(87 days)
K#940264, K020857, K# 012141
Not Found
No
The description focuses on the mechanical function of the device (inflatable/deflatable cuffs synchronized with the heartbeat) and does not mention any AI or ML components for data analysis, decision-making, or control.
Yes.
The device is specifically intended for the treatment of various medical conditions, including congestive heart failure and angina pectoris, by applying physical pressure to the lower extremities to assist blood circulation.
No
The device is described as a non-invasive external counter pulsation device intended for treatment, not diagnosis. It applies pressure to the lower extremities to assist blood flow and reduce cardiac workload.
No
The device description explicitly states it consists of a "central control unit and three pairs of inflatable/deflatable cuffs," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a non-invasive external counter pulsation device used for the treatment of various cardiovascular conditions. This involves applying external pressure to the patient's body.
- Device Description: The description details a system with inflatable cuffs that apply pressure to the lower extremities in synchronization with the heartbeat. This is a physical intervention on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body. This device operates on the patient's body.
N/A
Intended Use / Indications for Use
The Mobile External Counter Pulsation System AngioNew-IV is a non-invasive external counter pulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction or cardiogenic shock.
Product codes
74 DRN
Device Description
The Mobile External Counter Pulsation System AngioNew-IV 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.
The Living Data Technologies AngioNew-IV system consists of a central control unit and three pairs of inflatable/deflatable 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 diatolic period, pressure is applied sequentially from calves to thighs and then to buttocks to force blood back to the hear, increase coronary perfusion pressure (diatolic and augmentation) and, at the same time, increases coronary blood flow and enchances the development of coronary collateral circulation. Just before the heart starts eiecting 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities (calves, thighs, and buttocks)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing and non-clinical testing for electrical safety and EMC. Critical functions tested include: ECG Signal Processing, QRS Detection and Inflation/Deflation Timing, Effective Heart Rate Range, Inflation/Deflation Duration Time, Time Intervals between the Three Sequential Inflation Signals. Non-critical functions tested include: CRT Display Freezing, CRT Display Sweep Speed, Treatment Timer, Number Display on CRT.
Key Metrics
Not Found
Predicate Device(s)
K#940264, K020857, K# 012141
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
EXHIBIT #1
JAN 3 0 2003
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:
1. Submitter's Identification:
Living Data Technologies Corporation 140 53[d Street Brooklyn, NY 11232
Contact: Mr. Jun Ma (718) 492-7400
Date Summary Prepared:
October 31, 2002
Name of the Device: 2.
AngioNew-IV
3. Predicate Device Information:
-
- Vasogenics, Inc., K#940264, Vasogenics EECP-MC2, Port Jefferson Station, NY.
-
- Vasomedical, Inc., K020857, Enhanced External Counterpulsation EECP®MC-2 External Counter Pulsating Device, Westbury, NY.
-
- Beit Hapa'amon Automatic External Counterpulsating Device (AECP-A), K# 012141, Kfar Saba, Israel.
4. Device Description:
The Mobile External Counter Pulsation System AngioNew-IV 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.
1
The Living Data Technologies AngioNew-IV system consists of a central control unit and three pairs of inflatable/deflatable 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 diatolic period, pressure is applied sequentially from calves to thighs and then to buttocks to force blood back to the hear, increase coronary perfusion pressure (diatolic and augmentation) and, at the same time, increases coronary blood flow and enchances the development of coronary collateral circulation. Just before the heart starts eiecting 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.
5. Intended Use:
The Mobile External Counter Pulsation System AngioNew-IV is a non-invasive external counter pulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction or cardiogenic shock.
6. Comparison to Predicate Devices:
All major components of LDT AngioNew-IV are same in function and specifications as the predicate device Vasogenics/Vasomedical EECP-MC2 System, with the exception of three components. They are: Inflation/deflation timing control, valves and the dimensions of cuffs. These differences do not result in any changes in the precautions or contraindications of the device, nor any changes in the intended use, safety and effectiveness of the device. See discussions below.
An additional difference between AngioNew-IV and EECP MC-2 is the use of artery plethysmography. AngioNew-IV uses the same temporal artery sensor as in the AECP-A, another predicate device.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
In addition to electrical safety testing in accordance with IEC 60601-1, and EMC testing in accordance with IEC 60601-1-2, En 55011, EN 6100-4-2, EN 61000-4-3. EN 61000-4-4 and EN 61000-4-5, testing was also conducted:
2
Critical Functions:
- ECG Signal Processing .
- QRS Detection and Inflation/Deflation Timing .
- Effective Heart Rate Range .
- . Inflation/Deflation Duration Time
- Time Intervals between the Three Sequential Inflation Signals .
Non-Critical Functions:
- CRT Display Freezing .
- CRT Display Sweep Speed .
- Treatment Timer .
- Number Display on CRT .
Conclusions: 9.
The subject device, AngioNew-IV, has the same intended use and similar characteristics as the predicate devices. Morever, 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 questions of safety or effectiveness. Thus, the AnqioNew-IV device is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The text is in all capital letters and is relatively small compared to the size of the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 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: K023701
The Mobile External Counter Pulsation System AngioNew-IV Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class III (three) Product Code: 74 DRN Dated: October 31, 2002 Received: November 4, 2002
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 mav publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Susan D. Goldstein-Falk
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 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 (OS) 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 (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
ho D. Zeller M.D.
Bram D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
Page
510(k) Number (if known):
Device Name The Mobile External Counter Pulsation System AngioNew-IV
1-02370
Indications For Use:
The Mobile External Counter Pulsation System AngioNew-IV is a non-invasive external counter pulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction or cardiogenic shock.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. DeWitt
Division Sian-Off 510(k) Numb
Prescription Use Only