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

K073155 · Vitalograph (Ireland) , Ltd. · BZG · Jun 4, 2008 · Anesthesiology

Device Facts

• Record ID: K073155
• Device Name: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
• Applicant: Vitalograph (Ireland) , Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Jun 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

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 Story

Handheld, battery-powered electronic spirometer (Model 4000 series: asma-1 and copd-6); measures expired Peak Flow and forced expired volume in one second (FEV1) via uni-directional rotating vane flow sensor. Patient exhales into flowhead; device processes signal and displays results on LCD. Used by patients at home for condition monitoring or by GPs in clinics. Navigation via four buttons. Includes Bluetooth/USB for data export. Provides audible beeps for test guidance and quality indicators (cough/poor blow detection). Helps clinicians diagnose/manage asthma and COPD; enables patient self-monitoring.

Clinical Evidence

Bench testing only. Device performance validated against ATS 2005 and ISO 23747:2007 standards. Accuracy for FEV1 and FEV6 is +/- 3%; PEF accuracy is +/- 5%.

Technological Characteristics

PC/ABS construction; rotor-stator flow sensor; battery-powered (2x AAA); handheld form factor (113x63x48mm). Connectivity via Bluetooth/USB. Compliant with EN 60601-1, IEC 61000-4-2/3, ATS 2005, and ISO 23747:2007. Features non-volatile memory, audible feedback, and quality factor indicators for test validity.

Indications for Use

Indicated for patients with asthma or COPD to monitor lung function (FEV1, PEF, FEV6) at home or in a clinical setting.

Regulatory Classification

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.

Predicate Devices

• PulmoLife (K061283)

Submission Summary (Full Text)

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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<br>(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<br>Copd-6: Yes | Yes |
| Set Predicted /<br>reference values | Yes (by qualified person, not user) | No |
| Memory Type:<br>Sounds: | Non-volatile<br>Colour zones: 3 or 4 Zone (Green, Yellow, Red). +<br>Orange in 4 zone plan<br>Quality Factor: Warning & indicator for cough or poor blow<br>Audible beeps emitted during power on, whilst performing a test, at end of test and for each key press. | Non-volatile<br>Color Zone: 3 Color Zones (Green, Yellow, Red)<br>Quality Factor: Warning & indicator for cough or abnormal blow<br>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<br>EN13826:2003. | ATS 2005 |
| Compliance: | EN 60601 (EN 60601-1-1 and EN 60601-1-2)<br>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:

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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: