(121 days)
Not Found
No
The description focuses on the physical filtration mechanism and materials, with no mention of AI or ML.
No
The device is described as a filter used to prevent cross-contamination in diagnostic pulmonary instruments, not to treat a condition or disease. Its intended use is for "diagnostic applications."
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is indicated for diagnostic applications."
No
The device description clearly states it is a physical filter made of electrostatic polypropylene medium enclosed in a molded polystyrene shell, indicating it is a hardware device.
Based on the provided information, the AstraGuard Pulmonary Function Filter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to reduce cross-contamination of spirometers and pulmonary testing instruments. This is a barrier function to protect the equipment and potentially other patients, not to perform a diagnostic test on a patient's sample in vitro.
- Device Description: The description details a physical filter medium and housing. There is no mention of reagents, assays, or any components designed to analyze a biological sample.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status based on sample analysis.
- Predicate Devices: The predicate devices listed are also pulmonary function filters, which serve the same barrier purpose and are not classified as IVDs.
While the device is used in a diagnostic application (pulmonary function testing), its function is supportive to the diagnostic process by preventing contamination, rather than being a diagnostic test itself.
N/A
Intended Use / Indications for Use
The AstraGuard Pulmonary Function Filter is intended for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.
Product codes
CAH
Device Description
The SDI AstraGuard Pulmonary Function Filter is an electrostatic polypropylene medium enclosed in a molded polystyrene shell. The highly efficient medium is ultrasonically welded to the shell body.
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
Not Found
Intended User / Care Setting
Not Found
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)
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
Koco2913
| 510(k) Summary | JAN 26 2007 |
|---|---|
| [As Required by 21 CFR 807.92] | |
| Owner / Submitter of 510(k) | SDI Diagnostics, Inc. |
| Michael J. Boyle - President | |
| 10 Hampden Drive | |
| Easton, MA 02375 | |
| e-mail: mjboyle@sdidiagnostics.com | |
| Establishment Registration No.: | 1221256 |
| Contact: | Cosimo Cariolo |
| e-mail: ccariolo@sdidiagnostics.com | |
| Tel: (508) 238-7033, fax (508) 230-8497 | |
| Trade Name: | SDI AstraGuard Pulmonary Function filter |
| Common Name: | Disposable PFT Filter |
| Classification Name: | Filter, Bacterial |
| Regulation Number | 21 CFR 868.5260 |
| Classification Panel: | Anesthesiology |
| Regulatory Class: | II |
| Product Code: | CAH |
| Predicate Devices | 510(k) #K934509 SDI Pulmoguard Filter |
| 510(k) #K043148 Alliance Tech Medical All Flow Filter | |
| 510(k) # K934475 Koko Disposable PFT Filter II | |
| Device Description: | The SDI AstraGuard Pulmonary Function Filter is an |
| electrostatic polypropylene medium enclosed in a molded | |
| polystyrene shell. The highly efficient medium is ultrasonically | |
| welded to the shell body. | |
| Intended Use: | The AstraGuard Pulmonary Function Filter is intended for use in |
| reducing possible bacterial and/or viral cross contamination of | |
| spirometers and pulmonary testing instruments, associated | |
| valves and hoses, from aerosols and particulates, which may be | |
| present in a patient's exhaled gas. The device is indicated for | |
| diagnostic applications |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design representing the interconnectedness of health and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus, indicating the department's full name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Cosimo Cariolo Director of Marketing SDI Diagnostics, Incorporated 10 Hampden Drive Easton, Massachusetts 02375
JAN 2 6 2007
Re: K062913
Trade/Device Name: AstraGuard Pulmonary Function Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: January 10, 2007 Received: January 16, 2007
Dear Mr. Cariolo:
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.
2
Page 2 - Mr. Cariolo
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 regulties. 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 systems (QS) regulation (21 CFR Part 82pirend 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyite Y. Michin Oms
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SDI Diagnostics, Inc. AstraGuard Pulmonary Function filter 510(k) Submission
INDICATIONS FOR USE STATEMENT
510(k) Number (if known) K062913
AstraGuard Pulmonary Function Filter Device Name:
Indications for Use:
The AstraGuard Pulmonary Function Filter is intended to for use in reducing possible The AstraOuard Pulmonary Panonination of spirometers and pulmonary testing bacterial and/or viral cross contamination of epirements and particulates, which may be Instruments, associated varies and more is indicated for diagnostic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matt Welch
on Sign-Cfi) on of Anesthesiology, General Hospital, . Tion Control, Dental Devices
unty purchar Kolza13
Prescription Use
(per 21 CFR 801.109
OR
Over-the-Counter Use (Optional Format 1-2-96)