The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry.

The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

Device Description

The Welch Allyn Spot Ultra Vital Signs (Spot Vital Signs LXi) is not a monitor, but a one-time vital signs measurement device. This product will not have continuous monitoring capability with timed cycle intervals or any various programmable alarm features. Welch Allyn Spot Vital Signs LXi will include Blood Pressure with Temp, as the base feature, SpO2 is an option. A mobile stand, custom wall mount, an external printer, a barcode reader, weight scales and 802.11 a,b,g wireless communications are accessories that Welch Allyn Spot Ultra Vital Signs Device can be configured.

The Welch Allyn Spot Vital Signs LXi is designed to non-invasively measure systolic and diastolic blood pressure, pulse rate, temperature, and oxygen saturation (spO2) for adult and pediatric patients. The Welch Allyn Spot Vital Signs LXi will also calculate Mean Arterial Pressure (MAP). All blood pressure, pulse, temperature, and SpO2 values are displayed on a large, easy-to-read LCD display, and may be printed via an external thermal printer, as desired. The rechargeable battery and wide variety of mounting accessories make the Welch Allyn Spot Ultra Vital Signs Device convenient for many locations. The Spot Vital Sign LXi will also allow for data entry for weight, height, pain and will calculate Body Mass Index (BMI).

AI/ML Overview

Here's an analysis of the provided text regarding the Welch Allyn Spot Ultra Vital Signs and Welch Allyn Spot Vital Signs LXi, focusing on acceptance criteria and the supporting study:

Important Note: The provided text is a 510(k) summary for a premarket notification. This document primarily focuses on demonstrating "substantial equivalence" to a predicate device (Welch Allyn Spot Ultra Vital Signs K040490) rather than presenting a comprehensive standalone clinical study report. Therefore, some of the requested information, particularly detailed acceptance criteria for a new clinical study and comprehensive study statistics, might not be explicitly stated for the current 510(k) submission but are instead referenced back to the predicate device's clearance.

Acceptance Criteria and Device Performance

The provided 510(k) pertains to a device, the Welch Allyn Spot Ultra Vital Signs (and LXi model), which is stated to have "no hardware or software modifications" from its predicate device (Welch Allyn Spot Ultra Vital Signs K040490). The core argument for this submission is that the new device is substantially equivalent to the predicate. Therefore, the "acceptance criteria" for this specific 510(k) are implicitly met by demonstrating that the device is functionally identical to a previously cleared device.

The essential performance required of the device in this submission is that it performs equivalently to the predicate device, which itself would have met specific performance standards. The key performance aspect highlighted is for Blood Pressure (BP) measurement.

Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (Reference to Predicate)
Blood Pressure (BP) Accuracy: Measured against AAMI SP10 standards.	"STEP Blood Pressure (BP) mode of the SURE BP algorithm is functionally equivalent to the SURE BP Mode and cleared per K040490. A copy of the specification and validation from that study, as presented for the Welch Allyn Spot Ultra Vital Signs submission K040490."
Pulse Rate Accuracy:	"The Blood Pressure interface performances have not changed." (Implies same as predicate)
Temperature Accuracy:	"The Welch Allyn Spot Vital Signs LXi has equivalent vital signs measurement as the Welch Allyn Spot Ultra Vital Signs (K040490)."
SpO2 Accuracy:	"The Welch Allyn Spot Vital Signs LXi has equivalent vital signs measurement as the Welch Allyn Spot Ultra Vital Signs (K040490)."
Compliance with Recognized Standards:	"All requirements of the recognized and applicable standards are in compliance: SP10 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4."

Study Details

Given that the current 510(k) is based on substantial equivalence and states "There are no hardware or software modifications to the Spot Ultra Vital Signs Device," the detailed study information below refers to the validation study conducted for the predicate device (Welch Allyn Spot Ultra Vital Signs K040490), which the current device references for its performance claims.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this 510(k) summary for the predicate device's validation. The summary refers to an "AAMI SP10 - validation report." AAMI SP10 (now ANSI/AAMI/ISO 81060-2) typically requires a minimum of 85 subjects for clinical validation of non-invasive sphygmomanometers.
- Data Provenance: Not specified in this document. It would have been part of the original K040490 submission.
- Retrospective or Prospective: Not specified in this document for the predicate's study. AAMI SP10 validations are typically prospective clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the same way as AI/imaging studies. For blood pressure validation, an independent, "blinded" observer (or two for inter-observer variability checks) typically measures reference blood pressure according to a strict protocol (e.g., using a mercury sphygmomanometer or an oscillometric reference device simultaneously). The qualifications would typically be trained medical personnel, but not "experts" in the context of interpreting complex images or diagnoses.
Adjudication method for the test set:
- Not directly applicable to blood pressure validation in the same way it is for imaging. The "ground truth" for blood pressure is established through a standardized, direct measurement protocol (e.g., AAMI SP10 protocol), not through expert consensus or adjudication of ambiguous cases.
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, an MRMC study was not done. This device is a vital signs measurement device, not an AI-assisted diagnostic imaging system. Therefore, the concept of "human readers improving with AI assistance" is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the performance of the oscillometric blood pressure algorithm and other measurement modules is evaluated in a standalone manner. The "AAMI SP10 – validation report" would demonstrate the inherent accuracy of the device's measurements compared to a reference standard, independent of human interpretation improvements. The vital signs are automatically measured and displayed, meaning the device's accuracy is its standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Standard Measurements: For blood pressure, the ground truth is established through simultaneous, highly accurate, auscultatory blood pressure measurements performed by a trained observer using a calibrated reference device (e.g., mercury sphygmomanometer) as per AAMI SP10 standards. For SpO2 and temperature, similar reference devices and protocols would be used.
The sample size for the training set:
- Not specified. For a traditional medical device (not an AI/ML device in the sense of learning from data), there isn't a "training set" in the same way there would be for a machine learning algorithm. The algorithm for oscillometric BP is developed and refined based on engineering principles and physiological models, then validated on a test set.
How the ground truth for the training set was established:
- Not applicable as there is no "training set" for the current device in the context of iterative algorithm learning from labeled data. The ground truth for validation (see point 6) is established through reference standard measurements.

Summary

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Welch Allyn

K101680
p1/5

510(k) Summary [As described in 21 CFR 807.92] JUL - 9 2010

Submitted by:

Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220

Contact Person:

Fred Schweitzer Vice President, QA/RA Phone: (315) 554-4001 Fax: (315) 685-2532 E-mail: schweitzerf(@welchallyn.com

June 02, 2010 Date Prepared:

Trade Name:

Welch Allyn Spot Ultra Vital Signs and Welch Allyn Spot Vial Signs LXi

Spot Vital Signs Measurement Device Common Name:

Classification Reference:

Class II, 870.1130 Noninvasive Blood Pressure System Product Code - DXN

Predicate Device:

Welch Allyn, Inc. 510(k) Document Control Number K040490

Welch Allyn Spot Ultra Vital Signs

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Welch Allyn

Description of the Device:

Indications for Use:

The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

Technological Characteristics:

The Welch Allyn Spot Vital Signs LXi is intended for use by trained operators in healthcare facilities.

The Welch Ally Spot Ultra Vital Signs Device utilizes an Oscillometric Blood Pressure Algorithm, SpO2 OEM and temperature module technology. The original (predicate) device was cleared under FDA 510(k) number K040490. The dame fundamental scientific technology and intended use are the same for the modified device as the predicate device ..

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WelchAllyn

The following table summarizes the similarities between the subject Welch Allyn Spot Vital Signs LXi and the predicate Welch Allyn Spot Ultra Vital Signs Device (K040490).

*There are no hardware or software modifications to the Spot Ultra Vital Signs Device.

*Welch Allyn Spot Ultra Vital Signs Device (K040490)
Substantial Equivalence Comparison
Subject Area	Similarities	Differences
Indications for Use	Same for Spot Vital Signs Blood Pressure measurement –automatically measures systolic and diastolic pressure andcalculated Mean ArterialPressure (MAP)	There are no differences in indications for use from what hasbeen previously cleared by theFDA.
Target Population	Remains the same for Spot Vital functions	There are no changes from what has been previously cleared by the FDA.
Where Used	Spot Vital Signs functions remain the same. Where used for the Vital Signs has not changed.	No differences
Design	Welch Allyn Spot Vital Signs functions continue to use the same design. Blood Pressure interface functionality also remains the same.	No differencesDocument objective evidence that the STEP Blood Pressure(BP) mode of the SURE BP algorithm is functionallyequivalent to the SURE BPMode (AAMI SP10 – Validation Report)
Human Factors	All hardware and software functionality are identical	There are no changes from what has been previously cleared by the FDA.
Performance	The Blood Pressure interface performances have not changed.	There are no changes from what has been previously cleared by the FDA.Document objective evidence that the STEP Blood Pressure(BP) mode of the SURE BP algorithm is functionallyequivalent to the SURE BPMode (AAMI SP10 – Validation
*Welch Allyn Spot Ultra Vital Signs Device (K040490)
Substantial Equivalence Comparison
Subject Area	Similarities	Differences
		Report)
Materials	All materials are the same asreferenced to the original FDA	None
Efficacy	Efficacy of existing Spot VitalSigns products and BloodPressure interface has notchanged.	None
Sterility	Not Applicable	Not Applicable
Biocompatibility	All materials are the same asreferenced to the original FDA	None
Safety	There are no changes from whathas been previously cleared bythe FDA.	None
Compatibility	Hardware & Softwarecompatibility has not changed.	There are no changes from whathas been previously cleared bythe FDA.
Packaging	Packaging for existing SpotVital Signs hardware productshave not changed.	None

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Welch Allyn

The Welch Allyn Spot Vital Signs LXi has equivalent vital signs measurement as the Welch Allyn Spot Ultra Vital Signs (K040490).

They are no technological differences between the two devices that affect the safety or effectiveness of the device.

Summary of Effectiveness:

The Welch Allyn Spot Vital Signs team has determined that the software "Level of Concern" is Moderate.

The document objective evidence (AAMI SP10 - validation report) that the STEP Blood Pressure (BP) Mode of the SURE BP algorithm is functionally equivalent to the SURE BP Mode and cleared per K040490. A copy of the specification and validation from that study, as presented for the Welch Allyn Spot Ultra Vital Signs submission K040490.

All requirements of the recognized and applicable standards are in compliance: SP10 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4.

Additionally, risk management (risk, SFMEA and safety analysis) activities have been conducted in accordance with ISO 14971 Medical Devices - Application of risk management to medical devices and comply with IEC 60601-1-4 Medical Electrical

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WelchAllyn

Equipment Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

JUL - 9 2010

Welch Allyn, Inc. c/o Mr. Huy Doan Director, Corporate Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

Re: K101680

Trade/Device Name: Welch Allyn Spot Ultra Vital Signs/Spot Vital Signs LXi Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN, DQA, FLL Dated: June 2, 2010 Received: June 15, 2010

Dear Mr. Doan:

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, Dr to 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 1 1717). general controls provisions of the Act include requirements for annual registration, l'isting 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 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 max publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Huy Doan

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/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,

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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KI0I680

Welch Allym

Indications for Use Statement

510(k) Number (if known):

Device Name: Welch Allyn Spot Ultra Vital Signs Device

Indications for Use:

The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

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)

W.M.

of Cardiovascular Devices

510(k) Number K101620

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).