(390 days)
Not Found
Not Found
No
The summary describes a mechanical device for resistance breathing during aerosol treatment and makes no mention of AI or ML.
Yes
The device is described as permitting "resistance breathing during aerosol treatment," which implies it is used for therapeutic purposes, specifically for respiratory therapy in conjunction with aerosol delivery.
No
The device is described as an assist for aerosol treatment, permitting resistance breathing during the treatment. It does not appear to collect or analyze data to diagnose a condition.
No
The device description explicitly states it is a physical exerciser placed "in-line with an aerosol treatment," indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "PERMIT RESISTANCE BREATHING DURING AEROSOL TREATMENT". This describes a therapeutic or assistive function related to breathing mechanics, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, etc.).
- Device Description: The description reinforces the intended use by explaining how it works in conjunction with an aerosol treatment system to facilitate resistance breathing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Mercury Expiratory Resistance Exerciser, as described, falls under the category of a medical device used for treatment or therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT
Product codes
73BWF
Device Description
The Mercury Expiratory Resistance Exerciser, when placed in-line with an aerosol treatment, permits resistance breathing during aerosol treatment in a manner consistent with the Circulaire "Aerosol Drug Delivery System by Westmed.
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
Not Found
Intended User / Care Setting
Not Found
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)
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
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a distinctive design, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 1996
Ms. Kathy L. Hann QA/Regulatory Manager Mercury Medical® 11300A-49th Street North Clearwater, Florida 34622-4800
K954492 Re : Mercury Expiratory Resistance Exerciser Trade Name: Regulatory Class: II Product Code: 73BWF Dated: July 9, 1996 Received: July 17, 1996
Dear Ms. Hann:
We have reviewed your Section 510 (k) notification of intent to market We have reviewed your section be have determined the device is the device referenced above and we nate accedin interstate commerce
substantially equivalent to devices markets of the Medical Device substantially equivalence co derrest date of the Medical Device prior to May 28, 1976, the enatenane been reclassified in accordance Amendments, or to devices that have been and Cosmetic Act (Act) .
with the provisions of the Federal Food, Drug, and Cosmeral controls with the provisions of the reactar room and ageneral controls
You may, therefore, market the device, subject to the Act You may, therefore, market the actively provisions of the Act. include requirements for anual registration, listing of devices, good include requirements for amuar regioused.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device is classified (see above), it may be subject to such Controls) or class III (remax.comprevulations affecting your device additional concrols. Extreming major ecylations, Title 21, Parts 800
can be found in the Code of Federal Regulation assumes compliance can be found in the code of feacher desermination assumes compliance
to 895. A substantially equivalent determination Devices: General to 895. A subscanciary organisation for Medical Devices: General with the Good Manufacturing reasoned that, through periodic GMP
(GMP) regulation (21 CFR Part 820) and them (gDA) will werify g (GMP) regulation (2) Crk Parc Car) and Internation (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. assumptions. Fallure to comply from was publish further announcements
regulatory action. In addition, FDA may publish floase note: this Please note: this concerning your device in the Federal Register. concerning your device in the ification submission does not affect any
response to your premarket notification 502 of the Act obligation you might have under sections 531 through 542 of the Act. obligation you might have under because of the control provisions,
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Kathy L. Hann
This letter will allow you to begin marketing your device as described This letter will allow you co begin mannounce substantial
in your 510(k) premarket notification. The Finding of substantial in your 310 (K) premarket notices and and there predicate device equivalence of your device or a segment device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice box prionally 809.10 for in xitro regulation (21 Crk Part 601 and address of Compliance at (301)
diagnostic devices), please contact the organism and Additionally, for questions on the promotion and 594-4648. 594-4648. Additionarity, for qase contact the Office of Compliance at
advertising of your device, please contact as a completion on it led (301) 594-4639. Also, please note the regulation entitled, (301) 594-4639. "ALBO, premarket notification" (21 CFR 807.97).
"Misbranding by reference to premarket rocibilition under the Act may "Misbranding by reference on your responsibilities under the Act may Other general information of your morphilation of Small Manufacturers at its De obtained from the Break or at (301) 443-6597.
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Image /page/2/Picture/0 description: This image shows a document from Mercury Medical, dated October 18, 1996, at 08:35. The document includes the Mercury Medical logo, which features a stylized graphic of two figures. The document also contains the number 1301 and the code K954.
REVISED ENCLOSURE I 510 (k) Summary
OCT 21, 1996
- Mercury Expiratory Resistance Exerciser (RESISTEX) ●
- Common Name Expiratory Resistance Exerciser and Adapter .
- Classification Name Spirometer, Therapeutic .
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21CFR807.92. The Mercury Expiratory Resistance Exerciser, when placed in-line with an aerosol treatment, permits resistance breathing during aerosol treatment in a manner consistent with the Circulaire "Aerosol Drug Delivery System by Westmed.
TABLE OF COMPARISON
| | MERCURY
EXPIRATORY RESISTANCE
EXERCISER | WESTMED
CIRCULAIRE" AEROSOL
DRUG DELIVERY SYSTEM |
|-------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| INTENDED USE | PERMITS RESISTANCE
BREATHING DURING
AEROSOL TREATMENT | PERMITS RESISTANCE
BREATHING DURING
AEROSOL TREATMENT |
| MATERIALS | STYRENE & LDPE | POLYPROPYLENE |
| MODE OF OPERATION | ROTATING RESISTANCE
ORIFICE WITH IN-LINE
NEBULIZER | ROTATING RESISTANCE
ORIFICE WITH IN-LINE
NEBULIZER |
| ONE WAY VALVE | BETWEEN NEBULIZER AND
EXHALATION RESISTOR | BETWEEN NEBULIZER AND
EXHALATION RESISTOR |
| PROVIDES POSITIVE
EXPIRATORY PRESSURE
BENEFIT DURING
TREATMENT | HAS VARIABLE
RESISTANCE ADJUSTMENT | HAS VARIABLE RESISTANCE
ADJUSTMENT |
| PATIENT CONNECTION | LDPE MOUTHPIECE | LDPE MOUTHPIECE |
| PACKAGING | SINGLE PACKED 20/BOX | SINGLE PACKED 25/BOX |
Arthur J. Ward
10/12/06
Date
11300A-49th Street North
11300A-19th Street North · Clearwater, Florida 34622-4800 · 813-573-0088