(156 days)
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.
The KoKo LEGEND is a configurable, non-invasive pulmonary function tester (PFT) testing system. It is a diagnostic spirometer.
The provided text is a 510(k) summary for the KoKo LEGEND Diagnostic Spirometer and does not contain detailed information about a specific study testing the device's performance against acceptance criteria in the way a clinical trial or algorithm validation study would.
Instead, it declares conformity to recognized standards and lists technical specifications, which implicitly serve as acceptance criteria for a diagnostic spirometer.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
For a diagnostic spirometer, the "acceptance criteria" are primarily established by recognized performance standards. The device's "reported performance" is its technical specifications, which are implicitly stated to meet these standards.
| Acceptance Criteria (from ATS Standardization of Spirometry 1994 Update) | Reported Device Performance (KoKo LEGEND) |
|---|---|
| Appropriately calibrated (e.g., with a 3-liter syringe) | 3-liter calibration syringe |
| Resistance < 1.5 cm H2O/L/sec | < 1.5 cm H2O/L/sec as tested with KoKo Moe filter |
| Accuracy +/- 3% or 100 ml, whichever is greater | +/- 3% or 100 ml, whichever is greater |
| Flow Range (implied by ATS standards for spirometry) | +/- 16 L/sec |
| Reproducibility (implied requirement for consistent measurements) | < +/- 0.5% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on technical specifications and conformity to established performance standards for spirometers, rather than a clinical study involving a "test set" of patients or data. The testing mentioned (e.g., "as tested with KoKo Moe filter") indicates laboratory-based performance testing rather than patient-based data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. As explained above, this 510(k) summary describes a diagnostic spirometer, which directly measures physiological parameters. The "ground truth" for a spirometer's measurements is the physical accuracy and reproducibility of its readings against known standards (e.g., a 3-liter syringe for volume, controlled flow rates). It does not involve expert interpretation of images or complex data where "ground truth" is established by multiple human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers interpret data, and their interpretations are compared to a consensus or gold standard. For a spirometer's technical validation, the "adjudication" is against metrological standards and physical measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable and not mentioned. This device is a diagnostic spirometer, which performs direct measurements. It does not incorporate AI for interpretation that would require human-in-the-loop performance improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an algorithm's standalone performance. The device itself is a "standalone" diagnostic instrument in that its measurements are directly generated by the device. The reported performance metrics (accuracy, resistance, etc.) are its "standalone" performance against physical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for verifying the KoKo LEGEND's performance is based on metrological standards and physical measurements. Specifically:
- Known volume standards: A 3-liter calibration syringe is explicitly mentioned for calibration, implying its use for validating volume measurements.
- Controlled flow/resistance measurements: The "as tested with KoKo Moe filter" for resistance indicates the use of a known resistance standard.
- ATS (American Thoracic Society) Standardization of Spirometry 1994 Update: This standard defines the acceptable ranges and methodologies for accurate spirometry, serving as the ultimate ground truth for the device's technical performance.
8. The sample size for the training set
This information is not provided and not applicable for this type of device. As a diagnostic spirometer without AI or machine learning components mentioned, there is no "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
This information is not provided and not applicable for this type of device. There is no concept of a "training set" ground truth for a physical diagnostic instrument like a spirometer.
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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 – K831779KoKo Spirometer - K914272KoKoMate 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
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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 (Switchingpower 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 to31 °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 | <+/- 0.5% |
| Resistance | <1 .5 cm H2O/L/sec as tested with KoKo Moefilter |
| Accuracy | +/- 3% or 100 ml, whichever is greater |
| Flow Range | +/- 16 L/sec |
| CalibrationVolume | 3-liter calibration syringe |
| Hardware Options | |
| Computer interface | Ethernet or USB connection with KoKoPFTSpirometry Software 4.5 or higher, operating onWindows 2000 or XP |
| Printers | HP Color Inkjet |
| Tests Performed | Spirometry |
Attachment 5 - 2
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Conformity to Recognized Standards
Electrical safety: UL 2601-1, EN 60601-1, IEC 60601-1-1, and CSA 22.2 No. 1 Emissions and Immunity: IEC 60601-1-2 Performance: ATS American Thoracic Society Standardization of Spirometry 1994 Update, Am J Respir Crit Care Med Vol 152. (1995)
Substantial Equivalence
The Ferraris Respiratory KoKo LEGEND has the same intended use and indications, principle of operation, technological characteristics, and is substantially equivalent in safety and effectiveness to the former marketed predicate devices with respect to its intended use.
Attachment 5 - 3
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Image /page/3/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of three lines that resemble a person.
NOV 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald Henton Director, Regulatory Affairs/Quality Assurance Pulmonary Data Services, Incorporated 908 Main Street Louisville, Colorado 80027
Re: K051572
Trade/Device Name: Koko Legend Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: November 11, 2005 Received: November 14, 2005
Dear Mr. Henton :
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.
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Page 2 - Mr. Henton
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. or me ret 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 and instille (s 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.
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), 11 Joe contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snytie Y. Michau OMD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K051572
Device Name: Koko Legend
- Indications for use: 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.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sign-Off) | |
|---|---|
| of Anesthesiology, General Hospital, | |
| ection Control, Dental Devices | |
| (510(k)) Number: | K051572 |
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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).