The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.

Device Description

The Welch Allyn NIBP device consists of 1) a software program running on a laptop computer; 2) an NIBP module which measures and reports the patient's blood pressure and pulse rate readings. The device is intended to operate with a series of standard blood pressure cuffs and blood pressure tubing. The Welch Allyn NIBP device is designed to non-invasively measure systolic and diastolic blood pressure and pulse rate for adult, pediatric and neonatal patients using the oscillometric method. The Welch Allyn NIBP device will also calculate Mean Arterial Pressure (MAP). All blood pressure and pulse values are displayed on the large, easy-to-read LCD display of the laptop computer. The Welch Allyn NIBP device is intended for use in a wide variety of health care settings. This includes hospital departments; alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes.

AI/ML Overview

The provided text describes the Welch Allyn Non-invasive Blood Pressure (NIBP) Device. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy for systolic, diastolic, or mean arterial pressure, or pulse rate. Instead, it refers to compliance with the ANSI/AAMI SP10: 2002 (R2008) standard for Manual, electronic or automated sphygmomanometers + Amendment 1 & 2 standards. This standard itself defines performance requirements for NIBP devices.

Therefore, the "acceptance criteria" are the performance requirements outlined in the ANSI/AAMI SP10 standard. The device "meets" these criteria by demonstrating compliance through its clinical performance data.

Performance Metric	Acceptance Criteria (per ANSI/AAMI SP10: 2002)	Reported Device Performance
Blood Pressure Accuracy	(Specific criteria for mean difference and standard deviation, as defined by ANSI/AAMI SP10 for systolic, diastolic, and MAP)	"Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard"
Pulse Rate Accuracy	(Specific criteria for heart rate accuracy, as defined by ANSI/AAMI SP10)	"Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard"

Note: To get the exact numerical acceptance criteria, one would need to consult the ANSI/AAMI SP10: 2002 (R2008) standard directly, as the provided 510(k) summary only states compliance with it.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance data was collected to meet the ANSI/AAMI SP10 standard. Typically, NIBP accuracy studies compliant with ANSI/AAMI SP10 involve a specific number of subjects across different blood pressure ranges and patient populations (adult, pediatric, neonatal).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For NIBP studies, ground truth is typically established by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer or direct arterial line measurement), but the document does not elaborate on this.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not mentioned. This type of study is more common for imaging devices where human readers interpret medical images. For NIBP devices, the focus is on the accuracy of the device's measurements compared to a reference method, not on human interpretation of data generated by the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The clinical performance data described for the Welch Allyn NIBP device appears to be for its standalone performance (algorithm only), as it focuses on the device's ability to measure and report blood pressure and pulse rate accurately according to a recognized standard. The intended use indicates clinicians use the device, but the performance evaluation is centered on the device's measurements themselves, not on how humans interpret those measurements in an assisted workflow.

7. The Type of Ground Truth Used

Based on the reference to ANSI/AAMI SP10, the ground truth for an NIBP device study typically involves:

Simultaneous comparison with a reference method: This usually means either:
- Auscultation by trained observers using a mercury sphygmomanometer (or an equivalent validated method), with specific protocols to minimize observer bias.
- Direct intra-arterial blood pressure measurement for studies involving more critical accuracies or specific patient populations.

The document does not explicitly state which specific ground truth method was used, but given the compliance with ANSI/AAMI SP10, it would be one of these validated reference methods.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. The device utilizes an "Oscillometric BP Algorithm that is equivalent to the BP Algorithm in the Spot Ultra Vital Signs and Welch Allyn VSM 53000." This suggests the algorithm may have been trained or developed in previous iterations or products, but details of that training are not included in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As no information about a training set or its sample size is provided, how the ground truth for the training set was established is not detailed in this document.

Summary

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K093907

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Abbreviated 510(k) Premarket Notification Welch Allyn Non-invasive Blood Pressure (NIBP) Device

Premarket Notification [510(k)] Summary 6. February 3, 2010 Date: APR 1 4 2010 Submitted By: Welch Allyn. Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 (315) 685-3694 Phone: Fax: (315) 685- 2532 Contact: Huy Doan, Senior Manager, Regulatory Affairs Common Name: Non-invasive Blood Pressure (NIBP) Device Trade Name: Welch Allyn Non-invasive Blood Pressure (NIBP) Device Classification Name: Noninvasive blood pressure measurement system Class II; Product Code: DXN- 21 CFR 870.1130 Modification to VSM- Vital Signs Monitor (VSM 300) (K063419) Predicate Devices: Welch Allyn Spot Ultra Vital Signs Device (K040490) The Welch Allyn NIBP device consists of 1) a software program running on a Description: laptop computer; 2) an NIBP module which measures and reports the patient's blood pressure and pulse rate readings. The device is intended to operate with a series of standard blood pressure cuffs and blood pressure tubing. The Welch Allyn NIBP device is designed to non-invasively measure systolic and diastolic blood pressure and pulse rate for adult, pediatric and neonatal patients using the oscillometric method. The Welch Allyn NIBP device will also calculate Mean Arterial Pressure (MAP). All blood pressure and pulse values are displayed on the large, easy-to-read LCD display of the laptop computer. The Welch Allyn NIBP device is intended for use in a wide variety of health care settings. This includes hospital departments; alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes. Indications for Use:

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Image /page/1/Picture/0 description: The image contains the text "Welch Allyn" in a stylized font. The word "Welch" is in a lighter, less bold font compared to "Allyn." The text appears to be a logo or brand name.

Premarket Notification [510(k)] Summary 6.

Contraindications for Use:

The Welch Allyn Non-Invasive Blood Pressure device is not intended for use with severe arrhythmia. The Welch Allyn Non-Invasive Blood Pressure device is not intended for patients who are experiencing convulsions or tremors.

Technological Characteristics:

The Welch Allyn NIBP Device utilizes an Oscillometric BP Algorithm that is equivalent to the BP Algorithm in the Spot Ultra Vital Signs and Welch Allyn VSM 53000. The Welch Allyn NIBP Device is powered from USB power from the Laptop PC. It uses the same operating principle and incorporates the same basic material. The subject device has the same technological characteristics as the predicate devices.

Non-clinical performance data:

The subject device was also tested to evaluate its safety and effectiveness based on the following standards:

IEC 60601-1:1988+Al:1991+A2:1995 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
IEC 60601-1-2:2001+Al:2004 Medical Electrical Equipment Part 1-2: . General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test
IEC 60601-1-4:(2000) General Requirement for Safety: Collateral Standard: . Programmable Electrical Medical Systems
AAMI SP10: 2002: Manual, electronic or automated sphygmomanometers . (A1:2003, A2:2006)

Clinical performance data:

Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard for Manual, electronic or automated sphygmomanometers + Amendment 1 & 2 standards

Conclusions:

The intended use and the technological characteristics of the Welch Allyn NIBP device are the same as the predicate devices and the product meets FDA's recognized concensus standards. Therefore Welch Allyn believes the Welch Allyn NIBP device is substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR 1 4 2010

Welch Allyn, Inc. c/o Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K093907

Trade/Device Name: Welch Allyn Non-Invasive Blood Pressure (NIBP) Device Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: March 18, 2010 Received: March 22, 2010

Dear Mr. Lehtonen:

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 -- Mr. Daniel W. Lehtonen

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

[signature]

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): ≤093907

Device Name: Welch Allyn Non-invasive Blood Pressure (NIBP) Device

Indications for Use:

Prescription Use × AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.W.C.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093590

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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).