The provided document is a 510(k) summary for the MicroDL DiaryCard Spirometer. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states "Performance Testing: None applicable" in the comparison table and includes no dedicated section on performance criteria or a study demonstrating the device meets those criteria.

Therefore, based on the provided text, it's not possible to extract the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present. The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance study results.

Summary

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K9605042

JUN 17 1997

Non-Confidential Summary of Safety and Effectiveness December 15, 1996

page 1 of 2

Micro Direct, Inc.840 Pownal RoadAuburn, ME 04210	Tel - (207) 786-7808	Fax - (207) 786-7280
Official contact:	David R. Staszak, President
Proprietary or Trade Name:	MicroDL DiaryCard Spirometer
Common/Usual Name:	Diagnostic Spirometer
Classification Name:	73 BZG - Diagnostic Spirometer
Intended device:	Diagnostic Spirometer
Predicate devices:	Micro Medical Micro Spirometer - K963035
Device description:	A hand-held portable electronic spirometer measuringFEV1, FVC, and PEF.

Indicated use:

� i

The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1, FVC, and PEF.

Targeted population:

Patients requiring lung function evaluations.

Environment of use:

Places where a qualified clinician desires to take these lung measurements - FEV1, FVC, and PEF.

Comparison to predicate devices:

Attribute	Intended device	Micro Medical Micro Spirometer
UseIntended as a spirometer	Yes	Yes
Intended to measurelung function FEV1, FVC, and PEF	Yes	FEV1 and FVC

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Non-Confidential Summary of Safety and Effectiveness December 15, 1996

page 2 of 2

Comparison to predicate devices (continued)

イ・

Attribute	Intendeddevice	Micro MedicalMicro Spirometer
Use (continued)Indicated for measuringpatients lung function	Yes	Yes
Indicated for use by a clinicianin environments such as thehome or hospital	Yes	Yes
Manufactured by Micro Medical	Yes	Yes
DesignTransducer - flow sensing turbine	Yes	Yes
Output	RS232	No
Flow range LPs BTPS 0-12	Yes	Yes
Volume range liters 0-9.99	Yes	Yes
Test Parameters	FEV1, FVC, PEF	FEV1, FVC
Accuracy +/- 3	Yes	Yes
Display LCD	Yes	Yes
Transducer cleaned after use	Yes	Yes
Utilizes paper mouthpiece	Yes	Yes
MaterialsSame materials as K963035	Yes	Yes
Performance TestingNone applicable	Yes	Yes

Differences

The only differences are the addition of the displayed test parameter of PEF (Peak Expired Flow) and the ability to retain the test values in memory for later review.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a person with outstretched arms, with three wavy lines below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1997

Mr. David R. Staszak Micro Direct, Inc. 840 Pownal Road P.O. Box 239 Auburn, Maine 04212-0239

Re: *K965042 MicroDL DiaryCard Spirometer Regulatory Class: II (two) Product Code: 73 BZG March 17, 1997 Dated: Received: March 19, 1997

Dear Mr. Staszak:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Cood Manufacturing Practice for Medical Devices. General (GMF) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David R. Staszak

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number	K965042 (To be assigned)
Device Name:	MicroDL DiaryCard Spirometer
Indications for Use:	To measure lung functions - FEV 1 , FVC, and PEFand to effect historical serial transfer of measured testindices to PC compatible computers
Targeted population:	Patients requiring lung function measurements
Environment of use:	Places where a qualified clinician desires to takethese lung measurements - FEV 1 , FVC, and PEF.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory,
Devices alogical Devices Division of Carchological Devices
and Neurological Devices & La ×965042

510(k) Number _

Prescription Use (Per 21 CFR 801.109)

、

. ) :

Over-The-Counter Use __

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).