GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130

K030917 · Collins Medical, Inc. · BZG · May 14, 2003 · Anesthesiology

Device Facts

• Record ID: K030917
• Device Name: GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
• Applicant: Collins Medical, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EAGLE is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The EAGLE is indicated for use in: pulmonary function testing.

Device Story

EAGLE is a configurable, non-invasive pulmonary function test (PFT) system. It utilizes a pneumotach (bi-directional, single-screen) and pressure transducers to measure airflow; gas analyzers (infrared for CO, CO2, CH4; electrochemical for O2) measure gas concentrations. Device operates via 115-240 VAC power. Used in clinical settings by healthcare professionals to assess pulmonary function. Output data assists clinicians in diagnosing and treating pulmonary illnesses. System performance adheres to ATS standards for spirometry and single-breath carbon monoxide diffusing capacity.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against ATS (American Thoracic Society) 1994/1995 standards for spirometry and single-breath carbon monoxide diffusing capacity. Technical specifications verified for flow range, volume accuracy (+/- 3%), and gas analyzer response times/accuracy.

Technological Characteristics

System includes pneumotach (single-screen, pressure differential) and gas analyzers (infrared for CO, CO2, CH4; electrochemical for O2). Power: 115-240 VAC, 50-60 Hz. Compliance: UL 2601-1, EN 60601-1, IEC 60601-1-1, CSA 22.2 No. 1, IEC 60601-1-2. Performance standards: ATS 1994/1995. Calibration via 3-liter syringe.

Indications for Use

Indicated for pulmonary function testing in pediatric and adult patients. Used for diagnostic purposes in the treatment of pulmonary illnesses.

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 CPL (K992743)
• Collins GEM (K030464)

Submission Summary (Full Text)

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# MAY 1 4 2003

### 510(k) SUMMARY

#### Collins Medical, Inc.'s EAGLE

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Collins Medical, Inc. 220 Wood Road Braintree, MA 02184

Phone: [phone] Facsimile: 781-843-4024

Contact Person: Donald Henton

March 21, 2003 Date Prepared:

#### Common or Usual Name EAGLE (Diffusion Spirometer)

| Classification Name | Spirometer, Diagnostic |
|---------------------|------------------------|
|---------------------|------------------------|

| Predicate Devices | Collins CPL - K992743 |
|-------------------|-----------------------|
| | Collins GEM - K030464 |

#### Intended Use

The EAGLE is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The EAGLE is indicated for use in: pulmonary function testing.

Attachment 5 - 1

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# Technological Characteristics and Substantial Equivalence

Electrical: A medical grade switching power supply is used that operates on 115-240 VAC 50-60 Hz, at 3.15 Amps.

Weight: 19 lbs., 8.6 Kg

Spirometer: The pneumotach is a single-screen bi-directional device that is used in conjunction with commercially available pressure transducers. Resistance is < 1.4 cmH2O/L/Sec @ 14 L/Sec. Volume accuracy is +/- 3%, and it is calibrated by using a known volume displacement device 3-liter syringe as a standard.

GEMtach

Type: Single screen pressure differential Linearity: 2% Resistance: < 0.5 cmH2O/L/Sec @, 14 L/Sec Accuracy: +/- 3% Flow Range: +/- 15 L/Sec

Gas Analyzers: The analyzers consist of a fast-response Infrared analyzer for the measurement of carbon monoxide (CO), carbon dioxide (CO2), and methane (CH4), and an electrochemical sensor for fast-response oxygen (O2) measurement. Calibration is accomplished by setting the span with known gas concentrations. In production, step responses, linearity, noise, and drift parameters are monitored, and the pass/fail criteria are identical to that of the GEM.

Multi-Gas Type: Infrared CO, CH4 Range: 0-3000 ppm CO2 Range: 0-15% Response: < 100 ms Sample Rate: 100 Hz Accuracy: 1% Linearity: < 1% Noise < 1% full scale

Oxygen Type: Electrochemical Range: 0.1-100% O2 Accuracy: 1% Response 80 ms

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)

> ATS American Thoracic Society Single-breath Carbon Monoxide Diffusing Capacity (Transfer Factor) Recommendations for a Standard Technique - 1995 Update, Am J Respir Crit Care Med Vol 152. (1995)

#### Substantial Equivalence

The Collins EAGLE 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2003

Mr. Donald Henton Quality System Manager Collins Medical, Incorporated 220 Wood Road Braintree, Massachusetts 02184-2403

Re: K030917

Trade/Device Name: EAGLE Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: April 17, 2003 Received: April 18, 2003

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. 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 (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), please 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/dsma/dsmamain.html

Sincerely yours.

Patricia Ciccone/for

Susan Runner, DDS, MA Interim 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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Indications for Use Form

510(k) Number (if known):_K030917

Device Name: EAGLE

Indications for Use: The Collins EAGLE (Diffusion Spirometer)is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT) testing system. These tests are suitable for both pediatric and adult patient testing.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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C

(Per 21 C.F.R. 801.109)

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Over-The-Counter

(Optional Format 1-2-96)

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510(k) Number

Special 510(k)