(226 days)
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No
The description focuses on mechanical mixing and monitoring of basic parameters, with no mention of AI/ML terms or functionalities.
No
The device delivers a mixture of air and oxygen and allows the user to adjust oxygen percentage and flow rate, as well as monitor pressures and oxygen percentage. While it is used in conjunction with medical devices like oxygen hoods and nasal cannulas, its function is primarily to prepare and deliver gases, not to directly treat a medical condition itself. It acts as a component in oxygen therapy rather than a standalone therapeutic device.
No
Explanation: The device delivers a mixture of air and oxygen and monitors supply pressures and output oxygen percentage. It does not diagnose any medical condition, it is a therapy delivery device.
No
The device description clearly indicates a physical device ("M201 Mixer") that delivers a mixture of gases and monitors physical parameters like pressure and voltage. This involves hardware components beyond just software.
Based on the provided information, the M201 Mixer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to deliver a mixture of air and oxygen for respiratory support in conjunction with various delivery methods (hoods, bags, masks, cannulas). This is a therapeutic or life support function, not a diagnostic one.
- Lack of Diagnostic Activity: The description focuses on mixing and delivering gases, and monitoring pressures and oxygen percentage. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- No Mention of IVD Characteristics: The provided text lacks any of the typical characteristics associated with IVDs, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing diagnostic information about a disease or condition.
- Mentioning reagents, assays, or laboratory procedures.
Therefore, the M201 Mixer, as described, falls under the category of a medical device used for respiratory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The M201 Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.
Product codes
BZR, CCL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2003
Mr. Dipak Ghosh President SK Med. Incorporated 16000 Sherman Way # 224 Van Nuys, California 91406-4057
Re: K022864
Trade/Device Name: SK Med M201 Mixer Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR, CCL Dated: February 16, 2003 Received: February 19, 2003
Dear Mr. Ghosh:
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 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. Ghosh
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); 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runner, DDS, MA
Interim 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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Attachment 1 Indications for Use Statement
510(k) Number: K022864
Device Name: SK Med M201 Mixer
Indications for Use:
The M201 Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
f.A.Wustonham
ision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Ko22864