(379 days)
Not Found
No
The description focuses on the physical characteristics and filtration performance of a disposable filter, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or manages a disease or condition. This device is a filter used during ventilator delivery to reduce cross-contamination and provide humidification, which are supportive functions, not therapeutic treatments.
No
The device is described as a "disposable single-use filter" for humidification and filtration during ventilation. Its purpose is to prevent cross-contamination and humidify gases, not to diagnose any medical condition.
No
The device description clearly outlines a physical, disposable filter made of plastic resin with specific dimensions and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to humidify ventilator gases and provide filtration for reducing cross-contamination between the patient and equipment. This is a function related to the delivery of gases to a patient, not the examination of specimens derived from the human body.
- Device Description: The description details a physical filter and its components, designed to interact with gases in a respiratory circuit. It does not describe any components or processes for analyzing biological samples.
- Performance Studies: The performance studies focus on filtration efficiency (bacterial and viral), dead space, resistance to flow, and heat and moisture exchange. These are all related to the physical function of filtering and conditioning gases, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the BHF 104 is a respiratory accessory designed to improve the delivery of ventilator gases and prevent contamination, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible crosscontamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.
Product codes
CAH
Device Description
The BHF 104 filter is a single-use, barrier type filter, fabricated from a plastic resin, and delivered to the customer in a sealed, non-sterile package. The translucent housing has aligned connector ports (15mm ID x 22mm OD, 22mm ID x 15mm OD), a perpendicular filter media, and a gas sampler luer port, protruding at 45 degrees from the base of the filter housing. The entire filter is 90mm (3.54 inches) in length, with a maximum cross section diameter of 55mm (2.16 inches), and a mass of 24g (.85 ounces). The surface area is 26.4cm2.
The BHF 104 has 15mm ID x 22mm OD and 22mm ID x 15mm OD male and female connectors, which allows compatibility with various compressors, ventilators, masks, and aerosol tubes.
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, ICU, anesthesia, and respiratory therapy.
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)
Performance was based on the following tests, which are contained in the body of the 510(k) application:
- . Bacterial Filtration Efficiency (BFE)
- Viral Filtration Efficiency (VFE)
- Dead Space
- I Resistance to Flow
- Heat and Moisture Exchange (HME) l
- . Conical Connectors
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Tidal Volume: | 150-1500ml |
|---|---|
| Flow rate resistance: | 30lt/min 5mm/H20 |
| 60lt/min 13mm/H20 | |
| 90lt/min 28mm/H20 | |
| Bacterial filtration: | >99.9999% |
| Viral filtration: | 99.999% |
| Dead Space: | 53ml |
| HME Output per ISO 9360: | 37.5mg/L H2O at 500ml VT |
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
ال
510(k) Summary for the Bacterial/Viral HME Filter (BHF 104)
Name and Address of Sponsor
Sunset Healthcare Solutions, Inc 2201 S. Halsted St. Suite 1344 Chicago, IL 60608
Name and Address of Manufacturer
Altera Tibbi Malzeme San Ve Tic As. Turan Mah Tire Organize Sanayi Bolgesi. Tire/Izmir Aegean Region, 35900 Turkey Phone: 90-232-2375949
Establishment Registration Number
3006534321
Name and Address of Official Correspondent
Regulatory Insight, Inc. 5401 S. Cottonwood Ct. . Greenwood Village, Colorado 80121 Contact: Mr. Kevin Walls, RAC Tel: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Date Summary was Prepared
December 17, 2010
Device Name
Trade Name: Bacterial/Viral HME Filter (BHF 104) Common Name: Disposable Heat and Moisture Exchanger and Bacteria/Viral Filter Classification Name: Breathing circuit bacterial filter
Classification, Panel and Product Code
Class 2, Anesthesiology, Regulation Number: 868.5260 Product Code: CAH
1
Indications for Use
The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible crosscontamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.
Legally Marketed Device to Which Substantial Equivalence is Claimed
DATEX-OHMEDA HMEF 500 (K021265)
Device Description
The BHF 104 filter is a single-use, barrier type filter, fabricated from a plastic resin, and delivered to the customer in a sealed, non-sterile package. The translucent housing has aligned connector ports (15mm ID x 22mm OD, 22mm ID x 15mm OD), a perpendicular filter media, and a gas sampler luer port, protruding at 45 degrees from the base of the filter housing. The entire filter is 90mm (3.54 inches) in length, with a maximum cross section diameter of 55mm (2.16 inches), and a mass of 24g (.85 ounces). The surface area is 26.4cm2.
The BHF 104 has 15mm ID x 22mm OD and 22mm ID x 15mm OD male and female connectors, which allows compatibility with various compressors, ventilators, masks, and aerosol tubes.
Specifications
| Tidal Volume: | 150-1500ml |
|---|---|
| Flow rate resistance: | 30lt/min 5mm/H20 |
| 60lt/min 13mm/H20 | |
| 90lt/min 28mm/H20 | |
| Bacterial filtration: | >99.9999% |
| Viral filtration: | 99.999% |
| Dead Space: | 53ml |
| HME Output per ISO 9360: | 37.5mg/L H2O at 500ml VT |
Performance Testing
Performance was based on the following tests, which are contained in the body of the 510(k) application:
- . Bacterial Filtration Efficiency (BFE)
- Viral Filtration Efficiency (VFE)
- Dead Space 트
- I Resistance to Flow
- Heat and Moisture Exchange (HME) l
- . Conical Connectors
2
Substantial Equivalence
| DATEX-OHMEDA HMEF 500 | Bacterial/Viral HME Filter (BHF 104) | |
|---|---|---|
| 510(k) # | K021265 | N/A |
| Indications for use | The HMEF500 is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only. | The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross-contamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy. |
| Diameter | 45mm | 55mm |
| Length | 74mm | 90mm |
| BFE | 99.999% | 99.9999% |
| VFE | 99.98% | 99.999% |
| Housing Material | PP Polypropylene | K-Resin KR03 - Styrene Butadiene Block Copolymer |
| Filter Material | PP and Acrylic Fibers | 3M Filtrete Air Media Filter - Type G |
| Fittings | 15mm ID x 22mm OD | |
| 15mm OD x 22mm ID | 15mm ID x 22mm OD | |
| 15mm OD x 22mm ID | ||
| Moisture Output | 30mg H2O/L @ 500ml VT | 37.5 mg H2O/L @ 500ml VT |
| Tidal Volume Range | 120-500 | 150-1500 |
| Dead Space | 30ml | 53ml |
| Weight | 15g | 24g |
| Sampling Port | Luer lock | Luer lock |
None of the differences listed in the table above have any affect on safety or effectiveness.
. .
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sunset Healthcare Solutions. LLC C/O Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Incorporated 5401 S. Cottonwood Court Greenwood Village, Colorado 80121
SEP 13 2011
Re: K102483
Trade/Device Name: Sunset Healthcare Solutions Bacterial/Viral HME Filter (BHF 104) Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: August 19, 2011 Received: August 22, 2011
Dear Mr. Walls:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Mr. Walls
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
hr for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K102483
Device Name: Sunset Healthcare Solutions Bacterial/Viral HME Filter (BHF 104)
Indications for Use: The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross-contamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schutter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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K 102483 510(k) Number: _