Oxygen Concentrator

K230969 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · CAW · Nov 9, 2023 · Anesthesiology

Device Facts

• Record ID: K230969
• Device Name: Oxygen Concentrator
• Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

JMC5A Ni oxygen concentrator; electronically operated; provides supplemental oxygen to patients with respiratory disorders. Principle: Pressure Swing Adsorption (PSA); piston compressor draws room air through filters; pneumatic valve directs air into one of two molecular sieve beds; nitrogen adsorbed; oxygen concentrated; output regulated via flow meter to patient; second bed exhausts nitrogen. Used in home/clinical settings; operated by patient or clinician. Output: 0.5 to 5 L/min of 93% ± 3% oxygen. Benefits: provides supplemental oxygen for respiratory support. Device includes alarms for start-up failure, low oxygen concentration, power failure, and pressure failure. Healthcare providers use output to manage patient oxygenation levels.

Clinical Evidence

No clinical data. Bench testing only. Includes biocompatibility (ISO 10993, ISO 18562), electrical safety/EMC (ANSI AAMI ES60601-1, IEC 60601-1-2, etc.), software verification/validation, and performance testing (gas tightness, flow accuracy, oxygen concentration, alarm functionality, life testing, cleaning/disinfection). Usability study conducted with 15 participants.

Technological Characteristics

PSA oxygen concentrator; 120V AC power. Materials: Aluminum (heat exchanger, valve), Li2O·Al2O3·(2.2±0.2)SiO2·9/2H2O (molecular sieve), Silicone (tubing), ABS (tank, enclosure), Acrylic (flow meter). Dimensions: 330x260x540mm; Weight: 16.1kg. Connectivity: Standalone. Software: Embedded firmware. Standards: ISO 80601-2-69, ANSI AAMI ES60601-1, IEC 60601-1-8, ISO 10993, ISO 18562.

Indications for Use

Indicated for adult patients with respiratory disorders requiring supplemental oxygen. Not intended to sustain or support life.

Regulatory Classification

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).

Predicate Devices

• Oxygen Concentrator (K090007)

Reference Devices

• DigiFLO Concentrator ANALYZER (K072469)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [e-mail] Tel: [phone] Fax: [phone]

## 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: [e-mail] Telephone: [phone] Fax: [phone]

# 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<br>Number | ------ | K090007 | ------ |
| Product Code | CAW | CAW | Same |
| Proprietary<br>Name | Oxygen Concentrator | Oxygen Concentrator | ------ |
| Model | JMC5A Ni | JM-07000Hi,<br>JM-07000i, JM-07000 | ------ |
| Manufacturer | Jiangsu Jumao X-Care<br>Medical Equipment<br>Co., Ltd. | Jiangsu Jumao X-Care<br>Medical Equipment<br>Co., Ltd. | ------ |
| Indications<br>for use | The JUMAO Oxygen<br>Concentrator is<br>intended to provide<br>supplemental oxygen<br>to patients with<br>respiratory disorders,<br>by separating nitrogen | The intended function<br>and use of the Jumao<br>Oxygen Concentrator<br>is to provide<br>supplemental oxygen<br>to patients with<br>respiratory disorders. | Same |
| | | | |
| | from room air, by way<br>of a molecular sieve. It<br>is not intended to<br>sustain or support life. | by separating nitrogen<br>from room air, by way<br>of a molecular sieve. It<br>is not intended to<br>sustain or support life. | |
| Intended<br>patient<br>population | The device is intended<br>for use in adults. | The device is intended<br>for use in adults. | Same |
| Structure and<br>main<br>components | JMC5A Ni oxygen<br>concentrator is made<br>up of mainframe and<br>flowmeter.<br>The front panel of the<br>device contains the<br>controls and<br>indicators. These<br>include a standard<br>barb fitting for<br>attaching the oxygen<br>tubing, the adjustable<br>flow meter, a power<br>light indicator, an<br>elapsed time meter,<br>and a standard on/off<br>rocker type power<br>switch. | The front panel of the<br>device contains the<br>controls and<br>indicators. These<br>include a standard<br>barb fitting for<br>attaching the oxygen<br>tubing, the adjustable<br>flow meter, a power<br>light indicator, an<br>elapsed time meter,<br>and a standard on/off<br>rocker type power<br>switch. | Same<br>Same as JM-07000i<br>and JM-07000 models. |
| Filters | Cabinet, out HEPA,<br>Compressor inlet | Cabinet, out HEPA,<br>Compressor inlet | Same |
| HEPA Filter | Same as predicate<br>device | Same as proposed<br>device | Same |
| Oxygen<br>sensor | Model: OXY-III-B,<br>Gasboard-7500K | DigiFLO Concentrator<br>ANALYZER (clear by<br>FDA, K072469) | Different<br>The oxygen sensor<br>used in proposed<br>device does not have a<br>K number, while the<br>sensor used in<br>predicate device has a<br>K number.<br>The oxygen sensor of<br>predicate device has<br>been tested with<br>equipment.<br>The<br>difference does not |
| | | | and safety of the |
| | | | proposed device. |
| Compressor | Model: 1120-2-1-3,<br>1121-1-2-1(1000460) | GSE-ZW400D2-90<br>Compressor, Thomas<br>based double wobble | Different<br>Proposed device and<br>predicate device use<br>compressors from<br>different<br>manufacturers.<br>The compressor of<br>predicate device has<br>been tested with<br>equipment.<br>The<br>difference does not<br>affect the effectiveness<br>and safety of the<br>proposed device. |
| Material of<br>main<br>components | Components and<br>associated materials<br>which contact the gas<br>pathway to the patient:<br>filter-High efficiency<br>particulate air (HEPA)<br>filter paper;<br>Compressor- ASM;<br>Heat exchanger-<br>Aluminum; Valve<br>assembly-Aluminum;<br>Molecular sieve<br>module-<br>$Li2O \cdot A12O3 \cdot (2.2\pm0.2)$<br>SiO2·9/2H2O;<br>Silicone tube-<br>Silicone; Product<br>tank-ABS; Bacilli<br>filter- Non-woven<br>polyester fiber; Flow<br>meter-Acrylic; Check<br>valve-Fluororubber;<br>Oxygen outlet<br>connector-Copper;<br>Commute valve-<br>Fluororubber; Muffler,<br>Enclosure, Base-ABS; | Components and<br>associated materials<br>which contact the gas<br>pathway to the patient:<br>filter-High efficiency<br>particulate air (HEPA)<br>filter paper;<br>Compressor- ASM;<br>Heat exchanger-<br>Aluminum; Valve<br>assembly-Aluminum;<br>Molecular sieve<br>module-<br>$Li2O \cdot A12O3 \cdot (2.2\pm0.2)$<br>SiO2·9/2H2O;<br>Silicone tube-<br>Silicone; Product<br>tank-ABS; Bacilli<br>filter- Non-woven<br>polyester fiber; Flow<br>meter-Acrylic; Check<br>valve-Fluororubber;<br>Oxygen outlet<br>connector-Copper;<br>Humidifier<br>bottle-( Cup<br>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<br>1. 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.<br>2. 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<br>the predicate device.<br>Proposed device is<br>complied with<br>ISO80601-2-69.<br>The difference does<br>not affect the<br>effectiveness and<br>safety of the proposed<br>device. |
| Oxygen flow | 0.5~5L/min | 0.5 – 5 LPM | Same |
| Outlet<br>pressure | 38kPa±5kPa | 38kPa±5kPa | Same |
| Noise | Sound level: ≤ 50.5dB<br>(A);<br>Acoustic power level:<br>58.5dB (A) | 52 dB(A) | Different<br>Sound level of<br>proposed device is<br>lower than that of<br>predicate device.<br>Acoustic power level<br>is added to the propsed<br>device.<br>Proposed device is complied<br>with ANSI AAMI<br>ES60601-1.<br>The difference does not<br>affect the effectiveness<br>and safety of the<br>proposed device. |
| Release<br>pressure by<br>machine<br>operation | 250kPa±50kPa | 40bsi (275kPa) | Different<br>Range of release<br>pressure of proposed<br>device is larger than<br>that of predicate<br>device.<br>Proposed device is<br>complied with safe<br>standards.<br>The difference does<br>not affect the<br>effectiveness and<br>safety of the proposed<br>device. |
| Net weight | 16.1kg | 52 pounds (23.6kg) | Different<br>Net weight of<br>proposed device is |
| | | | lighter than that of predicate device.<br>Proposed device is complied with ANSI AAMI ES60601-1.<br>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.<br>Proposed device is complied with ANSI AAMI ES60601-1.<br>The difference does not affect the effectiveness and safety of the proposed device. |
| Electric<br>Classification | Class II, Type BF | Class II, Type B | Similar<br>They are both Class II.<br>But safety type of applied part is different, proposed device is type BF, predicate device is type B.<br>Proposed device is complied with ANSI AAMI ES60601-1.<br>The difference does not affect the effectiveness and safety of the proposed device. |
| Alarm | Start-up fail alarm…