(206 days)
Not Found
No
The summary describes a physical filter and tubing kit for infection control, with no mention of software, algorithms, or AI/ML terms.
No
The device is described as a filter kit intended for infection control by filtering airborne particulate matter and certain bacteria. Its purpose is to reduce cross-contamination between patients and equipment, allowing for the reuse of gauges, rather than directly treating or diagnosing a medical condition in a patient.
No
The device is a filter intended for infection control and to allow reuse of equipment by filtering airborne particulate matter and certain bacteria. It does not perform any diagnostic function.
No
The device description clearly states it is a "kit consisting of a hydrophobic bi-directional filter with tubing," which are physical hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to filter airborne particulate matter and certain bacteria to reduce cross-contamination between patients and respiratory therapy equipment. This is a physical filtering function, not a diagnostic test performed on biological samples.
- Device Description: The device is a filter kit with tubing. It physically prevents the passage of particles and bacteria.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to diagnose a disease, condition, or state of health.
- No Mention of Diagnostic Metrics: The document does not include any metrics typically associated with diagnostic tests, such as sensitivity, specificity, PPV, or NPV.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to prevent the spread of contaminants, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipment attachments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the reuse of aneroid gauges and pressure indicators from patient to patient per your institution's protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges.
Product codes
73 CAH
Device Description
The DHD Lichen Product is a kit consisting of a hydrophobic bi-directional filter with tubing that is connected to each side of the hydrophobic bi-directional filter. This assembled filter kit is a single-patient-use device intended for infection control for use with low flow pressure indicators and both inspiratory and expiratory maneuvers with low flow pressure indicators and gauges where the patient exhales at a pressure of less than 120cm H20.
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 home after a period of training.
Prescription Use (Per 21 CFR 801.109)
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
There were no specific studies completed in association with this submission.
Key Metrics
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
SEP 1 1998
510(k) SUMMARY As Required by 807.92(c)
9/11/1998
- DHD Healthcare Submitter: 1. 125 Rasbach Street Canastota, NY 13032
Phone: 315-697-2221 315-697-8083 Fax:
Contact:
Jean Wallace, Manager, Regulatory Affairs
2. Device Name
| • | Trade Name | - | Lichen (Final Name to be determined) |
|---|---|---|---|
| • | Common name | - | Bacterial In-Line Breathing Filter with Tubing |
| (Ambient Air) | |||
| • | Classification name | - | Filter, Bacterial, Breathing-Circuit |
| Predicate Device: | Pulmoguard™ Bacterial and Virus Filter (K934509) | ||
| SDI Diagnostics | |||
| 10 Hampden Drive, Easton, MA 02375 |
Device Description 4.
The DHD Lichen Product is a kit consisting of a hydrophobic bi-directional filter with tubing that is connected to each side of the hydrophobic bi-directional filter. This assembled filter kit is a single-patient-use device intended for infection control for use with low flow pressure indicators and both inspiratory and expiratory maneuvers with low flow pressure indicators and gauges where the patient exhales at a pressure of less than 120cm H20.
Intended Use 5.
The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the re-use of aneroid gauges and pressure indicators from patient to patient per your institution's protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges.
1
Technological Information દ.
The filter bodies of both the Pulmoguard and Lichen are both made of rigid plastic. The Pulmoguard's filter body is made from Polycarbonate Resin. Licher's filter body is a modified acrylic. The filter media's of both the Pulmoguard and Lichen are made of a polyester nonwoven fabric coated with an acrylic syrup. Lichen has flexible tubing made of Kraton G2705 Thermoplastic Elastomer. Pulmoguard has no flexible tubing. All materials used with Lichen meet USP Class VI and exceed biocompatibility requirements.
Both the Pulmoguard and Lichen claim to reduce the risk of cross-contamination between patients and between patients and healthcare providers. Pulmoguard claims to be a bacterial/viral fifter and to stop transmission of 99.8% of bacteria and viruses. Lichen claims to be a bacterial filter with a minimum Bacterial Filtration Efficiency of 99.97%.
7. Summary of Studies
There were no specific studies completed in association with this submission.
Conclusions Drawn from Studies 8. None
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Ms. Jean Wallace DHD Healthcare One Madison Street Wampsville, NY 13163
Re: K980662 Lichen Bacterial In Line Breathing Filter Requlatory Class: II (two) Product Code: 73 CAH Dated: June 15, 1998 Received: June 17, 1998
Dear Ms. Wallace:
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 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). 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 requlatory 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.
3
Page 2 - Ms. Jean Wallace
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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Lichen 510(k) Submission Intended Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name:
Lichen Filter Kit
Indications For Use:
- 1 Purpose/Claims:
The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipment attachments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the reuse of aneroid gauges and pressure indicators from patient to patient per your institution's protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges.
Caution Statement: Follow the recommended cleaning frequency and infection control procedures included in the gauge or pressure indicator's original labeling when used with the Lichen filter. Do not alter your institution's standard infection control procedures for equipment reuse.
2 - Target Patient Population:
Patients requiring the use of low flow pressure indicators and gauges in respiratory therapy as determined by professional medical personnel. The DHD Lichen Filter is recommended for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges.
3 - Intended Environment For Use
- Labeling reflects the statement: "Federal (USA) Law restricts this device to sale by or on the 4.1 order of a physician."
- 4.2 Hospital or home after a period of training.
- 4 Legally Marketed Predicate Devices:
Manufacturer: SDI Diagnostics, Inc.
Shovel Shop Square Building 11 North Easton, MA 02356 510(k) No. K934509
The SDI Diagnostics, Inc., Pulmoguard, is distributed by: Queset Medical Brockton, MA 02403 Phone: 1-800-728-8230
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | ---------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| | Lanh W. Madoo
9-11-98 |
| -- | -------------------------- |
|---|
(Optional Format 1-2-96)