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.
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.

Device Description

The EAGLE is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a pneumotach (single-screen bi-directional device), commercially available pressure transducers, and gas analyzers (fast-response Infrared analyzer for CO, CO2, and CH4, and an electrochemical sensor for O2). It operates on 115-240 VAC 50-60 Hz.

AI/ML Overview

The Collins Medical, Inc.'s EAGLE is a diffusion spirometer intended for diagnostic use in the treatment of pulmonary illnesses as a configurable, non-invasive pulmonary function tester (PFT) testing system for both pediatric and adult patients.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The given document does not explicitly present a table of acceptance criteria for the overall device directly alongside its performance. Instead, it lists performance specifications for key components and indicates conformity to recognized standards. I will extract these performance specifications for the core components that would typically have acceptance criteria.

Component / Parameter	Acceptance Criteria (Stated Performance)	Reported Device Performance (Same as criteria as these are specifications)
Spirometer
Pneumotach Resistance	< 1.4 cmH2O/L/Sec @ 14 L/Sec	< 1.4 cmH2O/L/Sec @ 14 L/Sec
Volume Accuracy	+/- 3%	+/- 3%
GEMtach
Linearity	2%	2%
Resistance	< 0.5 cmH2O/L/Sec @ 14 L/Sec	< 0.5 cmH2O/L/Sec @ 14 L/Sec
Accuracy	+/- 3%	+/- 3%
Flow Range	+/- 15 L/Sec	+/- 15 L/Sec
Multi-Gas (Infrared CO, CH4, CO2)
CO, CH4 Range	0-3000 ppm	0-3000 ppm
CO2 Range	0-15%	0-15%
Response	< 100 ms	< 100 ms
Sample Rate	100 Hz	100 Hz
Accuracy	1%	1%
Linearity	< 1%	< 1%
Noise	< 1% full scale	< 1% full scale
Oxygen Analyzer (Electrochemical)
Range	0.1-100% O2	0.1-100% O2
Accuracy	1%	1%
Response	80 ms	80 ms
Overall Performance Standards	ATS American Thoracic Society Standardization of Spirometry 1994 Update	Conforms to ATS standards
&	ATS American Thoracic Society Single-breath Carbon Monoxide Diffusing Capacity (Transfer Factor) Recommendations for a Standard Technique - 1995 Update	Conforms to ATS standards

2. Sample Size for the Test Set and Data Provenance

The provided document does not contain details about a specific clinical "test set" and its sample size for evaluating the EAGLE device. The submission relies on establishing substantial equivalence to predicate devices (Collins CPL - K992743 and Collins GEM - K030464) based on similar intended use, principle of operation, and technological characteristics.

The testing mentioned for component specifications (e.g., spirometer accuracy, gas analyzer performance) pertains to device verification/validation during development and manufacturing, not a clinical test set in the sense of patient data. For instance, the spirometer is calibrated using a "known volume displacement device 3-liter syringe as a standard." For gas analyzers, "step responses, linearity, noise, and drift parameters are monitored, and the pass/fail criteria are identical to that of the GEM" during production. This suggests internal testing against established engineering and performance standards, rather than a clinical study with patient data.

Therefore, there is no explicit sample size for a test set of patient data and no information on data provenance (e.g., country of origin, retrospective/prospective) for a dedicated clinical study for the EAGLE device in this document.

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

Since no specific clinical "test set" with patient data is detailed in the document, there is no information provided regarding experts used to establish ground truth for such a set. The regulatory pathway here is substantial equivalence to legally marketed predicate devices, which typically focuses on demonstrating that the new device is as safe and effective as the predicate without requiring extensive new clinical trials if the technological characteristics and indications for use are sufficiently similar.

4. Adjudication Method for the Test Set

As there is no clinical "test set" of patient data described, there is no adjudication method provided. The document describes internal testing and calibration methods that do not involve human adjudication in the context of interpreting patient results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC study is mentioned or implied in this submission. The focus is on the device's technical specifications and substantial equivalence to predicates, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The EAGLE is a pulmonary function testing system, not an AI-driven diagnostic algorithm. Its performance is inherent in its measurement capabilities. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this device as described. The performance metrics reported (e.g., accuracy, linearity, response time) are descriptive of the device's standalone operational capabilities.

7. The Type of Ground Truth Used

For the component performance, the ground truth used is based on:

Known physical standards: For the spirometer, a "known volume displacement device 3-liter syringe as a standard" is used for calibration and accuracy verification.
Known gas concentrations: For the gas analyzers, "known gas concentrations" are used for setting the span and ensuring accuracy.
Engineering specifications and predicate device performance: For the gas analyzers, "pass/fail criteria are identical to that of the GEM," implying that the ground truth for acceptability is derived from the established performance of a predicate device.
Recognized industry standards: Conformity to ATS (American Thoracic Society) standards implies adherence to clinically accepted performance benchmarks for spirometry and diffusing capacity measurements.

8. The Sample Size for the Training Set

The provided document does not describe any machine learning or AI components that would require a "training set" of data. The device's operation is based on established physical and chemical principles and therefore does not have a training set in the context of AI model development.

9. How the Ground Truth for the Training Set was Established

As there is no training set for an AI model, this question is not applicable.

Summary

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

Image /page/0/Picture/0 description: The image shows a handwritten string of numbers and letters, "K030917", oriented diagonally. The characters are written in a simple, clear style, making them easily readable. The background is plain white, which provides a stark contrast to the dark ink of the characters.

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: 781-843-0610 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

Attachment 5 - 1

{1}------------------------------------------------

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

{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)

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

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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.

{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. 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 (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 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

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

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
------------------	--------------------------------------------

(Per 21 C.F.R. 801.109)

Over-The-Counter

(Optional Format 1-2-96)

fothwh

510(k) Number

Special 510(k)

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).