(220 days)
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device. The Mini-Ciser may be helpful in loosening and removal of mucus.
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
The provided text is a 510(k) summary for the Mini-Ciser, a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria and study design (e.g., sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance) is not present in the provided document.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "Our bench testing has demonstrated substantial equivalence to another marketed device (Breather)." This implies that the acceptance criterion was likely "substantial equivalence" as determined by bench testing, specifically comparing the Mini-Ciser to the Breather device (K944412). The performance reported is that this substantial equivalence was achieved.
- Acceptance Criteria: Demonstration of substantial equivalence to the predicate device (Breather, K944412) through bench testing.
- Reported Device Performance: "Our bench testing has demonstrated substantial equivalence to another marketed device (Breather)."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only mentions "bench testing," which typically refers to laboratory or engineering tests, not a clinical test set with human subjects.
- Data Provenance: Not specified, but "bench testing" usually implies testing performed by the manufacturer in a controlled environment. It would be retrospective in the sense that the device was already designed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. For bench testing demonstrating substantial equivalence, expert consensus on a "ground truth" for clinical performance is not typically part of the submission in this format. The testing would focus on engineering specifications.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is relevant for clinical studies involving human interpretation or performance, which is not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study Done: No, an MRMC comparative effectiveness study was not done or reported in this document. The focus was on "bench testing" for substantial equivalence.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance Study Done: Not applicable. This device is a physical medical device, not an AI algorithm. "Bench testing" would be the closest analogue to evaluating the device's inherent physical performance.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not explicitly stated as "ground truth" in the clinical sense. For bench testing, the "ground truth" would be the established specifications and performance characteristics of the predicate device, against which the Mini-Ciser's measured performance from bench tests would be compared.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
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 for this type of device.
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AUG 6 1998
510 (k) SUMMARY
| 510 (k) SUMMARY | K974848 | |
|---|---|---|
| Date: | April 29, 1998 | |
| Contact Person: | Jeffery R. Miller | |
| Classification Name: | (PEP) Device/Inspiratory Muscle Trainer | |
| Common/Usual Name: | (PEP) Device/Inspiratory Muscle Trainer | |
| Proprietary Name: | Mini-Ciser® | |
| Claiming Equivalence To: | Breather (K944412) | |
| Intended Uses: | (PEP) Positive Expiratory Pressure(IMT) Inspiration Muscle Trainer |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Jeffery R. Miller Hougen MFG., Inc. 3001 Hougen Drive Swartz Creek, MI 48473
K974848 Re: Mini-Ciser Requlatory Class: II (two) Product Code: 73 BWF Dated: May 12, 1998 May 15, 1998 Received:
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jeffery R. Miller
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS
Mini-Ciser
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
Our bench testing has demonstrated substantial equivalence to another marketed device (Breather).
The Mini-Ciser may be helpful in loosening and removal of mucus.
Patient population: Adult & Children.
Single patient use and reusable.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Lark Madoo 8-6-98
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription
§ 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).