(281 days)
1 The Medisize Red devices with catheter mount are breathing circuit bacterial/viral filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2 The Medisize Blue devices with catheter mount are Filter/HME's. These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device is intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by patient during anesthesia and ventilator care.
Not Found
This document is a 510(k) clearance letter from the FDA for two medical devices: "Medisize Red Devices with Catheter Mount" and "Medisize Blue Devices with Catheter Mount." These devices are classified as Breathing Circuit Bacterial Filters. The letter confirms that the devices are substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance described in a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is a regulatory approval letter and does not include the detailed technical study data that would typically be found in a 510(k) submission's performance section. Therefore, I cannot generate the requested table and information based on the text provided.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol resembling an abstract caduceus or a series of flowing lines, representing the department's focus on health and well-being. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
Mr. William Greenrose President Qserve America, Incorporated 220 River Road Claremont, New Hampshire 03743
Re: K110246
Trade/Device Name: Medisize Red Devices with Catheter Mount Medisize Blue Devices with Catheter Mount Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: August 18, 2011 Received: August 22, 2011
Dear Mr. Greenrose:
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.
{1}------------------------------------------------
Page 2 - Mr. Greenrose
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); medical device reporting (reporting of 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 Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Medisize Special 510(k) - Medisize Red and Blue devices with catheter mount CONFIDENTIAL
Attachment 2: Indications for Use Statement
KII 0246 510(k) Number (if known):
Device Name: Medisize Red devices with catheter mount Medisize Blue devices with catheter mount
Indications For Use:
l The Medisize Red devices with catheter mount are breathing circuit bacterial/viral filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit.
2 The Medisize Blue devices with catheter mount are Filter/HME's. These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device is intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by patient during anesthesia and ventilator care.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 .
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 18 of 24
CONFIDENTIAL
220 River Road, Claremont, NH 03743, USA
T: 001.603.369.3550
F: 001 603 369 3562
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).