KOKO LEGEND

K051572 · Pulmonary Data Services, Inc. · BZG · Nov 17, 2005 · Anesthesiology

Device Facts

• Record ID: K051572
• Device Name: KOKO LEGEND
• Applicant: Pulmonary Data Services, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

KoKo LEGEND is a portable, non-invasive diagnostic spirometer used for pulmonary function testing (PFT). Device utilizes a flexible variable orifice pneumotach to measure airflow; connects via Ethernet or USB to a computer running KoKoPFT Spirometry Software (v4.5 or higher) on Windows 2000/XP. System requires a 3-liter syringe for calibration. Healthcare providers operate the device in clinical settings to perform spirometry; software processes flow data to generate diagnostic reports. Output assists clinicians in assessing lung function and diagnosing respiratory conditions. Benefits include portable, configurable pulmonary assessment for both pediatric and adult populations.

Clinical Evidence

Bench testing only. Performance validated against ATS 1994 Standardization of Spirometry guidelines. Accuracy specified as +/- 3% or 100 ml, with reproducibility <+/- 0.5%.

Technological Characteristics

Diagnostic spirometer; flexible variable orifice pneumotach; 110-240 VAC power supply; Ethernet/USB connectivity; Windows-based software interface. Complies with UL 2601-1, EN 60601-1, IEC 60601-1-1, CSA 22.2 No. 1, and IEC 60601-1-2. Performance meets ATS 1994 standards.

Indications for Use

Indicated for pulmonary function testing in pediatric and adult patients. Intended for prescription use as a diagnostic spirometer.

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

• Collins Eagle II System (K831779)
• KoKo Spirometer (K914272)
• KoKoMate Office Spirometer (K022276)

Submission Summary (Full Text)

{0}------------------------------------------------

K051572

# 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<br>KoKo Spirometer - K914272<br>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<br>power supply included 12 VDC output) |
| Fuse Type and Rating | N/A |
| Operating Environment | Temperature, 10 to 40 °C (50 to 104 °F)<br>Relative Humidity, 0% to 80% at temperatures to<br>31 °C |
| Storage and Transportation Environment | Temperature, -20 to 70 °C (-<br>40 to 158 °F)<br>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 Moe<br>filter |
| Accuracy | +/- 3% or 100 ml, whichever is greater |
| Flow Range | +/- 16 L/sec |
| Calibration<br>Volume | 3-liter calibration syringe |
| Hardware Options | |
| Computer interface | Ethernet or USB connection with KoKoPFT<br>Spirometry Software 4.5 or higher, operating on<br>Windows 2000 or XP |
| Printers | HP Color Inkjet |
| Tests Performed | Spirometry |

Attachment 5 - 2

{2}------------------------------------------------

### 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

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(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 |

Page 1 of __ 1 __