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.

AI/ML Overview

The provided text describes the PLAXTRON CPAP System, a non-invasive, disposable ventilator support system. The submission mainly focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against explicit acceptance criteria. Therefore, several of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, training set details) are not applicable or not explicitly stated in the document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. The "reported device performance" is largely framed as alignment with the predicate devices' capabilities and meeting standard requirements.

Characteristic	Acceptance Criteria (Inferred from Substantial Equivalence and Standards)	Reported Device Performance (PLAXTRON CPAP System)
Intended Use	Equivalent to predicate devices (Boussignac CPAP Device, Pulmodyne CHF Flow Generator).	"To provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment." (Matches Pulmodyne, broader than Boussignac in specified patient weight).
Environments of Use	Equivalent to predicate devices.	Hospital, pre-hospital (EMS) environments.
Patient Populations	Equivalent to predicate devices.	Spontaneously breathing adult patients (>30kg). (Matches Pulmodyne, broader than Boussignac in specified patient weight).
Operating Principle	Oxygen powered venturi entrains room air to provide inspiratory flow, similar to predicate devices.	Oxygen powered venturi entrains room air to provide inspiratory flow.
Peak Inspiratory Flow	Unlimited (via anti-suffocation valve or open system), similar to predicate devices.	Unlimited (via anti-suffocation valve).
Pressure Regulation	Achieves intended CPAP setting via adjustable valve (threshold resistor), similar to Pulmodyne.	Adjustable valve acts as pressure release valve when expiratory pressure is reached, limiting system pressure to intended setting.
CPAP Pressure Range	Comparable to predicate devices.	Up to 15 cmH2O. (This is a differentiator, being higher than Boussignac's 10 cmH2O, and within the 0-20 cmH2O range of the variable Pulmodyne model).
Display (Manometer)	Optional/available.	Manometer (optional, for CH-FFM-87XX), built-in (0-40 cmH2O, for CH-FFM-88XX).
Anti-suffocation Valve	Presence desired (similar to Pulmodyne, different from Boussignac's open design).	With anti-suffocation valve.
Excessive Pressure Relief	Mechanism for pressure relief similar to Pulmodyne.	For CH-FFM-87XX, integrated pop-off adjustable up to 15 cm H2O limits airway pressure. Excessive pressure relief from the PEEP valve.
CO2 Clearance	Sufficient to prevent accumulation of exhaled carbon dioxide.	Test results show performance specification is met for clearing exhaled CO2 at input flows of 5 Lpm, mitigating rebreathing risk.
Biocompatibility	Meets ISO 10993 requirements for skin surface contact and external communication device of limited duration.	Results from testing (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity) provide assurance that the proposed device is biocompatible and the same as the predicate device as per FDA guidance (G95-1 and April 23, 2013 draft guidance).
Manufacturing Standards	Designed and tested to assure conformance to ISO 5356-1:2004.	The device was designed and tested to assure conformance to the requirements of ISO 5356-1:2004.
Single Patient Use	Consistent with disposability for single patient use.	All components are single patient use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of the number of devices or clinical subjects. The "test set" refers to engineering and biocompatibility testing, not a clinical trial with patient data.
Data Provenance: The biocompatibility testing likely involved laboratory samples of the materials. CO2 clearance testing would have been conducted in a lab environment. There is no mention of clinical data or patient outcomes. The country of origin for the data (testing location) is not specified, but the manufacturer is Malaysian.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for the non-clinical performance data (CO2 clearance, biocompatibility, engineering specifications) is established by adherence to recognized technical standards (ISO 5356-1:2004, ISO 10993 series) and engineering validation, rather than an expert consensus on clinical diagnoses or outcomes.

4. Adjudication Method for the Test Set

Not applicable. This concept typically applies to clinical studies where different experts might disagree on a diagnosis or outcome, requiring a method to reach a consensus. For engineering and biocompatibility tests, the results are typically quantitative measurements or observations interpreted against predefined criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (CPAP system), not an AI algorithm for diagnostic interpretation. The focus is on the device's physical and functional performance, not its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is based on:

Engineering Specifications and Bench Testing: For characteristics like pressure range, flow, and the functioning of internal components.
Adherence to Recognized Standards: Specifically ISO 5356-1:2004 for general performance and ISO 10993 series for biocompatibility.
CO2 Clearance Testing: Demonstrating the device's ability to prevent CO2 rebreathing under specified flow conditions.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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PLAXTRON INDUSTRIAL (M) SDN. BHD.

	510 (K) SummaryAugust 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 ofManufacturer:	PLAXTRON INDUSTRIAL (M) SDN. BHD.plot 28, kawasan perusahaan, jelapang 2, ftz,ipoh, MALAYSIA 30020
EstablishmentRegistration Number:	8044169
Contact Person:	Doris YangEngineering / Regulatory Affairs ManagerOrLeo ChienGeneral Manager
	Tel: 886-2-26892001Fax: 886-2-26892468E-mail: chtwn@ms21.hinet.net
	AUG 0 5 2013
5.3 Device ClassificationNames/Code/RegulationNumber:	Positive end expiratory pressure breathing attachment/BYE/§868.5965
Device Common Name	CPAP flow generator/PEEP Valve
Regulation Description:	positive end expiratory pressure (PEEP) breathingattachment
Review Panel:	Anesthesiology,
Recognized PerformanceStandard	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

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5.5 Device Description	The PLAXTRON CPAP System is a state of the artnon-invasive, disposable ventilator support system. Itis a venturi type oxygen / air mixture delivery devicewhich provides CPAP pressure with a 50 PSIcompressed gas source at a low input flow to aspontaneously breathing patient. The controlled airwaypressure provides rapid relief for maximum patientbenefit with minimal oxygen consumption. The deviceis low cost and completely disposable for single patientuse and it is highly efficient to run from a low flowsource for longer cylinder life. It equips with filters oninhalation and exhalation to provide maximumprotection.
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 by21 CFR 93, is replaced with this 510(k) summary.

5.5 Device Description

The PLAXTRON CPAP System is a state of the artnon-invasive, disposable ventilator support system. Itis a venturi type oxygen / air mixture delivery devicewhich provides CPAP pressure with a 50 PSIcompressed gas source at a low input flow to aspontaneously breathing patient. The controlled airwaypressure provides rapid relief for maximum patientbenefit with minimal oxygen consumption. The deviceis low cost and completely disposable for single patientuse and it is highly efficient to run from a low flowsource for longer cylinder life. It equips with filters oninhalation and exhalation to provide maximumprotection.

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 by21 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

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	PLAXTRONCPAP System	Boussignac CPAPDevice	Pulmodyne CHFFlow Generator
510(k)	K122610	K013884	K080256
Intended Use	The PLAXTRONCPAP System isintended toprovide CPAP tospontaneouslybreathing adult(>30kg) patientsin the hospital andpre-hospital(EMS)environment.	The BoussignacCPAP Device isintended toprovide a constantairway positivepressure forspontaneouslybreathing patients.	The PulmodyneCHF FlowGenerator isintended toprovide CPAP tospontaneouslybreathing adult(>30kg) patientsin the hospital andpre-hospital(EMS)environment.
Environments ofUse	Hospital, pre-hospital (EMS)environments	Hospital, pre-hospital (EMS)environments	Hospital, pre-hospital (EMS)environments
PatientPopulations	spontaneouslybreathing adultpatients (>30kg)	spontaneouslybreathing adultpatients	spontaneouslybreathing adultpatients
Gas flow providedby	Wall gas orcylinder	Wall gas orcylinder	Wall gas orcylinder
OperatingPrinciple	oxygen poweredventuri entrainsroom air toprovideinspiratory flow	oxygen poweredventuri entrainsroom air toprovideinspiratory flow	oxygen poweredventuri entrainsroom air toprovideinspiratory flow
Peak InspiratoryFlow	Unlimited (viaanti-suffocationvalve)	Unlimited (opensystem)	Unlimited (viaanti-suffocationvalve)
PressureRegulation	(thresholdresistor)adjustable valveacts as pressurerelease valvewhen expiratorypressure isreached, limitingsystem pressure tointended setting	(orificial resistor)resulting outputflow from venturicreates expiratoryresistance andsubsequentincreasedexpiratorypressure	(thresholdresistor) 3 stepadjustable PEEPvalve OR singlestep PEEP valvesact as pressurerelease valvewhen expiratorypressure isreached, limitingsystem pressure tointended setting
CPAP pressurerange (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, 0-40cmH2O, for CH-FFM-88XX)	Manometer(optional)	$cmH2O$0-20 cmH2O(variable valve,2.5/5.0/7.5/10.0/12.5/15.0/20.0cmH2O).Manometer(optional)
Antisuffocationvalve	Withantisuffocationvalve	None, open designallows patient tobreath in event ofsource gas failure	Withantisuffocationvalve
Excessivepressure relief	for CH-FFM-87XX, Integratedpop-off adjustableup to 15 cm H2Olimits airwaypressure to theadjusted pressurein case of un-intentionalexhaust portblockedExcessivepressure relieffrom the PEEPvalve	No excessivepressure relief	Excessivepressure relieffrom the PEEPvalve
Patient Interface	Adjustable CPAPMask withForehead Padsand ComfortBonnet, CushionMask and SiliconeHeadstrap	Cushion Mask andSiliconeHeadstrap	Adjustable Facemask withadjustableheadgear
cushion mask	PVC, signal-patient use	PVC, signal-use	None
Accessories	Inspiratory andExpiratory Filters,Mask	Mask, Manometerand Nebulizer	Inspiratory Filter.Mask, Manometerand Nebulizer
Flow generatorwith 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 Valvewith adjustablePEEP for CH-FFM-87XX)	None,	O2-CPAP Valve
CPAP Masks withhead strapcushion mask	PC mask frame /Silicone maskPVC, signal-patient use	None	PC mask frame /Silicone maskNone
Requires a flowmeter	Yes, with -10Lpm range	Yes, with -30Lpm range	Yes, with -50Lpm range
Input Range	5~~10 lpm flowsource(for CH-FFM-87XX)4~~8 lpm flowsource(for CH-FFM-88XX)	10-25 lpm flowsource	15-45 Lpm flowsource
Single patient use	All componentsare single patientuse.	Single patient use	The PulmodyneCHF FlowGenerator ismulti-patient,reusable and canbe cleaned whilethe othercomponents:circuit, mask,entrainment filter,and PEEP valveare disposable,single patient use

PLAXTRON INDUSTRIAL (M) SDN. BHD.
PLAXTRON CPAP System

PAGE 14 PREMARKET NOTIFICATION

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PLAXTRON INDUSTRIAL (M) SDN. BHD.
PLAXTRON CPAP System

PAGE 15 PREMARKET NOTIFICATION

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).