The BPCard is a Non-Invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, adult subjects. The BPCard also measures heart rate.

Patient Population: Male/Female, Adults .
Environment of Use: Hospital, Clinic and Home Use .
Prescription Device by a Physician .

Device Description

Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the ausculatory method. The BPCard also measures heart rate.

. Patient Population: Male/Female Adults
. Environment of Use: Hospital, Clinic and Home Use
. Prescription Device by a Physician

AI/ML Overview

The provided text focuses on the 510(k) summary for the QRS Diagnostic BPCard, a blood pressure monitor. It compares the modified device to a previously cleared predicate device and lists compliance with various standards. However, it does not contain the detailed study information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically found when describing acceptance criteria and a study that proves a device meets those criteria.

The document primarily states that the device complies with the ANSI/AAMI SP10:2002 standard. This standard itself defines acceptance criteria for automated sphygmomanometers.

Based on the provided text, here's what can be extracted:

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

The document explicitly states that the device "Meets AAMI SP10:2002". Therefore, the acceptance criteria are implicitly those defined by the AAMI SP10:2002 standard for manual, electronic, or automated sphygmomanometers. The reported performance is that the device meets this standard.

Acceptance Criteria (Implicit from AAMI SP10:2002)	Reported Device Performance
Device meets the requirements of AAMI SP10:2002	Meets AAMI SP10:2002

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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:

MRMC Study: Not mentioned or implied. This device is a measurement system (blood pressure monitor), not an AI-assisted diagnostic tool for image interpretation, so an MRMC study is not applicable in this context.
Effect Size of AI assistance: Not applicable.

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

Standalone Performance Study: The document implies standalone performance testing by stating compliance with "ANSI/AAMI SP10:2002, Manual, Electronic or Automated Sphygmomanometers". Such standards define requirements for the automated device's accuracy. However, specific details of such a study are not provided. The device measures blood pressure using an "auscultatory method," which traditionally involves listening, but in an automated context, it refers to the device detecting Korotkoff sounds.

7. The type of ground truth used:

Type of Ground Truth: The AAMI SP10 standard typically requires comparison against a reference method, often auscultation by trained observers using a mercury sphygmomanometer as the gold standard for blood pressure measurement. The document doesn't explicitly state this but implies it through compliance with the standard.

8. The sample size for the training set:

Sample Size: Not applicable/Not specified. This device is a blood pressure monitor, not a machine learning model that requires a training set in the conventional sense. Its algorithms are based on established physiological principles and signal processing, not statistical learning from a labeled dataset.

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

Ground Truth Establishment for Training Set: Not applicable/Not specified. (See point 8).

Summary

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510(k) Summary of Safety and Effectiveness

Date:12/14/07

K073630

Submitter:

QRS Diagnostic, LLC Street Address: 14755 27th Ave N. City: Plymouth State: MN Zip Code: 55447 Telephone: 763-559-8492 Facsimile: 763-559-2961

JAN 1 1 2008

Contact: Mary Kay Jensen Phone: 763-559-8492 Ext 958 Facsimile: 763-559-2961 e-mail: mkjensen@grsdiagnostic.com

Device Name: Trade Name: BPCard Common Name: Blood Pressure Monitor Classification Name: System, Measurement, Blood-Pressure, Non-invasive Classification: Class II Panel Code: DXN Regulation Number: 21CFR. 870.1130 Noninvasive blood pressure measurement system.

Identification of Legally Marketed (Unmodified) Device (Predicate Device):

Name ofPredicate	Manufacturer	Use	510K)	DateCleared
BPCard™	QRSDiagnostic,LLC	Blood PressureMonitor	K031964	9/5/03

Device Description:

Indications for Use

Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the ausculatory method. The BPCard also measures heart rate.

. Patient Population: Male/Female Adults
. Environment of Use: Hospital, Clinic and Home Use
. Prescription Device by a Physician

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Technological Comparison to (Unmodified) Predicate Device:

The following summary table of comparisons compares the Modified BPCard Device to the Previously Cleared BPCard (Predicate) Device.

#	Area	Modified Device	Previously Cleared Device	Same	Different
Indications for Use
1	Patient Population	Male/FemaleAdult	Male/FemaleAdult	X
2	Environment of Use	Hospital, Clinic, Home Use	Hospital, Clinic, Home Use	X
Fundamental Scientific Technology
3	Measurements taken by Device	• Systolic Pressure• Diastolic Pressure• Pulse Rate	• Systolic Pressure• Diastolic Pressure• Pulse Rate	X
4	Measurement Method	Auscultatory	Auscultatory	X
5	Device Components	• BPCard (PCMCIA)• Microphone Assembly• Blood Pressure Cuff• Software	• BPCard (PCMCIA)• Microphone Assembly• Blood Pressure Cuff• Software	X
Contraindications
6	Contraindications	No contraindications	Contraindicated in patients who are not ambulatory, have heart failure, arrhythmia or cardiac valve abnormality.		X
Sterility/Expiration Dating
7	Sterile/Non Sterile	Non-Sterile/No Expiration Date	Non-Sterile/No Expiration Date	X
Energy Type
8	AC/DC	Both	Both	X
Environmental Specifications
9	Temperature/Humidity/EMCRequirements	Same	Same	X
Performance Standards
10	AAMI SP10	Meets AAMI	Meets AAMI		X
#	Area	Modified Device	Previously ClearedDevice	Same	Different
		SP10:2002	SP10:1992
	Device Hardware
11	Dimensional andPhysicalSpecifications	Same	Same	X
12	PCB Board	Same	Same	X
13	Air Coupling	Bayonet StyleConnector	Luer Slip		X
14	Deflation Valve	Lee Valve	Pneutronic Valve		X
15	EMC Protection	Added measures forEMC protection tomeet IEC/EN60601-1-2:2001 as aresult of otherchanges			X
16	Microphone Gain(Sensitivity)	X40	X10		X
17	MicrocontrollerFirmware	V 1.05	V 0.03		X
	Materials/Components
18	Blood PressureCuff	Trimline Kuff Link.Pre-amendmentdevice.	Pymah CorporationK884421		X
19	MicrophoneMaterial	Medical Grade ABSPlastic	ABS Plastic		X
20	Microphone CableAssembly	Dual Lumen Tubingenclosingmicrophone cable	No tubing enclosingmicrophone cable		X
	Algorithms
21	AutomaticMicrophone GainControl	Available	Not available		X
22	Level Based PulseDetection	Dynamic	Static		X
23	Pulse ProximityEvaluation	Available	Not available		X
24	Pulse RateCalculation	Calculated frommedian pulseintervals.	Calculated fromminimum pulseintervals.		X
	Software
25	Print Test Feature	Available	Not Available		X
26	Save and ReviewTests Feature	Available	Not Available		X
27	Accept/Reject or	Available	Not Available		X
#	Area	Modified Device	Previously ClearedDevice	Same	Different
			Device
	Edit Test Feature
28	Operating System	Windows	Windows	X
29	Software Platform	Integrated with QRSOffice Medic	Stand alone software		X
30	Deflation Rate	2.5 mmHg and 5.0mmHg	2.5 mmHg		X
31	Deflation Start	Starts when pressureand pulse detectioncriteria met	Starts when startbutton pushed		X
32	Maximum PressureExceeded	Test will stop andcuff will deflate	Software provideswarning		X
33	Zero Function andOpen and CloseValve function	PerformedAutomatically atstart and end of test	User selects ZeroingButton and End TestButton		X
34	Calibration	User can checkpressure calibration	User can checkpressure calibration	X
35	Pulse DetectionBeep and Display	System does notprovide audible ordisplay indicationwhen pulse isdetected	System providesaudible indicationwhen pulse isdetected and displaysnumber of pulses		X
36	Raw DataProcessing	Raw Data file canonly be reprocessedwith QRSdevelopmentsoftware.	Raw Data File can bereprocessed	X
37	Pressure Display	Pressure displayedafter test has begun	Pressurecontinuouslydisplayed		X
38	Start of Test	Test begins afterauto-zeroingcompleted and userbegins manualinflation	Test begins after usercompleted manualinflation		X
39	Battery Test	OS/ComputerBattery warning	BPCard softwareprovides low batterywarning		X

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Summary of Performance Testing:

The modified BPCard has been tested or found otherwise to comply with the following standards:

IEC/EN 60601-1, Medical electrical equipment Part 1: General requirements . for basic safety and essential performance
IEC/EN/UL 60601–1-2, Medical Electrical Equipment Part 1-2: General . requirements for safety - collateral standard: Electromagnetic compatibility -Requirements and Test
ISO 10993-1, Biological Evaluation Of Medical Devices Part 1: Evaluation . And Testing
. ANSI/AAMI SP10:2002, Manual, Electronic or Automated Sphygmomanometers
EN1060-1 "Non-Invasive Sphygmomanometers General Requirements" .
EN1060-3 "Non-Invasive Sphygmomanometers Supplementary . Requirements"

Conclusions:

The results of the tests discussed above, indicate that the modified QRS Diagnostic BPCard is as safe, as effective, and performs as well as or better than the non modified device.

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Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.

JAN 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

QRS Diagnostic, LLC c/o Ms. Mary Kay Jensen QA/RA Manager 14755 27th Ave. N. Plymouth, MN 55447

Re: K073630

BPCard, Model Z-7000-0700 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 14, 2007 Received: December 26, 2007

Dear Ms. Jensen:

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 -- Ms. Mary Kay Jensen

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 nft he 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours.

B. Bemmer for

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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Indications for Use

510(k) Number (if known): To be determined

K073630

Device Name: BPCard

Indications for Use:

Patient Population: Male/Female, Adults .
Environment of Use: Hospital, Clinic and Home Use .
Prescription Device by a Physician .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K073630

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).