(72 days)
Not Found
No
The summary describes a standard blood pressure monitor using the auscultatory method and lists various electrical, safety, and quality standards. There is no mention of AI, ML, or any related technologies in the device description, intended use, or the "Mentions AI, DNN, or ML" section.
No.
The device is a blood pressure monitor intended for measurement and does not provide therapy.
No
The device is a non-invasive blood pressure and heart rate monitor. While these measurements can be used as data points in a diagnostic process, the device itself simply measures parameters and does not provide a diagnosis.
No
The device description explicitly states that the BPCard is supplied with a cuff, valve, and microphone, which are hardware components. It also requires a Personal Computer with specific hardware requirements.
Based on the provided information, the BPCard is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BPCard Function: The BPCard is a non-invasive blood pressure monitor. It measures blood pressure and heart rate directly from the patient's body using the auscultatory method. It does not analyze any specimens taken from the body.
The description clearly states it's a "non-invasive Blood Pressure Monitor" and describes its use in measuring physiological parameters directly from the patient. This aligns with the definition of a non-invasive medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
DXN
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 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
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
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
pediatric and adult
adults and children
Male/Female Pediatric to Adult
Intended User / Care Setting
health care professionals in a hospital, clinic or home environment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 North |
| Plymouth, 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 |
1
C. Identification of Legally Marketed Devices
- Accutracker DX 1. Name:
-
- K Number: K913844
-
- 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
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
2
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 | Different |
|---|-------------------------------------------|-----------------------------------|-------------------------------------|------|-----------|
| 1 | Non-Invasive
Blood Pressure
Monitor | NIBP | NIBP | X | |
| 2 | Patient Population | Male/Female
Pediatric to Adult | Male/Female
Pediatric to Adult | X | |
| 3 | Environment | Hospital, Clinic, Home
Use | Hospital, Clinic,
Home Use | X | |
| 4 | Heart Rate | Heart Rate | Heart Rate | X | |
| 5 | Technique | Auscultatory | Auscultatory | X | |
| 6 | SP10
Conformance | Yes | Yes | X | |
| 7 | Accuracy | SP10 - Trained Observer | SP10 - Trained
Observer | X | |
3
| 8 | Power Source | Via Personal or Portable
Computer (Battery) | Battery | | X |
|----|--------------------------|------------------------------------------------|----------------------------------|---|---|
| 9 | Diastolic | 5th Korotkoff Sound | 5th Korotkoff Sound | X | |
| 10 | Weight |