(120 days)
None
No
The description explicitly states "There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use." and the technology described is based on "two compensated thorpe tube flowmeter". There is no mention of AI or ML.
Yes
The device is designed to provide controlled flows of air/oxygen gas mixtures to patients, which is a therapeutic intervention for respiratory support.
No
The MaxMixing Block is designed to provide controlled flows of air/oxygen gas mixtures for patients, not to diagnose a medical condition.
No
The device description clearly outlines hardware components like thorpe tube flowmeters and a mixing block, and discusses physical characteristics like pressure differential tolerance. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- MaxMixing Block Function: The MaxMixing Block is designed to mix and deliver gases (air and oxygen) to a patient's respiratory system. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it provides controlled flows of gas mixtures to patients.
- Device Description: The description focuses on the mechanics of mixing and delivering gases, not on analyzing biological samples.
Therefore, based on the provided information, the MaxMixing Block falls under a different category of medical device, likely a respiratory therapy device, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MaxMixing Block is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer device. The MaxMixing Block is a restricted medical device intended for use by qualified trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.
Product codes
BZR
Device Description
Both the subject and predicate devices are capable of measuring oxygen concentration with an accuracy of at least +/- 3%. As per predicates listed above, the indication noted has been cleared by the FDA. The MaxMixing Block uses the well known technology of two compensated thorpe tube flowmeter to control and measure medical grade air and oxygen at an accurate flow rate as per a calibrated reference pressure (50 psig +/- 5 psig). The two gases are then mixing block for continuous air/oxygen delivery at oxygen concentrations of 21 - 100% as prescribed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infant, pediatric, and adult patients
Intended User / Care Setting
qualified trained personnel under the direction of a physician in institutional environments
Description of the training set, sample size, data source, and annotation protocol
No clinical studies were performed.
Description of the test set, sample size, data source, and annotation protocol
No clinical studies were performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical functional and performance tests were performed for substantial equivalence testing. No clinical studies were performed for the UltraMaxO2 as the device represents a well known technology for a recognized indication. The conclusion drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K884973, K053232, K081335, K973646
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
6526 South Cottonwood Street • Salt Lake City, Utah 84107 • www.maxtecinc.com • 866.4.maxtec
510(k) Summary of Safety and Effectiveness 1113232
6526 South Cottonwood Street Salt Lake City, Utah 84107
Director of Regulatory and Quality
This summary of safety and effectiveness is provided as part of this Pre-Market Notification in compliance with 21 CFR Part 807, Subpart E, section 807.92, as a means of providing sufficient detail to provide understanding of the basis for a determination of substantial equivalence.
-
- Submitter's name, address, telephone number, a contact person and the date the summary was prepared.
Maxtec. LLC
- Submitter's name, address, telephone number, a contact person and the date the summary was prepared.
(801) 266-5300
(801) 270-5590
Maxtec, LLC
(801) 327-9870
(801) 270-5590
Tammy Lavery, RAC
Salt Lake City, UT 84107
Submitter's name/address:
Phone: Fax: Contact Name: Contact Title: Contact Address:
Phone: Fax:
Date Summary prepared:
10/19/2011
-
- Subject device information:
| Device Name: | Air/Oxygen Mixer |
|---|---|
| Trade Name(s): | MaxMixing Block |
| Classification Names: | Mixer, Breathing Gases, Anesthesia Inhalation |
| Common/Usual Name: | Breathing Gas Mixer |
| Classification: | II |
| Product Code: | BZR |
| CFR Reference: | 21 CFR 868.5330 |
| Classification Panel: | Anesthesiology |
-
- The following predicate devices were used to establish substantial equivalence for the MaxMixing Block/Analyzer System:
MAR - 1 2012
1
-
- Description of the subject device:
Both the subject and predicate devices are capable of measuring oxygen concentration with an accuracy of at least +/- 3%. As per predicates listed above, the indication noted has been cleared by the FDA.
- Description of the subject device:
-
- Statement of indication for use:
The MaxMixing Block is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer device. The MaxMixing Block is a restricted medical device intended for use by qualified trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.
- Statement of indication for use:
-
- Technological characteristics:
The MaxMixing Block uses the well known technology of two compensated thorpe tube flowmeter to control and measure medical grade air and oxygen at an accurate flow rate as per a calibrated reference pressure (50 psig +/- 5 psig). The two gases are then mixing block for continuous air/oxygen delivery at oxygen concentrations of 21 - 100% as prescribed. There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use. There are differences with respect to mixers, in that the subject device has a wider pressure differential tolerance requirement since Oxygen concentration is much less affected by pressure differential as compared to the blender predicate devices. The blender predicate devices have a single gas failure alarm which is intended to indicate narrow pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen. The subject device also has a single gas failure alam which indicates a broader pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen.
- Technological characteristics:
The intended use is the same as the combined predicate devices.
- Non-clinical functional and performance tests for substantial equivalence testing and a. the results are noted in the attached table.
- b. No clinical studies were performed No clinical studies were performed for the UltraMaxO2 as the device represents a well known technology for a recognized indication as evidenced in Section 5.0 by comparison to the predicate devices currently cleared for sale in the US market.
-
- The conclusion drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices in identified in 3) above.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tammy Lavery, RAC Director of Regulatory and Quality Maxtec, Inc 6526 South Cottonwood Street Salt Lake City, Utah 84107
Re: K113232
Trade/Device Name: MaxMixing Block Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: February 20, 2012 Received: February 22, 2012
Dear Ms. Lavery:
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 Eederal Register.
MAR - 1 2012
3
Page 2 - Ms. Lavery
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 I ou nike 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,
$\mathscr{A}$
Image /page/3/Picture/6 description: The image contains a handwritten symbol or character. It appears to be a cursive lowercase letter, possibly an 'l' or a stylized abbreviation. The stroke begins with a loop at the top and extends downward with a curved line, ending with a short horizontal stroke at the bottom.
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
4
Indications for Use Statement I.2
510(k) Number (if known):_
Device Name: MaxMixing Block
The MaxMixing Block, a breathing gas mixer designed to provide intermittent on controlled flows of an air/oxygen gas mixture to infant, pediation . The MaxMixing Block is .
flows of an air/oxygen gas mixture to infant, pediation a costristed modical intended to be used with a Maxtec Oxygen Analyzer. The MaxMixing Block is a restricted medical intended to be used with a Maxtec Oxygen Analyzer. The direction of a physician in institutional device mended for use by qualified attitude at air/oxygen mixtures is required.
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use _
AND/OR
Over-The-Counter Use
L. Schultheis
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital +
Division of Anesthesion Devices Division of Antonion Devices
510(k) Number: u113232