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}

AI/ML Overview

Here's an analysis of the provided text to extract information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and the Reported Device Performance:

Feature	Acceptance Criteria (Vitalograph Model 4000)	Reported Device Performance (Vitalograph Model 4000)
Volume Range	0-9.99 Litres	Meets: 0-9.99 Litres
Flow Range	0-840 L/minute	Meets: 0-840 L/minute
Accuracy FEV1	+/- 3%	Meets: +/- 3%
Accuracy FEV6	+/- 3%	Meets: +/- 3%
Accuracy PEF	+/- 5%	Meets: +/- 5%
Back Pressure	Better than 0.15kPa/L/s at 14L/s	Meets: Better than 0.15kPa/L/s at 14L/s
Operating Temp	17-37°C per ATS 2005	Meets: 17-37°C per ATS 2005
Storage Temp	0 - 50 °C	Meets: 0 - 50 °C
Humidity	10 - 95% relative humidity	Meets: 10 - 95% relative humidity
Standard	ATS 2005, ISO 23747:2007 for PEF (formerly EN13826:2003)	Meets: ATS 2005, ISO 23747:2007 for PEF (formerly EN13826:2003)
Compliance	EN 60601 (EN 60601-1-1 and EN 60601-1-2), IEC 61000-4-2, IEC61000-4-3 (battery operated)	Meets: EN 60601 (EN 60601-1-1 and EN 60601-1-2), IEC 61000-4-2, IEC61000-4-3 (battery operated)
Regulatory	FDA - 510(k), CE (0086) Class 2a	Meets: FDA - 510(k), CE (0086) Class 2a
Lung Age Display	ASMA-1: NO, COPD-6: Yes (This is a feature comparison to the predicate, not strictly an acceptance criterion, but included for completeness as it differentiates the models)	Meets: ASMA-1: NO, COPD-6: Yes
Set Predicted /reference values	Yes (by qualified person, not user) (This is a feature comparison to the predicate, not strictly an acceptance criterion, but included for completeness)	Meets: Yes (by qualified person, not user)
Communication	Bluetooth and/or USB to be incorporated. (This describes the intended feature, and its functionality would need to be verified during testing).	Meets: Bluetooth and/or USB to be incorporated. (The approval implies this was considered functional, though specific performance details for this are not in the table).
Battery Warnings	On-screen Battery Full, Half Full and Battery Empty (Flashing icon) (This describes the intended feature, and its functionality would need to be verified during testing).	Meets: On-screen Battery Full, Half Full and Battery Empty (Flashing icon).
Autopowerdown	2 minutes (This is a design specification, and its functionality would need to be verified during testing).	Meets: 2 minutes.

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study for novel device performance. The acceptance criteria are primarily based on established international standards for spirometers (ATS 2005, ISO 23747:2007) and regulatory compliance (EN 60601 series, IEC 61000 series, FDA 510(k), CE marking).

The statement "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices" implies that Vitalograph submitted data demonstrating that their device meets these established performance and safety standards. However, the 510(k) summary itself does not explicitly detail the study or studies that generated the performance data (e.g., how the +/- 3% accuracy was verified). Instead, it states the specifications and that the device meets them, likely supported by internal testing reports that are part of the larger 510(k) submission, but not included in this summary.

Given the nature of a spirometer, the "study" would likely involve:

Bench testing: Using calibrated flow and volume generators to assess the accuracy of FEV1, FEV6, and PEF measurements across the specified ranges.
Environmental testing: Subjecting the device to various temperature and humidity conditions to verify operating and storage parameters.
Electromagnetic Compatibility (EMC) testing: Conforming to IEC 61000 standards.
Safety testing: Conforming to EN 60601 standards for medical electrical equipment.

Detailed Information Not Available in the Provided Text:

The document is a 510(k) summary, which often omits the granular details of testing methodologies and underlying data. Therefore, the following information is not provided in the extracted text:

Sample size used for the test set and the data provenance: Not specified. The performance metrics (e.g., accuracy) are stated as specifications rather than results from a particular test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. For spirometer accuracy, ground truth is typically established by physical standards and calibrated equipment, not by human expert consensus or annotations in the way AI/radiology devices might.
Adjudication method for the test set: Not applicable/specified, as the ground truth is based on physical standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standalone diagnostic spirometer, not an AI-assisted diagnostic tool that helps human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the performance metrics listed (e.g., accuracy for FEV1, FEV6, PEF) would be derived from the device's inherent measurement capabilities operating in a standalone mode, without human interpretation for the measurement itself (though human interpretation of the results is part of its intended use).
The type of ground truth used: For accuracy measurements (FEV1, FEV6, PEF), the ground truth would be established by calibrated spirometer verification equipment (e.g., a syringe pump or flow/volume simulator) that can deliver known volumes and flows.
The sample size for the training set: Not applicable. This device is a measurement instrument, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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Vitalograph® K073/155

VITALOGRAPH (IRELAND) LIMITED, ENNIS INDUSTRIAL ESTATE, GORT ROAD, ENNIS, CO. CLARE TELEPHONE: (065) 6864100. FAX: (065) 6829289.

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: +353656864100 Fax: +353656829289.
1. Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
1. Date of Submission: October 04, 2007.
1. Device Trade Name: Vitalograph Model 4000. {asma-1 and copd-6}
1. Common / Usual name: Electronic Peak Flow Meter, handheld spirometer,
1. 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:

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:

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 :NOCopd-6: Yes	Yes
Set Predicted /reference values	Yes (by qualified person, not user)	No
Memory Type:Sounds:	Non-volatileColour zones: 3 or 4 Zone (Green, Yellow, Red). +Orange in 4 zone planQuality Factor: Warning & indicator for cough or poor blowAudible beeps emitted during power on, whilst performing a test, at end of test and for each key press.	Non-volatileColor Zone: 3 Color Zones (Green, Yellow, Red)Quality Factor: Warning & indicator for cough or abnormal blowAudible 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 (formerlyEN13826:2003.	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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: : – ----

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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).