(276 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (peak flow meter) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is described as a peak flow meter, which is used for measurement and diagnosis, not for treatment.
Yes
Explanation: The device is a peak flow meter intended to measure a patient's peak expiratory flow, which indicates its use in monitoring a patient's respiratory health, a form of diagnosis.
No
The device is described as a "peak flow meter," which is a physical device used to measure peak expiratory flow. The summary does not mention any software component or indicate that the device is solely software.
Based on the provided information, the GaleMed Model 3751 and Model 3752 peak flow meters are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to "measure a patient's peak expiratory flow." This is a measurement of a physiological function (lung capacity/airflow), not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description (Not Found): While the description is missing, peak flow meters typically involve the patient exhaling into the device, which then measures the force of the airflow. This is a direct interaction with the patient's breath, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
In summary, peak flow meters are devices used to measure a physical parameter of the patient's respiratory system directly, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.
Product codes
73 BZH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
§ 868.1860 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2003
Mr. Bruce Kuo GaleMed Corporation 87, Li-Gong 2nd Road Wu-Jia, I-Lan TAIWAN, ROC 268
Re: K022124
Trade/Device Name: GaleMed Peak Flow Meter, Models 3751/3752 Regulation Number: 21 CFR 868.1860 Regulation Name: Peak Flow Meter for Spirometry Regulatory Class: Class II (two) Product Code: 73 BZH Dated: March 8, 2003 Received: March 14, 2003
Dear Mr. Kuo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 - Mr. Bruce Kuo
systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours.
Susan Gunner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Applicant:___GALEMED CORPORATION
510(k) Number: _ K022124
Device Name:_GALEMED PEAK FLOW METER 3751 / 3752
Indications for Use :
The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
OR
Over-The-Counter
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: