CLINDATALINK VERSION 1.0 FOR SPIROMETRY

K020004 · Compleware Corp. · BZG · Jul 24, 2002 · Anesthesiology

Device Facts

• Record ID: K020004
• Device Name: CLINDATALINK VERSION 1.0 FOR SPIROMETRY
• Applicant: Compleware Corp.
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ClinDataLink Version 1.0 is an application software that will be used to collect spirometry data for clinical research studies using the FDA Cleared ORS Diagnostics, LLC Type II PCMCIA cards and software development kit. The ORS SpiroCard was cleared by the agency on October 28, 1998 via K973138. ClinDataLink will permit the entry and management of these data and the transmission to a central or local database for integration with other clinical research data. ClinDataLink is compliant with 21 CFR Part 11 requirements for electronic records.

Device Story

Software application for clinical research data collection; interfaces with QRS Diagnostics Type II PCMCIA SpiroCard. System captures demographic and respiratory data (FVC, SVC, MVV) via pressure transducer/mouthpiece; converts pressure to electrical signals. Operates on PC (Pentium II, Windows 98/ME/2000). Manages data entry, storage, and transmission to central/local databases for research integration. Used in hospitals, clinics, or home settings under physician prescription. Ensures 21 CFR Part 11 compliance for electronic records. Facilitates standardized data management for clinical trials.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to confirm software compatibility and performance across four operating systems (Windows 98, 98SE, ME, and 2000) using the QRS SpiroCard hardware.

Technological Characteristics

Software application for PC (Pentium II, 200 MHz, 32 MB RAM). Integrates with QRS PCMCIA Type II SpiroCard for respiratory sensing. Connectivity via PCMCIA interface. Compliant with 21 CFR Part 11. Verification performed for Windows 98, 98SE, ME, and 2000 operating systems.

Indications for Use

Indicated for collection of spirometry data (FVC, MVV, SVC) in clinical research studies for male and female patients, ranging from pediatrics to adults. Intended for use in hospital, clinic, or home environments. Prescription use only by a physician.

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

• SpiroCard (K973138)

Submission Summary (Full Text)

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# JUL 2 4 2002 COMPLEWARE® CORPORATION

K 820004

## 510(k) SUMMARY of SAFETY and EFFECTIVENESS

## A. General Information

B.

| 1. | Submitter's Name: | CompleWare Corporation |
|---------------|----------------------|-------------------------------------------------------|
| 2. | Address: | 221 East Burlington Street<br>Iowa City<br>Iowa 52240 |
| 3. | Telephone: | 319-338-8888 |
| 4. | Contact Person: | Kay Weiler |
| 5. | Date Prepared: | December 18, 2001 |
| 6. | Registration Number: | FDA Form 2891 Submitted |
| <b>Device</b> | | |
| 1. | Name: | ClinDataLink Version 1.0 for Spirometry |
| 2. | Trade Name: | ClinDataLink |

- Application Software and Diagnostic Spirometry 3. Common Name:
- Classification Name: 4. Spirometer, Diagnostic
- 5. Product Code: BZG
- 6. Class: II
- 7. Regulation Number: 868.1840

# C. Identification of Legally Marketed Devices

- 1. Name: SpiroCard
- 2. K Number: K973138

Comple Ware Corporation - PO Box 3090 - Iowa City, Iowa 52244-3090 Phone: [phone] - Fax: [phone] - Web: www.compleware.com

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- 3. Date Cleared: October 28, 1998
### D. Description of the Device

ClinDataLink Version 1.0 is a software application that will be used to collect spirometry data for clinical research studies using QRS Diagnostics, LLC Type II PCMCIA cards and software development kit.

ClinDataLink will capture demographic data, spirometry data (FVC, SVC, and MVV) and time/date of visits based upon Protocol Wizard.

The components of the ClinDataLink System are the following:

- . ClinDataLink Version 1.0 on CD-ROM.
- ClinDataLink User's Guide ●
- ClinDataLink Help File .
- . Pentium II with a 200 MHZ processor with 32 MB of RAM and 2 GB hard drive
- Windows 98, 98SE, ME, or 2000 Operating System ●
- QRS PCMCIA Card Type II ●
- QRS Software
- QRS SpiroCard, PC Card to sample the respiratory function of a ● patient via an attached pressure/transducer/mouthpiece and convert the measured pressure difference to an electrical signal.
- . QRS Pressure Tubes
- QRS Disposable Pneumotach (Mouthpiece)
- QRS User's Manual .

#### E. Intended Use Statement

The ClinDataLink Version 1.0 is an application software that will be used to collect spirometry data for clinical research studies using the FDA Cleared ORS

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The ClinDataLink Version 1.0 is an application software that will be used to collect spirometry data for clinical research studies using the FDA Cleared ORS Diagnostics, LLC Type II PCMCIA cards and software development kit. The ORS SpiroCard was cleared by the agency on October 28, 1998 via K973138.

ClinDataLink will permit the entry and management of these data and the transmission to a central or local database for integration with other clinical research data.

ClinDataLink is compliant with 21 CFR Part 11 requirements for electronic records.

#### F. Technical Characteristics Summary

The ClinDataLink Version 1.0 for Spirometry is substantially equivalent to the ORS SpiroCard cleared on October 28, 1998.

The ClinDataLink utilizes the QRS SpiroCard to collect spirometry data for clinical research studies.

The ClinDataLink was verified by QRS to support the usage of four operating systems with their components.

CompleWare Corporation undertook extensive validations of the four operating systems via standard verification/validation activities.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2002

Ms. Kay Weiler Vice President CompleWare Corporation 221 East Burlington Street Iowa City, Iowa 52240

Re: K020004

Trade/Device Name: ClinDataLink Version 1.0 for Spirometry Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: April 24, 2002 Received: April 25, 2002

Dear Ms. Weiler:

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.

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.

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Page 2 - Ms. Weiler

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy W. Ulatowski

Timothy 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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#### 510(k) Number: To be determined

Device Name: ClinDataLinkTM Version 1.0 for Spirometry

Indications for Use:

- The ClinDataLinkTM Version 1.0 for Spirometry is an application software . that will collect spirometry data for clinical research studies in male/females, pediatrics to adults, and measure FVC, MVV, and SVC, in a hospital, clinic, or home use environment.
- Prescription device by a physician. .

#### PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.

OVER-THE-COUNTER USE_ (optional Form 1-2-96)