DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)

K971058 · Medical Analysis Systems, Inc. · DIF · Apr 8, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971058
• Device Name: DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
• Applicant: Medical Analysis Systems, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Apr 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-hospital and alternative site arenas.

Device Story

BabyPAC is a pneumatically powered ventilator for respiratory support. Used by paramedics and trained medical personnel in rescue, pre-hospital, and alternative care settings. Device provides mechanical ventilation to patients suffering from respiratory distress or insufficiency. Operation is pneumatic; no complex electronic processing or software-based analysis described. Healthcare providers use the device to manage patient airway and breathing during emergency transport or field care. Benefits include portable, reliable ventilation support in environments outside traditional hospital settings.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Pneumatically powered ventilator. Portable form factor designed for rescue and pre-hospital use. Operates via pneumatic pressure; no electronic or software-based control systems described. Subject to device tracking requirements under 21 CFR 821.

Indications for Use

Indicated for patients experiencing respiratory distress or insufficiency requiring ventilation. Intended for use by qualified medical caregivers, paramedics, and trained personnel in rescue, pre-hospital, and alternative site settings.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 26 1999

Mr. Norman Gray
President
pneuPAC Incorporated
814 Parkway
Broomall, PA 19008

Re: K970158
BabyPac
Regulatory Class: II (two)
Product Code: 73 CBK
Dated: September 27, 1997
Received: April 14, 1998

Dear Mr. Gray:

This letter corrects our substantially equivalent letter of April 28, 1998, regarding the BabyPac. Our letter identified the product code as 73 MNT. This is in error, the correct product code is 73 CBK as indicated above. Please note the tracking section of this letter.

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, Drug, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the

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Page 2 - Mr. Norman Gray

Food and Drug Administration (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 regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the *Federal Register*, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 *Federal Register* beginning on page 43447.

This letter will allow you to continue 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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510(k) Number (if known): K970158

Device Name: babyPAC

Indications for Use:

The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-hospital and alternative site arenas.

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 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)

(Mr. Rupic)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970158

NG/JAP/p7092