(390 days)
PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT
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.
The provided document is a 510(k) summary for the Mercury Expiratory Resistance Exerciser (RESISTEX) and does not contain detailed information about acceptance criteria or specific study results that would allow for a comprehensive breakdown as requested.
However, based on general understanding of 510(k) submissions, the “Table of Comparison” serves as the core of the submission, demonstrating substantial equivalence to a predicate device. This table effectively is the study, and the criteria for acceptance are met if the device is found to be "substantially equivalent."
Here's an attempt to structure the available information according to your request, acknowledging the limitations of the provided text:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the Mercury Expiratory Resistance Exerciser (RESISTEX) is that it is substantially equivalent to the predicate device, the Westmed Circulaire™ Aerosol Drug Delivery System, in terms of intended use, materials, mode of operation, and key functional components. The device performance is demonstrated by directly comparing its features and specifications to those of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k) submission, the "acceptance criteria" are the characteristics of the predicate device, and the "reported device performance" is the equivalent characteristics of the Mercury Expiratory Resistance Exerciser.
| Acceptance Criteria (Predicate: Westmed Circulaire™) | Reported Device Performance (Mercury Expiratory Resistance Exerciser) |
|---|---|
| INTENDED USE: PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT | PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT |
| MATERIALS: POLYPROPYLENE | STYRENE & LDPE |
| 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 25/BOX | SINGLE PACKED 20/BOX |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this comparison table. This is a descriptive comparison of device specifications, not a clinical trial or performance test on a sample of devices.
- Data Provenance: The data is presented by the manufacturer, Mercury Medical, as part of their 510(k) submission. It's a retrospective comparison based on existing device specifications rather than prospective data collection. The country of origin of the data is implicitly the USA, where both companies operate and the submission was made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. For 510(k) submissions of this nature, the "ground truth" (i.e., the specifications of the predicate device) is typically established by the manufacturer through their own design and testing documentation, along with publicly available information for the predicate device. It doesn't usually involve external experts establishing ground truth for the comparison itself.
- Qualifications of Experts: Not specified. The comparison table is likely compiled by the manufacturing and regulatory teams at Mercury Medical.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a direct feature-by-feature comparison rather than an interpretation study requiring adjudication. The FDA's review process itself serves as a form of "adjudication" on whether the presented comparison supports substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a therapeutic spirometer/exerciser, and the 510(k) process for such devices typically relies on demonstrating substantial equivalence through design and functional comparisons, and sometimes bench testing, rather than complex clinical effectiveness studies involving multiple readers. The document does not mention any human-in-the-loop performance evaluation for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical device (spirometer/exerciser), not an AI algorithm or software-only device. Its performance is inherent in its physical design and operation, which is compared to the predicate device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this comparison is the published and established specifications and intended use of the predicate device, the Westmed Circulaire™ Aerosol Drug Delivery System. It is essentially an "expert consensus" or "regulatory acceptance" of the predicate device's characteristics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no concept of a "training set" for this type of device submission. The device design and specifications are developed internally by Mercury Medical, and compared against the fixed characteristics of the predicate device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for this type of 510(k) submission.
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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.
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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
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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
| MERCURYEXPIRATORY RESISTANCEEXERCISER | WESTMEDCIRCULAIRE" AEROSOLDRUG DELIVERY SYSTEM | |
|---|---|---|
| INTENDED USE | PERMITS RESISTANCEBREATHING DURINGAEROSOL TREATMENT | PERMITS RESISTANCEBREATHING DURINGAEROSOL TREATMENT |
| MATERIALS | STYRENE & LDPE | POLYPROPYLENE |
| MODE OF OPERATION | ROTATING RESISTANCEORIFICE WITH IN-LINENEBULIZER | ROTATING RESISTANCEORIFICE WITH IN-LINENEBULIZER |
| ONE WAY VALVE | BETWEEN NEBULIZER ANDEXHALATION RESISTOR | BETWEEN NEBULIZER ANDEXHALATION RESISTOR |
| PROVIDES POSITIVEEXPIRATORY PRESSUREBENEFIT DURINGTREATMENT | HAS VARIABLERESISTANCE ADJUSTMENT | HAS VARIABLE RESISTANCEADJUSTMENT |
| 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
§ 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).