The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis on a windows based PC.

Device Description

The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by:
a) The contact sensor channel, which records the data for later analysis.
b) An air microphone channel. This is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above. This can be achieved by listening, or otherwise determining, signals such as speech and other noises that will be ignored when examining channel (a) data.
These two individual analogue signals are electronically conditioned and then digitally sampled. The sampled information data is then stored to a suitable internal memory module. The data will be transferred to the PC by removing the memory card from the VitaloJAK.

AI/ML Overview

The provided document, K110525 for the Vitalograph Model 7100 VitaloJAK, is a 510(k) summary for a medical device. As such, it describes the device's intended use and technological characteristics, and compares it to a predicate device to establish substantial equivalence. However, it does not contain the detailed study results, acceptance criteria, or performance metrics that would typically be presented in a dedicated clinical validation or performance study report.

The document states: "Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing. ... As with the predicate device the Vitalograph Model 7100 underwent validation testing to ensure performance according to its specifications. All tests demonstrated satisfactory results. Evidence of successful validation has been provided with this submission." This indicates that such testing was performed and submitted to the FDA, but the details are not included in this publicly available summary.

Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to address the points based only on the available information, with explicit statements where information is missing.

Acceptance Criteria and Device Performance Study for Vitalograph Model 7100 VitaloJAK

The provided 510(k) summary for the Vitalograph Model 7100 VitaloJAK does not explicitly state quantitative acceptance criteria or detailed device performance results in a comparative table format. Instead, it attests that "All tests demonstrated satisfactory results" and that "Evidence of successful validation has been provided with this submission." The focus of this 510(k) summary is on comparing the device's characteristics to a predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric Category	Acceptance Criteria	Reported Device Performance
Device Functionality	The device should accurately acquire, record, and store ambulatory cough sounds from patients for up to 24 hours via its two channels (contact sensor and air microphone). Data should be transferable to a PC for playback, review, and analysis.	"The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis of the cough sounds on a windows based PC." "The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by: a) The contact sensor channel... b) An air microphone channel." "All tests demonstrated satisfactory results."
Safety and Effectiveness	Compliance with IEC 60601 standards for electrical safety and EMC/EMI. Device specific performance testing to ensure performance according to specifications.	"Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing." "All tests demonstrated satisfactory results."
Comparison to Predicate Device	The device's technological characteristics and performance should be similar to the predicate device (Karmelsonix Pulmotrack 5050 Wholter) without raising new questions of safety or effectiveness, specifically in its non-diagnostic function of data acquisition, recording, and storage.	"The characteristics of the Model 7100 is similar to those of the predicate device listed." "As with the predicate device the Vitalograph Model 7100 does not perform diagnosis."
Accuracy of Cough Sound Recording	Explicit quantitative acceptance criteria for the accuracy of cough sound acquisition and recording are not provided in this summary. This would typically involve metrics such as signal-to-noise ratio, fidelity of sound capture, or consistency of recording over time.	The summary extensively describes the technical characteristics for recording, including two separate channels (contact sensor and ambient microphone) and digital sampling. It states, "The air microphone channel is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above." This suggests an internal validation mechanism, but no quantitative results are given. "All tests demonstrated satisfactory results."

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: This information is not provided in the 510(k) summary.
Data Provenance (country of origin, retrospective/prospective): This information is not provided in the 510(k) summary. The document focuses on the technical characteristics and regulatory compliance, not on clinical study data.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

This information is not provided in the 510(k) summary. Since the device itself is not diagnostic and "The user identifies each incident of coughing," the role of experts in establishing a ground truth for device performance (beyond general technical specifications) is not detailed. If a study involved expert review of the recorded data, it is not mentioned here.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No evidence of an MRMC comparative effectiveness study is presented in this 510(k) summary. The device is explicitly stated to not perform diagnosis and requires a user to identify cough incidents. Therefore, a study comparing human readers with and without AI assistance would not be applicable to this device's stated function.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) was not performed or is not detailed in this 510(k) summary for automated cough detection or analysis. The device's stated function is solely to "acquire, record and store ambulatory cough sounds," and for "later playback, review, and analysis of the cough sounds on a windows based PC" where "The user identifies each incident of coughing." The device itself does not contain an algorithm for automatic cough identification or diagnosis.

7. Type of Ground Truth Used

The 510(k) summary does not mention a specific type of ground truth used to evaluate the device's core function of recording. The "validity of the data obtained" (from the contact sensor) is stated to be ascertained by the air microphone channel, but this refers to technical signal validity rather than a clinical ground truth for cough events. For the analysis phase, where the user identifies coughs, the ground truth would implicitly be human expert identification, but this is a post-recording step leveraging the user, not an automated function of the device that requires an inherent ground truth during device operation.

8. Sample Size for the Training Set

This information is not applicable and not provided. The device is a data recorder, not an AI-driven diagnostic or analytical tool that requires a training set (in the machine learning sense). Its functionality is based on hardware and firmware for signal acquisition and storage.

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

This information is not applicable and not provided. As mentioned above, the device does not use a training set in the machine learning context.

Summary

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K110525

510K Summary as required by 21 CFR 807.92

1. Company Information: Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.
  Tel: +353656864100 Fax: +353656829289.

)

1. Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
1. Date of Submission: 8th February 2011.
1. Device Trade Name: Vitalograph Model 7100
1. Common / Usual name: Vitalograph Model 7100 VitaloJAK,
1. Classification number: Recorder, magnetic tape, medical, Class II per 21 CFR 870.2800

Manufacturer	: Karmelsonix
Device Name	: Pulmotrack 5050 Wholter{Recorder, magnetic tape, medical}
510(k) No	: K101022

8. Intended Use / Description of Device:

1. Technological Characteristics
  The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by:

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a) The contact sensor channel, which records the data for later analysis.
b) An air microphone channel. This is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above. This can be achieved by listening, or otherwise determining, signals such as speech and other noises that will be ignored when examining channel (a) data.

These two individual analogue signals are electronically conditioned and then digitally sampled. The sampled information data is then stored to a suitable internal memory module. The data will be transferred to the PC by removing the memory card from the VitaloJAK. .

Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing.

The device itself is not diagnostic. It acquires the respiratory data for later review after removing the memory card and transferring the data to a PC. The user identifies each incident of coughing.

Comparison with Predicate

As with the predicate device the Vitalograph Model 7100 does not perform diagnosis.

As with the predicate device the Vitalograph Model 7100 underwent validation testing to ensure performance according to its specifications. All tests demonstrated satisfactory results. Evidence of successful validation has been provided with this submission.

	Vitalograph Model 7100	Karmelsonix Pulmotrack 5050Wholter.{K101022}
Number of sensors	2 {incl ambient microphone}	4 {incl ambient sensor}
Acoustic sensors (attached to the patient using adhesive pads)	Yes	Yes
Non-invasive	Yes	Yes
Tension-sensitive respiration belt	No	Yes
Ambient microphone	Yes	Yes
Firmware and Flash memory	Yes	Yes
USB cable	No	Yes

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Conclusion:

The characteristics of the Model 7100 is similar to those of the predicate device listed.

Based on the above, including the successful completion of all device testing, Vitalograph conclude that this device is substantially equivalent to the legally marketed predicate device and is safe and effective for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

NOV 213 2008

Vitalograph (Ireland) Ltd. c/o Mr. Tom J. Healy Regulatory Affairs/Quality Assurance Manager Gort Road Business Park Ennis, Co Clare IRELAND

Re: K110222

Trade/Device Names: Vitalograph Model 7100 -- VitaloJAK Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (Two) Product Code: DSH Dated: October 27, 2011 Received: November 3, 2011

Dear Mr. Healy:

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 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. Tom J. Healy

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.

M.A. Hillemann

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): K110525

Device Name: Vitalograph Model 7100- VitaloJAK

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. S. Hillebenne

(Division Sign-Off) Division of Cardiovascular Devices

KII0525 510(k) Number_

Page 1 of 1 .

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).