(86 days)
The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.
The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
The provided documents are a 510(k) premarket notification letter for a device called RESPALERT and its Indications for Use. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.
The device, RESPALERT, is described as a peak flow monitor that indicates lung condition through the presence or absence of a whistle, rather than providing a quantitative reading. The indications for use state it's for adults with respiratory diseases to monitor their status.
Therefore, I cannot provide the requested information from the given text.
However, based on the nature of the device (a simple whistle-based peak flow indicator), a hypothetical description of acceptance criteria and a study design might look something like this:
Hypothetical Acceptance Criteria and Study Design for RESPALERT (not found in the provided text)
Given that the RESPALERT's function is to produce a whistle if the lung condition is "under control" (presumably above a set peak flow threshold) and no whistle if treatment is necessary or ineffective (below the threshold), the acceptance criteria would likely focus on the device's accuracy in detecting this binary state.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Hypothetical) |
|---|---|---|
| Accuracy (Sensitivity) | > 90% | 95% |
| Accuracy (Specificity) | > 90% | 92% |
| Timeliness of Whistle | Whistle produced within 1 second of sufficient airflow. | Whistle produced within 0.5 seconds for all successful trials. |
| Durability (Whistle integrity over time) | Whistle function maintained after X uses (e.g., 500 uses) or Y months. | Whistle function maintained for 1000 uses in accelerated aging tests, and 24 months in a subset of patient-used devices. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: 150 patients (e.g., 75 with controlled respiratory conditions, 75 with uncontrolled conditions requiring intervention).
- Data Provenance: Prospective, multi-center clinical trial conducted in several clinics and hospitals across the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: 3 independent pulmonologists.
- Qualifications of Experts: Each pulmonologist had at least 15 years of experience in diagnosing and managing chronic respiratory diseases, board-certified in Pulmonary Medicine.
4. Adjudication Method
- Adjudication Method: 2+1. If two pulmonologists agreed on a patient's lung status (controlled vs. uncontrolled based on spirometry and clinical assessment), that was established as the ground truth. If there was disagreement between the first two, the third pulmonologist's assessment would serve as the tie-breaker.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not applicable. The RESPALERT is a diagnostic aid providing a binary signal (whistle/no whistle), not an imaging device or AI-driven interpretive system that improves human reader performance in complex image analysis. It's a direct patient monitoring tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, this is essentially what the primary accuracy study assesses. The device's performance (whistle/no whistle) is directly compared to the clinical ground truth without any human interpretation of the device's output influencing the assessment of the device's accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus on clinical status, primarily supported by objective lung function data (e.g., spirometry, specifically Peak Expiratory Flow (PEF) measurements) taken simultaneously or within a very short timeframe of the RESPALERT use. For example, a patient would be deemed "uncontrolled" if their PEF was below a predefined "action plan" threshold corresponding to their set whistle level on the RESPALERT, as determined by their physician.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the context of this device. The RESPALERT is a mechanical device with a fixed set point, not a machine learning algorithm that requires a training set. Its "setting" is calibrated to a specific PEF threshold on a lung function apparatus.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. The "training" for this device involves its initial calibration by a medical professional using a standard lung function apparatus (e.g., spirometer) to set the whistle threshold, not a data-driven training process in the AI sense.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Mr. E.J. Smith Harwill Medical (PTY) LTD. c/o Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K992618 RESPALERT Regulatory Class: II (two) Product Code: 73 BZH Dated: July 29, 1999 Received: August 4, 1999
Dear Mr. Smith:
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 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 (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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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. E.J. Smith
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 ¾800). 638-2041 or (301) 443-6597, or at its internet-address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christy touman for
Ceila M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Whistle Watch RESPALERT
Classification Panel: 73BZH, 868.1860
Indications for Use:
The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Christy Loumen
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ |
|---|---|
| or | |
| Over the Counter Use |
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§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).