The Vitals Software Developer's Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be licensed to Computerized Patient Record (CPR) manufacturers who will integrate it with and sell it as part of their CPR system. The SDK is designed to communicate with and collect data from diagnostic instruments using an instrument specific interface that is compatible with the instrument's existing communications capability. Existing instruments will not have to be changed. The data that is collected will be displayed for the user to verify before it is sent to the CPR where it is saved as part of the CPR's database.

For access by the CPR, the data is translated from its original form into industry standard software object form (XML, Active X, COM). The SDK also provides sample program software that demonstrates how to display the data in the appropriate form.

The SDK is required for both the collection and the retrieval/review of data. The SDK will also provide the necessary set-up or configuration guidelines and help files that will allow the user to designate which instruments are connected to a personal computer (PC) at a specific location.

Device Description

The Welch Allyn Vitals Software Developer's Kit (SDK) is strictly a software product. It is designed to work with Microsoft Window 98, NT, 2000 and XP. It communicates with the VSM 5200 series and the SPOT 4200 series medical devices via an RS232 cable in one configuration and an Infrared dongle in the other both are standard synchronous RS-232 serial interfaces.

Once integrated with a third-party computerized patient record, the SDK will provide the CPR the ability to request, receive and parse alphanumeric observational data, and error messages from these medical devices. It will provide the user with the ability to configure to a single device. It will also display information to the user, using and ActiveX display control, in a manner that is consistent with the medical device used to capture the data.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a software product (Welch Allyn Vitals Software Developers Kit - SDK) and does not specify quantitative acceptance criteria in terms of accuracy or clinical metrics. Instead, the "effectiveness" is described in terms of its functional capabilities and user satisfaction.

Acceptance Criteria (Implied)	Reported Device Performance
Communicates with and collects data from diagnostic instruments	Designed to communicate with VSM 5200 series and SPOT 4200 series devices via RS232 or Infrared dongle. Collects alphanumeric observational data and error messages.
Translates data into industry standard software object form	Translates data into XML, ActiveX, COM.
Provides ability for CPR to request, receive, and parse data	Provides CPR ability to request, receive, and parse data.
Displays information consistent with the medical device	Displays information to the user, using an ActiveX display control, consistent with the medical device.
Allows user to configure to a single device	Provides the user with the ability to configure to a single device.
Provides necessary set-up/configuration guidelines and help files	Provides necessary set-up/configuration guidelines and help files.
Meets the needs and expectations of practitioners	"The results of the testing and evaluations indicate that the Welch Allyn Vitals Software Development Kit (SDK) meets the needs and expectations of the practitioners who will be using this software device."
Operates with specified Windows operating systems	Designed to work with Microsoft Windows 98, NT, 2000, and XP.

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

The document does not explicitly state a "test set" with a specific sample size. The description of effectiveness relies on:

Proven Windows technology and tools: This implies general computing infrastructure, not a medical dataset.
Specific medical devices noted: Refers to the VSM 5200 series and SPOT 4200 series for compatibility, but no data sample size from these devices is mentioned.
Vendors who supply CPR systems: Suggests interaction with real-world CPR systems, but no details on the number of systems, patients, or data records used for testing are provided.

Therefore, no information on data provenance (e.g., country of origin, retrospective/prospective) for a distinct "test set" is available.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided. Given the nature of the device (software interface for data collection and display, not a diagnostic device), the concept of "ground truth" as typically applied to diagnostic performance (e.g., presence/absence of a disease) does not directly apply. The "ground truth" for this device would relate to the accurate transmission and display of data as generated by the source medical devices. The document mentions "practitioners" whose "needs and expectations" were met, implying their input was considered, but no details on their number or specific qualifications are given.

4. Adjudication Method for the Test Set:

Not applicable, as no formal "test set" with adjudicated ground truth for diagnostic performance is described. The evaluation appears to be based on functional verification and user feedback.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the impact of AI on human reader performance. The SDK is a software interface, not a diagnostic tool that interacts with human readers in the same way.

6. If a Standalone Study was done:

Yes, in essence, the evaluation performed was a standalone assessment of the SDK's functionality. The SDK itself (the algorithm/software) was tested for its ability to communicate, collect, translate, and display data as intended. The "effectiveness" summary discusses the SDK's capabilities on its own, independent of a specific human-in-the-loop scenario.

7. The Type of Ground Truth Used:

The "ground truth" for this device's effectiveness is primarily functional correctness and adherence to specifications. This means:

Data integrity: Ensuring the data received by the SDK matches the data sent by the medical device.
Protocol compliance: Verifying that communication protocols (RS232, Infrared) are correctly implemented.
Data translation accuracy: Confirming that data is accurately converted to XML, ActiveX, COM.
Display accuracy: Checking if the displayed information is consistent with the source device.
User expectations: Satisfying the functional requirements of CPR manufacturers and end-users (practitioners).

There is no mention of pathology, outcomes data, or expert consensus in a diagnostic sense.

8. The Sample Size for the Training Set:

Not applicable. The Welch Allyn Vitals SDK is a software product designed for communication and data handling, not a machine learning or AI model trained on a dataset. Therefore, there is no "training set" in the context of supervised learning.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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Welch Allyn SDK Pre-market Notification_

K623495

page 1 of 3

OCT 31 2002

V. 510(k) Summary

[As described in CFR 807.92]

Submitted by:	Welch Allyn Inc.4341 State Street RoadSkaneateles Falls, NY 13153
Contact Person:	David KlementowskiCorporate Regulatory Affairs Manager
Date Prepared:	18 October 2002
Proprietary Name:	Welch Allyn Vitals Software Developers Kit (SDK)
Common Name:	Software Instrument Interface

Classification Name: Class II 870.1130 Noninvasive Blood Pressure Measurement System

Predicate Devices: Welch Allyn Instrument Interface Module (IIM) Welch Allyn, Inc. 510(k) Document Control Number K001265

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Intended Use

Safety

Due to the fact this is a software device, it is considered very safe for both practitioner and patient. The device is non-contact, its operational technique is low risk, and it only collects and displays data. The SDK is not intended to be used as a diagnostic device.

Therefore, typical safety areas are not applicable (e.g., electrical and mechanical, biocompatibility, corrosion, explosion, temperature, and fire). However, the software has undergone or will undergo the following reviews.

Risk Analysis FMEA

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Verification & Validation Tests

Summary of Effectiveness:

The determination of the Welch Allyn Vitals Software Developers Kit (SDK) effectiveness was established using:

1. Proven Windows technology and tools.
2 . Specific medical devices noted under "Device Description, Intended Use, and Effectiveness".
з. Vendors who supply CPR systems to physicians and medical facilities.

The results of the testing and evaluations indicate that the Welch Allyn Vitals Software Development Kit (SDK) meets the needs and expectations of the practitioners who will be using this software device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of a human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2002

Welch Allyn Inc. c/o Mr. David Klementowski Corporate Regulatory Affairs Manager 4341 State Street Road Skaneateles Falls, NY 13153

Re: K023495

Trade Name: Welch Allyn Vitals Software Developers Kit (SDK) Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 18, 2002 Received: October 18, 2002

Dear Mr. Klementowski:

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. David Klementowski

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Dell Tiller

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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Welch Allyn SDK Pre-market Notification

III. Indications for Use Statement

510(k) Number: Unknown

Device Name:

Welch Allyn Vitals Software Developers Kit (SDK)

Indications for use:

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

Prescription Use	X
Or Over-The-Counter Use

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices

510(k) Number	K223495
---------------	---------

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).