The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates.

The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatric patients, using the oscillometric method on a cuffed arm.

Device Description

The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure and pulse rate over and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Ambulo 2400 Ambulatory Blood Pressure Monitoring System. It describes the device, its intended use, and the testing performed to demonstrate its safety and effectiveness.

However, the document does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria in the format requested. It mentions performance testing and compliance with various standards but lacks the quantitative data needed to complete the requested table and detailed study information.

Therefore, I cannot provide a complete answer to your request based on the provided text. The document refers to "predetermined requirements" and "predetermined specification" for performance and software testing but does not explicitly state what these are in numerical terms or provide the specific results that would fill out your table.

Based on the available information, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text in a quantifiable manner (e.g., specific accuracy ranges for blood pressure). The document mentions compliance with standards like IEC 80601-2-30:2009+A1:2013 for automated non-invasive sphygmomanometers, which would contain the acceptance criteria.
Reported Device Performance: Not numerically reported in the provided text. The document states that "Test results indicated that the Mortara Ambulo 2400 complies with its predetermined specification" and that it "performs as well as or better than the predicate device," but no actual performance numbers are given.

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

Sample Size: Not specified. The document only states "Performance Testing - Clinical: The Ambulo 2400 was evaluated for clinical performance to demonstrate safety and effectiveness."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not available in the provided text.

5. 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:

The Ambulo 2400 is an automated blood pressure monitor, not an AI assistance tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type.

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

Yes, implicitly. The device is an automated blood pressure monitor. Its primary function is to measure blood pressure without continuous human intervention during the measurement period. The "Performance Testing - Clinical" would evaluate this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For an automated blood pressure monitor, the "ground truth" in clinical performance testing would typically be reference measurements taken simultaneously by a validated, highly accurate manual method (e.g., auscultation by trained observers) or another highly accurate automated device. The document does not specify the ground truth methodology used for its clinical testing.

8. The sample size for the training set:

Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The device measures physical parameters.

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

Not applicable as this is not an AI/machine learning device.

In summary, while the document confirms that clinical performance testing was conducted and that the device complies with predetermined specifications and relevant standards, it lacks the specific quantitative data and detailed methodology to answer most of your detailed questions regarding acceptance criteria and study particulars.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2014

Mortara Instrument, Inc. Amy Yang Sr. Regulatory Affairs Engineer 7865 North 86th St. Milwaukee, Wisconsin 53224

Re: K133989

Trade/Device Name: Ambulo 2400 Ambulatory Blood Pressure Monitoring System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 13, 2014 Received: October 15, 2014

Dear Amy Yang.

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

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) K133989

Device Name

Ambulo 2400 Ambulatory Blood Pressure Monitor

Indications for Use (Describe)

The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k): Ambulo 2400 Device Summary

Submitter:

Date: November 25, 2014

Amy Yang, Sr. Regulatory Affairs EngineerMortara Instrument, Inc.7865 N. 86th Street
Milwaukee, WI 53224
FAX:	(414) 354-4760
Phone:	(414) 354-1600
Contact:	Amy Yang (see above)
Trade Name:	Mortara Ambulo 2400 Ambulatory Blood Pressure Monitor
Common Name:	Ambulatory Blood Pressure Monitoring System
Classification Name:	System, Measurement, Blood-Pressure, Non-Invasive
Classification Description:	Noninvasive blood pressure measurement system
Classification Regulation:	21 CFR §870.1130
Product Code:	DXN
Legally marketed devices to which S.E. is claimed:
Mortara Ambulo 2400	Predicate 510(k) Number	Predicate Manufacturer / Model

System, Measurement, Blood-Pressure, Non-Invasive	K080274	Tiba Medical / Ambulo 2400

Description:

Since blood pressure naturally fluctuates throughout a full day according to various factors, such as sleep patterns, medication, diet, exercise and stress, a single measurement is not sufficient to make a sound diagnosis. Analyzing a person's blood pressure over an extended period of time can improve the diagnosis and ultimately the treatment. The Ambulo 2400 can collect blood pressure data under a variety of daily activities over a 24 hour period and then downloaded to a computer for analysis and treatment. The Ambulo 2400 may also be use on an ongoing basis to evaluate the effectiveness of a prescribed treatment.

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Abbreviated 510(k) Notification

Technology Comparison:

The Mortara Ambulo 2400 utilizes the same or similar technology for each parameter as utilized by the predicate device.

Intended Use:

The Ambulo 2400 is intended to be a compact, non-invasive Ambulatory Blood Pressure Monitoring (ABPM) system. ABPM technology involves the use of an automatic, non-invasive device to measure blood pressure over an extended period of time – typically 24 hours. The ABPM procedure is an essential tool for physicians, clinical researchers, and other healthcare professionals to analyze a patient's blood pressure as it relates to his/her circadian rhythm. This process offers insight into diagnostic factors as they relate to the spectrum of activity within everyday life.

Indications for Use:

The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates.

The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatic patients, using the oscillometric method on a cuffed arm.

Standards and Testing:

Performance testing has been completed on the Mortara S4 Mobile Monitor and demonstrates compliance with International and FDA-recognized consensus standards:

IEC 60601-1-1:2000 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Collateral Standard: Safety Requirements for Medical Electrical Systems.

IEC 60601-1-2:2007 – Medical Electrical Equipment – Part 1-2: General requirements for safety – Collateral Standard: Electromagnetic Compatibility.

IEC 60601-1-4 Consol. Ed. 1.1:2000 – Medical Electrical Equipment – Part 1-4: General requirements for Collateral Standard: Programmable Electrical Medical Systems.

IEC 60601-1-6:2004 – Medical Electrical Equipment – Part 1-6: General Requirements for Safety and Essential Performance - Collateral Standard: Usability.

IEC 60601-1-6:2010 - Medical Electrical Equipment - Part 1-6: General Requirements for Safety and Essential Performance - Collateral Standard: Usability.

IEC 60601-2-30:1999 - Medical Electrical Equipment. Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

IEC 80601-2-30:2009+A1:2013 – Medical Electrical Equipment. Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

IEC/EN 62304:2006+AC:2008 - Medical device software - Software life-cycle processes.

IEC 62366:2007 - Medical devices - Application of usability engineering to medical devices.

ISO 14971:2007 – Medical devices – Application of Risk Management to Medical Devices

AAMI/ANSI SP10:2002/ 2008 & AAMI SP10:2002/A1:2003 - Manual, electronic or automated sphygmomanometers.

Additionally, verfication, validation, performance and environmental tests have been performed to address the intended use, requirement specifications, usability and risk management requirements.

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Abbreviated 510(k) Notification

Performance Testing:

Sterilization Validation:

The Mortara Ambulo 2400 is not sterilizable, and therefore this section does not apply to the device itself.

Shelf Life Testing:

The Mortara Ambulo 2400 is not sterilizable, and therefore this section does not apply to the device itself.

Biocompatibility Testing:

The cuffs used are parts of the system that come in contact with the patient. These component devices have been previously tested in their own right for other submissions and found to be acceptable. However, the Ambulo 2400 itself does not involve direct / indirect patient contact.

Software Testing:

Software for the Mortara Ambulo 2400 was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Ambulo 2400 complies with its predetermined specification.

Electrical Safety:

The Mortara Ambulo 2400 was evaluated for patient safety in accordance with applicable Standards.

Electromagnetic Compatibility Testing:

The Mortara Ambulo 2400 was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Ambulo 2400 complies with its predetermined specification.

Performance Testing - Bench:

The Mortara Ambulo 2400 was tested in accordance with internal requirements and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional.

Performance Testing - Animal:

Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Ambulo 2400.

Performance Testing - Clinical:

The Ambulo 2400 was evaluated for clinical performance to demonstrate safety and effectiveness.

Conclusion:

The results of these activities demonstrate that the Mortara Ambulo 2400 is as safe, as effective and performs as well as or better than the predicate device.

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).