The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.

The SPIRO PD spirometer is indicated for the following age groups:

2-12 years Child
13-21 years Adolescent
22 and over- Adult

Device Description

The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical signals must be changed to electrical signals. The devices responsible for this change are called transducers. The SPIRO PD has a Turbine-type transducer. The turbine transducer performs transduction in two stages: The volume to be measured crosses the turbine vane and records its rotation that is proportional to that Volume, this rotation is detected by the interrupting of a beam of infrared light, the sensor of which converts the light received into a digital-type electrical signal.

The SPIRO PD performs the following tests:

FVC,
FEV1 .
FEV1/FVC ●
PEF
FEF 25-75%
Estimated Lung Age and Flow/Volume Curve .

The Spiro PD performs the following calculations:

% Predicted of FVC ●
Severity of FVC .
% Predicted of FEV1
Severity of FEV1 .
% Predicted of FEV1/FVC .
Severity of FEV1/FVC .
% Predicted of FEF 25-75% .
Severity of FEF 25-75%
% Predicted of PEF, Severity of PEF .

The physical configuration of the Spiro PD:

Display Color, Touch screen LCD 320 x 240 resolution .
Keyboard - Touch screen
Power supply 3.7V Lithium-ion battery 650 mAh .
Dimensions 200 x 96 x 40mm .
Weight 256g with battery .

AI/ML Overview

Acceptance Criteria and Device Performance Study for SPIRO PD Spirometer

The SPIRO PD Spirometer's acceptance criteria and performance are primarily based on demonstrating substantial equivalence to predicate devices and adherence to relevant industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

This device is a spirometer, and its performance is judged on several technical specifications, adherence to guidelines, and safety. There isn't a single "acceptance criteria" table with corresponding "reported device performance" in the submission that details a pass/fail against specific clinical accuracy thresholds. Instead, the acceptance is demonstrated through a combination of comparative analysis with predicate devices and successful completion of non-clinical tests.

Below is a summary of the key performance and safety characteristics, showing how the device performance aligns with generally accepted standards for spirometers and its predicate devices.

Acceptance Criteria (Inferred from Predicate Comparison & Standards)	Reported Device Performance
Functional Parameters:
Maximum Volume (Comparable to predicates)	0 - 10 L (Identical to SDI Diagnostics' Spirotel, greater than Vitalograph's 0.99 L BTPS, which has a more limited test scope)
Flow Range (Comparable to predicates)	0 - 16 L/s (Comparable to SDI Diagnostics' Spirotel which is +16 L/s. Vitalograph has a different metric of 0.15 kPa/L/s at 14 L/s)
Flow Accuracy (Comparable to predicates and ATS/ERS guidelines)	±5% or 200 mL/s (Identical to SDI Diagnostics' Spirotel. Vitalograph reports ±3%)
Volume Accuracy (Comparable to predicates and ATS/ERS guidelines)	±3% or 50 mL, whichever is greater (Identical to SDI Diagnostics' Spirotel. Vitalograph reports ±3%)
Adherence to ATS Spirometry Performance Recommendations	Yes
Test Duration (Compliance with ATS guidelines)	Minimum of three tests at 15 sec per test (Consistent with ATS guidelines and Vitalograph. Spirotel has a maximum of 60 seconds)
Biocompatibility (ISO 10993 Series)	Elution Test (ISO 10993-5): Test article's extracts meet requirements.Guinea Pig Closed Patch Sensitization Test (ISO 10993-10) Cottonseed Oil Extract: Elicited a minimal sensitization reaction.Guinea Pig Closed Patch Sensitization Test (ISO 10993-10) Saline Extract: Did not elicit a sensitization reaction.Primary Dermal Irritation in Rabbits (ISO 10993-10) Cottonseed Oil Extract: Elicited a negligible dermal response.Primary Dermal Irritation in Rabbits (ISO 10993-10) Saline Extract: Elicited a negligible dermal response. (Patient contacting materials passed biocompatibility testing in accordance with ISO-10993)
Electrical Safety & EMC (IEC 60601 Series)	IEC 60601-1: PassIEC 60601-1-4: PassIEC 60601-1-6: PassIEC 60601-1-2: Pass (All electrical safety and EMC tests required for medical devices passed)
Human Factors/Usability	Ease of Use Scores: Averaged greater than 92.5% across all age groups.Label Comprehension Scores: Averaged 97% across all age groups. (Data provided confidence that all age groups could use the device effectively and achieve expected results)
Operation Environment (Temperature, Humidity, Pressure)	Temperature range: 15 °C - 50 °C Humidity Range: Relative humidity below 95% (without condensation) Atmospheric Pressure Range: 430mmHg to 800 mmHg (Within the same range as the predicate Spirotel, and comparable to Vitalograph's specified temperature/humidity ranges.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly define a "test set" in the context of clinical performance data, as no clinical data was collected or assessed for this 510(k) submission.
- For the Human Factors Study, a sample size of 45 participants was used.
  - 15 participants aged 2-12 years
  - 15 participants aged 13-21 years
  - 15 participants aged 22+ years
Data Provenance: The human factors study data was generated by PMD Healthcare, implying it was conducted specifically for this device submission. The country of origin of the participants is not specified. The study was prospective for its specific purpose.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. Since no clinical performance data was collected or assessed, there was no "ground truth" to be established by experts for a test set in a clinical evaluation context. The human factors study involved participants using the device, but "ground truth" for clinical performance metrics was not applicable.

4. Adjudication Method for the Test Set

N/A. As no clinical data was collected for performance evaluation, no adjudication method for a test set was applied.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data was not required to determine the safety and effectiveness of the Spiro PD or to show substantial equivalence to the predicate devices. Therefore, no clinical data was collected or assessed as part of this 510(k) premarket notification." Therefore, there is no effect size reported for human readers improving with or without AI (which this is not an AI device).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device includes algorithms for calculations, its standalone performance was demonstrated through non-clinical (engineering) testing against established standards (e.g., accuracy for flow and volume measurements as per ATS guidelines) and comparison with predicate devices' technical specifications. It is a diagnostic device used by a human, and its core function involves direct interaction. The "standalone" performance here refers to the device's technical measurement accuracy, not an AI algorithm performing a diagnostic task.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the technical performance aspects (flow, volume accuracy), the ground truth can be considered the reference standards used in factory calibration and the ATS (American Thoracic Society) guidelines for spirometry performance recommendations.

For the human factors study, the ground truth for "ease of use" and "label comprehension" would be the observed user interactions and responses collected during the study, quantified by the scores (e.g., >92.5% for ease of use, 97% for label comprehension).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device in the context of requiring a "training set" for model development. The algorithms are based on established physiological calculations and predictive models like NHANES III.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable as this device does not utilize a "training set" in the context of machine learning model development. The predictive models (e.g., NHANES III) are pre-established and widely accepted in pulmonary medicine. The device incorporates these existing models.

Summary

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K103575

NOV - 9 2011

510(k) Summary

Sponsor:

PMD Healthcare

6620 Grant Way Company Address: Allentown, PA 18106

484-664-7600 Telephone: Fax: 484-664-7500

Contact Person:

Wayne Meng

Summary Preparation Date: November 7, 2011

Device Name: Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel:

SPIRO PD Spirometer Spirometer, Diagnostic 868.1840 BZG Class 2 Anesthesiology

Predicate Device

Company Name	Product Name	510(k) Number
SDI Diagnostics	Spirotel	K031643
Vitalograph	Model 4000 Series	K073155

Device Description

The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical signals must be changed to electrical signals. The devices responsible for this change are called transducers. The SPIRO PD has a Turbinetype transducer. The turbine transducer performs transduction in two stages: The volume to be measured crosses the turbine vane and records its rotation that is proportional to that Volume, this rotation is detected by the interrupting of a beam of infrared light, the sensor of which converts the light received into a digital-type electrical signal.

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The SPIRO PD performs the following tests:

. FVC,
FEV1 .
FEV1/FVC ●
PEF
. FEF 25-75%
Estimated Lung Age and Flow/Volume Curve .

The Spiro PD performs the following calculations:

% Predicted of FVC ●
Severity of FVC .
. % Predicted of FEV1
Severity of FEV1 .
% Predicted of FEV1/FVC .
Severity of FEV1/FVC .
% Predicted of FEF 25-75% .
. Severity of FEF 25-75%
% Predicted of PEF, Severity of PEF .

The physical configuration of the Spiro PD:

Display Color, Touch screen LCD 320 x 240 resolution .
. Keyboard - Touch screen
Power supply 3.7V Lithium-ion battery 650 mAh .
Dimensions 200 x 96 x 40mm .
Weight 256g with battery .

Device Indications for Use

The Spiro PD spirometer is indicated for the following age groups:

2-12 years Child ●
13-21 years Adolescent �
22 and over- Adult .

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Predicate Product Comparison

Predicate Product Comparison Chart
Parameter	SPIRO PD	SDI Diagnostics'Spirotel	Vitalograph
510(k) Number		K031643	K073155
Indications for Use(IFU)	Indications For Use:The SPIRO PDspirometer isintended to be usedby a patient underthe instruction of aphysician orrespiratorytherapist to testlung function inpeople of all ages. Itis also intended tobe used as a single-patient device onlyand can be used inthe home, factory,hospital orphysician's office.The Spiro PDspirometer isindicated for thefollowing agegroups:• 2-12 years -Child• 13-21 years- Adolescent• 22 and over-Adult	Indications For Use:The Spirotelspirometer isintended to be usedby a patient underthe instruction of aphysician orrespiratory therapistto test lung functionin people of all ages.It is also intended tobe used as a single-patient device onlyand can be used inany setting - home,factory, hospital orphysician's office.	The VitalographModel 4000 is abattery powered,handheld electronicspirometer used tomeasure Peak Flow(PEF) and Forcedexpired volume(FEV).
Device Description	The SPIRO PDspirometer is ahand-held portablediagnosticspirometer for themeasurement ofpatient breath flow	The SpirotelSpirometer is ahand-held portablediagnosticspirometer for themeasurement ofpatient breath flow	The VitalographModel 4000 series{ama-1 and copd-6}are batterypowered handheldelectronicspirometers used to
	and volume. The	and volume. The	measure expired
	device uses a	device uses a	Peak Flow and
	turbine transducer	turbine transducer	Forced Expired
	that measures flow	that measures	Volume after one
	via infrared	flow via infrared	second. The results
	interruption.	interruption.	can aid in the
	Algorithms are used	Algorithms are used	diagnosis of Asthma
	to determine values	to determine	and COPD in
	based on this flow	values based on this	patients.
	measurement.	flow measurement.	All variants {asma-1
	Tabular and	Tabular and	and copd-6} within
	graphical data are	graphical data are	the range use the
	displayed on the	displayed on the	very same
	spirometer LCD	spirometer LCD	operating principle,
	display.	display	LCD, Buttons, and
			Mouldings. Items
			that may vary
			within the range are
			list of parametersthat the different
			variants display. I.e.,
			Asma-1 displays
			FEV1 and PEF whilst
			the copd-6 displays
			FEV1 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 and
			LCD.
PhysicalConfiguration	Display:Color,Touchscreen LCD320 x 240resolutionKeyboard:	Display:STN LCD, 2 lines x16 alphanumericcharactersKeyboard:	Display:Color LCDKeyboard;
	Touchscreen	5 keys membrane	User Buttons
	Power supply:3.7V Lithium-ionbattery 650 mAhDimensions:	Power supply:3V Lithium batteryCR123ADimensions:70 x 80 x 30mm	Power Supply:2 x 1.5v AAAbatteriesDimensions
	200 x 96 x 40mmWeight:256g with battery	Weight:100g with battery	113 x 63 x 48mmWeight:83g with battery
Power Source	3.7 V, 650 mAhLithium-ion Battery	3V Lithium Battery	2x1.5v AAA Battery
ATS SpirometryPerformanceRecommendations	Yes	Yes	Yes
CrossContaminationControl	Yes, single patientdevice.	Yes	Yes
Flow DetectionPrinciple	Digital Turbine	Digital Turbine	Rotor Stator Design
FlowmeterCalibration Method	Factory Calibration	Factory Calibration	Factory Calibration
Display and PrinterUsed	The SPIRO PD usesa color touchscreenLCD	STN LCD, 2 Lines x16 alphanumericcharacters	The VitalographModel 4000 uses acolor LCD Display
Graphic Output	Graphic output canbe shown on theLCD screen anddownloaded to acomputer	Graphic output canbe shown on theLCD screen anddownloaded to acomputer	Graphic Outputshown on LCDscreen anddownloaded to acomputer
Tests Performed	FVC, FEV1,FEV1/FVC, PEF, FEF25-75%, EstimatedLung Age andFlow/Volume Curve	FVC, FEV1, FEV1%,PEF, FEF25-75%,FET, andFlow/Volume Curve	FEV1, FEV6,FEV1/FEV6 andestimated Lung Age
Indices Calculated	% Predicted of FVC,Severity of FVC, %Predicted of FEV1,Severity of FEV1, %Predicted ofFEV1/FVC, Severityof FEV1/FVC, %Predicted of FEF 25-	% Predicted of FVC,Severity of FVC, %Predicted of FEV1,Severity of FEV1, %Predicted ofFEV1/FVC, Severityof FEV1/FVC, %Predicted of FEF 25-	FEV1 and FEV1 %PredictedFEV6 and FEV6 %PredictedFEV1/FEV6 andFEV1/FEV6PredictedFEV1/FEV6 ration
	75%, Severity of FEF25-75%, %Predicted of PEF,Severity of PEF	75%, Severity of FEF25-75%, % Predictedof PEF, Severity ofPEF	75%, Severity of FEF25-75%, % Predictedof PEF, Severity ofPEF
Predictive ModelsUsed	NHANES III	NHANES III, Crapo,Morris	NHANES III
General ElectricalSafety Tests IEC60601-1 and IEC60601-1-2	Yes	Yes	Yes
Provides Test dateand time, plussymptom scores	Yes	Yes	Yes
Diary storage	180 days	100 Days	None
Replies to simplequestions and testquality control	Yes	Yes	No
Maximum Volume	0 - 10 L	10 L	0.99 L BTPS
Flow Range	0 -16 L/s	+16 L/s	0.15 kPa/L/s at 14L/s
Flow Accuracy	$\u00b15%$ or 200 mL/s	$\u00b15%$ or 200 mL/s	$\u00b13%$
Volume Accuracy	$\u00b13%$ or 50 mL,whichever isgreater	$\u00b13%$ or 50 mL,whichever is greater	$\u00b13%$
Lung Age	Yes	NO	Yes
Test Duration	Minimum of threetests at 15 sec pertest.	60 sec
TechnicalSpecifications	Temperature range:15 °C - 50 °CHumidity Range:Relative humiditybelow 95%(withoutcondensation)AtmosphericPressure Range:430mmHg to 800mmHg	Temperature range:15 °C - 50 °CHumidity Range:Relative humiditybelow 95%(withoutcondensation)AtmosphericPressure Range:430mmHg to 800mmHg	TemperatureRange:17-37°CHumidity Range:10-95% RelativeHumidity

ﺘ

12.2 Predicate Product Comparison Chart

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Summary of Biocompatibility Tests

Standard	Test Description	Results
ISO 10993-5	Elution Test (ISO)	The test article's extractsmeet the requirements ofthe test.
ISO 10993-10	Guinea Pig Closed PatchSensitization Test (ISO)Cottonseed Oil Extract	This test article'scottonseed oil extractelicited a minimalsensitization reaction inguinea pigs under theconditions of this test.
ISO 10993-10	Guinea Pig Closed PatchSensitization Test (SO)Saline Extract	This test article's salineextract did not elicit asensitization reaction inguinea pigs under theconditions of this test.
ISO 10993-10	Primary Dermal Irritation inRabbits (ISO) CottonseedOil Extract	This test article'scottonseed oil extractelicited a negligible dermalresponse in rabbits underthe conditions of this test.
ISO 10993-10	Primary Dermal Irritation inRabbits (ISO) Saline Extract	This test article's salineextract elicited a negligibledermal response in rabbitsunder the conditions of thistest.

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Electrical Testing Summary Table 3 Electrical Safety and EMC Tests and Results

Standard	Description of Test	Results
IEC 60601-1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance	Pass
IEC 60601-1-4	Medical electrical equipment Part 1-4 – CollateralStandard: Programmable electrical medical systems	Pass
IEC 60601-1-6	Medical electrical equipment Part 1-6 – CollateralStandard: Usability	Pass
IEC 60601-1-2	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests	Pass

Human Factor Study

PMD Healthcare conducted a Human Factor Study using 45 participants.

o 15 Participants 2-12 years of age
o 15 Participants 13-21 years of age
o 15 Participants 22+ years

Summary of Results

Ease of Use scores for all age groups averaged greater than 92.5% Label comprehension scores for all age groups averaged 97%

Comparison of Spiro PD to Predicate Devices

Indications for Use

The Indications for Use of Spiro PD are identical to the Spirotel device with the addition of a clarification of the age groups of the intended users.

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Technological Characteristics

The Spiro PD and the predicate devices are physically & technologically similar. All devices are portable, hand-held, battery powered devices for measurement of lung performance. The Spiro PD and Spirotel utilize lithium-based batteries while the Vitalograph uses AAA batteries. All3 devices are similar in size and weight.

All 3 devices adhere to the American Thoracic Society (ATS) guidelines. The Spiro PD is a single patient device; the mouthpiece is removable and can be cleaned. The Spirotel has a disposable mouthpiece. Both the Spirotel device employ digital turbine technology to measure flow. All 3 devices are calibrated at the factory.

All 3 devices employ an LCD to present information; the Spirotel is not color. All 3 devices can download to a computer. The Spiro PD and the Spirotel devices measure the most commonly used lung performance parameters and calculate the most common indices. All 3 devices use the NHANES III equations for their predictive models.

All 3 devices meet the safety requirements for medical electrical equipment.

All 3 devices provide the test date and time, plus symptom scores for each test. Both the Spiro PD and the Spirotel save a large number of test data sets. The maximum volume, flow range, flow accuracy, and volume accuracy are the same for the Spiro PD and the Spirotel; the Vitalograph has minor differences.

Both the Spiro PD and the Vitalograph devices estimates lung age; the Spirotel does not. The Vitalograph Model 4000 device is included as a Predicate Device specifically because it estimates lung age as does the Spiro PD.

The Spiro PD and Vitalograph have minimum test durations of 15 seconds per test and a minimum of 3 tests per session per the ATS guidelines. The Spirotel test duration has a maximum of 60 seconds.

All 3 devices operate in the same range of temperature, humidity, and pressure. The Vitalograph does not specify an operating range for atmospheric pressure.

The differences between the Spiro PD and the predicate devices are minor. The Spiro PD has a touch screen user interface while the Spirotel has a 5 key membrane and the Vitalograph has user buttons. All 3 means allow the user to enter information similarly.

Spirotel & Vitalograph use batteries that are not rechargeable whereas the Spiro PD can be recharged. This does not create a meaningful difference in the way in which the devices operate.

The Vitalograph device uses a rotor stator design to measure flow rather than digital turbine technology. Both methods provide sufficient accuracy.

The Vitalograph only measures FEV1, FEV6, FEV1/FEV6 and Lung Age and calculates the associated indices. Although the Vitalograph does not measure the full range of parameters as the Spiro PD and Spirotel, it is measures a subset of these parameters including lung age.

The Spirotel can use the Crapo equations in addition to the NHANES III for its predictive model. Although this provides an alternative model, the NHANES III method is employed by the Spiro PD and both predicate devices.

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The differences in the technological characteristics between the Spiro PD and the predicate devices are minimal. All 3 devices are portable, hand-held, battery powered devices for measurement of lung performance. They employ similar means of user interaction, data presentation, and measure the same parameters adhering to the ATS guidelines.

Non-clinical data

The Spiro PD has passed all electrical safety and EMC tests that are required for medical devices. It has passed the standard tests required by IEC 60601-1, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-6, IEC 60601-1-2.

The patient contacting materials of the Spiro PD have passed biocompatibility testing in accordance with ISO-10993.

Human Factors/Usability testing was carried out across all 3 age groups to evaluate use related risks and labeling comprehension. The data generated in this study provided confidence that all the 3 age groups were able to use the device and to achieve the expected results in accordance with the intended use.

Clinical data

Clinical data was not required to determine the safety and effectiveness of the Spiro PD or to show substantial equivalence to the predicate devices. Therefore, no clinical data was collected or assessed as part of this 510(k) premarket notification.

Conclusion

Based on a comparison of the Spiro PD and the predicate devices with regard to their intended use and their technological characteristics, and based on successful completion of all device testing and thorough evaluation of use-related risks assessed during human factor studies, PMD healthcare concludes that the Spiro PD is safe and effective, and is substantially equivalent to legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that appear to be flames or waves.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV - 9 2011

PMD Healthcare C/O Mr. E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K 103575

Trade/Device Name: SPIRO PD Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: November 7, 2011 Received: November 7, 2011

Dear Mr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. Smith

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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 Form

Indications for Use

510(k) Number (if known):

Device Name: SPIRO PD

Indications for Use:

The SPIRO PD spirometer is indicated for the following age groups:

2-12 years Child .
13-21 years Adolescent .
. 22 and over- Adult

Prescription Use _ _ _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

L. Schulthess

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

510(k) Number: _ L L 3 5 75

Page 1 of _ 1_

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).