K Number

Device Name

MODIFICATION TO: BPCARD, MODEL Z-7000-0700

Manufacturer

QRS DIAGNOSTIC, LLC.

Date Cleared

2008-01-11

(16 days)

Product Code

DXN

Regulation Number

870.1130

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031964

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard blood pressure monitor using the auscultatory method and does not mention any AI or ML terms, image processing, or data training/testing sets typically associated with AI/ML applications.

Therapeutic

No
The device is a non-invasive blood pressure monitor, which is used for measurement and monitoring, not for therapeutic purposes.

Diagnostic

Yes

Explanation: The device is a "Non-Invasive Blood Pressure Monitor" that measures "blood pressure (systolic and diastolic)" and "heart rate." These measurements are used to assess a patient's health status, which falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the ausculatory method." This method typically involves hardware components like a cuff, stethoscope, and pressure sensor, and the listed performance standards (IEC/EN 60601-1, ANSI/AAMI SP10, EN1060) are for physical medical devices, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the BPCard is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
BPCard Function: The BPCard is described as a "Non-Invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method." This is a direct measurement of a physiological parameter from the body, not an analysis of a specimen taken from the body.
Lack of Specimen Analysis: The description does not mention any analysis of biological samples.

Therefore, the BPCard falls under the category of a non-invasive medical device used for monitoring physiological signs, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

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

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

Adults

Intended User / Care Setting

Hospital, Clinic and Home Use

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K031964

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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 of
Predicate | Manufacturer | Use | 510K) | Date
Cleared |
|----------------------|---------------------------|---------------------------|---------|-----------------|
| BPCard™ | QRS
Diagnostic,
LLC | Blood Pressure
Monitor | 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

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/Female
Adult	Male/Female
Adult	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/EMC
Requirements	Same	Same	X
Performance Standards
10	AAMI SP10	Meets AAMI	Meets AAMI		X
#	Area	Modified Device	Previously Cleared
Device	Same	Different
		SP10:2002	SP10:1992
	Device Hardware
11	Dimensional and
Physical
Specifications	Same	Same	X
12	PCB Board	Same	Same	X
13	Air Coupling	Bayonet Style
Connector	Luer Slip		X
14	Deflation Valve	Lee Valve	Pneutronic Valve		X
15	EMC Protection	Added measures for
EMC protection to
meet IEC/EN
60601-1-2:2001 as a
result of other
changes			X
16	Microphone Gain
(Sensitivity)	X40	X10		X
17	Microcontroller
Firmware	V 1.05	V 0.03		X
	Materials/Components
18	Blood Pressure
Cuff	Trimline Kuff Link.
Pre-amendment
device.	Pymah Corporation
K884421		X
19	Microphone
Material	Medical Grade ABS
Plastic	ABS Plastic		X
20	Microphone Cable
Assembly	Dual Lumen Tubing
enclosing
microphone cable	No tubing enclosing
microphone cable		X
	Algorithms
21	Automatic
Microphone Gain
Control	Available	Not available		X
22	Level Based Pulse
Detection	Dynamic	Static		X
23	Pulse Proximity
Evaluation	Available	Not available		X
24	Pulse Rate
Calculation	Calculated from
median pulse
intervals.	Calculated from
minimum pulse
intervals.		X
	Software
25	Print Test Feature	Available	Not Available		X
26	Save and Review
Tests Feature	Available	Not Available		X
27	Accept/Reject or	Available	Not Available		X
#	Area	Modified Device	Previously Cleared
Device	Same	Different
			Device
	Edit Test Feature
28	Operating System	Windows	Windows	X
29	Software Platform	Integrated with QRS
Office Medic	Stand alone software		X
30	Deflation Rate	2.5 mmHg and 5.0
mmHg	2.5 mmHg		X
31	Deflation Start	Starts when pressure
and pulse detection
criteria met	Starts when start
button pushed		X
32	Maximum Pressure
Exceeded	Test will stop and
cuff will deflate	Software provides
warning		X
33	Zero Function and
Open and Close
Valve function	Performed
Automatically at
start and end of test	User selects Zeroing
Button and End Test
Button		X
34	Calibration	User can check
pressure calibration	User can check
pressure calibration	X
35	Pulse Detection
Beep and Display	System does not
provide audible or
display indication
when pulse is
detected	System provides
audible indication
when pulse is
detected and displays
number of pulses		X
36	Raw Data
Processing	Raw Data file can
only be reprocessed
with QRS
development
software.	Raw Data File can be
reprocessed	X
37	Pressure Display	Pressure displayed
after test has begun	Pressure
continuously
displayed		X
38	Start of Test	Test begins after
auto-zeroing
completed and user
begins manual
inflation	Test begins after user
completed manual
inflation		X
39	Battery Test	OS/Computer
Battery warning	BPCard software
provides low battery
warning		X

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.

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.

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

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