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.)

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BPBIO320 and BPBIO320n blood pressure monitors, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from ANSI/AAMI SP10)	Reported Device Performance
Accuracy
Pressure	±3mmHg	±3mmHg
Pulse rate	±2%	±2%
Measurement Range
Blood pressure	N/A (Compared to predicate)	40~300mmHg
Pulse rate	N/A (Compared to predicate)	30~240bpm

Note: The document explicitly states that the device met "all applicable requirements of the standard" for ANSI/AAMI SP10. The table above focuses on the specific numerical performance metrics that are directly comparable to the predicate or listed as a specification for the proposed device.

Study Information

The document describes a clinical test conducted to demonstrate compliance with ANSI/AAMI SP10, especially given the difference in measurement methodology (inflation vs. deflation) compared to the predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The document only mentions "a new clinical test is done in accordance with ANSI/AAMI SP10." The ANSI/AAMI SP10 standard itself specifies minimum subject requirements for clinical validation (e.g., typically a minimum of 85 subjects with specific blood pressure ranges).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It simply refers to "a new clinical test."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not explicitly stated. For blood pressure monitor validation, ground truth is typically established by trained human observers using a mercury sphygmomanometer or an equivalent reference device, not necessarily by "experts" in the sense of radiologists. The ANSI/AAMI SP10 standard details the requirements for these observers (e.g., blinded measurements, simultaneous readings, specific training).

4. Adjudication method for the test set:

Not explicitly stated. The ANSI/AAMI SP10 standard outlines specific protocols for comparing the automated device's readings to reference measurements, which often involves multiple observers and statistical analysis, but the exact adjudication method (e.g., 2+1, 3+1) is not detailed in this summary.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No. This type of study (MRMC) is typically associated with imaging devices where multiple readers interpret cases. For a blood pressure monitor, the "effectiveness" is assessed by its accuracy against a reference measurement, not by human readers interpreting the device's output.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The clinical test described is a standalone performance evaluation of the device as it measures blood pressure and pulse rate directly. There isn't a human interpreting an "algorithm output" in the traditional sense; the device itself provides the final measurement.

7. The type of ground truth used:

The ground truth would be reference blood pressure measurements obtained simultaneously by trained observers using a validated method (e.g., mercury sphygmomanometer) as mandated by the ANSI/AAMI SP10 standard.

8. The sample size for the training set:

Not applicable/Not stated. Blood pressure monitors like the BPBIO320/BPBIO320n are hardware devices that use an oscillometric method. While there's an "arithmetic" (algorithm) involved, especially given the inflation detection method, the device is not typically "trained" on a dataset in the way a machine learning algorithm would be. The design and parameters of the oscillometric algorithm are established during development and then validated through clinical testing.

9. How the ground truth for the training set was established:

Not applicable. See point 8. The "ground truth" for the development of the oscillometric algorithm would come from physiological principles and previous research relating cuff pressure oscillations to arterial blood pressure, rather than a specific "training set" with established ground truth in the context of supervised machine learning.

Summary

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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

1. 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
1. Equivalent legally marketed devices: (Predicate device Information) A&D Engineering Inc. Digital Blood pressure monitors Model TM2655P (K010828)
1. 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:

1. 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

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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 deviceBPBIO320/BPBIO320	Predicate deviceTM2655P	Similarities	Differences
Device Classification	Class II	Class II	Equivalent	Negligible
Classification Panel	Cardiovascular	Cardiovascular	Equivalent	Negligible
Intended Use(Indications for use)	Monitor non-invasiveblood pressure andpulse rate	Monitor non-invasiveblood pressure and pulserate	Equivalent	Negligible
Anatomical sites	Upper arm or limb	Upper arm or limb	Equivalent	Negligible
Device Description
Technology-measurementmethodology	Oscillometric measureupon inflation	Oscillometric measureupon deflation	Different	SP10 andsafetystandards weremet. Clinicaltest accordingto the SP10was 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, PULSERATE	SYS, DIA, PULSERATE	Equivalent	Negligible
System output	RS232-compatible;digital; mini-dinconnector	RS232-compatible;digital; mini-dinconnector	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
Operatingenvironment	10-40℃ (50~~104°F),30~~75%RH; 70~106kPa	10-40 °C, 85%RH or less,non condensing	Similar	Negligible
Storage environment	-20-70 ℃ (-4~~158°F),10~~95%RH,50~106kPa (Nocondensation)	-20 to 60 °C, 95%RH orless, non condensing	Similar	Negligible
Measurement range	Blood pressure :40~~300mmHg.Pulse rate : 30~~240bpm	Blood pressure :10~280mmHgPulse rate : 30-200bpm	Similar	Negligible
Accuracy	Pressure : ±3mmHgPulse rate : ±2%	Pressure : ±3mmHgPulse 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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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:

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use ✗(21 CFR 807 Subpart C)
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(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'

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).