(51 days)
Not Found
No
The document describes standard pulmonary function testing equipment and does not mention AI, ML, or any related technologies.
No.
The device is intended for diagnostic use as a pulmonary function tester, not for therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The EAGLE is intended to be used for diagnostic use in the treatment of pulmonary illnesses..." and also mentions it is a "pulmonary function tester (PFT) testing system," which are inherently diagnostic tools.
No
The device description explicitly lists hardware components such as a pneumotach, pressure transducers, gas analyzers, and states it operates on AC power, indicating it is not software-only.
Based on the provided information, the EAGLE device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for diagnostic use in the treatment of pulmonary illnesses" and "pulmonary function testing."
- Device Description: While the description details the components (pneumotach, transducers, gas analyzers), the function of these components is to measure physiological parameters related to pulmonary function. These measurements are then used for diagnostic purposes.
- Nature of Pulmonary Function Testing: Pulmonary function tests involve measuring and analyzing gases and airflow within the respiratory system. While the device itself is external to the body, the tests it performs are analyzing biological samples (inhaled and exhaled air) to provide diagnostic information about the patient's internal state.
While the device doesn't process images or use AI/ML, and the input modality isn't imaging, the core function of the EAGLE is to perform tests on biological samples (air) to aid in the diagnosis of pulmonary illnesses. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
The Collins EAGLE (Diffusion Spirometer)is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT) testing system.
Product codes
BZG
Device Description
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
§ 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).
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
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
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 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 | ✓ |
|---|---|
| ------------------ | -------------------------------------------- |
C
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)
fothwh
510(k) Number
Special 510(k)