(351 days)
Not Found
No
The device description explicitly states that it is a "passive device" and its function is to provide a space extension. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device facilitates the delivery of medication but does not directly provide therapy itself. Its main function is to extend the space for medication inhalation from a metered dose inhaler.
No
The device is described as a spacer intended to administer aerosolized medication, facilitating the inhalation of medication from a metered dose inhaler. It is a passive device designed to extend the space between the inhaler and the patient's nose and mouth. There is no mention of it being used to detect, monitor, or diagnose any medical condition.
No
The device description explicitly states it is composed of "wrought plastic parts and assembled together by a process of thermoplastic injection," clearly indicating it is a physical hardware device.
Based on the provided information, the AgaChamber Spacer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- AgaChamber Spacer Function: The AgaChamber Spacer is a device used to facilitate the delivery of aerosolized medication from a Metered Dose Inhaler to a patient's lungs. It is a passive device that helps with the inhalation process.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is purely mechanical, aiding in the administration of medication.
The description clearly outlines its purpose as a drug delivery aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare 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 healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.
Product codes
NVP
Device Description
AgaChamber Spacer is composed of a conical chamber with openings on both of its sides, where in one of these opening there is an attached base with an orifice into which the medication dose is inserted and the Metered Dose Inhaler dispenses the medication. On the other side, there is a nozzle which holds the mask. which the patient will fit over his/her nose and mouth so that the medication can be inhaled. The device has been developed for use, with or without mask. The percentage of the drug dose delivered into the chamber is totally dependent on the Metered Dose Inhaler's pressure and quantity of metered doses the healthcare provider prescribes. Another point that should be clear is that, AgaChamber is a passive device and its main function is to provide a space extension between the Metered Dose Inhaler and the patient's nose and mouth in order to facilitate the inhalation of the medication. AgaChamber is composed of wrought plastic parts and assembled I together by a process of thermoplastic injection. IMPORTANT NOTE: AGACHAMBER SPACER IS LATEX FREE.
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
Adult and child
Intended User / Care Setting
patients, who are under the care or treatment of a licensed healthcare provider or physician. The intended environments for use include home, hospitals and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Agachamber Spacer with mask with respect to the predicate device. Third party testing was performed including biocompatibility testing per ISO 10993-10:2002/AM:2006 and ISO10993-5:2009 as well as Aerosol Performance Testing per the FDA Guidance document "Reviewer Guidance for Nebulizers, MDI's, Spacers and Actuators". The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Exhibit 1
510(K) SUMMARY
APR 2 9 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:
Submitter's Identification: 1.
Agaplastic Industria e Comercie Ltda. Rue Cuba, 353 Rio de Janeiro RJ Brasil CEP:210-160
Tel.: 55 21 2573 0969 Fax.: 55 21 2573 2336
Date Summary Prepared: November 10, 2010
2. Name of the Device:
Proprietary name: Agachamber Spacer with mask
- 21 CFR 868.5630, Class II 3. Classification: Product Code: NVP
4. Common or Usual Name:
Common name: Spacer Classification name: Nebulizer (Direct Patient Interface)
Predicate Device Information: 5.
a) Legally Marketed Equivalent Device:
Aerochamber Plus Anti-Static Valved Hold Manufactured by Trudell Medical International with 510k Number: K070674. Product code: NVP
6. AgaChamber Spacer Description:
AgaChamber Spacer is composed of a conical chamber with openings on both of its sides, where in one of these opening there is an attached base
1
with an orifice into which the medication dose is inserted and the Metered Dose Inhaler dispenses the medication. On the other side, there is a nozzle which holds the mask. which the patient will fit over his/her nose and mouth so that the medication can be inhaled. The device has been developed for use, with or without mask.
The percentage of the drug dose delivered into the chamber is totally dependent on the Metered Dose Inhaler's pressure and guantity of metered doses the healthcare provider prescribes. Another point that should be clear is that, AgaChamber is a passive device and its main function is to provide a space extension between the Metered Dose Inhaler and the patient's nose and mouth in order to facilitate the inhalation of the medication.
- AgaChamber is composed of wrought plastic parts and assembled I together by a process of thermoplastic injection.
- IMPORTANT NOTE: AGACHAMBER SPACER IS LATEX FREE ..
7. Intended Use:
The AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare 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 healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.
Technological Characteristics: 8.
AgaChamber's techonological characteristics are similar to the legally marketed equivalent. AeroChamber, from its basic material compositions (please see images below), to its function, as well as its intended use, which is classified as; "to facilitate the use of an inhaler and to improve the passage of medication to the lungs".
AgaChamber has been developed for adult and child use, with or without the use of the mask, in accordance with necessity and medical orientation. AgaChamber, likewise legally marketed AeroChamber, is to be used according to a doctor's orientation.
There are no distinctions in the usage of AgaChamber and AeroChamber, both are intended to maximize the efficacy of inhaling medications that need to be delivered to the lungs to treat respiratory ailments. Both have the same overall structure and carry on the same delivery process,
2
therefore both serve for the same purposes. (Please see images below.)
Image /page/2/Picture/10 description: The image shows two different brands of medical inhaler chambers. On the left is an "Aerochamber" inhaler chamber, which is a small, clear plastic tube with a black mouthpiece. On the right is an "AgaChamber" inhaler chamber, which is a larger, clear plastic tube with a white mask attached to the end. The AgaChamber also has instructions printed on the side of the chamber.
9. Performance Data:
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Agachamber Spacer with mask with respect to the predicate device.
Third party testing was performed including biocompatibility testing per ISO 10993-10:2002/AM:2006 and ISO10993-5:2009 as well as Aerosol Performance Testing per the FDA Guidance document "Reviewer Guidance for Nebulizers, MDI's, Spacers and Actuators".
The device passed all of the tests based on pre-determined Pass/Fail criteria.
10. Conclusions:
The data from the biocompatibility and non clinical tests show that the Agachamber Spacer with mask is as safe and effective as the legally marketed predicate device.
Therefore we conclude that the Agachamber Spacer with mask is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Agalastic Industria e Comercie Ltda. C/O Ms. Maria F. Griffin Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
APR 2 9 2011
Re: K101348
Trade/Device Name: AgaChamber Spacer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: April 21, 2011 Received: April 22, 2011
Dear Ms. Griffin:
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.
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Page 2- Ms. Griffin
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,
Wh 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
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: AgaChamber Spacer
Indications For Use:
The AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare 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 healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.
Prescription Use X
Over-The Counter Use
(Per 21 CFR 801 Subpart D) OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schutter
Division Sign-Off) Tivision of Anesthesiology, General Hospital fection Control, Dental Devices
4101348 10(k) Number: