(86 days)
Not Found
Not Found
No
The summary describes a mechanical device for dispensing medication and contains no mention of AI, ML, or related concepts.
Yes
The device is described as dispensing medication into a breathing circuit for patients, thus serving a therapeutic purpose.
No
The device is described as an adapter for dispensing medication, not for diagnosing conditions.
No
The device description clearly states it is a "single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Dual Spray MINISPACER® MDI adapter is a device used to deliver medication (from a metered dose inhaler) into a patient's breathing circuit. It is a drug delivery device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit." This is a therapeutic function, not a diagnostic one.
The description focuses on how the device facilitates the delivery of medication, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner.
The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments.
The device is intended for sale by or on the order of a physician.
Product codes
CAF
Device Description
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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
Physician or other licensed health care practitioner; short term and long term critical care environments.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
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
Mr. James M. Strickland Chief Executive Officer Thayer Medical Corporation 4575 South Palo Verde Road. Suite 337 Tucson, Arizona 85714-1961
DFC 1 0 2010
Re: K102658
Trade/Device Name: MiniSpacer® Dual Spray MDI Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 9, 2010 Received: November 10, 2010
Dear Mr. Strickland:
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. Strickland
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.
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
Indications for Use
510(k) Number (if known):
DEC 1 0 2010
Device Name: MiniSpacer® Dual Spray MDI Adapter
Indications For Use:
The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner.
The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments.
The device is intended for sale by or on the order of a physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deylee Eva
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices (Division Sign-Off) Division of Anesthesisters
510(k) Number: