K Number
K992743
Device Name
COLLINS CPL
Date Cleared
1999-09-13

(28 days)

Product Code
Regulation Number
868.1840
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Collins CPL Pulmonary Function Test System is intended as a configurable, noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.
Device Description
Not Found
More Information

Not Found

No
The provided 510(k) summary does not mention AI, ML, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or complex pattern recognition beyond standard physiological measurements).

No
The device is described as a "pulmonary function testing (PFT)" system, which is used for diagnosis and monitoring, not for treating a disease or condition. Its intended use is for "testing," not therapy.

Yes
The device is intended for pulmonary function testing, which is used to diagnose and assess lung conditions.

No

The description explicitly mentions "Complete plethysmography capabilities are an optional module," which implies hardware components are involved in the system.

Based on the provided information, the Collins CPL Pulmonary Function Test System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the system as a "noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system." These are tests performed on the patient directly, measuring physiological responses and parameters.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
  • Lack of IVD Indicators: The description does not mention analyzing biological samples or performing tests on specimens outside the body.

Therefore, the Collins CPL Pulmonary Function Test System falls under the category of a medical device used for physiological measurements, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Collins CPL Pulmonary Function Test System is intended as a configurable, noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.

Product codes

73 BZG

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pulmonary

Indicated Patient Age Range

pediatric and adult

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K925459

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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).

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Image /page/0/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 image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 13 1999

Mr. Dale F. Hubbard Collins Medical, Inc. 220 Wood Road 02184-2403 Braintree, MA

Re: K992743 Collins CPL Pulmonary Function Test System Requlatory Class: II (two) Product Code: 73 BZG Dated: August 12, 1999 Received: August 16, 1999

Dear Mr. Hubbard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

1

Page 2 - Mr. Dale F. Hubbard

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbrandinq by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Intended Use and Labeling 3

Intended Use Statement

510(k) Number:

K992743

Collins CPL Device Name:

Indications for Use:

The Collins CPL Pulmonary Function Test System is intended as a configurable, noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.

This is the same intended use as previously cleared for the GS Modular Pulmonary Function Test System, 510(k) 925459.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format)

M.R.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number.