(64 days)
The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.
Not Found
This is a 510(k) premarket notification letter from the FDA to Kolster Methods, Incorporated, regarding their SSW-Sterile Solution Warmer. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. It is a regulatory approval letter based on a declaration of substantial equivalence, not a detailed study report.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them from the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol on the right side. On the left side, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 0 2017
President Kolster Methods, Incorporated 708 North Valley Street Unit N Anahein, California 92801
Re: K002859
Trade/Device Name: SSW-Sterile Solution Warmer Regulation Number: 21 CFR 890.5950 Regulation Name: Powered heating unit Regulatory Class: Class I Product Code: LHC Dated: September 9, 2000 Received: September 13, 2000
Dear Mr. Alwin H. Kolster,
This letter corrects our substantially equivalent letter of November 16, 2000.
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
{1}------------------------------------------------
Page 2 - Mr. Alwin H. Kolster
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 8091 ), 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 I. 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
{2}------------------------------------------------
Section 4
Anaheim 9-9-00
Intended use
The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.
Patricia Cuscente
(Division Sign-Off)
്രസ്ഥാന Of Dental, Infection Control, and Central Hospital Devicess . Homber _ 400 28 Spilar Devices
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.