VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

• K Number: K073155
• Device Name: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
• Manufacturer: VITALOGRAPH(IRELAND) LTD.
• Date Cleared: 2008-06-04 ( 209 days)
• Product Code: BZG
• Regulation Number: 868.1840

Intended Use

To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.

Device Description

The Vitalograph Model 4000 series {asma-1 and copd-6} are battery powered handheld electronic spirometers used to measure expired Peak Flow and forced expired volume after one second {FEV1} .. The results can aid in the diagnosis of Asthma and COPD in patients. All variants {asma-1 and copd-6} within the range use the very same operating principle, LCD, Buttons, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. I.e. Asma-1 displays FEV 1 and PEF, whilst the copd-6 displays FEV 1 and FEV6 only. A uni-directional rotating vane with flow sensor to measure lung function is used. The measurements are taken via expiration into the unit flowhead, which is In-turn displayed onto an LCD. Navigation is allowed via the use of four buttons {Up, Down, Enter/Select and power On/Off}

Predicate Devices

K061283

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard electronic spirometer using a rotating vane and flow sensor to measure lung function parameters (PEF, FEV1, FEV6). There is no mention of AI, ML, image processing, or any data processing beyond direct measurement and display of these parameters. The performance metrics are standard accuracy measurements for spirometry.

Therapeutic

No.
The device is for monitoring and aiding in diagnosis, not for treating or preventing disease.

Diagnostic

Yes

The device measures Peak Flow and FEV1, and the description explicitly states that "The results can aid in the diagnosis of Asthma and COPD in patients."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "battery powered handheld electronic spirometer" with a "uni-directional rotating vane with flow sensor" and an "LCD" for display, indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The Vitalograph Model 4000 series measures lung function parameters (PEF, FEV1, FEV6) by having the patient exhale directly into the device. This is a direct measurement of a physiological function, not an analysis of a sample taken from the body.
• Intended Use: The intended use is for monitoring asthma/COPD and aiding in diagnosis, which is achieved through the measurement of lung function, not through the analysis of a biological sample.

Therefore, while it's a medical device used for diagnosis and monitoring, it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.

Product codes

BZG

Device Description

The Vitalograph Model 4000 series {asma-1 and copd-6} are battery powered handheld electronic spirometers used to measure expired Peak Flow and forced expired volume after one second {FEV1} .. The results can aid in the diagnosis of Asthma and COPD in patients.
All variants {asma-1 and copd-6} within the range use the very same operating principle, LCD, Buttons, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. I.e. Asma-1 displays FEV 1 and PEF, whilst the copd-6 displays FEV 1 and FEV6 only.
A uni-directional rotating vane with flow sensor to measure lung function is used. The measurements are taken via expiration into the unit flowhead, which is In-turn displayed onto an LCD.
Navigation is allowed via the use of four buttons {Up, Down, Enter/Select and power On/Off}

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lungs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

asthma / copd patient at home, General Practitioner's clinic

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K061283

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).

Summary

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Vitalograph® K073/155

VITALOGRAPH (IRELAND) LIMITED, ENNIS INDUSTRIAL ESTATE, GORT ROAD, ENNIS, CO. CLARE TELEPHONE: [phone]. FAX: [phone].

510K Summary

as required by 21 CFR 807.92

JUN - 4 2008

• 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: October 04, 2007.
• 4. Device Trade Name: Vitalograph Model 4000. {asma-1 and copd-6}
• 5. Common / Usual name: Electronic Peak Flow Meter, handheld spirometer,
• 6. Classification number: Spirometer as classified in Class II per 21 CFR 868.1840

Extracted from 21 CFR 868 on September 28, 2007:

Subpart B -- Diagnostic Devices

Sec. 868.1840 Diagnostic spirometer.

• (a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
• (b) Classification. Class II (performance standards)

7. Predicate Device:

Manufacturer	: Micro Medical
Device Name	: PulmoLife
510(k) No	: K061283

8. Description of Device:

The Vitalograph Model 4000 series {asma-1 and copd-6} are battery powered handheld electronic spirometers used to measure expired Peak Flow and forced expired volume after one second {FEV1} .. The results can aid in the diagnosis of Asthma and COPD in patients.

All variants {asma-1 and copd-6} within the range use the very same operating

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principle, LCD, Buttons, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. I.e. Asma-1 displays FEV 1 and PEF, whilst the copd-6 displays FEV 1 and FEV6 only.

A uni-directional rotating vane with flow sensor to measure lung function is used. The measurements are taken via expiration into the unit flowhead, which is In-turn displayed onto an LCD.

Navigation is allowed via the use of four buttons {Up, Down, Enter/Select and power On/Off}

9. Intended use:

To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.

10. Technological Characteristics

The Vitalograph Model 4000, as with the Pulmo life uses a rotating vane to measure lung function. All are intended to be handheld, portable devices. All are battery powered and operated via four buttons {On / Off, Up, Down, Enter / Select}.

The primary difference between the Model 4000 and the predicate device is the inclusion of Bluetooth and/or USB in the Model 4000 for data export / printing where the predicate uses bi- directional IR as a means of communication.

Also, the Model 4000 range allows the General Practitioner to set expected predicted values. These entries are not adjustable by the end user.

| | Vitalograph Model 4000
(asma-1 /copd-6) Specifications | PulmoLife Specifications |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume Range: | 0-9.99 Litres | 0-8Litres |
| Flow Range | 0-840 L/minute | 0-14 Litres / second (0-840 L/minute) |
| Accuracy FEV1: | +/- 3% | +/-3% |
| Accuracy FEV6 | +/- 3% | +/- 3% |
| Accuracy PEF | +/- 5% | N/A |
| Technology: | Rotor stator design | Rotor stator design |
| Lung age | Asma-1 :NO
Copd-6: Yes | Yes |
| Set Predicted /
reference values | Yes (by qualified person, not user) | No |
| Memory Type:
Sounds: | Non-volatile
Colour zones: 3 or 4 Zone (Green, Yellow, Red). +
Orange in 4 zone plan
Quality Factor: Warning & indicator for cough or poor blow
Audible beeps emitted during power on, whilst performing a test, at end of test and for each key press. | Non-volatile
Color Zone: 3 Color Zones (Green, Yellow, Red)
Quality Factor: Warning & indicator for cough or abnormal blow
Audible beeps emitted during power on, at end of test and for each key press. |

Witchsofanh

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Communication:	Bluetooth and/or USB to be incorporated.	Bi-directional Infra Red port (RS232 format)
	On-screen Battery Full, Half Full and Battery	Low Battery warning and audible beep.
Battery Warnings:	Empty (Flashing icon)
Battery Type:	2 x 1.5V AAA	3v Li coin cell (CR2450)
Autopowerdown	2 minutes	4 minutes
Dimensions:	113 x 63 x 48 mm	131 x 59 x 38 mm
Weight:	Incl batteries 83g net, packaged 125g	Incl batteries 96 g, complete with accessories 260g
Material Type:	PC/ABS
Back Pressure:	Better than 0.15kPa/L/s at 14L/s
Operating Temp:	17-37°C per ATS 2005.	0 to 40°C
Storage Temp:	0 - 50 °C	(-20) to 70oC
Humidity:	10 - 95% relative humidity	30 - 90% relative humidity
Standard:	ATS 2005, ISO 23747:2007 for PEF (formerly
EN13826:2003.	ATS 2005
Compliance:	EN 60601 (EN 60601-1-1 and EN 60601-1-2)
IEC 61000-4-2, IEC61000-4-3 (battery operated)	EN 60601 (EN 60601-1-1 and EN 60601-1-2)
	FDA - 510(k)	FDA - 510(k)
Regulatory:	CE (0086) Class 2a
Warranty:	1 Year	7 months (batteries not included)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2008

Mr. Tom J. Healy Regulatory Affairs & Quality Assurance Manager Vitalograph (Ireland) Limited Gort Road Business Park Ennis, Co. Clare IRELAND

Re: K073155

Trade/Device Name: Vitalograph Model 4000 (ASMA-1 and COPD-6) Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: May 22, 2008 Received: May 27, 2008

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 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. 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); 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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/cdrh/industry/support/index.html.

Sincerely yours,

Suite H. Michie Ound.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

4000 Device Name: OOFL

Indications For Use:

The 106

AND/OR Subbait &

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Goncurremos of CDRH, Office of Device Evaluation (ODE)

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Clive

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Gontrol, Dental Devilage Infection Control, Dental Devices

510(k) Number: