.

8. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence

In addition to safety tests in accordance with IEC 60601-1 and EN 60601-1; EMC tests in accordance with IEC 60601-1-2, EN 55011, EN 61000-3-2, and EN 61000-3-3; other testing was also conducted, such as:

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Living Data Technology Corp.

R-wave Detection and Heart Rate Calculation; .
Inflation/deflation Timing Control and Counterpulsation Effect; .

etc.

It is concluded that AngioNew-V meets all safety and EMC requirement, as well as all design specifications. Therefore it is substantially equivalent to AngioNew-IV in safety and effect.

ਹੈ. Conclusions

The subject device, AngioNew-V, has the same intended use and similar characteristics as the predicate device. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrate that there are no differences in their technological characteristics, thereby not raising any new Thus, the AngioNew-V device is questions of safety or effectiveness. substantially equivalent to the predicate device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like design with three curved lines emanating from its head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Living Data Technology Corporation c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021

Re: K033657

Mobile External Counter Pulsation System AngioNew-V Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class III (three) Product Code: DRN Dated: November 19, 2003 Received: November 21, 2003

Dear Ms. Goldstein-Falk:

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.

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Page 2 - Ms. Susan D. Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanter equires with other requirements of the Act
that FDA has made a determination that your device adder Edgeral Pourmust that FDA has made a determilation administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federation and listing or any Federal statutes and regulations and including, but not limited to: registration and listing (21)
comply with all the Act's requirements, including, and circus provine comply with all the Act s requirements, menanting practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as settroni CFR Part 807); labeling (21 CFK Patl on (21 CFR Patt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scetions 35 - 3 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -This letter will allow you to begin marketing your active as walence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the , premarket notification. The FDA inding of subsantial equivalence of 1.
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
rs of the results of the most (2011/64), also are the regulation entitled If you desire specific advice for your ac tree of 666. Also, please note the regulation entitled, and the may obtain contact the Office of Compliance at (301) 37 - 10 - (21CFR Patt 807.97). You may obtain "Misbranding by reference to prematics houltiedable in the Act from the Division of Small other general information on your responsion.com and with toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address.

Sincerely yours,

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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Special 510(k) for AngioNew-V

EXHIBIT B

of Page 1

K033657 510(k) Number (if known): __

Device Name: The Mobile External Counter Pulsation System AngioNew-V

Indications for Use:

The Mobile External Counter Pulsation System AngioNew-V is a non-invasive external counter pulsating device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, actual myocardial infraction or cardiogenic shock.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

O. M. 22

(Division Sign-Off)
Division of Cardiovascular Devices

510/k) Numbe

Regulation Number and Section

§ 870.5225 External counter-pulsating device.

(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.