(90 days)
HG Oxygen concentrator is intended to provide supplemental oxygen to patient continuously in home, hospital or health care facility environments. It is not for supporting or sustaining life.
The subject device, HG Oxygen Concentrator, contains two models, HG5-W and HG5-WN. These two models follow the same design principle, same raw material, same main function and same specification. The only difference between the two models is that HG5-WN oxygen concentrator provide an addition interface on the front panel, which can be connected to the nebulizer and supply air to the nebulizer.
The subject device, HG Oxygen Concentrator, is intend to provide ≥90% supplemental low flow oxygen, which is separated from the room air, to the patient in the home, nursing homes, patient care facilities, etc. Oxygen is delivered to the patient via a nasal cannula or oxygen mask, but these accessories are not supplied with the concentrator, the user shall select appropriate and legally marketed accessories themselves. The subject device is not intended to support or sustain life.
The subject device, HG Oxygen Concentrator, uses Pressure Swing Adsorption technology to deliver concentrated oxygen. Two chambers and a valve allow compressed air to enter the embedded sieve, which will separate the nitrogen from the air. When one chamber is receiving compressed air, the other is expelling nitrogen back to the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in an oxygen store cylinder to be delivered to a patient. This working principle is widely used in the oxygen concentrator, it will not arise new question of safety and effectiveness.
The provided text is a 510(k) summary for the HG Oxygen Concentrator and does not contain detailed information about specific acceptance criteria or a comprehensive study demonstrating that the device meets those criteria. The document states that "Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device," but it does not provide the specifics of those design specifications or the results of the laboratory testing with numerical data.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the limited information available and explicitly stating what cannot be found:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Provide ≥90% supplemental low flow oxygen | Subject device is intended to provide ≥90% supplemental low flow oxygen (This is an intended performance, not a reported measured performance from a study in this document). |
| Substantially equivalent to predicate device (Delphi Portable Oxygen Concentrator K073242) | Stated as "Substantially Equivalent Conclusion: The subject device, HG Oxygen Concentrator, is substantially equivalent to the predicate device." |
| Meeting all design specifications | Stated as "Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications." (No specific design specifications or results are provided). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but "Laboratory testing was conducted" implies it was likely internal testing by Shenyang Canta Medical TECH. Co., Ltd. Given the company's location in China, the testing likely occurred there. It would be prospective testing as it relates to validating new design specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an oxygen concentrator, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the context of radiologists, pathology, etc. Its performance evaluation would involve instrumental measurements of oxygen concentration, flow rates, etc.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and the information provided. Adjudication methods like 2+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation.
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 device is an oxygen concentrator; it does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is typically relevant for AI algorithms. For an oxygen concentrator, the "standalone" performance would refer to the device's functional operation in terms of oxygen output, purity, and flow rates. The document indicates that "Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications," which implies standalone testing of the device's technical performance. However, no specific details or results of this testing are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an oxygen concentrator, the "ground truth" would likely be based on objective physical measurements using calibrated equipment (e.g., oxygen analyzers) to confirm oxygen purity, flow rates, pressure, and other technical specifications against engineering standards. The document does not specify the exact methods or standards used.
8. The sample size for the training set
Not applicable. This device is hardware (an oxygen concentrator), not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is hardware (an oxygen concentrator), not a software algorithm that requires a training set and its associated ground truth establishment.
{0}------------------------------------------------
K0Y1508
Image /page/0/Picture/1 description: The image shows a dark, abstract shape that resembles a triangle or a mountain range. The shape is composed of dark, overlapping lines and areas, creating a sense of depth and texture. The background is lighter and more textured, providing contrast to the dark shape. The overall effect is mysterious and intriguing.
AUG 2 7 2008
Shenyang Canta Medical TECH. Co., Ltd
Chapter III 510(k) Summary
As Required by CFR 807.92
The assigned 510(k) Number is:
-
- Date Prepared: May 27, 2008
-
- Sponsor Information
Shenyang Canta Medical Tech. Co., Ltd No.127 Nujiang Street, Huanggu District Shenyang 110036, P.R.China
Contact Person: Mr. Qiu Xiao, Quality Manager Tel: +86-24-86728299 Fax: +86-24-86728298 E-Mail: qiuxiao1971@163.com
-
- Submission Correspondent
Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China
- Submission Correspondent
-
- Device Name and Classification:
Device Trade Name: HG Oxygen Concentrator Modes: HG5-W & HG5-WN Device Common Name: Oxygen Concentrator Device Classification Name: generator, oxygen, portable
- Device Name and Classification:
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a dark, blurry figure against a lighter background. The figure appears to be somewhat triangular in shape, with a broader base and a narrower top. The background is speckled with light and dark spots, creating a textured effect. Due to the image quality, specific details of the figure are difficult to discern.
Shenyang Canta Medical TECH. Co., Ltd
Review Panel: Anesthesiology Product Code: CAW Regulation Number:868.5440 Device Class: II
-
- Predicate Device Identification: Delphi Portable Oxygen Concentrator K-number: K073242
-
- Intended Use:
HG Oxygen concentrator is intended to provide supplemental oxygen to patient continuously in home, hospital or health care facility environments. It is not for supporting or sustaining life.
-
- Device Description:
The subject device, HG Oxygen Concentrator, contains two models, HG5-W and HG5-WN. These two models follow the same design principle, same raw material, same main function and same specification. The only difference between the two models is that HG5-WN oxygen concentrator provide an addition interface on the front panel, which can be connected to the nebulizer and supply air to the nebulizer.
- Device Description:
The subject device, HG Oxygen Concentrator, is intend to provide ≥90% supplemental low flow oxygen, which is separated from the room air, to the patient in the home, nursing homes, patient care facilities, etc. Oxygen is delivered to the patient via a nasal cannula or oxygen mask, but these accessories are not supplied with the concentrator, the user shall select appropriate and legally marketed accessories themselves. The subject device is not intended to support or sustain life.
The subject device, HG Oxygen Concentrator, uses Pressure Swing Adsorption technology to deliver concentrated oxygen. Two chambers and a valve allow compressed air to enter the embedded sieve, which will separate the nitrogen from the air. When one chamber is receiving compressed air, the other is expelling nitrogen back to the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in an oxygen store cylinder to be delivered to a patient. This working principle is widely used in the oxygen concentrator, it will not arise new question of safety and effectiveness.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows a black and white symbol that appears to be a stylized design. The symbol consists of a triangle shape at the top, with a curved line or arc below it. The overall design has a somewhat tribal or mystical appearance, with the black ink contrasting against the white background. The image quality is grainy, which gives the symbol a textured look.
Shenyang Canta Medical TECH. Co., Ltd
Test Conclusion 8.
Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device.
-
- Substantially Equivalent Conclusion:
The subject device, HG Oxygen Concentrator, is substantially equivalent to the predicate device.
- Substantially Equivalent Conclusion:
3
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shenyang Canta Medical TECH Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongshan Zhongxin Masion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030 CHINA
AUG 2 7 2008
Re: K081508
Trade/Device Name: HG Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 27, 2008 Received: May 29, 2008
Dear Ms. Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{4}------------------------------------------------
Page 2 - Ms. Hong
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
JK. Ammels-Find my for //
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
Indication for Use
510(k) Number:
Device Name: HG Oxygen Concentrator
Indications for Use:
HG Oxygen concentrator is intended to provide supplemental oxygen to facility hospital or continuously in health care home, patient environments. It is not for supporting or sustaining life.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mohr
Page 1 of __1
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
10(k) Number: K041508
§ 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).