MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
Device Facts
| Record ID | K081536 |
|---|---|
| Device Name | MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED |
| Applicant | Medisize BV |
| Product Code | CAH · Anesthesiology |
| Decision Date | Jan 23, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5260 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The Medisize Red devices are breathing circuit bacterial filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit. These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device in intended to be positioned over a trached to trached to the pollows during the-same into the using by passive means gases breathed in by patient dynng anaesthesia and ventilator care
Device Story
Medisize Red devices are breathing circuit filters designed to remove microbiological and particulate matter from gases within a breathing circuit. The devices are used during anesthesia and ventilator care. They function by passive means to filter gases breathed in by the patient. The device is positioned in the breathing circuit to ensure gas filtration before reaching the patient. This helps maintain a clean breathing environment, reducing the risk of contamination during respiratory support.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Breathing circuit bacterial filter; passive filtration mechanism; intended for use in anesthesia and ventilator circuits; various form factors (Big, Small, Angled, Straight) for different patient sizes.
Indications for Use
Indicated for patients undergoing anesthesia and ventilator care requiring filtration of microbiological and particulate matter from breathing circuit gases.
Regulatory Classification
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.
Submission Summary (Full Text)
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized human figure embracing a globe.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medisize B V C/O Mr Harry J van Vugt Responsible Third Party Official KEMA Qualıty B V 4377 County Line Road Chalfont, Pennsylvania 18914
JAN 2 3 2009
K081536 Re
> Trade/Device Name Bacterial/Viral Medizize Blue and Medisize Red Filters Regulation Number 21 CFR 868 5260 Regulation Name Breathing Circuit Bacterial Filter Regulatory Class II Product Code CAH Dated January 8, 2009 Received January 9, 2009
Dear Mr van Vugt
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 affectung 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
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Page 2 - Mr van Vugt
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 requrements 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 hmited to regustration and listing (21 CFR Part 807), labeling (21 CFR Part 801), 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 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 B10met11c'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,
Anthony D, Roberts for
Ginette Michaud, M D Acting Director DIVISIOn of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Section #3 -INDICATIONS FOR USE
51Q(k) Number (it known): k081536
Bacterial/Viral filter and HME combination device Device Name
See table below Product numbers.
| Device name | Catalogue code |
|-----------------------------------|----------------|
| Medisize Blue Big HMEF | 303 100 000 |
| Medisize Blue Small HMEF | 303 200 000 |
| Medisize Blue S-Angled HMEF | 303 210 000 |
| Medisize Blue HMEF Child Straight | 303 520 000 |
| Medisize Blue HMEF Child Angled | 303 510 000 |
| Medisize Red Big Filter | 303 300 000 |
| Medisize Red Small Filter | 303 400 000 |
| Medisize Red Angled Filter | 303 410 000 |
## Indications for Use
- The Medisize Red devices are breathing circuit bacterial filters, which are intended to 1 I he wedisize Red devices are broulate matter from the gases in the breathing tircuit
- remove microbleinglical and parkloute These devices are intended to remove 2 microbiological and particulate matter from the gases in the breathing circuit and at the same time the device in intended to be positioned over a trached to trached to the pollows during the-same into the using by passive means gases breathed in by patient dynng anaesthesia and ventilator care
Prescription Use (Part 21 OFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 809 Subpart C)
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## Concurrence of CDRH, Office of Device Evaluation (GDE)
Page of
(Posted November 13, 2003)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infaction Control, Dental Devices
510(k) Number
K081536
8.12 - Quality manage
as january 2009
