(121 days)
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.
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.
The provided 510(k) summary for the SDI AstraGuard Pulmonary Function Filter does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against them. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's technical specifications and intended use.
However, based on the information provided, we can infer some aspects and highlight what is missing.
Here's an attempt to answer your questions based only on the provided text, recognizing significant gaps:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific acceptance criteria (e.g., a minimum filtration efficiency percentage for particles of a certain size) nor does it report the device's performance against such criteria in a quantitative table.
The device description mentions: "The highly efficient medium is ultrasonically welded to the shell body." This implies a claim of efficiency, but no specific performance metric is given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. There is no mention of a test set, sample sizes, or data provenance for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided 510(k) summary. As no explicit performance study with a test set generating "ground truth" is described, there's no mention of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) summary. No details about adjudication methods are present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a physical filter, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical filter, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided 510(k) summary. As no explicit performance study with a test set generating "ground truth" is described, there's no mention of the type of ground truth. For a filter, "ground truth" would likely relate to objective measurements of filtration efficiency for specific microorganisms or particle sizes, rather than expert consensus on images or pathology.
8. The sample size for the training set
This information is not available in the provided 510(k) summary. As this is not an AI/machine learning device, the concept of a "training set" in this context is not applicable.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) summary, as the concept of a training set and its ground truth is not applicable to this type of device.
Summary of what the document does indicate about meeting criteria/proving performance:
The basis for market clearance of the SDI AstraGuard Pulmonary Function Filter appears to be its substantial equivalence to existing predicate devices (K934509 SDI Pulmoguard Filter, K043148 Alliance Tech Medical All Flow Filter, K934475 Koko Disposable PFT Filter II).
The "study" proving the device meets acceptance criteria, in this context of a 510(k) for a medical device filter, would primarily involve:
- Bench testing: Demonstrating that the filter physically meets design specifications and potentially functional performance similar to or better than the predicates (e.g., flow resistance, dead space, and filtration efficiency against specified pathogens or particle sizes). While not explicitly detailed in this summary, these types of tests are standard for such devices. The statement "The highly efficient medium is ultrasonically welded to the shell body" alludes to design and manufacturing ensuring efficiency.
- Comparison to Predicate Devices: The 510(k) process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and intended use. The fact that the device uses an "electrostatic polypropylene medium enclosed in a molded polystyrene shell" suggests a similar construction to other filters on the market.
The FDA's letter states: "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... to legally marketed predicate devices." This is the "proof" the device met the regulatory acceptance criteria for market clearance under the 510(k) pathway. However, the details of the specific tests and their results that underpinned this substantial equivalence claim are not included in this provided summary.
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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 - President10 Hampden DriveEaston, MA 02375e-mail: mjboyle@sdidiagnostics.com |
| Establishment Registration No.: | 1221256 |
| Contact: | Cosimo Carioloe-mail: ccariolo@sdidiagnostics.comTel: (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 Filter510(k) #K043148 Alliance Tech Medical All Flow Filter510(k) # K934475 Koko Disposable PFT Filter II |
| Device Description: | The SDI AstraGuard Pulmonary Function Filter is anelectrostatic polypropylene medium enclosed in a moldedpolystyrene shell. The highly efficient medium is ultrasonicallywelded to the shell body. |
| Intended Use: | The AstraGuard Pulmonary Function Filter is intended for use inreducing possible bacterial and/or viral cross contamination ofspirometers and pulmonary testing instruments, associatedvalves and hoses, from aerosols and particulates, which may bepresent in a patient's exhaled gas. The device is indicated fordiagnostic applications |
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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.
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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
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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
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Prescription Use
(per 21 CFR 801.109
OR
Over-the-Counter Use (Optional Format 1-2-96)
§ 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).