(111 days)
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
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.
The provided K030535 filing describes the EKGCard™ System, a diagnostic electrocardiograph. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.
Based on the provided document, there is no detailed information describing acceptance criteria and a study dedicated to proving the device meets those criteria. Instead, the submission relies on a comparison to legally marketed predicate devices (Biolog 3000 and ECG Interface) to establish substantial equivalence.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated or presented in a table format within the provided document. The submission details the features and specifications of the EKGCard™ System and compares them to the predicate devices. The "performance" assessment is implicitly based on matching or being similar to the predicate devices' capabilities.
| Acceptance Criteria (Inferred from comparison) | Reported Device Performance (EKGCard™ System) |
|---|---|
| Indications for Use (Match Predicate) | ECG and Connection to Pocket PC |
| Patient Population (Match Predicate) | Male/Female, Pediatric to Adult |
| Environment (Match Predicate) | Hospital, Clinic, Home Use |
| Number of Electrodes (Match Predicate) | 12 Lead ECG |
| Batteries (Match Predicate) | No |
| Internal Isolation (Match Predicate) | Yes |
| Defibrillator Protection (Match Predicate) | Yes |
| Banana Plugs (Match Predicate) | Yes |
| Types of Electrodes (Match Predicate) | Snap or Tab |
| CMRR (Match Predicate) | Yes |
| Heart Rate (Match Predicate) | Yes |
| Standards AAMI, EC11 (Compliance) | Yes |
| Standards 60601-2-25 (Compliance) | Yes |
| Interpretation (Not applicable, explicitly different) | No |
| Transtelephonic (Not applicable, explicitly different) | No |
| Cable Length (Match Predicate) | Yes |
| Type BF (Match Predicate) | Yes |
| Filters (Match Predicate) | 50 or 60 Hz |
| Connection Status (Match Predicate) | Yes |
| Electrode Labeling (Match Predicate) | IEC or AAMI |
| Print EKG's (Not applicable, explicitly different) | No |
| Supplied Non-Sterile (Match Predicate) | Yes |
| Prescription Device (Match Predicate) | Yes |
| Safety Standards (Compliance) | Yes |
| EMC Standards (Compliance) | Yes |
| Operating Conditions (Match Predicate) | Yes |
Note: The "acceptance criteria" here are inferred to be "being substantially equivalent to the predicate device" in each listed characteristic or demonstrating compliance with relevant industry standards. The reported performance is the EKGCard™ System's stated feature/capability.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" of patient data for evaluating the EKGCard™ System's performance in a clinical or analytical study. The comparison is feature-based against predicate devices and compliance with standards. Therefore, information on sample size and data provenance is not available in this filing related to performance validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no specific test set or clinical study to establish performance is described, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no specific test set or clinical study for performance evaluation is detailed, there is no information on an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical comparisons and compliance with standards, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The EKGCard™ System is a diagnostic electrocardiograph, which is a device for acquiring ECG signals. It does not appear to incorporate an AI algorithm for interpretation, as explicitly stated under "Differences" that "The EKGCard does not have interpretation, whereas the Biolog 3000 does or can." Therefore, a standalone algorithm performance study is not applicable and not reported.
7. The Type of Ground Truth Used
Given the nature of the device (an ECG acquisition system) and the type of submission (substantial equivalence based on technical features and standards compliance), the "ground truth" implicitly refers to the established technical specifications and validated performance of the predicate devices and/or compliance with recognized industry standards (e.g., IEC 601-1, ANSI/AAMI EC11). There's no mention of expert consensus on specific cases, pathology, or outcomes data being used as ground truth for performance validation of the EKGCard™ System itself.
8. The Sample Size for the Training Set
The document does not mention any training set as there is no indication of an AI or machine learning component being developed or trained for this device. The device is for ECG acquisition.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned, this question is not applicable.
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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
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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.
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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 orECG Interface | Same | Different |
|---|---|---|---|---|---|
| 1 | Indications forUse | ECG and Connection toPocket PC | ECG and Connectionto Pocket PC | X | |
| 2 | Patient Population | Male/FemalePediatric to Adult | Male/FemalePediatric to Adult | X | |
| 3 | Environment | Hospital, Clinic, HomeUse | Hospital, Clinic,Home Use | X | |
| 4 | Number ofElectrodes | 12 Lead ECG | 12 Lead ECG | X | |
| 5 | Batteries | No | No | X | |
| 6 | Internal Isolation | Yes | Yes | X | |
| 7 | DefibrillatorProtection | Yes | Yes | X | |
| 8 | Banana Plugs | Yes | Yes | X | |
| 9 | Types ofElectrodes | Snap or Tab | Snap or Tab | X | |
| 10 | CMRR | Yes | Yes | X | |
| 11 | Heart Rate | Yes | Yes | X |
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| 12 | StandardsAAMI, EC11 | Yes | Yes | X | |
|---|---|---|---|---|---|
| 13 | Standards60601-2-25 | Yes | Yes | X | |
| 14 | Interpretation | No | Yes | X | |
| 15 | Transtelephonic | No | Yes | X | |
| 16 | Cable Length3 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 | ElectrodeLabeling | IEC or AAMI | IEC or AAMI | X | |
| 21 | Print EKG's | No | Yes | X | |
| 22 | SuppliedNon-Sterile | Yes | Yes | X | |
| 23 | PrescriptionDevice | Yes | Yes | X | |
| 24 | Safety Standards | Yes | Yes | X | |
| 25 | EMC Standards | Yes | Yes | X | |
| 26 | OperatingConditions | 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 .
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- 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.
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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.
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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
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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)
§ 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).