(54 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard oxygen concentrator and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The 'Intended Use / Indications for Use' section states that the device is "intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy". The word "therapy" clearly indicates a therapeutic purpose.
No
The device is an oxygen concentrator used to provide supplemental oxygen therapy, not to diagnose a medical condition.
No
The device description clearly outlines physical components like a compressor, molecular sieve adsorbent, motorized valve, pressure relief valve, power switch, flow meter knob, circuit breaker, oxygen outlet, and a monitor display. This indicates it is a hardware device with integrated software for control and monitoring, not a software-only medical device.
Based on the provided text, the A&J 5L POCA series Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities." This describes a therapeutic device that delivers a substance (oxygen) to the patient's body.
- Device Description: The description details how the device separates oxygen from ambient air and delivers it to the user via a nasal cannula or mask. This is a physical process for delivering a gas for therapeutic purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The A&J 5L POCA series Oxygen Concentrator does not interact with or analyze any bodily specimens.
Therefore, the A&J 5L POCA series Oxygen Concentrator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A&J 5L POCA series Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series is available by prescription only under the supervision of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
A&J 5L POCA series Oxygen concentrator is AC power electrically operated. The unit separates oxygen from room air (ambient air) which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized value and protected from over pressurization by the compressor's pressure relief value.
Oxygen provided by the A&J 5L POCA series Oxygen concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.
The front panel of the A&J 5L POCA series Oxygen concentrator contains the controls and indicators. These include the status lights (included power light, normal oxygen light, fow oxygen light and service required light), standard power switch, flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc.). The user could operate the device conveniently according to the instructions.
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
Not Found
Intended User / Care Setting
Home, nursing homes, patient care facilities.
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)
Bench performance testing has demonstrated that the A&J 5L POCA series Oxygen Concentrator is substantially equivalent to the predicate device. Laboratory testing was conducted to validate and verify that the A&J 5L POCA series Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device. The testing consisted of all environmental testing identified in the FDA's "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (October 1, 1993)". Testing was also performed to demonstrate the sponsored device series achieves the standards' requirements of ASTM F1464 and ISO 8359. Hazard analysis of the system and its software was performed and testing was conducted to validate overall operation of the system. The A&J 5L POCA series Oxygen Concentrator has also been tested to assure its compliance to the requirements of various standards of IEC60601-1, IEC60601-1-2.
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
Chapter 4. 510(k) Summary
1121531
JUL 1 7 2012
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
1. Submitter Information
- � Establishment Registration Number: 3004443928
- � Company Name: Zhongshan A&J Medical Equipment Co., Ltd.
- Address: #3 Shenghui South Road, Nantou Town, Zhongshan City, Guangdong, China �
- � Phone: +86-760-2313 0562
- Fax: +86-760-2313 0754 �
- � Contact Person (Title): Ms. Hebe An (Management Representative)
- E-mail: xa1218@126.com �
2. Application Correspondent
- � Company Name: MEDLAB (Shenzhen) Information Service Co., Ltd.
- Address: Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road, Shenzhen, � Guangdong, P.R. China, 518034
- Phone: +86-755-8308 9699 �
- � Fax: +86-755-8632 9134
- � Contact Person (Title): Ms. Sabrina Wei (Project Manager)
- � E-mail: sabrinawei@hotmail.com
Subject Device Information: 3.
- � Product Code: CAW
- Regulation Number: 868.5440 �
- Class: 2 �
- Review Panel: Anesthesiology �
- Classification Name: Generator, oxygen, portable �
- Trade Name: A&J 5L POCA series Oxygen Concentrator �
- Model: POCA01B, POCA03, POCA04, POCA05, POCA06 ◆
1
Zhongshan A&J Medical Equipment Co., Ltd. Sponsor: Subject Device: A&J 5L POCA series Oxygen Concentrator File No .: 510(k) submission report (V1.0), Chapter 4
4. Predicate Device Information:
- � 510(k) Number: K071608
- Sponsor: Zhongshan A&J Medical Equipment Co., Ltd. �
- Classification Name: Generator, oxygen, portable �
- Trade Name: A&J 5L Oxygen concentrator �
- Product Code: CAW �
- Model: POCA01 �
Device Description 5.
A&J 5L POCA series Oxygen concentrator is AC power electrically operated. The unit separates oxygen from room air (ambient air) which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized value and protected from over pressurization by the compressor's pressure relief value.
Oxygen provided by the A&J 5L POCA series Oxygen concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.
The front panel of the A&J 5L POCA series Oxygen concentrator contains the controls and indicators. These include the status lights (included power light, normal oxygen light, fow oxygen light and service required light), standard power switch, flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc.). The user could operate the device conveniently according to the instructions.
6. Intended Use
A&J 5L POCA series Oxyqen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series Oxygen concentrator is available by prescription only under the supervision of a physician.
Report by Zhongshan A&J Medical Equipment Co., Ltd.
2
Sponsor: Zhongshan A&J Medical Equipment Co., Ltd. Subject Device: A&J 5L POCA series Oxygen Concentrator 510(k) submission report (V1.0), Chapter 4 File No.:
7. Contraindication
The device is not intended to support or sustain life.
8. Performance Summary
Technologies utilized by the A&J 5L POCA series Oxygen Concentrator conduces no questions of safety and effectiveness. The same technologies are being used on the identified predicate device. Bench performance testing has demonstrated that the A&J 5L POCA series Oxygen Concentrator is substantially equivalent to the predicate device.
9. Testing
.
Laboratory testing was conducted to validate and verify that the A&J 5L POCA series Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device. The testing consisted of all environmental testing identified in the FDA's "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (October 1, 1993)". Testing was also performed to demonstrate the sponsored device series achieves the standards' requirements of ASTM F1464 and ISO 8359.
Hazard analysis of the system and its software was performed and testing was conducted to validate overall operation of the system. The A&J 5L POCA series Oxygen Concentrator has also been tested to assure its compliance to the requirements of various standards of IEC60601-1, IEC60601-1-2.
10. Comparison to Predicate Device
Compare the subject devices to the predicate device: they are same in design principle, intended use, functions, performance, material and applicable standards. The main difference between subject devices and the predicate device is enclosure style and the following list notes. These differences do not raise any new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Judgment | ||
|---|---|---|---|---|---|
| Device Name | A&J 5L POCA series Oxygen | ||||
| Concentrator, Models: | |||||
| POCA01B, POCA03, POCA04, | |||||
| POCA05, POCA06 | A&J 5L Oxygen Concentrator, | ||||
| Model: POCA01 | |||||
| Operation and Storage Environment | |||||
| Operating | |||||
| Conditions | Temperature: 10-40 ℃ | ||||
| Humidity: 30-70 % | |||||
| Atmospheric Pressure: 50~106 | |||||
| kPa (7.3-15.4 psi) | Temperature: 10-35 ℃ | ||||
| Humidity: 30~70 % | |||||
| Atmospheric Pressure: 50~106 | |||||
| kPa (7.3-15.4 psi) | SE | ||||
| Note 1 |
3
Zhongshan A&J Medical Equipment Co., Ltd. Sponsor: Subject Device: A&J 5L POCA series Oxygen Concentrator
510(k) submission report (V1.0), Chapter 4 File No.:
| Elements of
| Comparison | Subject Device | Predicate Device | Judgment |
|---|---|---|---|
| Storage | |||
| Conditions | Temperature: -40~70 ℃ | ||
| Humidity: 10~100 % | |||
| Atmospheric Pressure: 50 | Temperature: -40~70 ℃ | ||
| Humidity: 10~100 % | |||
| Atmospheric Pressure: 50 | SE | ||
| Safety Factor | |||
| Power Input | 115V, 60Hz, 3.1A | 115 V, 60 Hz, 1.8A (Max.) | SE |
| Note 2 | |||
| Degree of | |||
| Protection Against | |||
| Electric Shock | Type B Equipment | Type B Equipment | SE |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC 60601-1- | ||
| 2 | Compliance with IEC 60601-1- | ||
| 2 | SE | ||
| Performance and Specification | |||
| Delivery Rate | 0 to 5 LPM | 0 to 5 LPM | SE |
| Oxygen | |||
| Percentage | 93% ± 2% | 93% ± 2% | SE |
| Outlet Pressure | 8.5 psi (58.6 kPa) | 8.5 psi (58.6 kPa) | SE |
| Sound Level |