(276 days)
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.
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This FDA 510(k) clearance letter (K022124) for the GaleMed Peak Flow Meter, Models 3751/3752, primarily focuses on establishing substantial equivalence to a predicate device. As such, it does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness profiles as a previously cleared device.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here is an attempt to address the prompt based solely on the provided documents 0, 1, and 2, and highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The 510(k) process relies on substantial equivalence to a predicate device. Acceptance criteria would typically be related to accuracy, precision, and repeatability of peak expiratory flow measurements, likely referencing established standards for peak flow meters (e.g., ISO 23747 or ATS/ERS guidelines), but these are not present in the provided text. | Not explicitly stated in the document. The document states the device is "substantially equivalent" to legally marketed predicate devices, implying its performance is comparable to those devices. Specific performance metrics (e.g., accuracy within a certain percentage, repeatability) are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. Performance data for a test set is not provided in this 510(k) clearance.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the context of this 510(k) submission. Establishing ground truth with experts is typically for diagnostic interpretation AI/ML devices, not for
performance of mechanical devices like peak flow meters where ground truth is typically established by instrumental measurement against a reference standard.
4. Adjudication Method for the Test Set
Not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant for a peak flow meter. This type of study is used for diagnostic systems where human readers interpret medical images or data, and the device assists in that interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not an AI/ML device, so "standalone algorithm performance" as typically understood does not apply. The device's performance would be assessed purely on its mechanical and measurement accuracy. Details of such a study are not provided.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a peak flow meter, ground truth would typically be established by a reference spirometer or a calibrated flow generator according to recognized standards (e.g., ISO 23747). The document does not specify the method used to establish ground truth for any potential performance testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a "training set" or ground truth for training purposes.
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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:
§ 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).