(86 days)
The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient.
Some uses for the device are :-
- Diagnosis of Nasal Obstruction
- Assessment of Response to Nasal Provocation
- Home Monitoring of PNIF
- Oral Inspiratory Flow Measurement
The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions.
The provided document focuses on the FDA 510(k) submission for the "IN-CHECK Inspiratory Flowmeter". It primarily addresses the regulatory approval process and indications for use. The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the detail required to populate the requested table and answer the specific study questions.
The document states:
- Safety Problems: "No safety problems should be experienced during use of the device for its intended purpose, and none have been reported for either the IN-CHECK OR YOULTON INSPIRATORY MINI." This indicates a lack of reported issues rather than a rigorous study proving safety against specific criteria.
- Effectiveness: The FDA determined the device to be "substantially equivalent" to predicate devices. This regulatory pathway does not typically require new clinical studies to prove effectiveness against specific quantitative acceptance criteria, but rather demonstrates that the new device is as safe and effective as a legally marketed device.
Therefore, since the document does not provide the requested details, I cannot complete the table or answer the specific study questions.
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance (e.g., accuracy, precision).
- Sample sizes for test sets, training sets, or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Specific ground truth types (beyond general safety and equivalence to predicate devices).
To answer your questions, additional documentation regarding the performance testing of the IN-CHECK Inspiratory Flowmeter would be required.
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K980960
Clement Clarke
A HAAG-STREIT COMPANY
Jement Clarke International Ltd., Edinburgh Wav. Harlow, Essex CM20 2TT. England Telechone: 01279 414969. International: +44 1279 414969. Fax: 01279 635232. Telex: 329118 EXECOM G
JUN 1 0 1998
APPENDIX 1
PRE-MARKET NOTIFICATION CERTIFICATION AND SUMMARY
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the IN-CHECK. I further certify that I am aware of the types of problems to which the IN-CHECK is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the IN-CHECK is complete and accurate :
Safety Problems
- No safety problems should be experienced during use of the device for its intended a) purpose, and none have been reported for either the IN-CHECK OR YOULTON INSPIRATORY MINI. As directed in the Instructions for Use, the users should check that no foreign objects have been introduced into the device.
- General Medical Standards of cleanliness should be observed in maintaining the b) instrument, and the mouthpiece should be routinely sterilised in accordance with the User's Instructions.
PRINTED NAME OF PERSON REQUIRED TO SUBMIT 510 (K) :
M.J. WILKINSON
SIGNATURE OF PERSON REQUIRED TO SUBMIT 510 (K) :
TITLE OF PERSON SUBMITTING 510 )K) :
QUALITY ASSURANCE MANAGER
NAME OF COMPANY :
CLEMENT CLARKE INTERNATIONAL LIMITED
DATE : .......................................................................................................................................................................
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1998
Mr. M. J. Wilkinson Clement Clarke International Ltd. Edinburgh Way, Harlow Essex CM20 2TT United Kingdom
Re: K980960 IN-CHECK Inspiratory Flowmeter Requlatory Class: II (two) Product Code: 73 BZH March 6, 1998 Dated: March 16, 1998 Received:
Dear Mr. Wilkinson:
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 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 tc 895. A substantially equivalent determination assumes compliance 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 Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. 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. M. J. Wilkinson
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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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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Clement Clarke
A HAAG-STREIT COMPANY
APPENDIX 3
Not yet allocated 510(K) Number (if known)
Device Name
IN-CHECK INSPIRATORY FLOWMETER
Indications for Use :
The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient.
Some uses for the device are :-
Diagnosis of Nasal Obstruction l .
In some patients who complain of nasal obstruction, nasal airway patency is quite normal, and the sympton is due to consciousness of some other abnormality of the nasal cavity such as a prominent turbinate. In some cases, surprisingly low readings are obtained in some patients who are unaware of nasal obstruction, because they have got used to it. Quiet breathing through the nose can in such cases be achieved in spite of a peak nasal inspiratory flow readings as low as 50.
Such patients are often unaware that they breath through the mouth for much of the time.
Reversibility of nasal obstruction can be assessed by measuring PNIF after application of a nasal decongestant such as ephedrine by spray or drops. If the PNIF is not raised to a reading of over 100 by such treatment, then the obstruction may be associated with mucosal oedema, extensive polyps or anatomical abnormality. A trial of topical or systemic steroids may also bring the PNIF into the normal range (100 to 300 L/min.).
2. Assessment of Response to Nasal Provocation
Allergen or pharmocological mediator (e.g. histamine) application to the nasal mucosa in doses halving PNF is usually associated with only minor and transient discomfort. Details of a simplified allergen provocation test using PNIF measurement have been published.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K980960 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR Over-the-Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |
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3. Home Monitoring of PNIF
This may be useful in drug or immunotherapy trials in rhinitis, or for assessing the importance of environmental factors at home or work in individual patients with thinitis. Cyclic changes in nasal airway patency can also be investigated, as can late responses to allergen provocation.
Oral Inspiratory Flow Measurement 4.
Measurements of sub-maximal inspiratory flows are valuable when training patients in the correct use of medical inhaler devices. Recent studies have indicated target inspiratory flows for many of the inhaled medication devices commonly used to deliver medication in respiratory diseases.
Feedback to the patient from IN-CHECK measurement enables the patient to adjust their inhalation technique to best suit their own inhaler.
PNIF = Peak Nasal Inspiratory Flow Note:
§ 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).