(135 days)
Not Found
Not Found
No
The summary describes a simple air filter for PFT equipment and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a filter for pulmonary function testing equipment, intended to protect the equipment from exhaled air, not to directly treat a patient's medical condition.
No
The device is described as a filter for pulmonary function testing equipment, intended to prevent the transfer of exhaled air to the equipment. Its primary function is to filter and protect the equipment, not to diagnose a medical condition.
No
The intended use and description clearly indicate a physical filter for pulmonary function testing equipment, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter air between the patient's exhaled air and pulmonary function testing equipment. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on a specimen.
- Device Description: While the description is "Not Found," the intended use clearly defines its function as a filter.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on the exhaled air itself. The device's purpose is to protect the equipment and potentially prevent cross-contamination, not to diagnose a condition.
IVDs are typically used to examine specimens like blood, urine, tissue, or other bodily fluids to detect diseases, conditions, or infections. This device's function falls outside of that scope.
N/A
Intended Use / 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
Product codes
BZG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Environment of Use -- Hospital, Sub-acute Institutions, Doctor's offices, Laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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
§ 868.1840 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms. The symbol is composed of three curved lines that overlap and create a sense of movement.
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