(156 days)
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No
The document does not mention AI, ML, or related terms, and the device description is consistent with traditional spirometry technology.
No
The device is described as a "diagnostic spirometer" and its intended use is for "pulmonary function testing (PFT)", which are diagnostic applications, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The KoKo LEGEND is intended to be used for diagnostic use" and "The KoKo LEGEND (Diagnostic Spirometer) is an Office Spirometer." The "Device Description" also refers to it as a "diagnostic spirometer."
No
The device description explicitly states it is a "pulmonary function tester (PFT) testing system" and a "diagnostic spirometer," which are hardware devices used for measuring lung function. While it might include software components, the core device is a physical instrument.
Based on the provided text, the KoKo LEGEND is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the device is intended for "diagnostic use in the pulmonary function testing (PFT)" and is a "diagnostic spirometer." This clearly indicates its purpose is to aid in diagnosis.
- Device Description: It is described as a "diagnostic spirometer."
While the term "In Vitro Diagnostic" isn't directly used, the core function and stated purpose of the device align with the definition of an IVD, which is a medical device used to perform tests on samples taken from the human body to help diagnose medical conditions. Pulmonary function testing involves measuring physiological parameters related to breathing, which are used in the diagnostic process.
N/A
Intended Use / Indications for Use
The KoKo LEGEND is intended to be used for diagnostic use in the pulmonary function testing (PFT) with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The KoKo LEGEND is indicated for use in: pulmonary function testing.
The KoKo LEGEND (Diagnostic Spirometer) is an Office Spirometer. It is intended as a configurable, portable, noninvasive pulmonary function tester (PFT) system. These tests are suitable for both pediatric and adult patient testing.
Product codes
BZG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
Office Spirometer
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Collins Eagle II System – K831779, KoKo Spirometer - K914272, KoKoMate Office Spirometer - K022276
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
NOV 1 7 2005
510(k) SUMMARY
Pulmonary Data Services, Inc.'s KoKo LEGEND
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Ferraris Respiratory, Inc. 908 Main Street Louisville, CO 80027
303-666-5555 ext. 416 Phone: Facsimile: 303-664-0485
- Contact Person: Donald Henton
- Date Prepared: June 13, 2005
Common or Usual Name KoKo LEGEND (Diagnostic Spirometer)
| Classification Name | Spirometer, Diagnostic |
|---|---|
| Predicate Devices | Collins Eagle II System – K831779 |
| KoKo Spirometer - K914272 | |
| KoKoMate Office Spirometer - K022276 |
Intended Use
The KoKo LEGEND is intended to be used for diagnostic use in the pulmonary function testing (PFT) with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The KoKo LEGEND is indicated for use in: pulmonary function testing.
Attachment 5 - 1
1
Technological Characteristics and Substantial Equivalence
| Dimensions | 9.25"W x 10"D x 2.75"H (23.5 cm X 25.4 cm X 7.0 cm) |
|---|---|
| Weight | 3.6 lbs. (1.6 Kg) |
| Electrical Requirements | 110 - 240 VAC 50, 60 Hz, 2.5 Amps (Switching |
| power supply included 12 VDC output) | |
| Fuse Type and Rating | N/A |
| Operating Environment | Temperature, 10 to 40 °C (50 to 104 °F) |
| Relative Humidity, 0% to 80% at temperatures to | |
| 31 °C | |
| Storage and Transportation Environment | Temperature, -20 to 70 °C (- |
| 40 to 158 °F) | |
| Humidity, 10% to 90% (non-condensing) | |
| Type of Pneumotach | Flexible Variable Orifice |
| Reproducibility |