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.
The Collins GEM (Gas Exchange Module) is a 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.

Device Description

The GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer (pneumotach), gas analyzers (infrared for CO, CO2, CH4 and electrochemical for O2), and associated electronics.

AI/ML Overview

The Collins GEM (Gas Exchange Module) is a diagnostic spirometer intended for use in pulmonary function testing.

Here is a summary of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Parameter	Acceptance Criteria (Standard/Reference)	Reported Device Performance
Spirometer Metrics
Resistance (Pneumotach)	< 1.4 cmH2O/L/Sec @ 14 L/Sec	< 1.4 cmH2O/L/Sec @ 14 L/Sec (from pneumotach description)
Volume Accuracy	+/- 3%	+/- 3%
Resistance (GemTach - separate component)	< 0.5 cmH2O/L/Sec @ 14 L/Sec	< 0.5 cmH2O/L/Sec @ 14 L/Sec
Accuracy (GemTach)	+/- 3%	+/- 3%
Flow Range (GemTach)	Not explicitly stated as acceptance criteria, but given as specification	+/- 15 L/Sec
Gas Analyzers Metrics
Response (Multi-Gas: CO, CO2, CH4)	Not explicitly stated as acceptance criteria, but "fast-response" mentioned and monitored during production with pass/fail criteria identical to CPL	< 100 ms
Accuracy (Multi-Gas: CO, CO2, CH4)	Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL	1%
Linearity (Multi-Gas: CO, CO2, CH4)	Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL	< 1%
Noise (Multi-Gas: CO, CO2, CH4)	Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL	< 1% full scale
Response (Oxygen)	Not explicitly stated as acceptance criteria, but "fast-response" mentioned and monitored during production with pass/fail criteria identical to CPL	80 ms
Accuracy (Oxygen)	Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL	1%
General Compliance/Performance
Electrical Safety	UL 2601-1, EN 60601-1, IEC 60601-1-1, CSA 22.2 No. 1	Conforms as stated implicitly by listing standards
Emissions and Immunity	IEC 60601-1-2	Conforms as stated implicitly by listing standards
Spirometry Performance	ATS American Thoracic Society Standardization of Spirometry 1994 Update	Conforms as stated implicitly by listing standards
Single-breath Carbon Monoxide Diffusing Capacity	ATS American Thoracic Society Recommendations for a Standard Technique - 1995 Update	Conforms as stated implicitly by listing standards

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes the technical specifications and adherence to recognized standards for the Collins GEM device. It does not contain information about a specific "test set" in the context of a clinical performance study with human subjects or a defined dataset. The performance metrics listed are technical specifications that would be verified through engineering and calibration tests, not typically a clinical test set with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The validation appears to be based on adherence to engineering specifications and industry standards.

4. Adjudication Method for the Test Set:

Not applicable. The document does not describe a study involving adjudication of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a diagnostic instrument, not an AI-based interpretation tool.

6. Standalone (Algorithm Only) Performance Study:

Yes, in the sense that the device's technical specifications and performance are evaluated independently against established standards and calibration procedures. The description mentions "production, step responses, linearity, noise, and drift parameters are monitored, and the pass/fail criteria are identical to that of the CPL." This implies standalone testing of the device's components against predefined thresholds.

7. Type of Ground Truth Used:

The "ground truth" for the device's technical specifications is rooted in:

Industry Standards: Performance guidelines set by organizations like the American Thoracic Society (ATS) for spirometry and carbon monoxide diffusing capacity.
Calibration Standards: Use of known volume displacement devices (e.g., 3-liter syringe) and known gas concentrations for calibration.
Engineering Specifications: Internal design and performance thresholds for electrical, mechanical, and analytical components.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device, not an AI model, so there is no concept of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI model, this question is not relevant to the provided text.

Summary

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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

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 (301) 594-4646. 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/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)

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)

Regulation Number and Section

§ 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).