(273 days)
Not Found
No
The description focuses on data acquisition, recording, storage, and playback for later manual analysis. There is no mention of automated analysis, algorithms, or any terms associated with AI/ML.
No.
The device is described as non-invasive and intended to acquire, record, and store ambulatory cough sounds for later analysis, not to provide therapy.
No
The device is intended to acquire, record, and store cough sounds for later review and analysis. It does not perform a diagnostic function itself, but rather provides data for analysis.
No
The device description explicitly states it is a "non-invasive battery operated device" that acquires, records, and stores data using physical sensors (contact sensor and air microphone) and a removable memory card. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Model 7100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Model 7100 Function: The Model 7100 acquires, records, and stores cough sounds from patients. This is a non-invasive process that involves capturing external physiological sounds, not analyzing biological specimens.
- Lack of Specimen Analysis: The device description focuses on the acquisition and storage of sound data for later analysis on a PC. There is no mention of analyzing any biological samples.
Therefore, the Model 7100 falls outside the scope of an In Vitro Diagnostic device. It is a device for physiological sound recording and analysis.
N/A
Intended Use / 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.
Product codes
DSH
Device Description
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, 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. .
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510K Summary as required by 21 CFR 807.92
-
- Company Information: Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.
Tel: +353656864100 Fax: +353656829289.
- Company Information: Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.
)
-
- Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
-
- Date of Submission: 8th February 2011.
-
- Device Trade Name: Vitalograph Model 7100
-
- Common / Usual name: Vitalograph Model 7100 VitaloJAK,
-
- 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:
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.
-
- Technological Characteristics
The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by:
- Technological Characteristics
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.
- 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
Wholter.
{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
- 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 (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
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_
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