(238 days)
Not Found
No
The summary describes a CPAP device with a "PVA function" which is compared to the predicate device. While "PVA" could potentially relate to pressure variation algorithms, the description focuses on standard performance tests and comparisons, with no mention of AI, ML, or related concepts. The modifications are described as material and PCB layout changes.
Yes
The device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients, indicating a therapeutic purpose.
No
The device is described as providing continuous positive airway pressure (CPAP) for the treatment of Obstructive Sleep Apnea (OSA). Its function is therapeutic (treatment), not diagnostic (identifying a disease or condition). While CPAP devices might collect some data, their primary intended use, according to the "Intended Use / Indications for Use" section, is treatment.
No
The device description explicitly mentions changes to hardware components (impeller material and PCB layout) and describes physical performance tests related to pressure, flow, temperature, and humidification, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA). This is a therapeutic device that directly interacts with the patient's airway.
- Device Description: The description details a CPAP machine with a humidifier, focusing on mechanical and airflow functions.
- Anatomical Site: The anatomical site is the airway, which is a part of the living body.
- Performance Studies: The performance studies focus on safety, electrical compatibility, firmware validation, noise, pressure, flow, temperature, humidification, and biocompatibility. These are all related to the physical and functional performance of a device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
This device is clearly a therapeutic medical device used for treating a condition, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.
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
Intended User / Care Setting
single patient reuse in the home 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)
Design verification tests were performed on the new device(s) based on the risk analysis and product requirements. In addition, the PVA function test was conducted with predicate device(s). The verified items are as follows:
- (1) Safety and EMC: according to ANSI/AAMI ES60601-1: 2005+C1:09+A2:10, IEC 60601-1-2: 2007 (Edition 3) and FDA reviewer guidance 638 (Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard)).
- Firmware Validation: FDA Guidance for the Content of Premarket Submissions (2) for Software Contained in Medical Devices (May 11, 2005)
- Noise Test (Refer to ISO 11201:2010/ ISO 7779:2010) (3)
- Performance Tests (Refer to ISO 17510-1:2007): (4)
- a) Pressure Long-term Stability Test
- b) Dynamic Pressure Stability
- c) Static Pressure Stability
- d) Maximum Temperature
- e) Maximum Flow
- Limitation of Maximum Pressure f)
- g) Overflow Test
- h) Expected Useful Life Validation
- Humidification Performance (Refer to ISO 8185:2007) i)
- PVA Function Comparison Test (5)
- a) Endurance Operation and Dynamic Testing (Refer to ISO 17510-1:2007)
- b) APAP Auto titration & AHI Test
- c) The comparison for PVA Waveform with different breathing frequencies and flow volumes
- d) PVA feature handling conditions of disordered breathing (apneas and hypopneas)
- e) The comparison for PVA Waveform upper and lower pressure control
- Comparison for PVA Pressure Average and Tolerance Error f)
- g) Performance Characteristics of PVA Comparison
- Biocompatibility Assessment (6)
- a) Genotoxicity, Carcinogenicity and reproductive toxicity test (ISO 10993-3:2003)
- b) In vitro cytotoxicity test (ISO 10993-5:2009)
- c) Implantation test (ISO 10993-6:2007)
- d) Irritation and skin sensitization (ISO 10993-10:2010)
- e) Systemic toxicity (ISO 10993-11:2006)
- Particle Test: Refer US EPA PM2.5:1997 (7)
- VOC Test: Refer US EPA TO-15:1999 (8)
In conclusion, the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522).
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.
APEX MEDICAL CORP. iCH CPAP with PVA 9S-007XXX series (K141522)
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, with flowing lines beneath them, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2015
Apex Medical Corp. Mr. Frank Lin Director of Quality Management Division No. 9, Min Sheng St. Tu-Cheng District New Taipei City, 23679 Taiwan
Re: K150111
Trade/Device Name: iCH CPAP with PVA 9S-007XXX Series Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (Ippb) Regulatory Class: Class II Product Code: BZD Dated: August 14, 2015 Received: August 17, 2015
Dear Mr. Frank Lin:
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.
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
1
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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150111
Device Name iCH CPAP with PVA 9S-007XXX Series
Indications for Use (Describe)
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary- iCH CPAP with PVA 9S-007XXX series
Date Prepared: 8/14/2015
| Applicant name: | Apex Medical Corp. |
|---|---|
| Contact Person: | Frank Lin |
| Address: | No.9, Min Sheng St., Tu-Cheng, New Taipei City, 23679, Taiwan |
| Phone number: | 886-2-22683100 |
| Fax numbers: | 886-2-22686525 |
| Device name | Trade name: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series |
| Common name: CPAP | |
| Classification name: | |
| Non-continuous ventilator Class II in accordance with 21 CFR 868.5905 | |
| Classification | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Regulation Number: 868.5905 | |
| Medical Specialty: Anesthesiology | |
| Product Code: BZD | |
| Device Class: II | |
| Predicate Device | APEX MEDICAL CORP. iCH CPAP with PVA 9S-007XXX series (K141522) |
| Reason for Submission | Modification of original APEX MEDICAL CORP. iCH CPAP with PVA 9S-007XXX series |
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Indications for Use
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.
Device Description
The modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device(s)
- A Same intended use
- A Same operating principle
- A Same technology
- A Same manufacturing process
| Device
Characteristic | Modified
iCH CPAP with PVA
9S-007XXX series
(New Device) | Predicate
iCH CPAP with PVA
9S-007XXX
(K141522) | Comment |
|--------------------------|-------------------------------------------------------------------|----------------------------------------------------------|------------|
| Intended user | Adult | Adult | Equivalent |
| Air Outlet | 22mm | 22mm | Equivalent |
| User | single patient reuse | single patient reuse | Equivalent |
| Operating Environment | +5 ~ 35℃
15 ~ 95%
Non-condensing | +5 ~ 35℃
15 ~ 95%
Non-condensing | Equivalent |
| Pressure Range | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | Equivalent |
5
| Device
Characteristic | Modified
iCH CPAP with PVA
9S-007XXX series
(New Device) | Predicate
iCH CPAP with PVA
9S-007XXX
(K141522) | Comment |
|-------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------|------------|
| Pressure Increment | 0.5 cmH2O | 0.5 cmH2O | Equivalent |
| Pressure Ramp Time | 045 min, 5 minutes45 min, 5 minutes
per step | 0
per step | Equivalent |
| Pressure Compensate | Yes | Yes | Equivalent |
| Altitude Compensate | Yes | Yes | Equivalent |
| Automatically Titrates
Pressure in APAP Mode | Yes (iCH Auto) | Yes (iCH Auto) | Equivalent |
| Expiration Pressure
Release
(PVA) | Yes
Three Constant
Levels (C1, C2, C3) | Yes
Three Constant
Levels (C1, C2, C3) | Equivalent |
| Alarm System | Error 001005007,
Warning 001
Low P | Error 001005007,
Warning 001
Low P | Equivalent |
| Impeller Material of
Blower | Plastic | Aluminum | Equivalent |
| Power Supply | 60W (DC 24V, 2.5A) | 90W (DC 24V, 3.75A) | Equivalent |
| Heater Platform | 60W (DC 24V, 2.5A) | 90W (DC 24V, 3.75A) | Equivalent |
Table of comparison with predicate devices
Design verification tests were performed on the new device(s) based on the risk analysis and product requirements. In addition, the PVA function test was conducted with predicate device(s). The verified items are as follows:
- (1) Safety and EMC: according to ANSI/AAMI ES60601-1: 2005+C1:09+A2:10, IEC 60601-1-2: 2007 (Edition 3) and FDA reviewer guidance 638 (Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard)).
- Firmware Validation: FDA Guidance for the Content of Premarket Submissions (2) for Software Contained in Medical Devices (May 11, 2005)
- Noise Test (Refer to ISO 11201:2010/ ISO 7779:2010) (3)
- Performance Tests (Refer to ISO 17510-1:2007): (4)
- a) Pressure Long-term Stability Test
- b) Dynamic Pressure Stability
- c) Static Pressure Stability
- d) Maximum Temperature
6
- e) Maximum Flow
- Limitation of Maximum Pressure f)
- g) Overflow Test
- h) Expected Useful Life Validation
- Humidification Performance (Refer to ISO 8185:2007) i)
- PVA Function Comparison Test (5)
- a) Endurance Operation and Dynamic Testing (Refer to ISO 17510-1:2007)
- b) APAP Auto titration & AHI Test
- c) The comparison for PVA Waveform with different breathing frequencies and flow volumes
- d) PVA feature handling conditions of disordered breathing (apneas and hypopneas)
- e) The comparison for PVA Waveform upper and lower pressure control
- Comparison for PVA Pressure Average and Tolerance Error f)
- g) Performance Characteristics of PVA Comparison
- Biocompatibility Assessment (6)
- a) Genotoxicity, Carcinogenicity and reproductive toxicity test (ISO 10993-3:2003)
- b) In vitro cytotoxicity test (ISO 10993-5:2009)
- c) Implantation test (ISO 10993-6:2007)
- d) Irritation and skin sensitization (ISO 10993-10:2010)
- e) Systemic toxicity (ISO 10993-11:2006)
- Particle Test: Refer US EPA PM2.5:1997 (7)
- VOC Test: Refer US EPA TO-15:1999 (8)
The modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards as following:
- (1) ANSI/AAMI ES60601-1:2005+C1:09+A2:10. Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (FDA recognition number: 19-5)
- (2) IEC 60601-1-2:2007. Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (FDA recognition number: 19-1)
- (3) FDA reviewer guidance 638 (Excerpts Related to EMI from November 1993
7
Anesthesiology and Respiratory Devices Branch (includes EMI standard)
- (4) FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- (5) ISO 5367:2000. Breathing tubes intended for use with anaesthetic apparatus and ventilators. (FDA recognition number: 1-46)
- (6) ISO 11201:2010. Noise emitted by machinery and equipment -- Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections.
- (7) ISO 7779:2010. Measurement of airborne noise emitted by information technology and telecommunications equipment.
- (8) ISO 17510-1:2007. Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment.
- (9) ISO 8185:2007. Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems.
- (10) Determination Of Volatile Organic Compounds (VOCs) In Air Collected In Specially-Prepared Canisters And Analyzed By Gas Chromatography/Mass Spectrometry (GC/MS):1999.
- (11) US EPA National Ambient Air Quality Standards (NAAQS) PM2.5:1997.
- (12) ISO 10993-1:2009/(R) 2013. Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (FDA recognition number: 2-156)
- (13) ISO 10993-3:2003. Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. (FDA recognition number: 2-175)
- (14) ISO 10993-5:2009. Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. (FDA recognition number: 2-153)
- (15) ISO 10993-6:2007. Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation. (FDA recognition number: 2-120)
- (16) ISO 10993-10:2010. Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. (FDA recognition number: 2-173)
- (17) ISO 10993-11:2006. Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity. (FDA recognition number: 2-176)
- (18) IEC 60601-1-11:2010. Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems
8
Apex Medical Corp.
Used In The Home Healthcare Environment. (FDA recognition number: 19-6)
In conclusion, the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522). The relevant test reports are described in this submission. Therefore, we state that the modified iCH CPAP with PVA 9S-007XXX Series is substantially equivalent to the predicate device - iCH CPAP with PVA 9S-007XXX Series (K141522).