(64 days)
Not Found
No
The summary describes a standard digital electrocardiograph for acquiring and storing ECG data, with no mention of AI or ML for analysis or interpretation.
No
The device is used to acquire, store, and print ECGs, which are diagnostic tools, not therapeutic interventions.
Yes
The device is an electrocardiograph, which is used to acquire 12-lead ECGs. ECGs are diagnostic tools that graphically record the heart's electrical activity, providing information that can be interpreted by a healthcare professional to identify cardiac conditions. The device collects data (ECG tracings) used to diagnose, making it a diagnostic device.
No
The device description explicitly states it is a "small, portable rechargeable-battery-powered digital electrocardiograph" and mentions hardware components like a keypad and direct connection to a printer, indicating it is a physical device with integrated software, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- CardioCollect Function: The Reynolds CardioCollect is an electrocardiograph. It measures the electrical activity of the heart directly from the patient's body using electrodes placed on the skin. This is an in vivo measurement, not an in vitro test of a specimen.
The description clearly states its purpose is to acquire 12-lead ECGs from patients, which is a direct physiological measurement, not a test on a biological sample.
N/A
Intended Use / Indications for Use
The Reynolds CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. Typical recording time is ten seconds; all leads are recorded prince. Typical "recording" time "is "is "ifications for 12-lead electrocardiographs. It has a provision for entry of patient data using its keypad.
Records include basic data on patients (name, number, and date of birth) as well Records morade basis and these can be printed with the tracing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technicians
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)
(a) Non-clinical tests
CardioCollect has passed the tests for ANSI/AAMI EC11, electrocardiographs, CardioConcer has passed usafety) and EN 60601-1-2 (electromagnetic compatibility).
(b) Clinical tests
A series of electrocardiograms has been taken with CardioCollect to show the quality of the tracings made.
(c) Conclusions
CardioCollect is equivalent in safety and efficacy to the legally-marketed predicate devices.
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.
Agilent M2662A, K002459
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
K013367 p.1/2
Page A2
| DEC 1 3 2001 | Reynolds Medical Ltd
510(k) Submission
CardioCollect
510(k) Summary |
| -------------- | ------------------------------------------------------------------------------ |
|---|
Submitter Information (1)
Name: Reynolds Medical Ltd.
Address:
1 Harforde Court John Tate Road Hertford, Herts. SG13 7NW ENGLAND
Telephone Number: 44-1992-507700
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: October 3, 2001
(2) Name of Device
Trade Name: CardioCollect Common Name: Ambulatory electrocardiograph without analysis Classification name: Electrocardiograph (74DPS, 870.2340)
(3) Equivalent legally-marketed devices.
Agilent M2662A, K002459
Description (4)
CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a
1
Reynolds CardioCollect
printer. Typical recording time is ten seconds; all leads are recorded prince. Typical "recording" time "is "is "ifications for 12-lead electrocardiographs. It has a provision for entry of patient data using its keypad.
Records include basic data on patients (name, number, and date of birth) as well Records morade basis and these can be printed with the tracing.
Intended Use (5)
The Reynolds CardioCollect is a small, portable rechargeable-battery-powered The Reynolds Cardroomeer is a intended to be used by technicians to aquire 12ulghal ciccitiveardiograph that is as as then print them or store them digitally in the patient's record in a computer (or both).
Performance Data (6)
- (a) Non-clinical tests
CardioCollect has passed the tests for ANSI/AAMI EC11, electrocardiographs, CardioConcer has passed usafety) and EN 60601-1-2 (electromagnetic compatibility).
(b) Clinical tests
A series of electrocardiograms has been taken with CardioCollect to show the quality of the tracings made.
(c) Conclusions
CardioCollect is equivalent in safety and efficacy to the legally-marketed predicate devices.
2
Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles, suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Reynolds Medical Ltd. c/o George H. Myers, Sc.D. Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604
Re: K013367
K013507
Trade Name: CardioCollect Portable Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 8, 2001 Received: October 10, 2001
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQC ) premaince is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure, to tegally manced the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1976, the elaculient and of the Federal Food, Drug, devices that have been reclassified in accordance when as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approval applications of th and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject could registration, listing of
general controls provisions of the Act include requires misbranding and general controls provisions of the Act merade roquisitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mito crain in persuations affecting your device can
may be subject to such additional controls. Existing major regulations allection may be subject to such additional controlis. Existing mays organisan In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may
11, 2 be found in the Code of Federal Regarations on the Federal Register.
3
Page 2 - George H. Myers, Sc.D.
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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dakota Tillah
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Reynolds CardioCollect
Page 5 ·
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Indications for Use Form
Device Name: CardioCollect
Indications for Use:
rechargeable-battery-powered is digital CardioCollect electrocardiograph intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a to 10 patiently (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use __________ | X |
|---|---|
| Use __________ | |
| (Per 21 CFR 810.109) |
OR
Over-the-Counter
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number KC13367