(200 days)
Not Found
Not Found
No
The description details a mechanically operated, time-cycled ventilator with electronic alarms. There is no mention of AI, ML, or any learning or adaptive capabilities. The technology is described as the same as existing legally marketed devices.
Yes
The device is a ventilator designed for patients with respiratory distress or insufficiency, which directly treats a medical condition.
No
The device is a portable ventilator designed for providing respiratory support, not for identifying or diagnosing a medical condition.
No
The device is a physical ventilator with mechanical and electronic components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency." This describes a device used to support a patient's breathing, which is a direct medical intervention on a living patient.
- Device Description: The description details a "portable, gas powered, time-cycled ventilator." It describes the mechanical and electronic components involved in delivering air to a patient's lungs.
- 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 diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly a medical device used for respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The paraPAC 200D 'Transport' ventilator is a portable, gas powered, time-cycled ventilator that is designed for ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency.
Product codes (comma separated list FDA assigned to the subject device)
BTL
Device Description
The paraPAC 'Transport' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC "Transport" ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate devices.
The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.
The module weighs 3.1 kilograms.
The module control panel has the following features:
- Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
- Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
- Inspiratory Time Range 3.0 to 0.5 seconds. .
- . Expiratory Time Range 6.0 to 0.5 seconds.
- Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
- Flow Range 0.1 to 1.0 L/sec. .
- Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
- Supply Gas Failure Alarm A mechanically operated visual alarm gives a warning that the . supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten word, "KO3OBO3", in what appears to be a slanted, cursive style. The letters are somewhat stylized, with the "3" resembling a mirrored "E" and the "O" shapes being circular. The writing is in black ink against a white background, and the image has been cropped closely around the word.
SEP 2 9 2003
Pneupac
Summary of Safety and Effectiveness
| Submitter: | Pneupac Ltd. |
|---|---|
| Address: | Bramingham Business Park, |
| Enterprise Way, Luton, | |
| Bedfordshire, LU2 OAH | |
| United Kingdom. | |
| Telephone: | (+44) (0) 1582 430000 |
| Contact: | Regulatory Affairs & Quality Assurance |
| Manager | |
| Prepared: | 24th October 2002 |
| Proprietary Name: | paraPAC 'Transport' model 200D |
| Common/ Classification Name: | Gas powered Transport Ventilator with |
| Electronic alarms |
New Device Description:
The paraPAC 'Transport' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC "Transport" ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate devices.
The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.
Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries com ww.pneupac.co.uk Section 2 /Page 1
1
Pneupac
Summary of Safety and Effectiveness
New Device Description (ctd.):
The module weighs 3.1 kilograms.
The module control panel has the following features:
- Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
- Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
- Inspiratory Time Range 3.0 to 0.5 seconds. .
- . Expiratory Time Range 6.0 to 0.5 seconds.
- Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
- Flow Range 0.1 to 1.0 L/sec. .
- Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
- Supply Gas Failure Alarm A mechanically operated visual alarm gives a warning that the . supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification ( Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries.com ww.pncupac.co.uk Section 2 /Page 3
3
Pneupac
Summary of Safety and Effectiveness
'Transport' to the babyPAC and paraPAC 'medic' with integrated electronic alarms.
The testing described above indicates that there is no functional difference between the operation of the paraPAC 'Transport' with its predicate counterparts the babyPAC and paraPAC 'medic' with integrated electronic alarms for delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters. Based on these results, it is our determination that the device models are safe, effective and perform as well as the legally marketed predicate device(s).
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Respectfully
Colin Walters
Regulatory Affairs and Quality Assurance Manager
Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries.com ww.pneupac.co.uk Section 2 /Page 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
SEP 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pneupac, Limited. C/O Mr. Donald Alexander Vice President of Regulatory Affairs BCI Incorporated N7 W22025 Johnson Road Waukesha, Wisconsin 53186-1856
Re: K030803
Trade/Device Name: paraPAC 'Transport' Model V 200D Regulation Number: 21 CFR 868.5925 Regulation Name: Emergency Powered Ventilator (Resuscitator) Regulatory Class: II Product Code: BTL Dated: July 8, 2003 Received: July 9, 2003
Dear Mr. Alexander:
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.
5
Page 2 - Mr. Alexander
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 (QS) 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. 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Susan Palmer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use
510(k) Number (if Known): __ K030 8 03
Device Name: paraPAC 200D 'Transport' Emergency & Transport gas powered Ventilator
Indications For Use:
Intended Use:
The paraPAC 200D 'Transport' ventilator is a portable, gas powered, time-cycled ventilator that is designed for ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency.
(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
Bohn
(Division Sign-Off) Division of Anesthesiciogy, General Hospital, Infection Control, Denial Devices
510(k) Number: K030803