(218 days)
Not Found
No
The description details a standard Pressure Swing Adsorption (PSA) oxygen concentrator with electronic controls and pneumatic valves. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended to provide supplemental oxygen to patients with respiratory disorders, which is a therapeutic purpose.
No
An oxygen concentrator is a therapeutic device that delivers oxygen to patients; it does not diagnose medical conditions.
No
The device description clearly outlines hardware components such as a mainframe, flowmeter, compressor, sieve beds, storage tank, and pneumatic valve, indicating it is a physical medical device, not software-only.
Based on the provided information, the JUMAO Oxygen Concentrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mechanical process of separating gases from ambient air and delivering enriched oxygen to a patient. This is a physical process, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The JUMAO Oxygen Concentrator is a medical device used for respiratory therapy, not for performing diagnostic tests in vitro.
N/A
Intended Use / Indications for Use
The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides high concentration of oxygen directly to patient/user through a nasal cannula or other methods.
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator which takes 120V ~ power source as power source. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 93% oxygen to the patient.
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
The device is intended for use in adults.
Intended User / Care Setting
Not Found
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)
Non-Clinical Tests Submitted:
Biocompatibility Testing:
- Performed toxicological evaluation according to ISO 18562-1:2017.
- Performed evaluation of emissions of ozone, carbon monoxide, carbon dioxide per recommendations in ISO 18562-1:2017.
- Performed test for emissions of particulate matter according to ISO 18562-2:2017.
- Performed test for emissions of volatile organic compounds according to ISO 18562-3:2017.
- Performed biocompatibility test for the parts that may directly contact the intact skin of the patient or operator, including in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021.
Electrical Safety and Electromagnetic Compatibility Testing:
- The Device was tested and complied with the applicable requirements of the following standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, AIM Standard 7351731, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69, demonstrated that the basic safety and performance of the device met the requirements.
Software Verification and Validation:
- Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Concise summary for performance testing - bench:
- Performance Test (Appearance requirement, Gas tightness, Sound pressure level, Operation, Accuracy of continuous flowrate, Oxygen yield and oxygen concentration, Oxygen output pressure, Alarm, Error of flowmeter, Leakage current, Dielectric strength).
- Use Life Test (Accelerated life test, and performance test after accelerated life test).
- Cleaning and Disinfection Verification (simulated cleaning and disinfection test, and performance test after simulated cleaning and disinfection test).
All the bench test results are provided in Performance Test Report.
Usability Study:
The JMC5A Ni oxygen concentrator was performed usability study separately by similar methods. Testing of 15 participants was conducted showing that the participants were able to understand the user manual and labeling and were able to safely and effectively use the device.
Clinical Study:
No clinical testing has been performed.
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
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".
November 9, 2023
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong 511660 China
Re: K230969
Trade/Device Name: Oxygen Generator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: October 10, 2023 Received: October 10, 2023
Dear Jinghua Zhou:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230969
Device Name Oxygen Concentrator
Indications for Use (Describe)
The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
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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4
Section 5 - 510(k) Summary
K Number: K230969 Date of Summary Preparation: March 31, 2023 Date of Summary modification: September 28, 2023
1. Submitter's Identifications
Submitter's Name: Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Address: No.36 Danyan Road, Danyang, Jiangsu 212300, China Official Contact Person: Yu Yao Zip code: 212300 Contact Title: General Manager Contact E-mail Address: 541640111@gq.com Tel: +86-511-86197666 Fax: +86-511-86197033
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Oxygen concentrator, Portable Product Name: Portable oxygen generator Trade Name: Oxygen Concentrator Model: JMC5A Ni Classification Panel: Anesthesiology Product Code: CAW Regulation Number: 21 CFR 868.5440 Device Classification: Class II
4. The Predicate Devices
Predicate device: K090007 Oxygen Concentrator
5. Device Description
JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides
5
high concentration of oxygen directly to patient/user through a nasal cannula or other methods.
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator which takes 120V ~ power source as power source. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 93% oxygen to the patient.
6. Intended Use of Device
The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
| 7. Summary of Substantial Equivalence | |
|---|---|
| --------------------------------------- | -- |
| Proposed device | Predicate device | Comparison | |
|---|---|---|---|
| 510k | |||
| Number | ------ | K090007 | ------ |
| Product Code | CAW | CAW | Same |
| Proprietary | |||
| Name | Oxygen Concentrator | Oxygen Concentrator | ------ |
| Model | JMC5A Ni | JM-07000Hi, | |
| JM-07000i, JM-07000 | ------ | ||
| Manufacturer | Jiangsu Jumao X-Care | ||
| Medical Equipment | |||
| Co., Ltd. | Jiangsu Jumao X-Care | ||
| Medical Equipment | |||
| Co., Ltd. | ------ | ||
| Indications | |||
| for use | The JUMAO Oxygen | ||
| Concentrator is | |||
| intended to provide | |||
| supplemental oxygen | |||
| to patients with | |||
| respiratory disorders, | |||
| by separating nitrogen | The intended function | ||
| and use of the Jumao | |||
| Oxygen Concentrator | |||
| is to provide | |||
| supplemental oxygen | |||
| to patients with | |||
| respiratory disorders. | Same | ||
| from room air, by way | |||
| of a molecular sieve. It | |||
| is not intended to | |||
| sustain or support life. | by separating nitrogen | ||
| from room air, by way | |||
| of a molecular sieve. It | |||
| is not intended to | |||
| sustain or support life. | |||
| Intended | |||
| patient | |||
| population | The device is intended | ||
| for use in adults. | The device is intended | ||
| for use in adults. | Same | ||
| Structure and | |||
| main | |||
| components | JMC5A Ni oxygen | ||
| concentrator is made | |||
| up of mainframe and | |||
| flowmeter. | |||
| The front panel of the | |||
| device contains the | |||
| controls and | |||
| indicators. These | |||
| include a standard | |||
| barb fitting for | |||
| attaching the oxygen | |||
| tubing, the adjustable | |||
| flow meter, a power | |||
| light indicator, an | |||
| elapsed time meter, | |||
| and a standard on/off | |||
| rocker type power | |||
| switch. | The front panel of the | ||
| device contains the | |||
| controls and | |||
| indicators. These | |||
| include a standard | |||
| barb fitting for | |||
| attaching the oxygen | |||
| tubing, the adjustable | |||
| flow meter, a power | |||
| light indicator, an | |||
| elapsed time meter, | |||
| and a standard on/off | |||
| rocker type power | |||
| switch. | Same | ||
| Same as JM-07000i | |||
| and JM-07000 models. | |||
| Filters | Cabinet, out HEPA, | ||
| Compressor inlet | Cabinet, out HEPA, | ||
| Compressor inlet | Same | ||
| HEPA Filter | Same as predicate | ||
| device | Same as proposed | ||
| device | Same | ||
| Oxygen | |||
| sensor | Model: OXY-III-B, | ||
| Gasboard-7500K | DigiFLO Concentrator | ||
| ANALYZER (clear by | |||
| FDA, K072469) | Different | ||
| The oxygen sensor | |||
| used in proposed | |||
| device does not have a | |||
| K number, while the | |||
| sensor used in | |||
| predicate device has a | |||
| K number. | |||
| The oxygen sensor of | |||
| predicate device has | |||
| been tested with | |||
| equipment. | |||
| The | |||
| difference does not | |||
| and safety of the | |||
| proposed device. | |||
| Compressor | Model: 1120-2-1-3, | ||
| 1121-1-2-1(1000460) | GSE-ZW400D2-90 | ||
| Compressor, Thomas | |||
| based double wobble | Different | ||
| Proposed device and | |||
| predicate device use | |||
| compressors from | |||
| different | |||
| manufacturers. | |||
| The compressor of | |||
| predicate device has | |||
| been tested with | |||
| equipment. | |||
| The | |||
| difference does not | |||
| affect the effectiveness | |||
| and safety of the | |||
| proposed device. | |||
| Material of | |||
| main | |||
| components | Components and | ||
| associated materials | |||
| which contact the gas | |||
| pathway to the patient: | |||
| filter-High efficiency | |||
| particulate air (HEPA) | |||
| filter paper; | |||
| Compressor- ASM; | |||
| Heat exchanger- | |||
| Aluminum; Valve | |||
| assembly-Aluminum; | |||
| Molecular sieve | |||
| module- | |||
| $Li2O \cdot A12O3 \cdot (2.2\pm0.2)$ | |||
| SiO2·9/2H2O; | |||
| Silicone tube- | |||
| Silicone; Product | |||
| tank-ABS; Bacilli | |||
| filter- Non-woven | |||
| polyester fiber; Flow | |||
| meter-Acrylic; Check | |||
| valve-Fluororubber; | |||
| Oxygen outlet | |||
| connector-Copper; | |||
| Commute valve- | |||
| Fluororubber; Muffler, | |||
| Enclosure, Base-ABS; | Components and | ||
| associated materials | |||
| which contact the gas | |||
| pathway to the patient: | |||
| filter-High efficiency | |||
| particulate air (HEPA) | |||
| filter paper; | |||
| Compressor- ASM; | |||
| Heat exchanger- | |||
| Aluminum; Valve | |||
| assembly-Aluminum; | |||
| Molecular sieve | |||
| module- | |||
| $Li2O \cdot A12O3 \cdot (2.2\pm0.2)$ | |||
| SiO2·9/2H2O; | |||
| Silicone tube- | |||
| Silicone; Product | |||
| tank-ABS; Bacilli | |||
| filter- Non-woven | |||
| polyester fiber; Flow | |||
| meter-Acrylic; Check | |||
| valve-Fluororubber; | |||
| Oxygen outlet | |||
| connector-Copper; | |||
| Humidifier | |||
| bottle-( Cup | |||
| body-translucent PE, | Same | ||
| Wheel, Control panel; Power cord-ASM; PCB- Flame Retardant Copper Clad Epoxy E Glass Cloth Laminate | Filter tube-transparent PVC); Nasal oxygen cannula-PVC; Commute valve-Fluororubber; Muffler, Enclosure, Base-ABS; Transformer, AC fan, Wheel, Control panel, Power cord-ASM; PCB- Flame Retardant Copper Clad Epoxy E Glass Cloth Laminate | ||
| Power supply | AC120V, 60Hz; Current: 3.5A; Power: 450VA | AC115V, 60 Hz, 4.3 A; Power consumption: 4.3 amps average 5L/min (400W) | Different Input voltage, rated current and rated input power of proposed device are different from those of predicate device. Proposed device is complied with safe standards. These difference do not affect the safety and effectiveness of proposed device. |
| Oxygen concentration | $93% \pm 3%$ at 0.5 to 5L/min (after turning on 5 minutes) | 95.6% to 87% at all flow rates | Similar |
- The expression of the proposed device is more standardized, and the requirements for oxygen concentration under the conditions of 0.5 to 5L/min are specified.
- The oxygen concentration range of the proposed device is narrower than that of the predicate device. Oxygen concentration of proposed device can reach $93% \pm 3%$ within the oxygen flow range. |
| | | | which is superior to
the predicate device.
Proposed device is
complied with
ISO80601-2-69.
The difference does
not affect the
effectiveness and
safety of the proposed
device. |
| Oxygen flow | 0.55L/min | 0.5 – 5 LPM | Same |15.37psi)
| Outlet
pressure | 38kPa±5kPa | 38kPa±5kPa | Same |
| Noise | Sound level: ≤ 50.5dB
(A);
Acoustic power level:
58.5dB (A) | 52 dB(A) | Different
Sound level of
proposed device is
lower than that of
predicate device.
Acoustic power level
is added to the propsed
device.
Proposed device is complied
with ANSI AAMI
ES60601-1.
The difference does not
affect the effectiveness
and safety of the
proposed device. |
| Release
pressure by
machine
operation | 250kPa±50kPa | 40bsi (275kPa) | Different
Range of release
pressure of proposed
device is larger than
that of predicate
device.
Proposed device is
complied with safe
standards.
The difference does
not affect the
effectiveness and
safety of the proposed
device. |
| Net weight | 16.1kg | 52 pounds (23.6kg) | Different
Net weight of
proposed device is |
| | | | lighter than that of predicate device.
Proposed device is complied with ANSI AAMI ES60601-1.
The difference does not affect the effectiveness and safety of the proposed device. |
| Dimension | 330×260×540(mm) | 28" (710mm)H x 17"(432) W x 15"(381)D | Different Dimension of proposed device is smaller than that of predicate device.
Proposed device is complied with ANSI AAMI ES60601-1.
The difference does not affect the effectiveness and safety of the proposed device. |
| Electric
Classification | Class II, Type BF | Class II, Type B | Similar
They are both Class II.
But safety type of applied part is different, proposed device is type BF, predicate device is type B.
Proposed device is complied with ANSI AAMI ES60601-1.
The difference does not affect the effectiveness and safety of the proposed device. |
| Alarm | Start-up fail alarm | Oxygen low-flow monitor, | Same
Different expressions, in fact the same principle |
| | | | |
| | Low oxygen
concentration alarm | Low oxygen purity
(JM-07000Hi,
JM-07000i) | Same
Different expressions, in fact the same principle. |
| | Power supply failure
alarm | Power failure | Same
Different expressions, in fact the same principle. |
| | Pressure failure alarm
1.Outlet block, oxygen
flowrate below 0.6
Lpm;
2.Compressor stop | Compressor 40 psi
pressure relief valve
Thermal protection on
compressor | Different
Proposed device
design takes into
account compressor
stop, outlet block,
oxygen flowrate below
resulting in pressure
failure alarm. The
alarm function is
complied with IEC
60601-1-8. The
difference does not
affect the effectiveness
and safety of the
proposed device. |
| Mode of
operation | Continuous duty | Continuous duty | Same |
| Normal
operating
ambient | Temperature range:
5°C ~ 40°C (41°F ~
104°F)
Relative humidity:
≤80%
Atmospheric pressure:
86kPa ~ 106kPa
(12.47psi
1828 meter (5997 feet)
height above sea level | 10 °C - 35 °C
30-75% Relative
Humidity
(non-condensing)
Up to 7,500 feet above
sea level | Different
The range of operating
temperature range and
relative humidity of
proposed device is
wider than those of
predicate device.
The height above sea
level of proposed
device is less than that
of predicate device. |
| Storage and
transport
ambient | Temperature Range:
0°C~+55°C (32°F~
+131°F)
Relative Humidity
Range: 10%90%15.37psi) | -40 °C to 70 °C, 10%
Atmospheric pressure:
70kPa ~ 106kPa
(10.2psi
to 100% R.H. | Different
The temperature range
and relative humidity
range of proposed
device are both narrow
than those of predicate
device. Atmospheric
pressure is added to |
| | | | proposed device.
The range of storage
and transport of
proposed device is
narrower than that of
predicate device.
The difference does
not affect the
effectiveness and
safety of the proposed
device. |
| Software
control | Yes | Yes | Same |
| Patient
interface type | Visual, direct contact
type patient interface | Visual, direct contact
type patient interface | Same |
| Standard | IEC 60601-1-2:2014+
A1:2020
IEC TR
60601-4-2:2016
AIM Standard
7351731:2021
ANSI AAMI
ES60601-1:2005/(R)2
012 and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012
IEC60601-1-11:2015
IEC60601-1-8:2012
ISO80601-2-69:2014
ISO18562-1:2017
ISO18562-2:2017
ISO18562-3:2017
ISO10993-1:2018
ISO10993-5:2009
ISO10993-10:2021
ISO10993-23:2021 | ASTM 1464-93 (2005)
ISO 8359:1996
IEC 60601-1:2005
IEC 60601-1-2:2007
UL 1431, 2nd ED.,
1996 | Similar - In the test standards
for proposed device
and predicate device:
basic safety and
performance
requirements for
medical electrical
equipment
(ES/IEC60601-1), and
electromagnetic
compatibility
(IEC60601-1-2), the
two standards have the
same number, but
different age numbers; - Standard
IEC60601-1-11 and
standard UL 1431 are
similar.
The requirements of
ISO80601-2-69
supersede ASTM 1464
and ISO 8359. - Proposed device
adds IEC TR
60601-4-2, AIM
Standard 7351731,
ISO18562-1 |
| Discussion
for
Substantially
Equivalent
(SE) | The proposed device JMC5A Ni oxygen concentrator has the same
indications for use, intended patient population, structure and main
components, filters, HEPA filter, material of main components, oxygen
flow, outlet pressure, alarm (start-up fail alarm, low oxygen concentration
alarm, power supply failure alarm), mode of operation. The main
differences are oxygen sensor and compressor used, power supply,
oxygen concentration, noise, release pressure by machine operation, net
weight, dimension, application types of electrical safety, pressure failure
alarm, normal operating ambient, storage and transport ambient, test
standards. These differences are slight and do not affect the effectiveness
and safety of the device, through the above comparative analysis.
The proposed device JMC5A Ni oxygen concentrator is determined to be
Substantially Equivalent (SE) to the predicate device, JM-07000Hi,
JM-07000i, JM-07000 oxygen concentrator in respect of safety and
effectiveness. | ISO18562-2, and
ISO18562-3 test. - Proposed device
adds ISO 10993-5,
ISO 10993-10, ISO
10993-23 test.
Proposed device are
tested against current
applicable standards,
and the test results
meet the standard
requirements. These
difference do not
affect the effectiveness
and safety of the
proposed device. | |
Table 1
6
7
8
9
10
11
12
13
Note: The oxygen concentrator can be used with accessories (i.e, nasal cannula, humidifier bottle) available in the market.
8. Non-Clinical Tests Submitted:
The following non-clinical testing was provided in this 510(k) submission:
Biocompatibility Testing
- According to ISO 10993-1:2018 and ISO 18562-1:2017, we performed the biocompatibility evaluation and test of the dry breathing gas pathway:
-
Performed toxicological evaluation according to ISO 18562-1:2017. Performed evaluation of emissions of ozone, carbon monoxide, carbon dioxide per recommendations in ISO 18562-1:2017.
-
Performed test for emissions of particulate matter according to ISO 18562-2:2017.
14
- Performed test for emissions of volatile organic compounds according to ISO 18562-3:2017.
- According to ISO 10993-1:2018, we performed biocompatibility test for the parts that may directly contact the intact skin of the patient or operator, including in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021.
Electrical Safety and Electromagnetic Compatibility Testing
- The Device was tested and complied with the applicable requirements of the following standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, AIM Standard 7351731, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69, demonstrated that the basic safety and performance of the device met the requirements.
Software Verification and Validation
- Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Concise summary for performance testing
From the performance testing - bench, we have a brief summary as follow:
-
Performance Test (Appearance requirement, Gas tightness, Sound pressure level, Operation, Accuracy of continuous flowrate, Oxygen yield and oxygen concentration, Oxygen output pressure, Alarm, Error of flowmeter, Leakage current, Dielectric strength).
-
Use Life Test (Accelerated life test, and performance test after accelerated life test).
-
Cleaning and Disinfection Verification (simulated cleaning and disinfection test, and performance test after simulated cleaning and disinfection test).
All the bench test results are provided in Performance Test Report.
10. Usability Study
The JMC5A Ni oxygen concentrator was performed usability study separately by similar methods.
Testing of 15 participants was conducted showing that the participants were able to understand the user manual and labeling and were able to safely and effectively use the device.
11. Clinical Study
No clinical testing has been performed.
12. Conclusions
After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantially equivalent to the predicate device.