(162 days)
To provide filtration of a patient's exhaled air and it may reduce the potential of contamination when it is utilized in anesthesia breathing circuit, ventilator circuits, manual resuscitators and during transport.
A filter with a translucent housing and filter media which connects to the patient connector and the circuit tubing and manual resuscitators.
The provided document describes a 510(k) submission for the ProMedic, Inc. Wye Filter, a breathing circuit filter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright safety and effectiveness studies in the same way a new drug or novel medical device might. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for a device's performance, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone algorithm performance) is not explicitly present or directly relevant for this specific type of device and submission.
However, I can extract the closest analogous information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are generally based on meeting the functional specifications and performance characteristics of predicate devices. The document compares the ProMedic filter to predicate devices based on various attributes.
| Criteria/Characteristic | ProMedic, Inc. Filter (Reported Performance) | Predicate Device 1 (Dryden) | Predicate Device 2 (Med-Plastics) | Predicate Device 3 (Engstrom) |
|---|---|---|---|---|
| Intended Use | ||||
| Provide filtration in a breathing circuit | Yes | Yes | Yes | Yes |
| Used with anesthesia breathing circuit, ventilator circuits, resuscitators | Yes | Yes | Yes | Yes |
| Environment of use - Hospital, OR, anesthesia, PACU, ICU, transport | Yes | Yes | Yes | Yes |
| Indicated for single patient use | Yes | Yes | Yes | Yes |
| Design | ||||
| Placed in the breathing circuit | Yes | Yes | Yes | Yes |
| Standard 15/22 mm fitting | Yes | Yes | Yes | Yes |
| May have a port for sampling CO2 gases | Yes | Yes | Yes | Yes |
| Media hydrophobic | Yes | Yes | Yes | Yes |
| Has a translucent housing | Yes | Yes | Yes | Yes |
| Compact, low deadspace | Yes | Yes | Yes | Yes |
| Performance Standards / Specifications | ||||
| Filtration efficiency rating of BFE and VFE 99%+ | Yes (Nelson) | 99.9% (Sangtec) | Yes (Nelson) | |
| Fittings - ASTM 1054 | Yes | Yes | Yes | Yes |
| Materials | ||||
| Housing - Polyethylene, polystyrene | Yes | Yes | Yes | Yes |
| Filter media - Electrostatic | Yes | Yes | Yes | Yes |
| Hydrophobic media | Yes | Yes | Yes | Yes |
Note: The table above synthesizes information from the "Comparison to Predicate Devices" section. The "Reported Device Performance" for the ProMedic filter is implied by the "Yes" responses, meaning it meets the characteristic/standard.
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for performance tests in the way one might for diagnostic accuracy studies. The "performance" assessment here is primarily a comparison against established characteristics and standards, often based on existing product specifications or industry standards rather than a new clinical trial with a "test set" of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for a device like a breathing circuit filter is its adherence to functional and material specifications and performance standards established by organizations like ASTM, and recognized by regulatory bodies. It's not about expert clinical interpretation of diagnostic images or data.
4. Adjudication method for the test set
Not applicable. There is no mention of a "test set" requiring adjudication in the context of this device and submission.
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
Not applicable. This is not an AI-assisted diagnostic device or a device involving human readers for interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" in this context refers to established performance standards, material specifications, and design criteria for breathing circuit filters, as exemplified by the characteristics of legally marketed predicate devices and industry standards like ASTM 1054. For filtration efficiency, methods like "Nelson" and "Sangtec" are mentioned, implying testing against defined laboratory standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The document indicates that the ProMedic Wye Filter demonstrates substantial equivalence to predicate devices through a comparative analysis of its intended use, design, performance standards/specifications, and materials.
- Intended Use: The ProMedic filter has the same intended use (filtration in a breathing circuit, for various environments and single-patient use) as the predicate devices.
- Design: Its design features (e.g., placement in circuit, standard fittings, potential CO2 port, hydrophobic media, translucent housing, compact size) are consistent with predicate devices.
- Performance Standards/Specifications: The ProMedic filter meets or is comparable to the filtration efficiency ratings (BFE and VFE 99%+) of predicate devices, as demonstrated by testing methods (e.g., "Nelson"). It also conforms to standards for fittings (e.g., ASTM 1054).
- Materials: The materials used for the housing and filter media are consistent with those in predicate devices.
The FDA's letter (Page 3 of the combined document) confirms that they "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This determination signifies that the FDA agreed with the presented evidence that the ProMedic filter meets the criteria for substantial equivalence to its predicate devices without raising new questions of safety or effectiveness.
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Image /page/0/Picture/0 description: The image shows the logo for ProMedic, Inc. The logo includes the company name in a bold, sans-serif font. Above the company name is the text "K970102" in a handwritten style. To the right of the company name is a drawing of a lightbulb.
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 January 7, 1997
.
JUN 2 4 1997
ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055
Tel - (317) 335-3780
Fax - (317) 335-9270
Official Contact: Proprietary or Trade Name: Common/Usual Name: Classification Name: Device: Predicate Devices:
Paul E. Dryden, President Filter Breathing circuit filter Filter, bacterial, breathing circuit Filter Dryden (Gibeck-Dryden) - K833066 Med-Plastics - K930760 Engstrom - wye filter - K954194
Device Description:
A filter with a translucent housing and filter media which connects to the patient connector and the circuit tubing and manual resuscitators.
| Intended Use: | ||
|---|---|---|
| Indicated Use -- | To provide filtration of a patient's exhaled air and it may reduce thepotential of contamination when it is utilized in anesthesia breathingcircuit, ventilator circuits, manual resuscitators and during transport. | |
| Environment of Use -- | Hospital, OR, anesthesia, ICU, PACU, manual resuscitators andduring transport. | |
| Page 3 of 27 |
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Non-Confidential Summary of Safety and Effectiveness
(continued)
page 2 of 3
January 7, 1997
Comparison to Predicate Devices:
| Use | |||
|---|---|---|---|
| Intended provide filtration ina breathing circuit | Yes | Yes | Yes |
| Used with anesthesia breathing circuit,ventilator circuits, resuscitators | Yes | Yes | Yes |
| Environment of use - Hospital, OR,anesthesia, PACU, ICU, transport | Yes | Yes | Yes |
| Indicated for single patient use | Yes | Yes | Yes |
| Design | |||
| Placed in the breathing circuit | Yes | Yes | Yes |
| Standard 15 / 22 mm fitting | Yes | Yes | Yes |
| May have a port for sampling CO2gases | Yes | Yes | Yes |
| Media hydrophobic | Yes | Yes | Yes |
| Has a translucent housing | Yes | Yes | Yes |
| Compact, low deadspace | Yes | Yes | Yes |
| Performance Standards / Specifications | |||
| Filtration efficiency rating of BFE andVFE 99%+ | Yes(Nelson) | 99.9%Sangtec | Yes(Nelson) |
| Fittings - ASTM 1054 | Yes | Yes | Yes |
| Materials | |||
| Housing - Polyethylene, polystyrene | Yes | Yes | Yes |
| Filter media - Electrostatic | Yes | Yes | Yes |
| Hydrophobic media | Yes | Yes | Yes |
| Differences between Other Legally Marketed Predicate Devices |
{2}------------------------------------------------
Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3
January 7, 1997
There is no significant differences between the intended device and the predicate devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.
JUN 2 4 1997
Mr. Paul E. Dryden ProMedic, Inc. -6329 W. Waterview Court .. . . .... McCordsvillé, Indiāña 46055-9501 ־
Re: K970102 ProMedic Wye Filter Regulatory Class: II (two) Product Code: 73 CAH Dated: April 15, 1997 Received: April 21, 1997
Dear Mr. Dryden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Paul E. Dryden
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
| SECTION 3 | |
|---|---|
| INDICATIONS FOR USE |
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | K970102 (To be assigned) |
|---|---|
| Device Name: | Filter |
| Intended Use : | To provide filtration for reducing possible contamination between patient and equipment. |
| Environment of use: | Hospital - OR, anesthesia, transport, PACU, manual resuscitators, and ICU |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard N. Phillips
Prescription Use √
(Per CFR 801.109)
or
Over-the-counter use
Page 10 of 27
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).