Who is the manufacturer of PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

Sen MU Technology Co., Ltd. filed the 510(k) submission for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (K122610).

What is the FDA product code for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

BYE. It is classified under 21 CFR 868.5965 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

Boussignac CPAP Device (K013884); Pulmodyne CHF Flow Generator (K080256).

Who can help prepare an FDA 510(k) submission like PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES

K122610 · Sen MU Technology Co., Ltd. · BYE · Aug 5, 2013 · Anesthesiology

Device Facts

Record ID	K122610
Device Name	PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
Applicant	Sen MU Technology Co., Ltd.
Product Code	BYE · Anesthesiology
Decision Date	Aug 5, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5965
Device Class	Class 2
Attributes	Therapeutic

Intended Use

To provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.

Device Story

Disposable, non-invasive ventilator support system; provides CPAP to spontaneously breathing patients. Operates via 50 PSI compressed gas source; venturi mechanism entrains room air to deliver oxygen/air mixture. Features adjustable PEEP valve (up to 15 cmH2O) and anti-suffocation valve. Used in hospital and EMS environments by clinicians. Includes inhalation/exhalation filters to prevent CO2 rebreathing and protect patient. Optional manometer displays airway pressure. Device provides rapid respiratory relief with minimal oxygen consumption. Single-patient use design.

Clinical Evidence

Bench testing only. Performance testing included CO2 clearance validation to ensure effective flushing of exhaled gas at 5 Lpm input flow. Biocompatibility testing conducted per ISO 10993 (cytotoxicity, sensitization, irritation/intracutaneous reactivity). Device conforms to ISO 5356-1:2004 standards.

Technological Characteristics

Materials: Polycarbonate (PC) flow generator, PVC cushion mask, PP CPAP valve. Principle: Oxygen-powered venturi entrainment. Energy: 50 PSI compressed gas source. Form factor: Disposable, single-patient use circuit with filters, mask, and optional manometer. Connectivity: None. Sterilization: Not specified (disposable).

Indications for Use

Indicated for spontaneously breathing adult patients (>30kg) requiring CPAP in hospital or pre-hospital (EMS) settings.

Regulatory Classification

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.

Predicate Devices

Boussignac CPAP Device (K013884)
Pulmodyne CHF Flow Generator (K080256)

Related Devices

K093862 — CAREVENT HANDHELD CPAP SYSTEM · O-Two Medical Technologies, Inc. · May 6, 2010
K081266 — MERCURY MEDICAL PEEP VALVE · Mercury Enterprizes Dba Mercury Medical · Mar 5, 2009
K192000 — D R Burton OxyPAP · D R Burton Healthcare, LLC · Feb 19, 2020
K983920 — EMS PEEP VALVES- ADJUSTABLE · Engineered Medical Systems · Jan 22, 1999
K092085 — ISPIRA RESUSCITATION UNIT · Neoforce Group, Inc. · Oct 7, 2009

Submission Summary (Full Text)

{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 | 5~10 lpm flow source(for CH- FFM-87XX) 4~8 lpm flow 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