The Primo™ Noninvasive Blood Pressure Measurement System is a hand held non-invasive blood pressure measurement system intended to be used on adult patients with wrist circumferences of 11 cm - 22 cm by trained medical personnel to measure systolic, diastolic blood pressure and pulse rate.

Device Description

The Primo™ Noninvasive Blood Pressure Measurement System is a hand-held non-invasive blood pressure measurement system that measure systolic, diastolic blood pressure and pulse rate from the user's wrist. The system is contained in hard plastic housings that contain a user interface panel and a wrist sensor. The characteristics of the arterial waveforms are recorded with a unique pressure sensor that is placed over the radial artery. This system provides a single reading of blood pressure, using a pressure sensor placed on the wrist over the radial artery. This sensor is noninvasive.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medwave, Inc. Primo™ Noninvasive Blood Pressure Measurement System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Primo™)
Mean difference of ± 5mmHg or less (Systolic/Diastolic Blood Pressure)	Mean difference of ± 5mmHg or less (for both systolic and diastolic blood pressure)
Standard deviation of 8mmHg or less (Systolic/Diastolic Blood Pressure)	Standard deviation of 8mmHg or less (for both systolic and diastolic blood pressure)
Pulse measurement accuracy of ± 5 bpm or 10% of measured pulse frequency	Pulse measurement accuracy of ± 5 bpm or 10% of the measured pulse frequency
Operating Temperature Conditions 10°C (50°F) - 40°C (104°F)	10°C - 40°C
Operating Humidity Conditions 15-90 percent (noncondensing)	10% to 85% relative humidity
Life test minimum of 10,000 full-scale cycles	Tested and successfully completed
Electrical safety (IEC60601)	Tested and successfully completed
Biocompatibility (ISO10993-1)	Tested and successfully completed
Electromagnetic Compatibility	Tested and successfully completed

Note: Many acceptance criteria listed in the table (e.g., Device Labeling, Storage Conditions, Vibration and Shock, Software Testing, etc.) refer to various standards (ANSI/AAMI SP10-2002, IEC60601, CDRH Guidance Document, NSTA, Medwave internal documents) and are stated as "X" or "Tested and successfully completed," indicating compliance. The table above focuses on the quantitative performance metrics explicitly stated.

Study Information

Here's the detailed information about the study that proves the device meets the acceptance criteria:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The text mentions "an extensive collection of tests" and "study results in the supporting Clinical Data on file at Medwave, Inc." (for pulse accuracy) and "study results in Appendix H" (for blood pressure accuracy against intra-arterial lines), but does not give specific numbers for the test set.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not explicitly stated. The document mentions that the algorithms were "tested against intra arterial line pressure waveforms," which implies a direct physiological measurement as ground truth rather than expert interpretation of images or other data.
Adjudication Method for the Test Set:
- Not applicable/Not stated. Since the ground truth primarily relies on intra-arterial line pressure waveforms, an adjudication method for expert consensus is not described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. The document does not mention any MRMC study or comparison of human readers with and without AI assistance for this device. This is a standalone device measuring physiological parameters directly.
- Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no such study was described.
Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Was it done? Yes. The entire description of the performance testing focuses on the device's accuracy in measuring blood pressure and pulse rate (algorithm only performance). The device is a "hand-held non-invasive blood pressure measurement system" that provides "a single reading." The algorithms' performance is directly assessed against intra-arterial line pressure waveforms.
Type of Ground Truth Used:
- Intra-arterial line pressure waveforms. The document explicitly states: "The algorithms have been tested against intra arterial line pressure waveforms and proven to meet industry standards..."
Sample Size for the Training Set:
- Not explicitly stated. The document refers to "Medwave's proprietary algorithms" and states they have been "tested against intra arterial line pressure waveforms," but does not provide information about the training set size for these algorithms.
How the Ground Truth for the Training Set Was Established:
- Not explicitly stated for the training set. However, given that the algorithms were tested against intra-arterial line pressure waveforms, it is highly probable that similar intra-arterial line pressure data would have been used as ground truth for establishing and refining these proprietary algorithms during their development/training phase. The document does not detail this process explicitly.

Summary

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SECTION 2. SUMMARY AND CERTIFICATION

A. 510(K) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Medwave, Inc. summary for the Primo TM.

SUBMITTER'S NAME:	Medwave, Inc.
ADDRESS:	4382 Round Lake Road WestSt. Paul, MN 55112
CONTACT PERSON:	Donna R. Lunak
TELEPHONE NUMBER:	651-639-1227
FAX NUMBER:	651-639-1338
DATE OF SUBMISSION:	11/14/05

1. Identification of device

Proprietary Name: Primo TM Common Name: Wrist Sphygmomanometer Classification Status: Class II per regulations 870.1130 Product Codes

2. Equivalent devices

Medwave, Inc. believes the Primo™ Noninvasive Blood Pressure Measurement System is substantially equivalent to Medwave, Inc. Vasotrax® Portable Wrist Noninvasive Blood Pressure Measurement System (K001898).

3. Description of the device

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053185 215

4. Intended Use

The Medwave, Inc. Primo™ Noninvasive Blood Pressure Measurement System is a hand held non-invasive blood pressure measurement system intended to be used on adult patients with wrist circumferences of 11 cm - 22 cm by trained medical personnel to measure systolic, diastolic blood pressure and pulse rate.

5. Technological characteristics, comparison to predicate device.

Like the predicate device, the Primo™ Noninvasive Blood Pressure Measurement System measures the diastolic, systolic blood pressure and pulse rate from the wrist using oscillometric methods. Both the Primo ™ Noninvasive Blood Pressure Measurement System and the Vasotrax® Portable Wrist Noninvasive Blood Pressure Measurement System (K001898) are microcomputer controlled.

Like the Vasotrax® Portable Wrist Noninvasive Blood Pressure Measurement System (K001898), the Primo™ Noninvasive Blood Pressure Measurement System display systolic, diastolic blood pressures ranging from 40 and 240 mmHg. Both systems have a blood pressure measurement accuracy of a mean difference of ± 5mmHg or less with a standard deviation of 8mmHg or less. The pulse measurement range is the same for both the Primo™ Noninvasive Blood Pressure Measurement Systcm and the Vasotrax® Portable Wrist Noninvasive Blood Pressure Measurement System (K001898), from 40 - 200 bpm. The accuracy of the pulse measurements are + 5 bpm or 10% of the measured pulse frequency. (Supported by study results in the supporting Clinical Data on file at Medwave, Inc.)

Both Primo™ Noninvasive Blood Pressure Measurement System and the Vasotrax® System (K001898) utilize the application of pressure to the artery (by the sensor); the counter pressure in the artery produces a pressure waveform. When maximum amplitude is achieved, mean blood pressure is calculated. The Primo™ Noninvasive Blood Pressure Measurement System and the Vasotrax® System (K001898) use a unique "sweep" technique for applying pressure to a the radial artery: downward pressure is applied by the sensor to the radial artery at a rate of ~10mmHg per heart beat increasing as the beat amplitude increases and decreasing rapidly when the beat amplitude begins to decrease. A curve fit is made using the amplitude of each beat versus the hold down pressure to form the bell shaped curve. This curve fit is used to determine the true peak that might occur between pulses as well as to filter out small variations due to artifacts or aberrancies.

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K053135
p3/5

Technological characteristics, comparison to predicate device (continued)

Both the Primo Noninvasive Blood Pressure Measurement System and the Vasotrax® (K001898) utilize Medwave's proprietary algorithms in analyzing the pressure waveforms to calculate the systolic and diastolic readings. Parameters are extracted from the waveforms and a set of coefficients is applied to them, yielding systolic and diastolic pressures. The algorithms have been tested against intra arterial line pressure waveforms and proven to meet industry standards set by the American Medical Instrumentation (AAMI), mean difference of + 5mmHg or less with a standard deviation of 8mmHg or less. (Supported by study results in Appendix H)

The Primo™ Noninvasive Blood Pressure Measurement System, as well as the Vasotrax ® System (K001898) has a power switch and a display. The operating environment of 10°C - 40°C and 10% to 85% relative humidity. Both the Primo System and the Vasotrax ® Portable Wrist Noninvasive Blood Pressure Measurement System (K001898) are battery powered. Any minor differences in the appearance, technology, or manufacture of the Primo ™ Noninvasive Blood Pressure Measurement System device and the predicate device do not raise any new questions of safety or effectiveness. Associated risks posed by the Primo™ Noninvasive Blood Pressure Measurement System are thought to be no more than those of a well designed automated cuff-based noninvasive blood pressure devices currently marketed in the interstate commerce. Both the device and the sensor have been designed to minimize the risk to patients from excessive pressure or sensor failure caused by cither normal device use by the caregiver and/or clinical abuse.

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6. Discussion of performance testing.

An extensive collection of tests has been conducted and successfully completed. Summary follows:

Requirements	ANSI/AAMI SP10-2002American National Standardsfor Electronic or AutomatedSphygmomanometers	IEC60601	Center For DevicesAnd RadiologicalHealth NoninvasiveBlood PressureMonitor GuidanceDocument	OtherAsListed
Device Labeling	X	X	X	----------
Outer ContainerLabeling	X	X	X	----------
Information Manual	X	X	X	----------
Component Labeling	X	X	X	----------
Power System Labeling	X	X	X	----------
Storage Conditions --20°C (-40°F) - 50°C(122°F)	X	X	----------	----------
Operating TemperatureConditions 10°C(50°F) - 40°C (104°F)	X	X	----------	----------
Operating HumidityConditions 15 90percent(noncondensing)	X	X	----------	----------
Operating Range inAltitude Conditions -170 to 1700 meters(-500 to 5000 feet).referenced to sea level	X	X	----------	----------
Vibration and Shock	----------	----------	----------	NSTA
Voltage Range	N/A	N/A	N/A	N/A
Life test minimum of10,000 full scale cycles	X	----------	----------	----------
Maximum cuffpressure	N/A	N/A	N/A	N/A
Cuff deflation	N/A	N/A	N/A	N/A
Electrical safety	----------	X	----------	IEC601
Conductivecomponents	----------	X	----------	----------
Pressure indicatoraccuracy	X	----------	----------	----------
Requirements	ANSI/AAMI SP10-2002American National Standardsfor Electronic or AutomatedSphygmomanometers	IEC60601	Center For DevicesAnd RadiologicalHealth NoninvasiveBlood PressureMonitor GuidanceDocument	OtherAsListed
Auscultatory method asthe reference standard	N/A	N/A	N/A	N/A
Intraarterial method asthe reference standard	X	----------	----------	----------
Battery indicator	X	----------	----------	----------
Requirements fordevices with manualinflation	N/A	N/A	N/A	N/A
Comparison Testing	N/A	N/A	N/A	N/A
Foreign Standards	N/A	N/A	N/A	N/A
Software Testing	----------	----------	----------	Medwave795-0092,795-0094
ElectromagneticCompatibility	----------	X	----------	----------
Biocompatibility	----------	----------	X	ISO10993-1-
Sterilization	N/A	N/A	N/A	N/A
Packaging	N/A	N/A	N/A	N/A
Shelf Life	N/A	N/A	N/A	N/A

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7. Conclusion

Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Medwave, Inc. that the Primo™ noninvasive Blood Pressure Measurement System is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the top of the circle.

JAN 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medwave, Inc. c/o Ms. Donna R. Lunak Vice President, Regulatory Affairs 4382 Round Lake Road West Arden Hills, MN 55112

Re: K053185

Trade Name: Primo™ Noninvasive Blood Pressure Measurement System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 14, 2005 Received: November 14, 2005

Dear Ms. Lunak:

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. Donna Lunak

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar 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):

s 3/85

Device Name: Primo™

Indications For Use:

The Primo™ Noninvasive Blood Pressure Measurement System is a hand held noninvasive blood pressure measurement system intended to be used on adult patients with wrist circumferences of 11 cm - 22 cm by trained medical personnel to measure systolic and diastolic blood pressure and pulse rate.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma

SIGIT on of Cardlov scular Davices S . Jig Number

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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).