(370 days)
The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.
The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.
The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
This document is a 510(k) clearance letter for an infusion warmer (FlexWarmer KZ-1 and KZ-2). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to software or AI performance. The device is an infusion pump, which is a physical medical device, and the information provided here is a regulatory clearance, not a technical performance report.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Karen Chen Manager of Regulatory Affairs Merlyn Associates, Incorporated 1542 Edinger Avenue, Suite A Tustin, California 92780
IAN 1 0 2017
Re: K062644
Trade/Device Name: FlexWarmer KZ-1 and KZ-2 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, IME Dated: August 31, 2007 Received: September 4, 2007
Dear Ms. Chen:
This letter corrects our substantially equivalent letter of September 11, 2007.
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. 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.
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 Parts 801 and 809 ); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062644
Device Name:____FlexWarmer KZ-1 and KZ-2
Indications For Use:
The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.
The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
Prescription Use _ X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chun Khan
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: __kgदबूढ़ (५५)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).