(26 days)
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Not Found
No
The summary describes a mechanical valved holding chamber for administering medication, with no mention of AI, ML, or related concepts.
No.
The device is described as a valved holding chamber for administering aerosolized medication, not as a device that provides therapy itself.
No
The device is described as a "Valved Holding Chamber" used to "administer aerosolized medication from most pressurized Metered Dose Inhalers." This indicates its function is for drug delivery, not for diagnosing a condition or disease.
No
The device description clearly identifies it as a "Valved Holding Chamber," which is a physical medical device used with inhalers, not a software-only product.
Based on the provided information, the AeroChamber Z-STAT Plus™ Valved Holding Chamber is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for administering aerosolized medication from Metered Dose Inhalers to patients. This is a therapeutic purpose, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The AeroChamber does not interact with bodily specimens in this way.
The device is a medical device used for drug delivery, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The AeroChamber Z-STAT Plus™ Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
Product codes
NVP
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
licensed health care provider or physician / home, hospitals and clinics
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)
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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.
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
§ 868.5630 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Straatman Director, Quality & Regulatory Affairs Traudell, Medical International 725 Third Street @ Oxford Street London Ontario N5V 5G4 CANADA
Re: K052332
Trade/Device Name: Aerochamber Z-Stat Plus Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: August 24, 2005 Received: August 26, 2005
Dear Mr. Straatman:
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 mendments, 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 approvisions 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 (1 will), it ind you casynd in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rear of ther announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Straatman
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 modified in any Federal statutes and regulations administered by other Federal agencies. or mo rice of any - 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 and fisulie (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bettronic 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) Fins fection with and in J 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), n 95% contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Cure
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number :
AeroChamber Z-STAT Plus™ Valved Holding Device Name: Chamber
Indications for Use:
The AeroChamber Z-STAT Plus™ Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
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Cuy Sulom
(Division Sign-Off)
Division of Aresthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K052333
Prescription Use: (per 21CFR 801.109) Over the Counter Use