(111 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the hardware and basic functionality of a standard ECG device.
No
Explanation: The device is described as a "diagnostic electrocardiograph (ECG or EKG)" and its intended use is for "Diagnostic ECG". It does not mention any therapeutic function or intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ECG".
No
The device description explicitly states the system requires a "Type II PC Card Slot" and "Windows CE Pocket PC 2002," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic ECG for 12 Channel Resting ECG". This describes a device that measures electrical activity of the heart from the body surface.
- Device Description: The description confirms it's a "diagnostic electrocardiograph (ECG or EKG)".
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device directly interacts with the patient's body to record electrical signals, not to analyze a biological specimen.
Therefore, the EKGCard™ System is a diagnostic medical device, but it falls under the category of in vivo diagnostic devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Diagnostic ECG for 12 Channel Resting ECG
Patient Population: Male/Female, Pediatric to Adult
Environment of Use: Hospital, Clinic and Home Use
Prescription Device by a Physician
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The EKGCard™ System is a diagnostic electrocardiograph (ECG or EKG) for 12 channel resting ECG's. The patient population is for both male and female, pediatric and adult. The System requires a Type II PC Card Slot and Windows CE Pocket PC 2002 and is a Prescription Device.
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
Pediatric to Adult
Intended User / Care Setting
Hospital, Clinic and Home Use
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)
Not Found
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.
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
Image /page/0/Picture/1 description: The image shows a logo with the letters QRS in a bold, sans-serif font. The letters are arranged horizontally, with the Q on the left, the R in the middle, and the S on the right. A thin, black oval surrounds the letters, adding a sense of motion or orbit to the design. The logo is simple, yet eye-catching, and would be easily recognizable.
B.
JUN 1 1 2003
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| 1. | Submitter's Name: | QRS Diagnostic, LLC |
|---|---|---|
| 2. | Address: | 14755 27th Avenue No. |
| Plymouth, MN 55447 | ||
| 3. | Telephone: | 763-559-8492, Ext. 952 |
| 4. | Contact Person: | Brad Sorenson |
| 5. | Date Prepared: | December 17, 2002 |
| 6. | Registration Number: | 2133542 |
| Device | ||
| 1. | Name: | EKGCard™ System |
| 2. | Trade Name: | EKGCard™ System |
| 3. | Common Name: | Diagnostic Electrocardiograph |
| 4. | Classification Name: | Electrocardiograph (ECG or EKG) |
| 5. | Product Code: | DPS |
| 6. | Class: | II |
| 7. | Regulation Number: | 870.2340 |
14755 27th Avenue N. • Plymouth, MN 55447 (763) 559-8492 • FAX (763) 559-2961 www.QRSdiagnostic.com
1
C. Identification of Legally Marketed Devices
| 1. Name: | Biolog 3000 and ECG Interface |
|---|---|
| 2. K Number: | K974351 and K974220 |
| 3. Date Cleared: | April 1, 1998 and August 25, 1998 |
D. Description of the Device
The EKGCard™ System is a diagnostic electrocardiograph (ECG or EKG) for 12 channel resting ECG's. The patient population is for both male and female, pediatric and adult. The system has been tested to the following standards:
- IEC 601-1, 60601-1; 1991 1
- IEC 601-2-25; 1993
- . ANSI/AAMI EC11 - 1991
- . ANSI/AAMI EC53 - 1995
- 트 ANSI/AAMI ES1 - 1993
- 처 CUL 601-1
- UL 2601-1
- 1 EN60601-1-2
- 트 EN 25011
- . EN 61000-4-2
- 트 EN 61000-4-3
- 트 EN 61000-4-4
- 트 EN-61000-4-6
- EN-61000-4-8
- 180 10993
- . 21CFR Part 898
- . 21CFR Part 801
- 1 93/42/EEC
- . EN 980
- 트 21CFR Part820
The EKGCard™ System is an electrocardiograph that detects signals associated with cardiac activity and produces an ECG; a graphical record of the voltage versus time. ECG's are routinely used to diagnose cardiac abnormalities, determine a patient's response to drug therapy, and reveal trends of changes in heart function.
The System requires a Type II PC Card Slot and Windows CE Pocket PC 2002 and is a Prescription Device.
2/5
2
Intended Use Statement E.
Diagnostic ECG for 12 Channel Resting ECG Patient Population: Male/Female, Pediatric to Adult Environment of Use: Hospital, Clinic and Home Use
F. Components/ Part Numbers
- 6000-4332 User's Manual ●
- 7000-1000 WLD ● EKGCard
- ECG Cable 2010-3722 (IEC) ●
- ECG Cable 2010-3721 (AAMI) ●
- Snap Adapters 5000-1861 ●
- Tab Adapters 2000-1858 .
- 2000-1859 Snap Electrodes .
- Tab Electrodes 5000-1858 ●
G. Table of Comparisons
The following summary tables of comparisons compare the new device (EKGCard System) to the predicate devices: Biolog 3000 and ECG Interface.
| # | Area | New Device:
EKGCard™ System | Predicate Device:
Biolog 3000 or
ECG Interface | Same | Different |
|----|-----------------------------|------------------------------------|------------------------------------------------------|------|-----------|
| 1 | Indications for
Use | ECG and Connection to
Pocket PC | ECG and Connection
to Pocket PC | X | |
| 2 | Patient Population | Male/Female
Pediatric to Adult | Male/Female
Pediatric to Adult | X | |
| 3 | Environment | Hospital, Clinic, Home
Use | Hospital, Clinic,
Home Use | X | |
| 4 | Number of
Electrodes | 12 Lead ECG | 12 Lead ECG | X | |
| 5 | Batteries | No | No | X | |
| 6 | Internal Isolation | Yes | Yes | X | |
| 7 | Defibrillator
Protection | Yes | Yes | X | |
| 8 | Banana Plugs | Yes | Yes | X | |
| 9 | Types of
Electrodes | Snap or Tab | Snap or Tab | X | |
| 10 | CMRR | Yes | Yes | X | |
| 11 | Heart Rate | Yes | Yes | X | |
3/5
3
| 12 | Standards
AAMI, EC11 | Yes | Yes | X | |
|----|--------------------------------|-------------|-------------|---|---|
| 13 | Standards
60601-2-25 | Yes | Yes | X | |
| 14 | Interpretation | No | Yes | | X |
| 15 | Transtelephonic | No | Yes | | X |
| 16 | Cable Length
3 Feet, 5 Feet | Yes | Yes | X | |
| 17 | Type BF | Yes | Yes | X | |
| 18 | Filters | 50 or 60 Hz | 50 or 60 Hz | X | |
| 19 | Connection Status | Yes | Yes | X | |
| 20 | Electrode
Labeling | IEC or AAMI | IEC or AAMI | X | |
| 21 | Print EKG's | No | Yes | | X |
| 22 | Supplied
Non-Sterile | Yes | Yes | X | |
| 23 | Prescription
Device | Yes | Yes | X | |
| 24 | Safety Standards | Yes | Yes | X | |
| 25 | EMC Standards | Yes | Yes | X | |
| 26 | Operating
Conditions | Yes | Yes | X | |
H. Discussion of Similarities and Differences
The EKGCard and Biolog 3000 or ECG Interface have the following similarities:
- . Indications for Use
- Patient Population ●
- Environment Number of Electrodes .
- Batteries .
- . Internal Isolation
- Defibrillator Protection .
- Banana Plugs ●
- Types of Electrodes . CMRR
- Heart Rate .
- Standards EC11 ●
- IEC 60601-2-25 .
4
- Cable Length ●
- . Type BF
- Filters ●
- Connection Status ●
- Electrode Labeling ●
- . Non-Sterile
- Prescription Device ●
- Safety ●
- EMC ●
- Operating Conditions .
The differences, with comments, are the following:
- Interpretation The EKGCard does not have interpretation, whereas the . Biolog 3000 does or can.
- . Transtelephonic – The EKGCard does not have the capability to transmit ECG's trans-telephonically.
- Print ECG The EKGCard does not yet have the ability to print EKG's. .
The above differences do not raise any new types of safety or effectiveness questions.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the eagle's body is formed by three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2003
ORS Diagnostics, LLC c/o Mr. Alan Barker British Standards Institution Maylands Avenue Hemel Hemostead Hertfordshire, HP2 4SQ United Kingdom
Re: K030535
Trade Name: EKGCard™ Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: Undated Received: May 27, 2003
Dear Mr. Barker:
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.
6
Page 2 -- Mr. Alan Barker
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), please contact the Office of Compliance at (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K030535
510(k) Number: To be determined
Device Name: EKGCard™ System
Indications for Use:
- Diagnostic ECG for 12 Channel Resting ECG ●
- Patient Population: Malc/Female/Pediatric to Adult -
- Environment of Use: Hospital, Clinic, and Home Use -
- Prescription Device by a Physician -
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030533
OVER-THE-COUNTER USE (optional Form 1-2-96)