(122 days)
Not Found
No
The summary describes a standard ECG monitoring system that converts a PC into an ECG monitor with ST segment measurement capability. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No
Explanation: This device is described as a patient monitor for ECG S-T Segment Analysis and stress tests, which falls under diagnostic or monitoring functions rather than providing therapy.
Yes
The device is described as a "patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis." It converts a PC into an "ECG monitor with ST segment measurement capability" and allows physicians to "initiate ST evaluations on patients." This functionality directly supports the analysis and diagnosis of ST segments, which are indicative of cardiac conditions, thus qualifying it as a diagnostic device.
No
The device description explicitly lists hardware components like "The QRS CARD™ Office ECG Device, ECG Patient Cable and Lead Wires" as part of the system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The QRS CARD™ S-T Segment Analysis Patient Monitoring System is an ECG monitor. It measures electrical activity of the heart from electrodes placed on the patient's skin. This is a non-invasive measurement taken directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for "patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise." This describes a monitoring function, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of a medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.
Product codes
DPS
Device Description
The QRS CARD™ S-T Segment Analysis Patient Monitoring System converts a commercially available personal computer (PC) into an ECG monitor with ST segment measurement capability. Physicians can initiate ST evaluations on patients and the data are transmitted, using Bluetooth wireless technology, to a computer screen. Test results can also be printed at any time during the testing, or saved in computer memory for future review or additional report generation.
The QRS CARD™ S-T Segment Analysis Patient Monitoring System consists of the following components:
- The QRS CARD™ Office ECG Device
- ECG Patient Cable and Lead Wires
- Product Software on CD .
- User Manual .
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
It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings.
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)
K972255, K080141, K061977, K082077
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Attachment A. 510(k) Summary
Image /page/0/Picture/20 description: The image shows a logo with two distinct elements. On the left, there is a hexagonal shape filled with a textured pattern, and within it, a stylized electrocardiogram (ECG) waveform is visible. To the right of the hexagonal shape, the letters 'PBI' are printed in a bold, sans-serif font. The overall design appears to be for a company or organization with the initials PBI, possibly related to healthcare or cardiology.
JUL 28 2010
Ise Biomedical, Inc
Pulse Biomedical GmbH
Filhete Bihler Str 4, 72474 Winterlingen, GERALANY
Tel: +49-7434-316038 Fax:+49-7434-316039
Special 510(k) - QRS Card™ S-T Segment Analysis Patient Monitoring System Modification
Section 6
510(k) Summary - 807.92
Applicant Name and Address
Pulse Biomedical Inc. 1305 Catfish Lane Norristown, PA 19403
Manufacturer Name and Address
Pulse Biomedical Inc. 1305 Catfish Lane Norristown PA 19403
Contact Person
Saleem Hasan - President Tel. No. - 610-660-5510 Fax No. - 610-666-5630
Establishment Registration Number 2529508 Device Name:
| Device
Trade
Name | Common
Classification
/ Name | Regulation
Number | Classification
Code | Device
Class | Classification
Name |
|-------------------------|------------------------------------|----------------------|------------------------|-----------------|------------------------|
| QRS
Card BT | Physiological
Monitor | N/A | DPS | II | Electrocardiograph |
1
Image /page/1/Picture/0 description: The image shows a logo with two distinct elements. On the left, there is a stylized hexagon shape with a jagged line running through the center, resembling a heartbeat or electrical signal. To the right of the hexagon, the letters 'PBI' are printed in a bold, sans-serif font. The overall design is simple and professional.
1305 Catfish Lane, Norristown, PA 19403, USA
Tel: 610-666-5510 Fax: 610-666-5630
Wuneim Binler Str 4, 72474 Winterlingen, GERMANY
Tel: +49-7434-316038 Fax: +49-7434-316039
Special 510(k) - QRS Card™ S-T Segment Analysis Patient Monitoring System Modification
Legally Marketed Devices to Which Substantial Equivalence is Claimed
| 510(k) Number | Trade Name | Company |
|---|---|---|
| K972255 | QRS CARD™ S-T Segment | |
| Analysis Patient Monitoring | ||
| System | Pulse Bio Medical Inc. | |
| K080141 | PC ECG 1200W System | Norav Medical LTD |
| K061977 | Plex 04 Wireless | |
| Electrocardiograph with | ||
| Software Accessories | PinMed, Inc. | |
| K082077 | BR3/6, BR12 | Coscience GmbH & Co KG |
Device Description:
The QRS CARD™ S-T Segment Analysis Patient Monitoring System converts a commercially available personal computer (PC) into an ECG monitor with ST segment measurement capability. Physicians can initiate ST evaluations on patients and the data are transmitted, using Bluetooth wireless technology, to a computer screen. Test results can also be printed at any time during the testing, or saved in computer memory for future review or additional report generation.
The QRS CARD™ S-T Segment Analysis Patient Monitoring System consists of the following components:
- The QRS CARD™ Office ECG Device ●
- ECG Patient Cable and Lead Wires ●
- Product Software on CD .
- User Manual .
Intended Use:
This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.
2
Image /page/2/Picture/0 description: The image shows a logo with two distinct elements. On the left, there is a stylized, geometric shape resembling a hexagon with a jagged line running through its center, possibly representing a heartbeat or signal. To the right of this shape, the letters 'PBI' are printed in a bold, sans-serif font. The overall design is simple and professional, suggesting a company or organization with a focus on precision or technology.
Pulse Biomedica
1/3
-666-5630
Special 510(k) - QRS Card™ S-T Segment Analysis Patient Monitoring System Modification
Conclusion:
The technological characteristics of the QRS CARD™ S-T Segment Analysis Patient Monitoring System are safe and effective and substantially equivalent to the legally marketed predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pulse Biomedical, Inc. c/o Mr. Saleem Hasan President 1305 Catfish Lane Norristown, PA 19403
JUL 2 3 2010
K100813 Re:
Trade/Device Name: QRS Card™ ST-Segment Analysis Patient Monitoring System Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: June 22, 2010 Received: June 23, 2010
Dear Mr. Hasan:
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 for assession to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered processified 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). and coosmeter fore, market the device, subject to the general controls provisions of the Act. The I ca mayy nevels 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 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.
4
Page 2 - Mr. Saleem Hasan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
buna R. Vohrer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a logo with the letters "PBI" to the right of a hexagonal shape. Inside the hexagon is a line graph that resembles a heartbeat. The hexagon is textured with a rough, possibly stone-like pattern. The letters "PBI" are in a simple, bold font.
Pulse Biomedical, Inc.
1305 Catfish Lane, Norristown, PA 19403, USA el: 610-666-5510
Pulse Biomedical GmbH Wilhelm Bihler Str 4; 72474 Winterlingen, GERMANY 49-7434-316038
Special 510(k) - QRS Card™ S-T Segment Analysis Patient Monitoring System Modification
Section 4
Indications for Use Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ (if known)
Device Name:
QRS Card™ S-T Segment Analysis Patient Monitoring System
Indications for Use:
This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over the Counter Use
Dina P. Weiner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ K100813