(124 days)
Not Found
No
The device is a simple disposable filter with no mention of software, algorithms, or any technology beyond basic filtration.
No
The device is a filter intended to prevent cross-contamination between the patient and instruments, not to directly treat a patient's condition.
No
This device is a filter intended to prevent cross-contamination during pulmonary function testing, not to diagnose a medical condition.
No
The device description clearly states it is a "disposable barrier type filter" consisting of a "plastic housing with a filtering efficiency greater than 99%". This describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent cross-contamination between the patient and the spirometers/pulmonary function testing instruments. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a "disposable barrier type filter." This reinforces its function as a physical barrier, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or any process that would lead to a diagnosis or provide information about a patient's health status based on in vitro testing.
The device is a medical device, specifically a filter used in conjunction with diagnostic equipment (spirometers), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BZG
Device Description
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 99%. The filter is designed for inspiratory and expiratory air flow.
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)
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 show 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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%.
1
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.
2
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.
3
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
4
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
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