COLLINS CPL

K992743 · Collins Medical, Inc. · BZG · Sep 13, 1999 · Anesthesiology

Device Facts

• Record ID: K992743
• Device Name: COLLINS CPL
• Applicant: Collins Medical, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Sep 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

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 Story

Collins CPL Pulmonary Function Test System is a configurable, noninvasive diagnostic platform; performs pulmonary function, exercise, nutritional, and metabolic testing; optional plethysmography module available. Used in clinical settings by healthcare professionals to assess respiratory and metabolic health. Device collects physiological data during testing; processes inputs to provide diagnostic metrics for clinician review. Output supports clinical decision-making regarding patient respiratory status and metabolic function. Benefits include comprehensive, noninvasive assessment of lung function and metabolic performance across pediatric and adult populations.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate.

Technological Characteristics

Configurable, noninvasive pulmonary function, exercise, and metabolic testing system; includes optional plethysmography module. Operates as a diagnostic workstation for respiratory and metabolic assessment.

Indications for Use

Indicated for noninvasive pulmonary function, exercise, nutritional, and metabolic testing in pediatric and adult patients.

Regulatory Classification

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.

Predicate Devices

• GS Modular Pulmonary Function Test System (K925459)

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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## 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.