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, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard.

Device Description

The BPCard™ is a non-invasive Blood Pressure Monitor. The patient population is for both male and female, pediatric and adult. The BP Card has been tested to the following standards: AAMI SP10-1992-Electronic or Automated Sphygmomanometers I FDA-1997-NIBP Monitor Guidance EN1060-1-Non-Invasive Sphygmomanometers General Requirements EN1060-3-Non-Invasive Sphygmomanometers Supplementary Requirements EN980-Symbols EN46001-Quality EN1441-Risk Analysis EN60601-1-2-EMC EN60601-1-Electrical Safety 93/42/EEC-MDD 89/336/EEC-EMC Directive 92/37/EEC-Product Safety 93/465/EEC-Conformity Assessment and CE Marking UL 2601-1-Safety US ISO 10993-1-Biological Evaluation ISO 9001:1994-Quality ISO 9001:2000-Quality ISO 13485:1996/1998-Medical Devices 21CFR Part801-Labeling 21CFR Part820-QSR FDA Blue Book Memorandum G95-1-Biocompatibility 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, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard. The BPCard is a Prescription Device, not life supporting or live sustaining, not an implant, supplied non-sterile with a cuff, valve and microphone that requires a Personal Computer with the following requirements: Windows 2000 Operating System 32 MB RAM 1 GB Free Hard Disc Space 133 MHz Processor

AI/ML Overview

The provided text describes the BPCard™ Blood Pressure Monitor and its comparison to a predicate device for 510(k) clearance. However, it does not contain a detailed study report that would include specific acceptance criteria with reported device performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.

The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (Accutracker DX) by demonstrating conformance to the AAMI SP10 Standard for electronic or automated sphygmomanometers.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not available:

Acceptance Criteria and Device Performance

The core acceptance criterion implicitly stated is conformance to the AAMI SP10 Standard. The document explicitly states:

"Thus, even though the BPCard is not identical to Accutracker DX, it does comply with the SP10 Standard and we at QRS believe it should be granted substantial equivalence by its conformance to SP10."

The document also directly compares the BPCard to the Accutracker DX on the "Accuracy" row, indicating "SP10 - Trained Observer" for both, implying the BPCard also meets the accuracy requirements of SP10.

Acceptance Criterion	Reported Device Performance (Implied by Conformance)
Conformance to AAMI SP10 Standard (specifically regarding accuracy)	"Yes" (Stated in comparison table for "SP10 Conformance" and "Accuracy")
Accuracy (as per AAMI SP10)	Not explicitly stated numerically in this document. Assumed to meet SP10 requirements.
Range Systolic	60-250 mm Hg
Diastolic Range	40-220 mm Hg

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "conformance to the SP10 Standard," which outlines testing methodologies, but the specific sample size used for the BPCard's SP10 conformance test is not reported here.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The comparison table mentions "SP10 - Trained Observer," suggesting that trained personnel were involved in generating the data for the SP10 conformance, but specific numbers or qualifications are not detailed.
- Qualifications of Experts: Only "Trained Observer" is mentioned, which is generic. Specific qualifications (e.g., years of experience, medical specialty) are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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:
- No. This device is a Blood Pressure Monitor, not an AI-assisted diagnostic tool for "readers." This type of study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The BPCard is described as a "non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method." It is a measurement device operated by healthcare professionals. It is not an "algorithm only" device in the context of AI performance studies. Its performance is inherent to its mechanical and electronic measurement capabilities. The "trained observer" mentioned for SP10 conformance implies human involvement in the measurement validation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure monitors, the "ground truth" or reference measurement in SP10 conformance testing typically involves simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference method. The document mentions "auscultatory method" as the technique and "trained observer" for accuracy testing, strongly suggesting this type of ground truth was used.
The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense. Its performance is based on its engineering design and adherence to physical measurement principles.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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K031964

SEP - 5 2003

Image /page/0/Picture/2 description: The image shows the letters QRS in a stylized font. The letters are black and bold, and they are surrounded by a thin black oval. The letters are slightly overlapping, and the oval is slightly offset from the letters. The image is simple and clean, and it is likely a logo or a symbol.

510(K) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1. Submitter,'s Name:	QRS Diagnostic, LLC
2. Address:	14755 27th Avenue NorthPlymouth, MN 55447
3. Telephone:	763-559-8492, Ext. 958
4. Contact Person:	Mary Kay Jensen
5. Date Prepared:	June 21, 2003
6. Registration Number:	2133542

B. Device

1. Name:	BPCardTM
2. Trade Name:	BPCard
3. Common Name:	Blood Pressure Monitor
4. Classification Name:	Non-Invasive Blood Pressure Measurement System
5. Product Code:	DXN
6. Class:	II
7. Regulation Number:	870.1130

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C. Identification of Legally Marketed Devices

Accutracker DX 1. Name:
1. K Number: K913844
1. Date Cleared: July 14, 1992

D. Description of the Device

The BPCard™ is a non-invasive Blood Pressure Monitor. The patient population is for both male and female, pediatric and adult. The BP Card has been tested to the following standards:

AAMI SP10-1992-Electronic or Automated Sphygmomanometers I
FDA-1997-NIBP Monitor Guidance 트
EN1060-1-Non-Invasive Sphygmomanometers General Requirements ■
트 EN1060-3-Non-Invasive Sphygmomanometers Supplementary Requirements
EN980-Symbols 트
EN46001-Quality 육
EN1441-Risk Analysis
트 EN60601-1-2-EMC
트 EN60601-1-Electrical Safety
트 93/42/EEC-MDD
트 89/336/EEC-EMC Directive
트 92/37/EEC-Product Safety
트 93/465/EEC-Conformity Assessment and CE Marking
트 UL 2601-1-Safety US
배 ISO 10993-1-Biological Evaluation
이 ISO 9001:1994-Quality
트 ISO 9001:2000-Quality
트 ISO 13485:1996/1998-Medical Devices
l 21CFR Part801-Labeling
21CFR Part820-QSR
해 FDA Blue Book Memorandum G95-1-Biocompatibility

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sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard.

The BPCard is a Prescription Device, not life supporting or live sustaining, not an implant, supplied non-sterile with a cuff, valve and microphone that requires a Personal Computer with the following requirements:

Windows 2000 Operating System
32 MB RAM .
1 GB Free Hard Disc Space ●
133 MHz Processor

E. Intended Use Statement

The BPCard can be used by health care professionals to measure blood pressure values (systolic and diastolic) and heart pulse rate in adults and children.

F. Components/ Part Numbers

BPCard User's Manual - 6000-XXXX
BPCard - PCMCIA Blood Pressure Monitor - 7000-XXXX
Cuff, Valve, Bulb and Microphone 5000-XXXX ●
BPCard Software Version 1.0 9000-0088 ●

G. Table of Comparisons

The following summary tables of comparisons compare the new device (BPCard) to the predicate device: Accutracker DX.

#	Area	New Device:BPCard™	Predicate Device:Accutracker DX	Same
1	Non-InvasiveBlood PressureMonitor	NIBP	NIBP	X
2	Patient Population	Male/FemalePediatric to Adult	Male/FemalePediatric to Adult	X
3	Environment	Hospital, Clinic, HomeUse	Hospital, Clinic,Home Use	X
4	Heart Rate	Heart Rate	Heart Rate	X
5	Technique	Auscultatory	Auscultatory	X
6	SP10Conformance	Yes	Yes	X
7	Accuracy	SP10 - Trained Observer	SP10 - TrainedObserver	X

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8	Power Source	Via Personal or PortableComputer (Battery)	Battery		X
9	Diastolic	5th Korotkoff Sound	5th Korotkoff Sound	X
10	Weight	< 6 ounces	12.6 ounces		X
11	Size	53 x 140 x 26W D H in mm	825 x 330 x 127W D H in mm		X
12	Deflation	2-3 mm Hg/ second	2, 3, 4, 5 or 6 mmHg/ Second		X
13	OperatingEnvironment	10 to 40° C15 - 95%	10 to 40° C< 95%	X
14	StorageEnvironment	-20 to 50° C15 - 95%	-20 - 50° C< 95%	X
15	Certification	UL, CE	UL, CE	X
16	Prink Reports	No	Yes		X
17	Safety Standards	Yes	Yes	X
18	EMC	Yes	Yes	X
19	PrescriptionDevice	Yes	Yes	X
20	Range Systolic	60-250 mm Hg	10-250 mm Hg		X
21	Diastolic Range	40-220 mm Hg	10-250 mm Hg		X
22	Bladder Deflation	Automatic	Automatic	X
23	Programmable	No	Yes		X
24	Inflation Method	Bulb	Automatic		X
25	Part of System	No	Yes		X
26	Sampling	No	Yes		X
27	Cuff Sizes	Multiple	Multiple	X
28	Clinical Reports	No	Yes		X
29	Print outs	No	Yes		X
30	Sampling Periods	No	Yes		X
31	510(k) Summary	Yes	No		X
32	Supplied Non-Sterile	Yes	Yes	X

H. Discussion of Similarities and Differences

The BPCard and Accutracker DX have the following similarities:

NIBP Monitor .
. Patient Population
Environment ●
. Heart Rate
Technique .
SP10 Conformance ●

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According to the FDA's NIBP Monitor Guidance "substantial equivalence can be demonstrated by showing either;

1. Sufficient comparison testing with a legally-marketed predicate device
1. Conformance to SP10 Standard
1. Conformance to any foreign or domestic standard which meets or exceeds the requirements of the SP10 Standard."

Furthermore, the FDA states, "It is strongly recommended that substantial equivalence be demonstrated by showing conformance to the SP10 Standard."

Thus, even though the BPCard is not identical to Accutracker DX, it does comply with the SP10 Standard and we at QRS believe it should be granted substantial equivalence by its conformance to SP10.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2003

ORS Diagnostic, LLC. c/o Ms. Mary Kay Jensen 14755 27th Ave. North Plymouth, MN 55447

Re: K031964

Trade Name: BPCard™ Regulation Number: 21 CFR §870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 21, 2003 Received: June 25, 2003

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.

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

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Page 2 - Ms. Mary Kay Jensen

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.

Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO31964

Device Name: BPCard

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K031964

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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).