K Number
K081536
Device Name
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
Manufacturer
Date Cleared
2009-01-23

(235 days)

Product Code
Regulation Number
868.5260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 Description
Bacterial/Viral filter and HME combination device
More Information

Not Found

Not Found

No
The summary describes a passive breathing circuit filter and does not mention any computational or analytical functions that would suggest AI/ML.

No.
The device is a bacterial/viral filter and HME combination, intended to remove microbiological and particulate matter from gases in the breathing circuit, which is a supportive function rather than direct treatment for a disease or condition.

No
The device is described as a bacterial/viral filter and HME (Heat and Moisture Exchanger) combination device, intended to remove microbiological and particulate matter from breathing gases. Its function is to filter and humidify air, not to diagnose medical conditions.

No

The device description clearly states it is a "Bacterial/Viral filter and HME combination device," which are physical hardware components used in breathing circuits.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is a "breathing circuit bacterial filter" intended to remove matter from gases in the breathing circuit. This is a mechanical function related to gas filtration, not a diagnostic test performed on biological samples in vitro (outside the body).
  • Device Description: The description as a "Bacterial/Viral filter and HME combination device" further supports its function as a filter and humidifier, not a diagnostic tool.
  • Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions

Therefore, the Medisize Red devices described are medical devices used in breathing circuits, but they do not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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.
  • The Medisize Blue 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 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.

Product codes (comma separated list FDA assigned to the subject device)

CAH

Device Description

Not Found

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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 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

1

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

2

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 nameCatalogue code
Medisize Blue Big HMEF303 100 000
Medisize Blue Small HMEF303 200 000
Medisize Blue S-Angled HMEF303 210 000
Medisize Blue HMEF Child Straight303 520 000
Medisize Blue HMEF Child Angled303 510 000
Medisize Red Big Filter303 300 000
Medisize Red Small Filter303 400 000
Medisize Red Angled Filter303 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)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

OF NEEDED)

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