(171 days)
The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.
The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.
The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.
The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" .
In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.
The provided text describes a 510(k) premarket notification for a Portable Oxygen Concentrator (P2-TOC). It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, the document does not contain information related to an AI/ML-enabled device or a study involving human experts, ground truth establishment, or comparative effectiveness with AI assistance.
Therefore, I cannot fulfill most of the requested points as the provided document is for a physical medical device (portable oxygen concentrator) and not an AI/ML diagnostic or therapeutic device.
The document primarily focuses on:
- Device Description and Indications for Use: What the portable oxygen concentrator does.
- Principle of Operation: How it separates oxygen from air.
- Comparison with Predicate Devices: Demonstrating similarity in function and safety to already-marketed oxygen concentrators.
- Non-Clinical Tests Performed: This section lists various engineering and safety standards (electrical safety, EMC, software verification, biocompatibility) that the device complies with. These are standard tests for medical devices to ensure quality and safety, not AI model performance.
- Absence of Clinical Accuracy Testing: Explicitly states "There was no clinical testing performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.
Here's what I can extract from the provided text regarding acceptance criteria and performance, focusing on what is relevant for a physical medical device:
The "acceptance criteria" for a physical device like a Portable Oxygen Concentrator are typically defined by compliance with recognized consensus standards and performance specifications. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to show compliance with these standards and performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance (Based on "Comparison with predicate device" and "Non-Clinical Tests Performed"):
| Acceptance Criteria Category | Specific Acceptance Standard/Criterion (Implied or Explicit) | Reported Device Performance / Compliance |
|---|---|---|
| Safety & Electrical | ANSI AAMI ES 60601-1 (General Safety) | Complies with AAMI ANSI ES60601-1 |
| IEC 60601-1-11 (Home Healthcare) | Complies with IEC 60601-1-11 | |
| Electromagnetic Comp. | IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 |
| Performance (Oxygen Conc.) | ISO 80601-2-69 (Oxygen Concentrator Equ.) | Complies with ISO 80601-2-69 |
| ISO 80601-2-67 (Oxygen-conserving Equ.) | Complies with ISO 80601-2-67 | |
| Software | IEC 62304 (Software Verification) | Complies; Software V&V performed per FDA Guidance |
| Usability | IEC 60601-1-6 (Usability) | Complies with IEC 60601-1-6 |
| Alarms | IEC 60601-1-8 (Alarm Systems) | Complies with IEC 60601-1-8 |
| Biocompatibility | ISO 18562-1, -2, -3 (Breathing Gas Pathways) | Complies with ISO 18562-1, -2, -3 |
| ISO 10993-1, -5, -10, -23 (Biological Evaluation - Patient Contact) | Complies with ISO 10993-1, -5, -10, -23 | |
| Battery Safety | IEC 62133-2 (Lithium Batteries) | Complies with IEC 62133-2 |
| Oxygen Concentration | 90%-3%/+6% at all settings (P2-TOC) | "90%-3%/+6% at all settings" (vs. Predicates 90% +/- 3%) - Risk mitigated by ISO 80601-2-67: 2020 testing. |
| Acoustic Noise | ≤ 60dB (A) (Gear 10 of pulse mode/ Gear 5 of continuous mode) | "litter bigger than predicate device Model 1000" but "standard requirements have been met" (ISO 80601-2-69, IEC 60601-1) |
| Physical Dimensions/Weight | (Not a specific standard, but compared to predicates) | Different from predicates but risks mitigated by ISO 80601-2-69, EC60601-1, ISO 80601-2-67 testing. |
| Flow Rates | (Not a specific standard, but compared to predicates) | Continuous: 1.0-3.0 LPM (Same as predicates). Pulse: 5-200 ml Pulse Volumes (differs from predicates, max flow rate is smaller) - risks mitigated by various ISO/IEC testing. |
Regarding the points specific to AI/ML devices, I must state that the document does not provide the requested information for the following reasons:
2. Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device's compliance with engineering standards, not an AI model trained on data. There is no concept of a "test set" from a data perspective. The "testing" refers to bench testing of the physical hardware and embedded software. Data provenance would not be a relevant concept as it pertains to clinical data for AI model training/testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned. The ground truth for device performance is based on physical measurements against established engineering and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical oxygen concentrator, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to a physical device, not a standalone AI algorithm. While it has embedded software, its "performance" is measured by its physical output (oxygen concentration, flow rate) and adherence to safety standards, not by an algorithm's classification or detection accuracy.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is determined by direct measurement of physical parameters (e.g., oxygen purity, flow volume, noise levels) and compliance with specified engineering and safety standards, as detailed in the "Non-Clinical Tests Performed" section.
8. The sample size for the training set: Not applicable. This is for an AI/ML model, not a physical medical device. The device itself is manufactured; it doesn't "learn" from a training set in the AI sense.
9. How the ground truth for the training set was established: Not applicable. See point 8.
In summary, the provided document is a regulatory submission for a physical Portable Oxygen Concentrator, and therefore, the information requested, which pertains to AI/ML device performance and validation studies, is not present. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this device are based on demonstrating compliance with a comprehensive set of recognized consensus engineering and safety standards through non-clinical bench testing.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. The words "FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
February 28, 2025
Qingdao Kingon Medical Science and Technology Co., Ltd Benrong Zhang Official Correspondent Room 301-302(B), No.15 Hancheng Road,Qingdao Free Trade Zone 24th Building, NO. 252 Yanhe Road, Huangdao Qingdao, Shandong 266510 China
Re: K242718
Trade/Device Name: Portable Oxygen Concentrator (P2-TOC) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: January 27, 2025 Received: January 27, 2025
Dear Benrong Zhang:
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.
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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.
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical
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devices/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. 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 Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242718
Device Name Portable Oxygen Concentrator (P2-TOC)
Indications for Use (Describe)
The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.
The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.
| 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 as required by section 807.92(c)
I. Date of the summary prepared: 20/01/2025
II. Administrative Information
| Manufacturerinformation | Establishment registration number | 3014777423 |
|---|---|---|
| Owner/Operator Number | 10061814 | |
| Name | Qingdao Kingon Medical Science andTechnology Co., Ltd. | |
| Address | Room 301-302, No.15 Hancheng Road,Qingdao Free Trade Zone,Shandong, China, 266555 | |
| Contact Person | Name: Benrong ZhangAddress: Room 301-302, No.15Hancheng Road, Qingdao FreeTrade Zone, Shandong, China, 266555TEL: +86-18565833539FAX: +86 532 58792324Email: augus@kingonmed.com |
III. Device Information
| Type of 510(k) | Traditional 510K |
|---|---|
| Prior submission | K240354 |
| Common Name | Generator, Oxygen, Portable |
| Classification name | Portable oxygen generator |
| Trade Name | Portable Oxygen Concentrator (Model:P2-TOC) |
| Review panel | Anesthesiology |
| Product code | CAW |
| Regulation Number | 868.5440 |
| Regulation Class | 2 |
IV. Predicate Device Information
| 1 Product name | Portable Oxygen Concentrator. Model:P2-S4,P2-S3,P2-K4,P2-K3 |
|---|---|
| 510(k) number | K230702 |
| 2 Product name | Portable Oxygen Concentrator. Model: P2-E7,P2-E |
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| 510(k) number | K223379 | |
|---|---|---|
| 3 | Product name | Portable Oxygen Concentrator. Model: P2-E6 |
| 510(k) number | K210371 | |
| 4 | Product name | Kingon P2 Oxygen Concentrator |
| 510(k) number | K190304 |
V. Device description and Indications for Use
Device description: The Portable Oxygen Concentrator P2-TOC is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.
The Portable Oxygen Concentrator P2-TOC has two oxygen supply modes, namely continuous oxygen supply mode and pulse oxygen supply mode. Hereinafter referred to as "continuous mode" and "pulse mode" .
In the continuous mode, the Portable Oxygen Concentrator P2-TOC can continuously deliver oxygen at a fixed flow rate. In the pulse mode, the Portable Oxygen Concentrator P2-TOC is able to deliver oxygen only when the user inhales by detecting the human respiratory rate.
Indications for Use: The Portable Oxygen Concentrator P2-TOC is intended to provide supplemental low flow oxygen.
The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adult only.
VI. Principle of operation
The Portable Oxygen Concentrator P2-TOC works by getting use of the molecular sieves character that the internal pressure of a sealed container containing of molecular sieve will increase when injecting air into it. At this time, the molecular sieve will absorb a lot of nitrogen in the air with the increasing of ambient pressure, while the oxygen in the air is still existed in gaseous form, then the oxygen are collected in the Air receiver. When the nitrogen absorption process in the container reaches a certain level, then exhaust of the vacuum container and nitrogen will be released from molecular sieve with the ambient pressure decreases. It will detect when the user begins to take a breath and then delivers a pulsed volume of oxygen during the inhalation period. The volume of the oxygen pulse is dependent on the setting value.
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Image /page/6/Picture/0 description: The image shows the word "kingo'n" in a dark blue font. The letters are all lowercase, and there is a small circle above the "o" in "kingo'n". The word is centered and takes up most of the frame.
VII. Comparison with predicate device
Model 1000 Portable Oxygen Concentrator and Model 4000 that manufactured by CAIRE was selected for comparison. See the following table for details of comparison:
| ID | Items | Predicate Device (K013931) | Reference Device (K120785) | Device to be submitted for 501K | Comparison |
|---|---|---|---|---|---|
| 1 | Device Name | Omni Portable Oxygen Concentrator | eQuinox Oxygen System | Portable Oxygen Concentrator | Similar |
| 2 | Model | Model 1000 | Model 4000 | P2-TOC | Different modenames |
| 3 | Indication forUse | The Omni portable oxygen concentratoris intended for the administration ofsupplemental oxygen. The device is notintended for life support nor does itprovide any patient monitoringcapabilities. | The eQuinox is intended for theadministration of supplemental oxygen. Thedevice is not intended for life support, nordoes it provide any patient monitoringcapabilities. | The Portable Oxygen Concentrator P2-TOC isintended to provide supplemental low flowoxygen..The device is not intended for life support, nordoes it provide any patient monitoringcapabilities. | Similar(See below noteID_3) |
| 4 | Environment ofUse | Home, outside the home and institutions | Home, outside the home | Home, outside the home | Similar(See below noteID_4) |
| 5 | Prescriptive | Yes | Yes | Yes | Same |
| 6 | Patient Interface | Nasal Cannula | Nasal Cannula | Nasal Cannula | Same |
| 7 | Technology | Pressure Swing Adsorption withmolecular sieve | Pressure Swing Adsorption with molecularsieve | Pressure Swing Adsorption with molecularsieve | Same |
| 8 | Dimensions | 19.3 high x 12.3 wide x 7.1 deep(inches)49.0 height x 31.2 wide x 18.0 deep | 15.5 high x10.8 wide x 7.3 deep (inches) | 11.1 length x 6.7 width x15 height (inch)28.2 length x 17.1 width x 38.2 height (cm) | Different (See belownote ID_8) |
| (cm) | |||||
| 9 | Weight | 17.9 pounds (8.1 kg) with PowerCartridge | 12lbs | 18.8 lbs / 8.5kg ( with battery) | Different (See belownote ID_9) |
| 10 | OxygenConcentration | 90% +/- 3% for all flow settings | 90%+3%/-3% at all settings | 90%-3%/+6% at all settings | Different (See belownoteID_10) |
| 11 | Equivalent FlowRates | Continuous Flow Mode: 1.0-3.0 LPM | Continuous Flow Mode: 1.0-3.0 LPM | Continuous Flow Mode: 1.0-3.0 LPM | Different (See belownoteID_11) |
| Pulse Dose Mode: 16-96 ml PulseVolumes | Pulse Dose Mode: 16-192 ml Pulse Volumes | Pulse Dose Mode: 5-133 ml Pulse VolumesBreathing rate is 15 times a minute | |||
| 6 to 25 breaths per minute average,sustainable | Breathing rate is 15 times a minute | Pulse Dose Mode: 5-200 ml Pulse Volumes | |||
| Breathing rate is 10 times a minute | |||||
| 12 | Filters | Air Inlet Filter | Air Inlet Filter | Air Inlet Filter | Same |
| 13 | User Interface | Buttons, LCD Display | Buttons, LCD Display | Buttons, LCD Display | Same |
| 14 | Power Supply | AC Power (100-240 VAC, 50-60 Hz) | AC Power (100VAC, 50-60 Hz) | AC Adaptor (Input: 100-240 VAC, 50-60 Hz) | Similar (See belownoteID_14) |
| DC Power (12V nominal) | DC Power (12V nominal) | DC Adaptor (Input: 11-16 VDC Output: 19V) | |||
| Battery (Lithium Ion) | Battery (Lithium Ion) | Battery (Lithium Ion) | |||
| 15 | Software | Embedded | Embedded | Embedded | Same |
| 16 | Acoustic Noise | 48 dBA at 3.0 LPM in Continuous FlowMode | <40 dBA | ≤ 60dB (A) (Gear 10 of pulse mode/ Gear 5 ofcontinuous mode) | Different (See belownoteID_16) |
| 40 dBA at 3.0 LPM in Pulse Flow Mode | |||||
| 17 | Alarms | Loss of power | Loss of power | Loss of power | Different (See belownoteID_17) |
| Low Battery | Low Battery | Low Battery | |||
| Low Therapeutic O2 Output | Low Therapeutic O2 Output | Low O2 Concentration | |||
| O2 flow outside normal limits | O2 flow outside normal limits | Gas Delivery Fail | |||
| No Inspiration detected in Pulse Dose Mode | No Inspiration detected in Pulse Dose Mode | Absenceof Breath (Only in Pulse Mode) | |||
| Unit Malfunction | Unit Malfunction | System Startup Fail | |||
| 18 | Status Indicator | Tool icon | Tool icon | Tool icon | Same |
| Battery Status Gauge | Battery Status Gauge | Battery Status Gauge | Same | ||
| External Power Indicator | External Power Indicator | External Power Indicator | Same | ||
| Flow Control Setting | Flow Control Setting | Flow Control Setting | Same | ||
| Low Priority Technical Alarm | Low Priority Technical Alarm | Low Priority Technical Alarm | Same | ||
| Buzzer | Buzzer | Buzzer | Same | ||
| 19 | Battery Duration | Up to 5.4 hours (Pulse setting of 1.0 at 12 BPM ) | Up to 5.94 hours (Pulse setting of 1.0 at 12 BPM ) | ||
| 20 | Operating Environment | Temperature: 50° F to 104° F (10° C to 40° C)Relative humidity: 10% - 95% at an 82.4° F (28°C) dew pointAltitude: 0 – 13,123 feet (0 - 4,000 meters) | 0 °C tot 40 °C (32 °F tot 104 °F) | Temperature: 41 to 104°F (5 to 40°C)Humidity: 10% to 90%, non-condensingAltitude: 0 to 10,000 ft. (0 to 3048 meters, 70kPa to 106kPa) | Different (See below note ID_20) |
| 21 | Shipping Storage Environment | -4° F to 140° F (-20° C to 60° C)Relative humidity: Up to 95% Non-Condensing | -25 °C tot 70 °C (-13 °F tot 158 °F)Vochtigheid: tot 95% niet condenserend-20 °C tot 50 °C (-4 °F tot 122 °F) voor accu's | Temperature: -4 to 158°F (-20 to 70°C)Humidity: 5% to 90%, non-condensingStore in a dry environmentAltitude range: 0 to 10,000 ft (0 to 3048 meters,70kPa to 106 kPa) | Different (See below note ID 21) |
| 22 | Principle of Operation | Pulse Flow Mode is designed to deliver 16 ml boluses of oxygen per incremental | Pulse Flow Mode is designed to deliver 16 ml boluses of oxygen per incremental flow | The Portable Oxygen Concentrator P2-TOC works by getting use of the molecular sieves | Similar.Both use pressure |
| flow setting for each patient inspirationdetected.Bolus volume is held constantregardless of breath rate within a givensetting. Delivery of the bolus is triggeredby detection of the end of inspirationfollowed by the start of a subsequentinspiration. Sensitivity is dealer/provideradjustable. Based on this inspirationtrigger signal, a "pulse" of oxygen isreleased to the patient by anelectronically controlled flow valve.There is no mixing of oxygen with roomair. | setting for each patient inspirationdetected.Bolus volume is held constantregardless of breath rate within a givensetting. Delivery of the bolus is triggered bydetection of the end of inspiration followed bythe start of a subsequent inspiration.Sensitivity is dealer/provider adjustable.Based on this inspiration trigger signal, a"pulse" of oxygen is released to the patient byan electronically controlled flow valve. Thereis no mixing of oxygen with room air. | character that the internal pressure of a sealedcontainer containing of molecular sieve willincrease when injecting air into it. At thistime, the molecular sieve will absorb a lot ofnitrogen in the air with the increasing ofambient pressure, while the oxygen in the airis still existed in gaseous form, then theoxygen are collected through some pipelines.When the nitrogen absorption process in thecontainer reaches a certain level, then exhaustof the vacuum container and nitrogen will bereleased from molecular sieve with theambient pressure decreases. It will detectwhen the user begins to take a breath and thendelivers a pulsed volume of oxygen during theinhalation period. The volume of the oxygenpulse is dependent on the setting value. | swing adsorptionwith molecular sieve | ||
| 23 | DeviceComponents | Oxygen concentrator, Universal Cart,AC Power Supply, DC Power Supply,Battery. | Oxygen concentrator, Cart, AC Power SupplyDC Power Supply, Battery. | Oxygen concentrator, Cart, AC Power Supply,AC Power Supply, Battery, Backpack. | Similar.A backpackis provided forpatient convenience |
| 24 | Materials forfilters | Chemical fiber | Chemical fiber | Chemical fiber | Same |
| 25 | Material ofPatient contactcomponents | Button panel: PETMain housing: PC+ABS | Button panel: PETMain housing: PC+ABS | Button panel: PETMain housing: PC+ABS | Same |
| 26 | Patient | Adult | Adult | Adult | Same |
| Population | |||||
| 27 | Single Patient, | Yes | Yes | Yes | Same |
| multi-use | |||||
| 28 | Electrical Safety | Class II | Class II | Class II | Same |
| Classification | |||||
| 29 | Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same |
| 30 | Electromagnetic | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| compatibility | |||||
| 31 | Biocompatibility | PM2.5,PM10, VOC's less than ambient | PM2.5,PM10, VOC's less than ambient | PM2.5,PM10, VOC's less than ambient | Same |
| 32 | Output | 5.0 psi nominal | 5.0 psi nominal | 5 PSI | Same |
| pressure | |||||
| 33 | Classification | 21CFR 868.5440 | 21CFR 868.5440 | 21CFR 868.5440 | Same |
| 34 | Product Code | CAW | CAW | CAW | Same |
| 35 | FDA Class | II | II | II | Same |
| 36 | Heat ex-changer | Cooling fan | Cooling fan | Cooling fan | Same |
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Note:
ID3,ID4:
The Indication for Use description of P2-TOC is similar to the description of Model 4000. We added a "low flow" reference to the intended use to prevent user misunderstanding and reduce risk.
The Environment of Use of P2-TOC is basically the same as the description of Model 4000.Therefore the difference does not raise new questions of safety and effectiveness.
ID8:
The dimensions of Model 1000and Model 4000 compared and theP2-TOC devices differ in dimensions due to their different designs. The risk is mitigated by tests tested according to ISO 80601-2-69: 2020,EC60601-1and ISO 80601-2-67: 2020, therefore the difference does not raise new questions of safety and effectiveness.
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kınqo'n
ID9, ID14, ID20 and ID21:
Although the weight, power supply, operating and shipping storage environment conditions of P2-TOC is different from the predicate devices (Model 1000 and Model 4000), but the subject device has passed the differences don't raise new questions of safety and effectiveness.
ID10:
The oxygen concentration of predicate devices Model 4000 both are 90% +- 3% for all 110w settings and of subject device P2-TOC is 90%-3% at all settings. The risk is mitigated by tests tested according to ISO 80601-2-67: 2020, therefore the difference does not raise new questions of safety and effectiveness.
ID11:
In continuous mode, both P2-TOC and predicate devices (Model 4000) have same ranges of 1.0-3.0L/min.
In pulse mode, the flow range of the Model1000 is 16-96 mL. The breathing rate is 6-25 beats per minute, so the maximum flow rate in pulse mode is 2400ml (25*96mL).
In pulse mode, the flow range of the Model4000 is 16-192mL when the breathing rate is 15 times per minute, so the maximum flow rate in pulse mode is 2880mL (15*192mL).
In pulse mode, the maximum flow rate of P2-TOC is 2000mL. The flow rate is smaller than that predicate devices. (Model 1000 and Model 4000).
The risk is mitigated by tests tested according to ISO 80601-2-67: 2020, ISO 18562-2: 2017, ISO 18562-3: 2017, ISO 18562-3: 2017, ISO 10993-5: 2009, ISO10993-10: 2021 and ISO10993-23: 2021, therefore the difference does not raise new questions of safety and effectiveness.
ID16:
The acoustic noise of subject device P2-TOC is litter bigger than predicate device Model 1000. Since the subject device has been tested against ISO 80601-2-69: 2020 and IEC60601- 1: 2005 /A1:2012 and A2:2020, the standard requirements have been met.The difference of subject device do not raise new questions of safety and effectiveness.
ID17:
The subject device and the predicate device have information displayed. However, the subject device meets the requirements of the standard ISO80601-2-69 and IEC60601-1-8. In addition, performance testing, risk analysis has been conducted on the
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subject device. Hence, the difference of subject device do not raise new questions of safety and effectiveness. ID19:
The subject device P2-TOC can be equipped with the battery, which can up to 9.0 hours (in pulse setting of 1 at 20 BPM). The risk is mitigated by test tested according to IEC 62133: 2017, therefore the difference does not raise new questions of safety and effectiveness.
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VIII. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601- 1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 80601-2-69 and ISO 80601-2-67 for performance and IEC 62304 for software verification are complied. See below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES 60601- 1:2005 /A1:2012 andA2:2020 | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| IEC 60601-1-2: 2020 | Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances --Requirements And Tests |
| IEC 60601-1-11:2015/A1:2020 | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances -Requirements And Tests |
| IEC 60601-1-8: 2006/A1:2012 /A2:2020 | Medical electrical equipment - Part 1-8: General requirementsfor basic safety and essential performance - CollateralStandard: General requirements, tests and guidance for alarmsystems in medical electrical equipment and medical electricalsystems |
| IEC 60601-1-6: 2010/A1:2013 /A2:2020 | Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability |
| ISO 80601-2-69: 2020 | Medical electrical equipment. Particular requirements for thebasic safety and essential performance of oxygen concentratorequipment |
| ISO 80601-2-67: 2020 | Medical electrical equipment. Particular requirements forbasic safety and essential performance of oxygen-conservingequipment |
| ISO 18562-1: 2017 | Biocompatibility evaluation of breathing gas pathways inhealthcare applications - Part 1 Evaluation and testing within arisk management process |
| ISO 18562-2: 2017 | Biocompatibility evaluation of breathing gas pathways inhealthcare applications - Part 2 Tests for emissions ofparticulate matter |
| ISO 18562-3: 2017 | Biocompatibility evaluation of breathing gas pathways in |
| healthcare applications - Part 3: Tests for emissions of volatile | |
| organic compounds | |
| IEC 62133-2: 2017 | Secondary cells and batteries containing alkaline or othernon-acid electrolytes - Safety requirements for portable sealedsecondary cells, and for batteries made from them, for use inportable applications-Part2: Lithium systems |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests forskin sensitization |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23:Tests forirritation |
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· Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device model P2-TOC. The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-11, ISO 80601-2-67, and ISO 80601-2-69 standards for electrical safety and the IEC 60601-1-2 standard for EMC.
·Software Verification and Validation Testing
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff.
·Biocompatibility Testing
Biocompatibility testing were conducted on the subject device model P2-TOC. The system complies with the ISO 18562-2, ISO 18562-3, ISO 18562-1, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility safety.
IX. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
X. Conclusions
The Portable Oxygen Concentrator (Model: P2-TOC) have the same intended use and similar characteristics as the cleared predicate device Portable Oxygen Concentrator, model 1000 and model 4000. Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between Portable Oxygen
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Concentrator (Model: P2-TOC) and Portable Oxygen Concentrator, model 1000 and model 4000 do not raise any new questions of safety or effectiveness.
The non-clinical tests support the safety of the device and the hardware and software verification and validation demonstrate that the Portable Oxygen Concentrator (Model: P2-TOC) performs as intended in the specified use conditions are same with predicate device. The performance tests demonstrate that the Portable Oxygen Concentrator (Model: P2-TOC) performs comparably to the predicate device that is currently marketed for the same intended use. Thus, Portable Oxygen Concentrator (Model: P2-TOC) is Substantially Equivalent (SE) to the predicate device.
§ 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).