HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN

{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: - 1. Date Prepared: May 27, 2008 - 2. 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 - 3. 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 - 4. 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 {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 - 5. Predicate Device Identification: Delphi Portable Oxygen Concentrator K-number: K073242 - 6. 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. - 7. 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. 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. - 9. Substantially Equivalent Conclusion: The subject device, HG Oxygen Concentrator, is substantially equivalent to the predicate device. 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