(162 days)
Not Found
No
The device description and intended use are purely mechanical filtration, with no mention of AI/ML terms or data processing.
No.
The device's intended use is to filter exhaled air to reduce contamination, not to treat a disease or condition in a patient.
No
The device is described as a filter for patient's exhaled air, intended to reduce contamination in breathing circuits. Its function is to filter, not to diagnose a condition or disease.
No
The device description clearly states it is a "filter with a translucent housing and filter media," indicating it is a physical hardware device, 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 filter exhaled air in breathing circuits to reduce contamination. This is a mechanical function related to patient breathing and circuit hygiene, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, or tissue outside the body).
- Device Description: The description details a filter with a housing and filter media, which aligns with a mechanical filtration device.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Predicate Devices: The predicate devices listed (K833066, K930760, K954194) are typically breathing circuit filters, not IVD devices.
Therefore, this device falls under the category of a medical device used in respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
To provide filtration for reducing possible contamination between patient and equipment.
Product codes
73 CAH
Device Description
A filter with a translucent housing and filter media which connects to the patient connector and the circuit tubing and manual resuscitators.
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
Hospital, OR, anesthesia, ICU, PACU, manual resuscitators and during transport.
Hospital - OR, anesthesia, transport, PACU, manual resuscitators, and ICU
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
§ 868.5260 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).
0
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 the | |
| potential of contamination when it is utilized in anesthesia breathing | ||
| circuit, ventilator circuits, manual resuscitators and during transport. | ||
| Environment of Use -- | Hospital, OR, anesthesia, ICU, PACU, manual resuscitators and | |
| during transport. | ||
| Page 3 of 27 |
1
Non-Confidential Summary of Safety and Effectiveness
(continued)
page 2 of 3
January 7, 1997
Comparison to Predicate Devices:
| Use | |||
|---|---|---|---|
| Intended provide filtration in | |||
| a 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 CO2 | |||
| gases | 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 and | |||
| VFE 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.
4
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