The Welch Allyn Printing Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject Devices will provide the following diagnostic functions:

Acquiring, viewing, storing and printing ECG waveforms patients using ECG . Front End modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
Using optional algorithms to generate measurements, data presentations, . graphical presentations and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.
Using the optional Spirometry module and associated accessories to acquire, . view, store and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The spirometer should only be used with patients able to understand the instructions for performing the test, such as with children greater than three (3) years of age.

Device Description

The Welch Allyn Multi-Channel Electrocardiographs, the low cost CP 100 or full-featured CP200. Both feature full alphanumeric keyboards for easy and fast entry of patient demographics, user-programmable report formats printed on patient chart size thermal paper, ECG measurement, advanced filters for optimal ECG trace quality and battery or AC operation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Welch Allyn CP 100/200 Electrocardiography and Spirometry Products, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it describes the intended functions of the device. Since specific numerical targets are not mentioned, I will infer the performance criteria from the device's stated functions.

Performance Characteristic	Acceptance Criteria (Inferred from Intended Use)	Reported Device Performance
ECG Functionality	Acquiring, viewing, storing, and printing ECG waveforms for up to twelve (12) leads.	The device provides these functions, as stated in its intended use.
ECG Interpretation (Optional Algorithm)	Generating measurements, data presentations, graphical presentations, and advisory interpretive statements for patients 16 years and older. These are for review and interpretation by a clinician.	The device offers these algorithmic capabilities as an option, with the caveat that they are advisory and require clinical review.
Spirometry Functionality (Optional Module)	Acquiring, viewing, storing, and printing measures and waveforms of pulmonary function (e.g., maximal volume and flow of air).	The device provides these functions as an optional module.
Spirometry Patient Age Range	Usable with patients able to understand instructions (e.g., children > 3 years old). Interpretive results are not calculated for children under six.	The device adheres to these age limitations for spirometry testing and interpretations.

Study Information

The provided 510(k) premarket notification does not contain details of a specific performance study (e.g., clinical trials, bench testing with detailed results) that "proves" the device meets acceptance criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that the device's design, intended use, technology, and performance are sufficiently similar to approved devices that it raises no new questions of safety or effectiveness. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the devices... are substantially equivalent."

Therefore, many of the specific study-related questions cannot be directly answered from the provided text.

Sample size used for the test set and the data provenance: Not mentioned in the provided text, as a specific "test set" for a new performance study is not described. The substantial equivalence determination would have involved a comparison of design and functional specifications, potentially using literature or prior predicate device data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no specific ground truth establishment for a new test set is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned, as no specific test set or adjudication process is described.
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: Not mentioned. This type of study is typically done for AI-driven diagnostic aids. While the device includes an "optional algorithm to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis," the document does not suggest a new MRMC study was conducted to evaluate its impact on human readers. Such a study might have been conducted for the predicate device's interpretive algorithm or would be part of a separate submission if the algorithm itself was novel and required performance validation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned. For the interpretive algorithm, its "advisory basis" implies it's not strictly standalone for diagnosis. The 510(k) process for substantial equivalence often means that the algorithm's performance is either comparable to or directly inherited from the predicate device's validated algorithm, or its performance is evaluated in a non-clinical context against established standards rather than a formal standalone clinical study described here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For substantial equivalence, ground truth for comparing device characteristics is often based on engineering specifications, recognized standards, and the performance characteristics of the predicate devices.
The sample size for the training set: Not mentioned. Training sets are relevant for machine learning algorithms. While an "optional algorithm" is mentioned, details about its development (including training data) are not part of this 510(k) summary, which focuses on substantial equivalence rather than novel algorithm validation.
How the ground truth for the training set was established: Not mentioned.

Summary of Substantial Equivalence:

The core of this 510(k) submission is the claim of substantial equivalence to two predicate devices:

PageWriter Trim Series Cardiograph (K031422) for electrocardiography.
Spirometer System (Medikro D9 Spirometer) (K971336) for spirometry.

The FDA's approval indicates they found no new questions of safety or effectiveness compared to these legally marketed devices, implying that the Welch Allyn CP 100/200 meets an acceptable level of performance based on comparison to its predicates, rather than through a new, detailed clinical performance study described within this document.

Summary

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MAR 2 2 2005

Welch Allyn

7AlBreviated 510(k) Prernarket Notification Welch Allyn Printing Electrocardiography and Spirometry Froducts

12. Premarket Notification [510(k)] Summary

Submitted By:	Welch Allyn, Inc.4341 State Street RoadSkaneateles Falls, NY 13153-0220Phone: 315-554-5289Fax: 315-685-2532Contact: Joshua S. Kim
---------------	-------------------------------------------------------------------------------------------------------------------------------------------------------

Electrocardiographs Common Name:
CP 100 and CP 200 (including Spirometry) Trade Name:
21 CFR 870.2340 Classification:
Predicate Device: The legally marketed medical devices to which substantially equivalent to the following:
- PageWriter Trim Series Cardiograph (K031422) ●
- Spirometer System (Medikro D9 Spirometer) (K971336) .
The Welch Allyn Multi-Channel Electrocardiographs, the low cost Description: CP 100 or full-featured CP200. Both feature full alphanumeric keyboards for easy and fast entry of patient demographics, userprogrammable report formats printed on patient chart size thermal paper, ECG measurement, advanced filters for optimal ECG trace quality and battery or AC operation.

Intended Use:

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WelchAllyn

Abbreviated 510(k) Premarket Notification Abbieriator Printing Electrocardiography and Spirometry Products

Acquiring, viewing, storing and printing ECG waveforms patients using ECG . Front End modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
Using optional algorithms to generate measurements, data presentations, . graphical presentations and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.
Using the optional Spirometry module and associated accessories to acquire, . view, store and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The spirometer should only be used with patients able to understand the instructions for performing the test, such as with children greater than three (3) years of age.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

MAR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Welch Allyn, Inc. c/o Mr. Christopher Klaczyk Regulatory Affairs Manager 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

Re: K050074 K050074
Trade Name: CP 100 and CP 200 (including Spirometry)
Trade Name: CP 100 and CPD 200 2340 Trade Name: 21 CFR 892.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 8, 2005 Received: March 9, 2005

Dear Mr. Klaczyk:

We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication in the supportual the dayson is substantially equivalent (for the We have reviewed your Section 5 IQC) premiated in useuivalent (for the indications
referenced above and have determined the devices marked in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally marketed previce Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug, commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug, devices that have been reclassified in accordance while to warder approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. and Cosmetic Act (Act) that do not require approval or the general ontrols of the Act. The Act. The
You may, therefore, market for any and registered registrations of list You may, therefore, market the device, subject to the general ocanced registration, listing of
general controls provisions of the Act Include requirements for any instranding general controls provisions of the Act Include requirements for the only of the many and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in the can and the cases of the class to desting major regulations If your device is classified (see above) mio entirer cass in openar over device can
may be subject to such additional controls. Listing major regulations affection, FDA may may be subject to such additional controls. Extraig major regalataons and and the may
be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, F be found in the Code of Federal Regulations, This 2017 - 1
publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 – Mr. Christopher Klaczyk

r age be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equivalented with other requirements of the Act
that FDA has made a determination that your device complies with of the that FDA has made a determination that your device compire Frederal agencies. You must
or any Federal statutes and regulations adminstered by other to: registration and lis or any Federal statutes and regulations administered by out its in the many institution and listing (21)
comply with all the Act 3 requirements, including, but not limited to comply with all the Act srequirements, including, out not mines were as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practices lequences and secondent of the electronic
forth in the quality systems (QS) regulation (21 CFR Part 82 forth in the quality systems (QS) regulation (2) CFA of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 33 - 3-2 of the Roy) = 1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inches if section for your device and th premarket notification. The FDA finding of substantial equivalies or your device
marketed predicate device results in a classification for your device and thus, permits your to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r in the supportunities and 10 10 - Also, please note the regulation entitl If you desire specific advice for your device on but nating bease note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, play obtain. contact the Office of Compliance at (240) 2/05/2017 (21CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may bolta "Misbranding by reference to premarket notification" (2) Act may be obtained from the
Other general information on your responsibilities under the Act may be obtained from th Other general information on your responsional and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its t Division of Sinal Manufact.rers, or at its Internet address (600) 056-2011 01 /cdrh/dsma/dsmamain.html

Sincerely yours,

Bhummoe 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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WelchAllyn

Abbreviated 510(k) Premarket Notification Welch Allyn Printing Electrocardiography and Spirometry Products

11. Statement of Indications For Use

510(k) Number (if known):

Device Name:

CP100 and CP200

K050074

Indications For Use:

The Welch Allyn Printing Electrocardiography and Spirometry Products (Subject

Devices) are intended for use by trained operators in health facilities. The subject

Devices will provide the following diagnostic functions:

Acquiring, viewing, storing and printing ECG waveforms patients using ECG � Front End modules and associated accessories that provide signal acquisition for Front End modules and associated accessories through surface electrodes adhered to the body.
Using optional algorithms to generate measurements, data presentations, graphical . presentations and interpretive statements on an advisory basis for patients of presentations and interpreive satences on above. These are presented for review and sixteen (10) years of age and as ven knowledge of the patient, the results of the prelation by the comreter. ECG tracings, and other clinical findings.
Using the optional Spirometry module and associated accessories to acquire, . Using the optional Spiromea's and waveforms of pulmonary function including, view, store and print measures and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of of a patient's lungs. These modeles for the treatment of certain lung diseases. The lung diseases and menventions for are able to understand the instructions Spirometer may be used with pations that are and interpretive results are not calculated for children under the age of six.

Prescription Use __ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 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)

and/or

Blimmerman
(Division Sign-Off)
Division of Cardiovascular Devices

Page 1 of 1

MPD FCD-0025, Rev. 1

510(k) Number

Section 11 - Page 1 of 1 This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).