(30 days)
No
The summary describes a standard pulmonary function testing system with spirometry and gas analysis, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a "non-invasive pulmonary function tester (PFT) testing system" intended for "diagnostic use in the treatment of pulmonary illnesses" via "pulmonary function testing". Its purpose is to diagnose, not to treat, making it a diagnostic device rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The GEM is intended to be used for diagnostic use in the treatment of pulmonary illnesses..." and "The GEM is indicated for use in: pulmonary function testing."
No
The device description explicitly states that the GEM includes hardware components such as a spirometer, gas analyzers, and associated electronics, in addition to being a testing system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the GEM is a "non-invasive pulmonary function tester (PFT) testing system" and is used for "pulmonary function testing." This involves measuring physiological parameters related to lung function directly from the patient (e.g., airflow, gas exchange).
- Device Description: The components listed (spirometer, gas analyzers) are used to measure these physiological parameters from the patient's breath.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. The GEM does not process such specimens.
Therefore, the GEM falls under the category of a medical device used for physiological measurement and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
BZG
Device Description
The GEM is described as a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer, gas analyzers for carbon monoxide (CO), carbon dioxide (CO2), methane (CH4), and oxygen (O2). It operates on 115-240 VAC 50-60 Hz and weighs 18 lbs. The spirometer uses a single-screen bi-directional pneumotach with a volume accuracy of +/- 3%. The gas analyzers consist of a fast-response Infrared analyzer and an electrochemical sensor for oxygen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patient testing.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
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: 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 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.
3
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.
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 (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
5
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)