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.

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets these criteria. The document is a 510(k) Summary for a "Special 510(k)" modification, stating that the technological characteristics of the device are "safe and effective and substantially equivalent to the legally marketed predicate devices." This type of submission generally relies on demonstrating equivalence to existing devices rather than presenting new clinical study data against defined performance metrics.

However, based on the information provided, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document primarily focuses on the device description, intended use, and substantial equivalence claim to predicate devices. It does not list specific numerical acceptance criteria or present performance data from a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As no specific performance study is detailed, there is no mention of a test set, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was done. The device is described as converting a PC into an ECG monitor with ST segment measurement capability, implying it's a diagnostic tool, not an AI-assisted reading system for human improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not detail any standalone algorithm performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

This information is not provided. If the device uses algorithms that require training data, there is no mention of such a training set or its size.

9. How the ground truth for the training set was established

This information is not provided.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a new study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.

Summary

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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:

DeviceTradeName	CommonClassification/ Name	RegulationNumber	ClassificationCode	DeviceClass	ClassificationName
QRSCard BT	PhysiologicalMonitor	N/A	DPS	II	Electrocardiograph

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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 SegmentAnalysis Patient MonitoringSystem	Pulse Bio Medical Inc.
K080141	PC ECG 1200W System	Norav Medical LTD
K061977	Plex 04 WirelessElectrocardiograph withSoftware Accessories	PinMed, Inc.
K082077	BR3/6, BR12	Coscience GmbH & Co KG

Device Description:

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:

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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.

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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.

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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

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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:

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

Regulation Number and Section

§ 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).