VITALOGRAPH MODEL 7100 - VITALOJAK

K110525 · Vitalograph (Ireland) , Ltd. · DSH · Nov 23, 2011 · Cardiovascular

Device Facts

• Record ID: K110525
• Device Name: VITALOGRAPH MODEL 7100 - VITALOJAK
• Applicant: Vitalograph (Ireland) , Ltd.
• Product Code: DSH · Cardiovascular
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

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.

Device Story

Vitalograph Model 7100 (VitaloJAK) is a non-invasive, battery-operated ambulatory recorder; captures cough sounds for up to 24 hours. Inputs: two-channel acoustic data via contact sensor and ambient microphone. Principle: electronic conditioning and digital sampling of acoustic signals; data stored on removable memory card. Workflow: device worn by patient; data transferred to Windows-based PC via memory card removal. Output: recorded sound files for clinician review. Clinical use: clinician identifies cough incidents during playback; device is not diagnostic. Benefit: facilitates long-term ambulatory cough monitoring for clinical assessment.

Clinical Evidence

Bench testing only. No clinical data provided. Validation testing performed to ensure device performance according to specifications; compliance with IEC 60601 standards for electrical safety and EMC/EMI verified.

Technological Characteristics

Non-invasive, battery-operated ambulatory recorder. Two-channel acoustic sensing (contact sensor and ambient microphone). Data storage via removable memory card. Connectivity: offline data transfer to Windows PC. Compliance: IEC 60601 (electrical safety, EMC/EMI).

Indications for Use

Indicated for patients requiring ambulatory monitoring of cough sounds for up to 24 hours. Non-invasive, battery-operated device for data acquisition and storage for subsequent clinical review.

Regulatory Classification

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.

Predicate Devices

• Pulmotrack 5050 Wholter (K101022)

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone] Fax: [phone].

)

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

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

### 8. Intended Use / Description of Device:

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.

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

{1}------------------------------------------------

- 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.

10. 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 5050<br>Wholter.<br>{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 |

{2}------------------------------------------------

11. 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.

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

# 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.

{4}------------------------------------------------

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 [phone] or [phone] 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

{5}------------------------------------------------

#### Indications for Use

510(k) Number (if known): K110525

Device Name: Vitalograph Model 7100- VitaloJAK

Indications for Use:

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.

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 .