(135 days)
For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.
Not Found
This document is a 510(k) premarket notification for spirometry filters and does not contain information on acceptance criteria or studies proving device performance against such criteria in the way typically expected for an AI/ML medical device.
The FDA 510(k) clearance letter (K111587) for "Alerkan Spirometry Filters - Models 9502, 9503, 9504, and 9505" indicates that the device is substantially equivalent to legally marketed predicate devices. This type of clearance primarily focuses on demonstrating that the new device is as safe and effective as devices already on the market, rather than requiring extensive clinical trials with specific performance criteria against a ground truth as would be expected for a novel diagnostic algorithm.
Therefore, most of the requested information (items 1 through 9) is not applicable to this document. The document describes the device's intended use and compatibility with various PFT equipment but does not define specific performance metrics for the filters themselves (e.g., filtration efficiency at certain pore sizes, pressure drop, etc.) nor does it present a study to demonstrate such performance.
Explanation for non-applicability of requested information:
- A table of acceptance criteria and the reported device performance: Not present. This document is a 510(k) clearance, which confirms substantial equivalence to predicate devices, not performance against novel acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable. No test set for algorithm performance is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic output is relevant here.
- Adjudication method: Not applicable. No diagnostic outputs requiring adjudication.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device, nor a diagnostic device requiring human interpretation of results.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical filter, not an algorithm.
- The type of ground truth used: Not applicable. No ground truth is established for assessing diagnostic performance.
- The sample size for the training set: Not applicable. No algorithm training.
- How the ground truth for the training set was established: Not applicable. No algorithm training.
The document essentially provides information about the administrative clearance of physical spirometry filters, including their models, intended use, compatibility, and environment of use for pulmonary function testing. It does not provide the kind of performance data and study details requested in your prompt, which are typically associated with the evaluation of diagnostic algorithms or imaging devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Alerkan LTD C/O Mr. Glen Feye President Accurate Consultants, Incorporated 1340 West Pennsylvania Avenue San Diego, California 92013
Re: K111587
Trade/Device Name: Alerkan Spirometry Filters - Models 9502, 9503, 9504, and 9505 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: October 11, 2011 Received: October 17, 2011
Dear Mr. Feye:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. Feye
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Cim
Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 4
INDICATIONS FOR USE
510(k) Number (if known):
Alerkan Spirometry Filters- Models 9502, 9503, 9504, and 9505 Device Name:
Indications for Use: For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.
Adaptable for use with the following PFT equipment
| Model | Standard Port Sizes | PFT Device Compliance |
|---|---|---|
| 9502 | Approx. 30mm ID X 34 mm OD | Fits Viasys, SensorMedics, Jeager |
| 9503 | Approx. 26.5 mm ID X 30 mm OD | Fits MIR, Zan, nSpire, Micro Medical,Datospir |
| 9504 | Approx. 45mm ID X 48.5 mm OD | Fits Koko Spirometer, KoKo Legend,KoKoDigidoser and Koko Trek |
| 9505 | Approx. 30mm ID X 34 mm OD &Approx. 26.5 mm ID X 30 mm OD | Fits Viasys, SensorMedics, Jeager, MIR,Zan, nSpire, Micro Medical, Datospir |
Environment of Use -- Hospital, Sub-acute Institutions, Doctor's offices, Laboratories
Target Patient Populations: Adults
Prescription Use V. (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Azhulthea
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111587
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).