The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.

Device Description

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

AI/ML Overview

Here's an analysis of the provided text regarding the Cardiocom Commander III, broken down by your requested categories.

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission relies on showing that a new device is as safe and effective as a legally marketed predicate device (K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor in this case), rather than requiring extensive de novo clinical trials to prove efficacy from scratch. Therefore, many of the typical acceptance criteria and study details for AI/ML devices, such as multi-reader multi-case studies or detailed ground truth establishment, are not present in this type of submission. The focus is on demonstrating comparability to the predicate device, particularly in areas like accuracy and safety standards.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (from predicate)	Reported Device Performance (Commander III)
Blood Pressure Measurement Accuracy	Pressure: ±3 mmHg or ±2%, whichever is greater	SAME (from AAMI) - Implied to meet this
Pulse Rate Accuracy	Pulse: ±5%	SAME (from AAMI) - Implied to meet this
Measurement Range (Pressure)	20 mmHg to 280 mmHg	SAME (from AAMI) - Implied to meet this
Measurement Range (Pulse)	40 to 200 pulses/minute	SAME (from AAMI) - Implied to meet this
Operating Principle	Oscillometric automated blood pressure monitoring	SAME
Display	LCD: Systolic, Diastolic, Pulse	SAME
Standards Compliance	ANSI/AAMI SP10: 1992+A1 (Blood Pressure Sphygmomanometers)	SAME
Electrical Safety	UL/IEC 60601-1	UL/IEC 60601-1
Electromagnetic Compatibility	IEC 60601-1-2	IEC 60601-1-2

Study Proving Acceptance Criteria:

The document states, "The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device." And in the conclusion: "After analyzing bench, test laboratory, and clinical testing data, it is the conclusion of Cardiocom that the Cardiocom Commander III is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

This indicates that studies were performed to demonstrate that the Commander III meets the same performance and safety standards as the predicate device, specifically ANSI/AAMI SP10: 1992+A1 for blood pressure accuracy.

Additional Information Not Extensively Detailed in the Provided Text:

Sample size used for the test set and the data provenance:
- The document mentions "clinical testing data" but does not specify the sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) based on substantial equivalence, the clinical testing would likely be focused on demonstrating comparable performance to the predicate against established standards (like AAMI SP10), which often involves a specific number of subjects. However, these specifics are not in the provided summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified in this type of submission. For blood pressure monitors, accuracy is typically assessed against a reference standard (e.g., a mercury sphygmomanometer used by trained clinicians) rather than "expert consensus" in the way it applies to diagnostic image interpretation. The AAMI SP10 standard outlines the methodology for such validation tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. "Adjudication" typically refers to resolving discrepancies in expert interpretations, which isn't the primary method for validating blood pressure device accuracy.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a measurement system, not an AI diagnostic tool that assists human readers/interpreters. There is no mention of AI or human-in-the-loop performance measurement in the provided text.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense that the device's ability to measure blood pressure, pulse, etc., is evaluated as a standalone function primarily against established standards (like AAMI SP10). The device itself is a standalone measurement system for collecting vital signs.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For blood pressure accuracy, the ground truth would typically be established by a reference method, such as a mercury sphygmomanometer, performed by trained observers according to standard protocols (e.g., specified in AAMI SP10). The document refers to "clinical testing data" which would be based on this type of ground truth.
The sample size for the training set:
- Not applicable/Not specified. This device is not described as using machine learning or AI that would require a distinct "training set." It is a hardware and software system for data collection and transmission.
How the ground truth for the training set was established:
- Not applicable, as a training set, as typically understood for AI/ML, is not described for this device.

Summary

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K053304

DEC 3 0 2005

EXHIBIT 2

510K Summary Cardiocom 1260 Park Road Chanhassen, MN 55317 Toll-Free: 888-243-8881 Tel: 952-474-4149 Fax: 952-474-4372 Contact: Daniel Cosentino, President Date: November 19, 2005

1 . Identification of the device Proprietary-Trade Name: Cardiocom Commander III Non-Invasive Automated Blood Pressure Monitor Classification Name: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. Common/Usual Name: Noninvasive Blood Pressure Measurement System
1. Equivalent legally marketed devices This product is similar in function and design to predicate K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor
1. Indications for Use (intended use). The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site. Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical cars in o
1. Description of the Device. Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephonel winn at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices not been modified; they are used as supplied from the manufacturer.

న్. Safety and Effectiveness, comparison to predicate device The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device.

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Designation	K982481 A&D Medical UA-767PCDigital Blood Pressure Monitor	Commander III
Operating Principle	Oscillometric automated blood pressuremonitoring	SAME
Indications	The UA-767PC is designed to be used by endusers who are eighteen (18) years and older athome and doctor/nurse office to monitor theirblood pressure (systolic and diastolic) and pulserate. At the end of each measurement, theresults will be stored in the UA-767PCmemory. UA-767PC through itscommunications port can also transfer themeasurements stored in memory to otherelectronic devices, such as a PC, a modem, or aprinter.	The Commander III device is for use bypatients to collect and transmit generalhealth questions and patient vital sign data(such as weight, blood pressure, glucose,pulse oximetry, peak flow) between thepatient, typically at home, and a healthcare professional at a remote site.Contraindications, Precautions andWarnings: The Commander III devicemakes no interpretation, evaluation,medical judgments or recommendationsfor treatment. Clinical judgment andexperience are required to check andinterpret the information transmitted. TheCommander III is not intended as asubstitute for medical care
Display	LCD: Systolic, Diastolic, Pulse	SAME
Controls	Start, pressure select	Yes, No, Up-arrow, Down-arrow, Four"selection buttons"
Power supply	4-A A alkaline batteries	AC Adapter only
External dimensions	2.7" tall 4.4" deep 6.5" wide	2.7" tall 6.8" deep 8.9" wide
Memory	126 measurements	200 measurements. Last measurement issent over the phone line.
Weight	0.32 kg without batteries	0.8kg without Blood Pressure cuff
Cuff ArmCircumference Range	5.1 inches -17.7 inches (small, medium, largecuff sizes)	7 inches-16.5 inches (small, medium, largecuff sizes)
OTC or prescription	OTC	Prescription
Standard	ANSI/AAMI SP10: 1992+A1	SAME
Electrical Safety	UL/IEC 60601-1	UL/IEC 60601-1
Electromagneticcompatibility	IEC 60601-1-2	IEC 60601-1-2
Patient ContactMaterials	Nylon Cuff	SAME
Designation	K982481 A&D Medical UA-767PCDigital Blood Pressure Monitor	Commander III
Description	This home blood pressure monitorcommunicates with your information hubthrough a serial communication cable and port.Real-time communication is achieved by sendingthe blood pressure measurement to theinformation hub immediately. The UA-767PCcan also operate in a batch-mode to send up to126 measurements with time and date in a singlerequest command. System integrators canprovide units to remotely located patientsenabling them to monitor their blood pressure athome. Combine this blood pressure monitor andthe LifeSource™ UC-321 personal scale and youhave a foundation for a complete telemonitoringsystem.	The Commander III device is for use bypatients to collect and transmit generalhealth questions and the following patientvital signs data: Non-invasive bloodpressure measurement, Non-invasive bloodoxygen saturation measurement using pulseoximetry, In vitro diagnostic quantitativemeasurement of glucose in fresh capillarywhole blood, Non-invasive measurement oflung peak flow, and Patient weight using astand-on electronic scale. The results ofthese measurements are transmitted to acomputer monitoring station in a clinicalsetting via common telephone lines fromthe patient's home setting. For sale by or onthe order of a physician.
Communicationcapability	Serial RS-232 with PC	Multiple serial RS-232 ports and telephonemodem Part 68 approved
Measurement Range	Pressure: 20 mmHg to 280 mmHg; Pulse: 40 to200 pulses/minute	SAME (from AAMI)
Accuracy	Pressure: ±3 mmHg or ±2%, whichever isgreater; Pulse: ±5%	SAME (from AAMI)
Pressurization	Automatic, using micropump	Automatic
Operating Environment	50° - 104° F (10° to 40° C)	SAME (from AAMI)

Electronic printed circuit boards inside an ABS

enclosure

Comparison matrix – new vs. Predicate device 6.

Construction

Electronic printed circuit boards inside an

A BS enclosure

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7. Conclusion

After analyzing bench, test laboratory, and clinical testing data, it is the conclusion of Cardiocom that the Cardiocom Commander III is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol.

DEC 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardiocom LLC c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K053304

Trade Name: Cardiocom Commander III Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 12, 2005 Received: December 13, 2005

Dear Mr. Job:

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 - Mr. Mark Job

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 (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 (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) _________________

Device Name: Cardiocom Commander III

Indications For Use:

Contraindications, Precautions and Warnings:

The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.

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)

B. L. Zimmerman
Division Supt. O.S.

Division of Cardiovascular Devices
510(k) Number K053304

Page 1 of 1

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).