(141 days)
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No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No.
The device is a diagnostic device used to measure blood pressure and pulse rate, not to treat a medical condition.
Yes
The device measures physiological parameters (blood pressure and pulse rate) which can be used to assess the health status of an individual. While it doesn't provide a diagnosis itself, the measurements it provides are critical inputs for medical professionals to make a diagnosis.
No
The device description clearly indicates it is a hardware device that uses an inflatable cuff and oscillometric principle to measure blood pressure. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Biospace blood pressure monitor measures blood pressure and pulse rate non-invasively by using a cuff wrapped around the arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the patient's body.
Therefore, based on the provided information, the Biospace blood pressure monitor is a non-invasive medical device for measuring vital signs, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Biospace blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. (BPBIO320n is the same device as the BPBIO320 and has same specifications except it has no printer module.)
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
BPBIO320/BPBIO320n is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff size is 545 × 120 (mm) and the arm circumference range is between to 17cm - 42cm. BPBIO320/BPBIO320n is designed and manufactured according to ANSI/AAMI SP10 manual, electronic or automated sphygmanometers. BPBIO320/BPBIO320n can measure systolic, diastolic pressure and pulse rate on the principle of oscillometric on inflation. The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Upper arm or limb
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medical professionals or at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests have been done as follows: Electromagnetic compatibility test according to IEC 60601-1-2 Electrical Safety test according to IEC 60601-1 FCC test according to FCC part 15 Safety and performance characteristics test according to ANSI/AAMI SP10.
Compared to deflation detection of predicate device TM2655P (K010828), BPBIO320/BPB10320n is an inflation detection device, so the arithmetic is changed. As a result, a new clinical test is done in accordance with ANSI/AAMI SP10, and the device met all applicable requirements of the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure : ±3mmHg, Pulse rate : ±2%
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.
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.
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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).
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§ 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).
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510(k) Summary K131064 Biospace Corporation Limited Donghyun Building, 518-10, Dogok 2 - Dong Gangnam-Gu, Seoul, KOREA 135-854 Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http:// www.inbody.com August 19, 2013 Contact: Kichul Cha, CEO
SEP 04 2013
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- Identification of the Device: Proprietary-Trade Name: BPBIO320 and BPBIO320n Common/Usual Name: Blood pressure monitor Classification Panel: Cardiovascular Classification Names: Non-invasive blood pressure measurement system Classification: II, Product Code: DXN
-
- Equivalent legally marketed devices: (Predicate device Information) A&D Engineering Inc. Digital Blood pressure monitors Model TM2655P (K010828)
-
- Indications for Use (intended use) The Biospace blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. (BPBIO320n is the same device as the BPBIO320 and has same specifications except it has no printer module.)
4. Description of the Device:
BPBIO320/BPBIO320n is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff size is 545 × 120 (mm) and the arm circumference range is between to 17cm - 42cm. BPBIO320/BPBIO320n is designed and manufactured according to ANSI/AAMI SP10 manual, electronic or automated sphygmanometers. BPBIO320/BPBIO320n can measure systolic, diastolic pressure and pulse rate on the principle of oscillometric on inflation. The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation.
-
- Safety and Effectiveness, comparison to predicate device. The testing results indicate that BPBIO320/BPB10320n is as safe and effective as the predicate device.
- Summary of technological characteristics of the device compared to the predicate 6. device.BPBIO320/BPBIO320n is intended to be used in measuring human systolic, diastolic and
1
pulse rate by oscillometric method. Performance characteristics are in accordance with ANSI/AAMI SP10:2002/ (R) 2008. The substantial equivalence between BPBIO320/BPBIO320n and TM2655P can be evaluated from several aspects as listed in below table.
| Item | Proposed device
BPBIO320/BPBIO320 | Predicate device
TM2655P | Similarities | Differences | | |
|-------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------|--------------|----------------------------------------------------------------------------------------------------|--|--|
| Device Classification | Class II | Class II | Equivalent | Negligible | | |
| Classification Panel | Cardiovascular | Cardiovascular | Equivalent | Negligible | | |
| Intended Use
(Indications for use) | Monitor non-invasive
blood pressure and
pulse rate | Monitor non-invasive
blood pressure and pulse
rate | Equivalent | Negligible | | |
| Anatomical sites | Upper arm or limb | Upper arm or limb | Equivalent | Negligible | | |
| Device Description | | | | | | |
| Technology-
measurement
methodology | Oscillometric measure
upon inflation | Oscillometric measure
upon deflation | Different | SP10 and
safety
standards were
met. Clinical
test according
to the SP10
was met. | | |
| Energy used | AC | AC | Equivalent | Negligible | | |
| Weight | 9kg | 9kg | Similar | Negligible | | |
| Dimensions | 489(W)x409(L)x284(H)
mm | 245(W)x320(H)x390(D)
mm | Similar | Negligible | | |
| Descriptive characteristics | | | | | | |
| Inflation & deflation | Automatic control | Automatic control | Equivalent | Negligible | | |
| Display | LED | LED | Similar | Negligible | | |
| Parameters | SYS, DIA, PULSE
RATE | SYS, DIA, PULSE
RATE | Equivalent | Negligible | | |
| System output | RS232-compatible;
digital; mini-din
connector | RS232-compatible;
digital; mini-din
connector | Equivalent | Negligible | | |
| Performance specifications | | | | | | |
| Standards met | ANSI/AAMI SP-10,
IEC60601-1,
IEC60601-1-2 | ANSI/AAMI SP-10, IEC-
60601-1, IEC60601-1-2 | Equivalent | Negligible | | |
| Operating
environment | 10-40℃ (50104°F),75%RH; 70
30106kPa | 10-40 °C, 85%RH or less,158°F),
non condensing | Similar | Negligible | | |
| Storage environment | -20-70 ℃ (-4
1095%RH,106kPa (No
50
condensation) | -20 to 60 °C, 95%RH or
less, non condensing | Similar | Negligible | | |
| Measurement range | Blood pressure :
40300mmHg.240bpm | Blood pressure :
Pulse rate : 30
10~280mmHg
Pulse rate : 30-200bpm | Similar | Negligible | | |
| Accuracy | Pressure : ±3mmHg
Pulse rate : ±2% | Pressure : ±3mmHg
Pulse rate : ±5% | Equivalent | Negligible | | |
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7. Determination of Substantial Equivalence is based on as assessment of performance data
Non-clinical tests have been done as follows: Electromagnetic compatibility test according to IEC 60601-1-2 Electrical Safety test according to IEC 60601-1 FCC test according to FCC part 15 Safety and performance characteristics test according to ANSI/AAMI SP10
None of the tests demonstrate that BPBIO320/BPBIO320n raises new questions of safety and effectiveness.
8. Clinical Test concerning the compliance of ANSI/AAMI SP10
Compared to deflation detection of predicate device TM2655P (K010828), BPBIO320/BPB10320n is an inflation detection device, so the arithmetic is changed. As a result, a new clinical test is done in accordance with ANSI/AAMI SP10, and the device met all applicable requirements of the standard.
9. Harmonized standards summarv
BPBIO320/BPBIO320n conforms to the following standards:
- . IEC 60601-1:1990 + A1: 1993 + A11: 1993 + A12: 1993 + A2: 1995 + A13: [1996] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ( = IEC 60601-1:1988 + A 1+ A2+corrigendum, mod. )
- IEC 60601-1-2 [2007] Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility Requirements and tests (IEC 60601-1-2:2007 (Modified))
- IEC 62304 [2006] Medical device software, Software life-cvcle processes o
- . ISO 14971 : 2009 Risk Management Process
- ANSI/AAMI SP10 : 2002/ (R) 2008 & ANSI/AAMI SP10 : 202/A1 : 2003/ (R) 2008 o & ANSI/AAMI SP10:2002 /A2 : 2006/ (R) 2008
10. Comparison to the predicate device and the conclusion
BPBIO320/BPBIO320n is substantially equivalent to the TM2655P whose 510(k) number is K010828. The devices are identical in intended use, and very similar in the design principles, the performance and the applicable standards. Only their appearance. the user interfaces are different. The measurement process is different, that is BPBIO320/BPBIO320n will get the measurement results when the device is inflating. while TM2655P gets the result during the deflating period. However the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
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Image /page/3/Picture/1 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 a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 4, 2013
Biospace Corporation Limited C/O Daniel Kamm 8870 Ravello Ct Naples, FL 34114 US
Re: . . K131064
Trade/Device Name: Biospace Blood Pressure Monitor, Models BPBIO320 and BPBIO320n Regulation Number: 21 CFR 870.1130 Regulation Name: Automated Non-Invasive Blood Pressure Meter Regulatory Class: Class II Product Code: DXN Dated: July 22, 2013 Received: April 16, 2013
Dear Daniel Kamm:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Daniel Kamm
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen-PFaris -S
for
Bram D. Zuckerman, Ph.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): K131064
Device Name: Models BPBIO320 and BPBIO320n
Indications for use:
The Biospace blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. (BPBIO320n is the same device as the BPBIO320 and has same specifications except it has no printer module.)
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ✗
(21 CFR 807 Subpart C) |
| ------------------------------------------------- | -------- | -------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Owen P. Farts -
s
Date: 2013.09.04 10:07:31 -04'00'