GEM, MODEL 004110

K030464 · Collins Medical, Inc. · BZG · Mar 14, 2003 · Anesthesiology

Device Facts

• Record ID: K030464
• Device Name: GEM, MODEL 004110
• Applicant: Collins Medical, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Mar 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GEM 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 GEM is indicated for use in: pulmonary function testing.

Device Story

GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function testing (PFT) system. Device utilizes a pneumotach (GemTach) for flow measurement and gas analyzers for respiratory gas analysis. Inputs include patient respiratory flow and gas concentrations (CO, CO2, CH4, O2). Analyzers employ fast-response infrared technology for CO, CO2, and CH4, and electrochemical sensors for O2. System processes these signals to provide diagnostic pulmonary data. Used in clinical settings for pulmonary function assessment. Healthcare providers use output to diagnose and treat pulmonary illnesses. Benefits include non-invasive diagnostic capability for pediatric and adult populations.

Clinical Evidence

Bench testing only. Performance validated against ATS standards for spirometry (1994) and single-breath CO diffusing capacity (1995). Analyzers verified for step response, linearity, noise, and drift with pass/fail criteria identical to the CPL predicate.

Technological Characteristics

Pneumotach: single-screen bi-directional pressure differential; flow range +/- 15 L/Sec. Gas Analyzers: Infrared (CO, CO2, CH4) and electrochemical (O2). Power: 115-240 VAC. Standards: UL 2601-1, EN 60601-1, IEC 60601-1-1, CSA 22.2 No. 1, IEC 60601-1-2, ATS 1995. Weight: 18 lbs.

Indications for Use

Indicated for pulmonary function testing in pediatric and adult patients. Compatible with Body Plethysmograph as an optional module.

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)
• SensorMedics VMAX (K942211)

Reference Devices

• GS Modular Pulmonary Function Test System

Submission Summary (Full Text)

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KO3046y

MAR 1 4 2003

# 510(k) SUMMARY

## Collins Medical, Inc.'s GEM

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

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

781-843-0610 Phone: Facsimile: 781-843-4024

Contact Person: Donald Henton

Date Prepared: Feb. 10, 2003

Common or Usual Name GEM (Gas Exchange Module)

Classification Name Spirometer, Diagnostic

Collins CPL - K992743 Predicate Devices SensorMedics VMAX - K942211

#### Intended Use

The GEM 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 GEM 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: 18 lbs., 8.2 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 CPL.

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 ATS American Thoracic Society Performance: 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 GEM has the same intended use and indications, principle of operation, and technological characteristerics. is substantially equivalent in safety and effectiveness to the former marketed predicate devices with respect to its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2003

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

Re: K030464

Trade/Device Name: Collins GEM Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: February 11, 2003 Received: February 12, 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 (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), 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 vours.

Chris Leffor

Susan Runner, DDS, M 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): ____________________________________________________________________________________________________________________________________________________

GEM (Gas Exchange Module) Device Name:

The Collins GEM (Gas Exchange Module)is a Indications for Use: : Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric and adult patient testing. Compatible with the Collins' Body Plethysmograph as an optional module.

> This is the same intended use as the previously cleared GS Modular Pulmonary Function Test System and CPL Comprehensive Pulmonary Laboratory.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use
(Per 21 C.F.R. 801.109)

OR

Over-The-Counter

fowilson

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number. K030464

(Optional Format 1-2-96)