BABYPAC

K970158 · Pneupac, Inc. · CBK · Apr 28, 1998 · Anesthesiology

Device Facts

• Record ID: K970158
• Device Name: BABYPAC
• Applicant: Pneupac, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• 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; provides mechanical ventilation to patients with respiratory distress or insufficiency. Used in rescue, pre-hospital, and alternative site environments; operated by qualified medical caregivers, paramedics, or trained personnel. Device delivers controlled gas flow to support patient breathing; assists healthcare providers in managing respiratory failure. Benefits include portable, reliable ventilation support in emergency or transport scenarios.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatically powered ventilator; portable form factor for rescue and pre-hospital use. Operates via pneumatic energy source. No software or electronic algorithm components described.

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 continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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 28 1998

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

Re: K970158
Trade Name: BabyPac
Regulatory Class: II
Product Code: MNT
Dated: September 27, 1997
Received: April 14, 1998

Dear Mr. Gray:

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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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

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Page 2 - Mr. Norman Gray

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.

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]. 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,

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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Page 1 of 1

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

NG/JAP/p7092