(124 days)
The Custom Plastic Products Pulmonary Function Filter is intended to prevent cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
The Custom Plastic Products Pulmonary Function Filter is intended to reduce cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
The Custom Plastic Products Pulmonary Function Filter is a disposable barrier type filter intended to prevent contamination cross-contamination when using spirometers and pulmonary function testing instruments. The filter also prevents the transmission of harmful bacteria from the instruments to the patient.
The device consists of a plastic housing with a filtering efficiency greater than The filter is designed for inspiratory and expiratory air flow. 99%.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Lotus Pulmonary Function Filter:
It's important to note that this 510(k) summary is for a medical device (a filter), not a software or AI-driven diagnostic tool. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML medical device submissions (like specificity, sensitivity, ROC analysis, MRMC studies, ground truth establishment for imaging, etc.) are not applicable here. The study focuses on the physical performance of the filter and its functional equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Physical Characteristics | First Article Inspections conducted on all components. | "Prior to testing, First Article Inspections were conducted on all components." (Implicitly, these were passed, as the device proceeded to further testing and submission.) |
| Material Verification | Material verification performed on all components. | "In addition, material verification was performed on all components." (Implicitly, these were passed.) |
| Filtration Efficiency | Filtering efficiency greater than 99%. | "The device consists of a plastic housing with a filtering efficiency greater than 99%." (This is a design claim, and "Bacterial Filtration Efficiency Testing were performed on the device's filter" indicates this claim was tested and presumably met.) |
| Biocompatibility | Cytotoxicity testing performed. | "Cytotoxicity... Testing were performed on the device's filter." (Implicitly, the device met biocompatibility standards, as no adverse findings are noted, and the device was deemed substantially equivalent.) |
| Functional Equivalence | Standard Force Vital Capacity (FVC) Tests using the Lotus Filter show results substantially equivalent to the predicate device (Creative Biomedics Inc. Clear Advantage Filter). | "Standard Force Vital Capacity Tests were performed using both the Lotus Filter and the predicate device. The results of testing showed that test results using the Lotus Filter were substantially equivalent to the Creative Biomedics Inc. Clear Advantage Filter." (This is the primary functional performance criterion demonstrating that the filter does not unduly impede airflow or affect spirometry results compared to an already approved device.) |
| Intended Use | Prevent cross-contamination between patient and spirometers/pulmonary function testing instruments. | The overall conclusion of "substantial equivalence" based on filtration efficiency, cytotoxicity, and functional equivalence supports the intended use. The device's design as a "disposable barrier type filter" also directly addresses this. |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the number of filters or tests performed for the "Standard Force Vital Capacity Tests," "Cytotoxicity," or "Bacterial Filtration Efficiency Testing." It only states that these tests "were performed." For the FVC tests, it implies a comparison between the Lotus Filter and the predicate device, so at least one of each would have been tested, likely multiple instances for statistical confidence, but the exact number isn't provided.
- Data Provenance: The data appears to be prospective as it was generated by the manufacturer (Custom Plastic Products, Inc.) specifically for the 510(k) submission. There is no information on the country of origin of the data beyond it being generated by a U.S. company for FDA submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like a filter, "ground truth" as understood in imaging or diagnostic AI (e.g., "radiologist consensus," "pathology") does not apply. The ground truth for filtration efficiency or cytotoxicity would be established by validated laboratory testing methods and controls, and for FVC, by the spirometry equipment itself, calibrated according to standards. The "experts" would be the technicians and scientists performing these laboratory tests and interpreting their results against established standards. Their specific qualifications are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 refer to human reader consensus-building for diagnostic accuracy in scenarios like image interpretation. This is a physical device performance study, not a diagnostic accuracy study involving multiple human readers. The results of the tests (e.g., FVC values, bacterial counts, cytotoxicity scores) would be objective measurements.
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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:
- Not Applicable. An MRMC study is relevant for AI systems that assist human readers in diagnostic tasks. This device is a filter, not an AI system, and the study did not involve human readers interpreting cases. It assessed the filter's physical and functional properties.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. The "standalone" testing refers to the filter's performance in isolation (e.g., filtration efficiency) and its performance in a functional system (e.g., FVC testing with a spirometer) compared to a predicate, but there is no algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on objective laboratory measurements and established test standards/protocols.
- For Bacterial Filtration Efficiency, the ground truth is defined by the number of bacteria captured vs. passed, measured using standardized microbiological methods.
- For Cytotoxicity, the ground truth is determined by standardized biocompatibility testing, observing cellular reactions to extracts of the material.
- For Force Vital Capacity, the ground truth for the "accuracy" is the spirometer's readings, which are themselves calibrated and standardized, comparing the measured values with the filter to those with the predicate filter. The goal wasn't absolute accuracy against a known "true" lung capacity (which would vary by individual), but rather equivalence in measurement through the filter compared to the predicate.
- The "ground truth" here is based on objective laboratory measurements and established test standards/protocols.
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The sample size for the training set:
- Not Applicable. This device is a physical filter, not a machine learning model. Therefore, there is no "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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K 033518
| 510(k) Summary |
|---|
| (As required by 21 CFR 807.92(a)) |
Submitter Information A.
Custom Plastic Products, Inc. 4519 Hastings Court Chino, CA 91710
| Phone Number: | 949-364-9349 |
|---|---|
| Fax Number: | 949-347-1204 |
Contact: Jim Barley Regulatory Affairs Date:
October 24, 2003
- Device Information B.
| Trade/Proprietary Name: | Lotus Pulmonary Function Filter | |
|---|---|---|
| Common name of device: | Pulmonary Function Filter | |
| Classification Name: | Filter, Bacterial, Breathing-Circuit | |
| C: | Predicate Device: | Creative Biomedics, Inc.Clear Advantage Pulmonary Function Filter |
| Predicate 510(k) #: | K951410 |
Device Description: D.
The Custom Plastic Products Pulmonary Function Filter is a disposable barrier type filter intended to prevent contamination cross-contamination when using spirometers and pulmonary function testing instruments. The filter also prevents the transmission of harmful bacteria from the instruments to the patient.
The device consists of a plastic housing with a filtering efficiency greater than The filter is designed for inspiratory and expiratory air flow. 99%.
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Intended Use: E.
The Custom Plastic Products Pulmonary Function Filter is intended to prevent cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
-
Comparison of Required Technological Characteristics: F.
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Custom Plastic Products Lotus Filter and the cited predicate device. -
Summary and Conclusion of Nonclinical and Clinical Tests: G.
Prior to testing, First Article Inspections were conducted on all components. In addition, material verification was performed on all components.
Cytotoxicity and Bacterial Filtration Efficiency Testing were performed on the device's filter.
To shown that test results using the Lotus Filter were accurate, Standard Force Vital Capacity Tests were performed using both the Lotus Filter and the predicate device. The results of testing showed that test results using the Lotus Filter were substantially equivalent to the Creative Biomedics Inc. Clear Advantage Filter.
Conclusion:
The Custom Plastic Products Lotus Filter is substantially equivalent to the Creative Biomedics Inc. Clear Advantage Filter in indications for use and technological characteristics.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
Mr. Jim Barley President, JB and Associates 28481 La Falda Laguna Niguel, CA 92677
Re: K033518
Trade/Device Name: Lotus Pulmonary Function Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, Diagnostic (Accessory to) Regulatory Class: II Product Code: BZG Dated: February 23, 2004 Received: February 24, 2004
Dear Mr. Barley:
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. Jim Barley
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 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.
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.
Chris
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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Indications for Use
510(k) Number (if known): K033518
Lotus Pulmonary Function Filter Device Name:
Indications For Use:
The Custom Plastic Products Pulmonary Function Filter is intended to reduce cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
Prescription Use (Part 21 CFR 801 Subpert D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ktin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K0335
Page 1 of 1
§ 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).