(343 days)
Not Found
No
The device description and performance studies focus on mechanical principles (venturi effect, Bernoulli principle) and standard medical device testing (biocompatibility, CO2 clearance). There is no mention of AI, ML, or related concepts.
Yes
The device is described as a "non-invasive, disposable ventilator support system" that "provides CPAP pressure to a spontaneously breathing patient" for "rapid relief" and "maximum patient benefit," which are therapeutic outcomes.
No.
The document describes a CPAP system, which is a therapeutic device designed to provide continuous positive airway pressure. It does not mention any diagnostic functions, such as analyzing patient data or identifying medical conditions. Its purpose is to deliver treatment, not to diagnose.
No
The device description clearly states it is a "non-invasive, disposable ventilator support system" and a "venturi type oxygen / air mixture delivery device," indicating it is a hardware-based medical device. The performance studies also focus on hardware characteristics like CO2 clearance and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment." This describes a therapeutic intervention applied directly to a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a "non-invasive, disposable ventilator support system" that delivers CPAP pressure. This is consistent with a respiratory support device, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
Therefore, the PLAXTRON CPAP System is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.
Product codes (comma separated list FDA assigned to the subject device)
BYE
Device Description
The PLAXTRON CPAP System is a state of the art non-invasive, disposable ventilator support system. It is a venturi type oxygen / air mixture delivery device which provides CPAP pressure with a 50 PSI compressed gas source at a low input flow to a spontaneously breathing patient. The controlled airway pressure provides rapid relief for maximum patient benefit with minimal oxygen consumption. The device is low cost and completely disposable for single patient use and it is highly efficient to run from a low flow source for longer cylinder life. It equips with filters on inhalation and exhalation to provide maximum protection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult (>30kg) patients
Intended User / Care Setting
Hospital and pre-hospital (EMS) environment.
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)
The PLAXTRON CPAP System has the identical intended use and indication for use as the predicate devices. Substantial equivalence to predicate devices was established by applying the product specification comparison. The requirements and test of the ISO 5356-1:2004. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Considering the risk in re-breathing of CO2 the CO2 clearance Testing is performed. The input flow used to drive the ERGO Emergency CPAP generator is small than the predicated device but sufficient to prevent accumulation of exhaled carbon dioxide. The basis of the pressure generator is through the use of a venturi. The Bernoulli principle describes the entrainment of air during a continuous flow of compressed gas. The venturi used in the ERGO Emergency CPAP System entrains significantly more air per liter of oxygen than the predicate device. The venturi used in the ERGO Emergency CPAP System is considerably strong and the total flow generated at 5 Lpm input flow in the ERGO Emergency CPAP System can provides a combined air/oxygen flow that is sufficient to flush the system of exhaled carbon dioxide. The test result shows that the performance specification of the Plaxtron CPAP system is met the requirements of design specifications for which it is intended in clearing the exhaled CO2 at input flows of 5 Lpm and the risk of the CO2 rebreathing is mitigated and acceptable.
Biocompatibility testing is identified by FDA guidance G95-1 that the biocompatibility is the same to the predicated device and US FDA Draft Guidance for Industry and Food and Drug Administration Staff, April 23, 2013, Use of International Standard 1SO-10993, "Biological Evaluation of Medical Devices Part I : Evaluation and Testing" The device is identified with the skin surface contact and external communication device (with the gas pathway), and with limited duration that the Cytotoxicity. Sensitization and the Irritation or intracutancous reactivity are the major biological effect identified and tested. Results from this testing provide assurance that the proposed device is biocompatibile.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).
0
:
PLAXTRON INDUSTRIAL (M) SDN. BHD.
| | 510 (K) Summary
August 5, 2013 |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 5.1 Device Trade Name: | PLAXTRON CPAP System, Model CH-FFM-87XX,
ERGO EMERGENCY CPAP SYSTEM, /CH-FFM-
88XX, ERGO II EMERGENCY CPAP SYSTEM,
series |
| 5.2 Named and Address of
Manufacturer: | PLAXTRON INDUSTRIAL (M) SDN. BHD.
plot 28, kawasan perusahaan, jelapang 2, ftz,
ipoh, MALAYSIA 30020 |
| Establishment
Registration Number: | 8044169 |
| Contact Person: | Doris Yang
Engineering / Regulatory Affairs Manager
Or
Leo Chien
General Manager |
| | Tel: 886-2-26892001
Fax: 886-2-26892468
E-mail: chtwn@ms21.hinet.net |
| | AUG 0 5 2013 |
| 5.3 Device Classification
Names/Code/Regulation
Number: | Positive end expiratory pressure breathing attachment
/BYE/§868.5965 |
| Device Common Name | CPAP flow generator/PEEP Valve |
| Regulation Description: | positive end expiratory pressure (PEEP) breathing
attachment |
| Review Panel: | Anesthesiology, |
| Recognized Performance
Standard | ISO 5356-1:2004 (BYE) |
| ·5.4 Predicate Devices: | (a) Boussignac CPAP Device: 510(k) Number: K013884 |
| | (b) Pulmodyne CHF Flow Generator: 510(k) Number:
K080256 |
PLAXTRON INDUSTRIAL (M) SDN. BHD.
PLAXTRON CPAP System
1
| 5.5 Device Description | The PLAXTRON CPAP System is a state of the art
non-invasive, disposable ventilator support system. It
is a venturi type oxygen / air mixture delivery device
which provides CPAP pressure with a 50 PSI
compressed gas source at a low input flow to a
spontaneously breathing patient. The controlled airway
pressure provides rapid relief for maximum patient
benefit with minimal oxygen consumption. The device
is low cost and completely disposable for single patient
use and it is highly efficient to run from a low flow
source for longer cylinder life. It equips with filters on
inhalation and exhalation to provide maximum
protection. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.6 Intended Use | To provide CPAP to spontaneously breathing adult
(>30kg) patients in the hospital and pre-hospital (EMS)
environment. |
| 5.7 510(k) Statement | A 510(k) statement for the new device, as required by
21 CFR 93, is replaced with this 510(k) summary. |
5.8 Substantial Equivlance
The Plaxtron CPAP System is substantially equivalent in indications for use, environment of use, patient population, and functions (gas flow provided by, Operating Principle, Peak Inspiratory Flow, Display(optional manometer ) ) to the Boussignac CPAP Device and Pulmodyne CHF Flow Generator identified as the predicate devices. The technologies are similar to the Pulmodyne CHF Flow Generator, by the adjustable valve to generate intended CPAP setting and both with the antisuffocation valves , and are different to Boussignac CPAP Device to generate intended CPAP setting by a venturi virtual valve and without antisuffocation valve. The difference among the predicated devices are the CPAP pressure range: Plaxtron CPAP valve with the range up to 15 cmH2O, Boussignac CPAP Device with the range up to 10 cmH2O and Pulmodync CHF Flow Generator with the three step range in 0-10 cmH2O or with the variable step range in 0-20 cmH2O. In biocompatibility, the Plaxtron CPAP System with the same intended patient face skin contact (by the non-sterilized, CPAP mask) and the same external gas communicate pathway (by the flow generator, the mask frame, the Filter, the corrugate tube and the CPAP Valve with adjustable PEEP ) to the Pulmodyne CHF Flow Generator all met corresponding ISO 10993 requirements except that the Pulmodyne CHF Flow Generator CPAP mask can be cleaned and reusable. The cushion mask of the Plaxtron CPAP System is equivalent to the one of the Boussignac CPAP Device to meet corresponding ISO 10993 requirements.
A complete comparative table is as below:
PLAXTRON INDUSTRIAL (M) SDN. BHD. PLAXTRON CPAP System
2
| | PLAXTRON
CPAP System | Boussignac CPAP
Device | Pulmodyne CHF
Flow Generator |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K122610 | K013884 | K080256 |
| Intended Use | The PLAXTRON
CPAP System is
intended to
provide CPAP to
spontaneously
breathing adult
(>30kg) patients
in the hospital and
pre-hospital
(EMS)
environment. | The Boussignac
CPAP Device is
intended to
provide a constant
airway positive
pressure for
spontaneously
breathing patients. | The Pulmodyne
CHF Flow
Generator is
intended to
provide CPAP to
spontaneously
breathing adult
(>30kg) patients
in the hospital and
pre-hospital
(EMS)
environment. |
| Environments of
Use | Hospital, pre-
hospital (EMS)
environments | Hospital, pre-
hospital (EMS)
environments | Hospital, pre-
hospital (EMS)
environments |
| Patient
Populations | spontaneously
breathing adult
patients (>30kg) | spontaneously
breathing adult
patients | spontaneously
breathing adult
patients |
| Gas flow provided
by | Wall gas or
cylinder | Wall gas or
cylinder | Wall gas or
cylinder |
| Operating
Principle | oxygen powered
venturi entrains
room air to
provide
inspiratory flow | oxygen powered
venturi entrains
room air to
provide
inspiratory flow | oxygen powered
venturi entrains
room air to
provide
inspiratory flow |
| Peak Inspiratory
Flow | Unlimited (via
anti-suffocation
valve) | Unlimited (open
system) | Unlimited (via
anti-suffocation
valve) |
| Pressure
Regulation | (threshold
resistor)
adjustable valve
acts as pressure
release valve
when expiratory
pressure is
reached, limiting
system pressure to
intended setting | (orificial resistor)
resulting output
flow from venturi
creates expiratory
resistance and
subsequent
increased
expiratory
pressure | (threshold
resistor) 3 step
adjustable PEEP
valve OR single
step PEEP valves
act as pressure
release valve
when expiratory
pressure is
reached, limiting
system pressure to
intended setting |
| CPAP pressure
range (cmH2O) | Up to 15 cmH2O | Up to 10 cmH2O | 0-10 cmH2O
(three step valve,
5.0/7.5/10.0) |
| | | | |
| Display | Manometer
(optional, for CH-
FFM-87XX)
(Built-in, 0-40
cmH2O, for CH-
FFM-88XX) | Manometer
(optional) | $cmH2O$
0-20 cmH2O
(variable valve,
2.5/5.0/7.5/10.0/1
2.5/15.0/20.0
cmH2O).
Manometer
(optional) |
| Antisuffocation
valve | With
antisuffocation
valve | None, open design
allows patient to
breath in event of
source gas failure | With
antisuffocation
valve |
| Excessive
pressure relief | for CH-FFM-
87XX, Integrated
pop-off adjustable
up to 15 cm H2O
limits airway
pressure to the
adjusted pressure
in case of un-
intentional
exhaust port
blocked
Excessive
pressure relief
from the PEEP
valve | No excessive
pressure relief | Excessive
pressure relief
from the PEEP
valve |
| Patient Interface | Adjustable CPAP
Mask with
Forehead Pads
and Comfort
Bonnet, Cushion
Mask and Silicone
Headstrap | Cushion Mask and
Silicone
Headstrap | Adjustable Face
mask with
adjustable
headgear |
| cushion mask | PVC, signal-
patient use | PVC, signal-use | None |
| Accessories | Inspiratory and
Expiratory Filters,
Mask | Mask, Manometer
and Nebulizer | Inspiratory Filter.
Mask, Manometer
and Nebulizer |
| Flow generator
with filter | Polycarbonate
(PC) | Polycarbonate
(PC) | Polycarbonate
(PC) |
| Corrugate | 12" corrugate tube | None | 72" corrugate tube |
| TUBE | for CH-FFM-87XX | | for CH-FFM-87XX |
| CPAP Valve | PP (CPAP Valve
with adjustable
PEEP for CH-
FFM-87XX) | None, | O2-CPAP Valve |
| CPAP Masks with
head strap
cushion mask | PC mask frame /
Silicone mask
PVC, signal-
patient use | None | PC mask frame /
Silicone mask
None |
| Requires a flow
meter | Yes, with -10
Lpm range | Yes, with -30
Lpm range | Yes, with -50
Lpm range |
| Input Range | 510 lpm flow8 lpm flow
source(for CH-
FFM-87XX)
4
source(for CH-
FFM-88XX) | 10-25 lpm flow
source | 15-45 Lpm flow
source |
| Single patient use | All components
are single patient
use. | Single patient use | The Pulmodyne
CHF Flow
Generator is
multi-patient,
reusable and can
be cleaned while
the other
components:
circuit, mask,
entrainment filter,
and PEEP valve
are disposable,
single patient use |
PLAXTRON INDUSTRIAL (M) SDN. BHD.
PLAXTRON CPAP System
PAGE 14 PREMARKET NOTIFICATION
3
PLAXTRON INDUSTRIAL (M) SDN. BHD.
PLAXTRON CPAP System
PAGE 15 PREMARKET NOTIFICATION
4
5.9 Assessment of Non-clinical Performance Data
The PLAXTRON CPAP System has the identical intended use and indication for use as the predicate devices. Substantial equivalence to predicate devices was established by applying the product specification comparison. The requirements and test of the ISO 5356-1:2004. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Considering the risk in re-breathing of CO2 the CO2 clearance Testing is performed. The input flow used to drive the ERGO Emergency CPAP generator is small than the predicated device but sufficient to prevent accumulation of exhaled carbon dioxide. The basis of the pressure generator is through the use of a venturi. The Bernoulli principle describes the entrainment of air during a continuous flow of compressed gas. The venturi used in the ERGO Emergency CPAP System entrains significantly more air per liter of oxygen than the predicate device. The venturi used in the ERGO
5
Emergency CPAP System is considerably strong and the total flow generated at 5 Lpm input flow in the ERGO Emergency CPAP System can provides a combined air/oxygen flow that is sufficient to flush the system of exhaled carbon dioxide. The test result shows that the performance specification of the Plaxtron CPAP system is met the requirements of design specifications for which it is intended in clearing the exhaled CO2 at input flows of 5 Lpm and the risk of the CO2 rebreathing is mitigated and acceptable .
Biocompatibility testing is identified by FDA guidance G95-1 that the biocompatibility is the same to the predicated device and US FDA Draft Guidance for Industry and Food and Drug Administration Staff, April 23, 2013, Use of International Standard 1SO-10993, "Biological Evaluation of Medical Devices Part I : Evaluation and Testing" The device is identified with the skin surface contact and external communication device (with the gas pathway), and with limited duration that the Cytotoxicity. Sensitization and the Irritation or intracutancous reactivity are the major biological effect identified and tested. Results from this testing provide assurance that the proposed device is biocompatibile.
5.10 Summary of Conclusion
The PLAXTRON CPAP System is demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device and is substantially equivalent to the predicated devices, in terms of intended use, principle of operation, technological characteristics, and performance characteristics to the listed predicates.
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
August 5. 2013
Plaxtron Industrial (M) SDN. BHD C/O Ming-Yie Jan, Ph.D. Sen Mu Technology Company, Limited No. 15-2. Lane 26. Mineyuan 1ª Rd. Lingya District Kaohsiung City 802, Taiwan R.O.C.
Re: K122610
Trade/Device Name: Plaxtron CPAP System Regulation Number: 21 CFR 868,5965 Regulation Name: Positive end expiratory pressure breathing attachment Regulatory Class: Class II Product Code: BYE Dated: July 22, 2013 Received: July 30, 2013
Dear Dr. Jan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
7
Page 2 - Dr. Jan
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Kwame Uimer, M.S.
Acting Division Director
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
8
Indications for use
510(k) Number (if known): _ K122610
Device Name: PLAXTRON CPAP System
Indications for Use:
The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ເ
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of_
Neha Gujarati For Lest 2013.08.02 14:5
(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510(k) Number: K122610