(203 days)
Not Found
No
The summary describes a software application for collecting and managing spirometry data, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device collects spirometry data for clinical research studies and measures FVC, MVV, and SVC, but it does not directly treat or prevent any medical condition.
No
The device collects spirometry data (FVC, MVV, SVC) for clinical research studies. While spirometry measures lung function, the provided text describes the software as collecting and measuring data, not interpreting or diagnosing conditions based on the data. It appears to be a data collection tool rather than a diagnostic one.
No
The device description explicitly states it uses "QRS Diagnostics, LLC Type II PCMCIA cards and software development kit," indicating reliance on specific hardware components for data collection.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The device collects spirometry data (FVC, MVV, SVC), which are physiological measurements related to lung function. While not directly analyzing biological samples in vitro, spirometry is a diagnostic test used to assess a patient's health status and diagnose conditions. The data collected is used for clinical research studies, which often involve evaluating the effectiveness of treatments or understanding disease progression, both of which fall under the umbrella of diagnostic purposes.
- Device Description: It's a software application that collects spirometry data. This data is then used for clinical research studies.
- Predicate Device: The predicate device listed is "SpiroCard" (K973138). Spirometers are generally considered diagnostic devices used to assess lung function. The fact that a spirometer is listed as a predicate device strongly suggests that the ClinDataLink, which collects data from a spirometer, is also intended for diagnostic purposes.
Why it's not a clear-cut "yes" without further information:
- "In Vitro" Aspect: The core definition of an IVD involves testing biological samples in vitro (outside the body). Spirometry measures physiological parameters in vivo (within the body). However, the data collected from the spirometry test is then processed and analyzed by the software, which could be considered an in vitro analysis of the collected data. Regulatory bodies often interpret the scope of IVDs broadly to include devices that analyze data derived from biological processes for diagnostic purposes.
- "Clinical Research Studies": While the data is used for clinical research, the purpose of collecting the data is still diagnostic in nature (measuring lung function to understand health status or disease).
Conclusion:
Given the intended use of collecting spirometry data for clinical research studies and the listing of a spirometer as a predicate device, the ClinDataLink Version 1.0 is very likely considered an IVD by regulatory bodies. The software's function is to collect and manage data from a diagnostic test (spirometry) for diagnostic purposes (clinical research related to health and disease).
To be absolutely certain, one would need to consult the specific regulatory definitions and guidance documents relevant to the jurisdiction where the device is being marketed or used. However, based on the provided information, the characteristics align strongly with those of an IVD.
N/A
Intended Use / 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.
Product codes
BZG
Device Description
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatrics to adults
Intended User / Care Setting
hospital, clinic, or home use environment.
Prescription device by a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 |
| Iowa City | ||
| 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 |
| Device | ||
| 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
-
- Product Code: BZG
-
- Class: II
-
- Regulation Number: 868.1840
C. Identification of Legally Marketed Devices
-
- Name: SpiroCard
-
- K Number: K973138
Comple Ware Corporation - PO Box 3090 - Iowa City, Iowa 52244-3090 Phone: 319-338-8888 - Fax: 319-338-1604 - Web: www.compleware.com
1
-
- 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
2
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.
3
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.
4
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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
5
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)