MODIFICATION TO: BPCARD, MODEL Z-7000-0700

K073630 · Qrs Diagnostic, LLC · DXN · Jan 11, 2008 · Cardiovascular

Device Facts

• Record ID: K073630
• Device Name: MODIFICATION TO: BPCARD, MODEL Z-7000-0700
• Applicant: Qrs Diagnostic, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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 Story

BPCard is a non-invasive blood pressure monitor using auscultatory method; measures systolic/diastolic pressure and heart rate. System comprises PCMCIA card, microphone assembly, blood pressure cuff, and software. Used in hospital, clinic, or home settings by physician-prescribed patients. Device integrates with QRS Office Medic software on Windows PCs. Input consists of acoustic signals from cuff; processed via microcontroller firmware (v1.05) and software algorithms including automatic microphone gain control, dynamic pulse detection, and pulse proximity evaluation. Output displayed on PC screen; provides clinical data for provider decision-making. Benefits include automated, accurate blood pressure monitoring and digital record-keeping. Hardware updates include bayonet-style air connector, Lee deflation valve, and improved EMC protection.

Clinical Evidence

Bench testing only. Compliance verified against IEC/EN 60601-1 (safety), IEC/EN/UL 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), and ANSI/AAMI SP10:2002 (sphygmomanometer performance). No clinical trial data presented.

Technological Characteristics

Non-invasive auscultatory sphygmomanometer. Components: PCMCIA card, microphone (medical grade ABS plastic), blood pressure cuff, dual lumen tubing. Energy: AC/DC. Connectivity: PC-based (Windows). Software: Firmware v1.05. Standards: AAMI SP10:2002, IEC 60601-1, IEC 60601-1-2, ISO 10993-1. Features: Automatic microphone gain control, dynamic pulse detection, pulse proximity evaluation.

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and heart rate in adult male/female patients. Prescription use only. Contraindications: None stated.

Regulatory Classification

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.

Predicate Devices

• BPCard™ (K031964)

Submission Summary (Full Text)

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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: [phone] Facsimile: 763-559-2961

JAN 1 1 2008

Contact: Mary Kay Jensen Phone: [phone] Ext 958 Facsimile: 763-559-2961 e-mail: [e-mail]

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<br>Predicate | Manufacturer | Use | 510K) | Date<br>Cleared |
|----------------------|---------------------------|---------------------------|---------|-----------------|
| BPCard™ | QRS<br>Diagnostic,<br>LLC | Blood Pressure<br>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

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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/Female<br>Adult | Male/Female<br>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<br>• Diastolic Pressure<br>• Pulse Rate | • Systolic Pressure<br>• Diastolic Pressure<br>• Pulse Rate | X | |
| 4 | Measurement Method | Auscultatory | Auscultatory | X | |
| 5 | Device Components | • BPCard (PCMCIA)<br>• Microphone Assembly<br>• Blood Pressure Cuff<br>• Software | • BPCard (PCMCIA)<br>• Microphone Assembly<br>• Blood Pressure Cuff<br>• 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/<br>Humidity/EMC<br>Requirements | Same | Same | X | |
| Performance Standards | | | | | |
| 10 | AAMI SP10 | Meets AAMI | Meets AAMI | | X |
| # | Area | Modified Device | Previously Cleared<br>Device | Same | Different |
| | | SP10:2002 | SP10:1992 | | |
| | Device Hardware | | | | |
| 11 | Dimensional and<br>Physical<br>Specifications | Same | Same | X | |
| 12 | PCB Board | Same | Same | X | |
| 13 | Air Coupling | Bayonet Style<br>Connector | Luer Slip | | X |
| 14 | Deflation Valve | Lee Valve | Pneutronic Valve | | X |
| 15 | EMC Protection | Added measures for<br>EMC protection to<br>meet IEC/EN<br>60601-1-2:2001 as a<br>result of other<br>changes | | | X |
| 16 | Microphone Gain<br>(Sensitivity) | X40 | X10 | | X |
| 17 | Microcontroller<br>Firmware | V 1.05 | V 0.03 | | X |
| | Materials/Components | | | | |
| 18 | Blood Pressure<br>Cuff | Trimline Kuff Link.<br>Pre-amendment<br>device. | Pymah Corporation<br>K884421 | | X |
| 19 | Microphone<br>Material | Medical Grade ABS<br>Plastic | ABS Plastic | | X |
| 20 | Microphone Cable<br>Assembly | Dual Lumen Tubing<br>enclosing<br>microphone cable | No tubing enclosing<br>microphone cable | | X |
| | Algorithms | | | | |
| 21 | Automatic<br>Microphone Gain<br>Control | Available | Not available | | X |
| 22 | Level Based Pulse<br>Detection | Dynamic | Static | | X |
| 23 | Pulse Proximity<br>Evaluation | Available | Not available | | X |
| 24 | Pulse Rate<br>Calculation | Calculated from<br>median pulse<br>intervals. | Calculated from<br>minimum pulse<br>intervals. | | X |
| | Software | | | | |
| 25 | Print Test Feature | Available | Not Available | | X |
| 26 | Save and Review<br>Tests Feature | Available | Not Available | | X |
| 27 | Accept/Reject or | Available | Not Available | | X |
| # | Area | Modified Device | Previously Cleared<br>Device | Same | Different |
| | | | Device | | |
| | Edit Test Feature | | | | |
| 28 | Operating System | Windows | Windows | X | |
| 29 | Software Platform | Integrated with QRS<br>Office Medic | Stand alone software | | X |
| 30 | Deflation Rate | 2.5 mmHg and 5.0<br>mmHg | 2.5 mmHg | | X |
| 31 | Deflation Start | Starts when pressure<br>and pulse detection<br>criteria met | Starts when start<br>button pushed | | X |
| 32 | Maximum Pressure<br>Exceeded | Test will stop and<br>cuff will deflate | Software provides<br>warning | | X |
| 33 | Zero Function and<br>Open and Close<br>Valve function | Performed<br>Automatically at<br>start and end of test | User selects Zeroing<br>Button and End Test<br>Button | | X |
| 34 | Calibration | User can check<br>pressure calibration | User can check<br>pressure calibration | X | |
| 35 | Pulse Detection<br>Beep and Display | System does not<br>provide audible or<br>display indication<br>when pulse is<br>detected | System provides<br>audible indication<br>when pulse is<br>detected and displays<br>number of pulses | | X |
| 36 | Raw Data<br>Processing | Raw Data file can<br>only be reprocessed<br>with QRS<br>development<br>software. | Raw Data File can be<br>reprocessed | X | |
| 37 | Pressure Display | Pressure displayed<br>after test has begun | Pressure<br>continuously<br>displayed | | X |
| 38 | Start of Test | Test begins after<br>auto-zeroing<br>completed and user<br>begins manual<br>inflation | Test begins after user<br>completed manual<br>inflation | | X |
| 39 | Battery Test | OS/Computer<br>Battery warning | BPCard software<br>provides low battery<br>warning | | 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 [phone]. 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 [phone] or [phone] 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:

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 .

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

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