(379 days)
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.
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.
The provided text describes the 510(k) summary for a Bacterial/Viral HME Filter (BHF 104). It details the device's specifications, indications for use, and a comparison to a legally marketed predicate device (DATEX-OHMEDA HMEF 500) to claim substantial equivalence. The document includes a "Performance Testing" section that lists the types of tests conducted, but it does not provide the acceptance criteria or the detailed results of those tests, nor does it describe specific studies that "prove" the device meets acceptance criteria. It only states that performance was based on these tests which are in the 510(k) application.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists "Specifications" for the new device and performance values for both the new device and the predicate. It does not explicitly state acceptance criteria for each test in the conventional sense (e.g., "must be > X"). However, the specifications and the "Substantial Equivalence" table implicitly serve as performance targets.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate/Specifications) | Reported Device Performance (BHF 104) |
|---|---|---|
| Bacterial Filtration Eff. (BFE) | ≥ 99.999% (Predicate BFE) | 99.9999% |
| Viral Filtration Eff. (VFE) | ≥ 99.98% (Predicate VFE) | 99.999% |
| Dead Space (ml) | Comparable to predicate (30ml) | 53ml |
| HME Output (mg/L H2O at 500ml VT) | Comparable to predicate (30mg H2O/L) | 37.5mg/L H2O at 500ml VT |
| Tidal Volume Range (ml) | Comparable to predicate (120-500ml) | 150-1500ml |
| Flow Rate Resistance | Not explicitly defined as acceptance criteria but listed as a specification | 30lt/min 5mm/H20, 60lt/min 13mm/H20, 90lt/min 28mm/H20 |
| Weight | Comparable to predicate (15g) | 24g |
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. The document only lists the types of performance tests conducted (Bacterial Filtration Efficiency, Viral Filtration Efficiency, Dead Space, Resistance to Flow, Heat and Moisture Exchange, Conical Connectors).
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The performance tests are laboratory-based, not involving human readers or expert evaluation in the traditional sense of image analysis or diagnostic assessment.
4. Adjudication Method for Test Set
This information is not provided in the document. This is not applicable to the listed performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted (or at least not mentioned as part of the 510(k) summary). The device is a filter, and the performance tests are physical/biological measurements, not human-in-the-loop diagnostic studies.
6. Standalone Performance (Algorithm Only)
"Standalone performance" in the context of an algorithm or AI system is not applicable here. The listed performance tests are for the physical device itself.
7. Type of Ground Truth Used
The "ground truth" for the performance tests would be established through laboratory measurements and adherence to specific testing standards for BFE, VFE, dead space, resistance to flow, and HME output. For example, BFE and VFE would involve challenging the filter with a known concentration of bacteria/viruses and measuring the penetration. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical filter, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical filter, not an AI/ML algorithm.
{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/H2060lt/min 13mm/H2090lt/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 OD15mm OD x 22mm ID | 15mm ID x 22mm OD15mm 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
Page 1 of 1
K 102483 510(k) Number: _
§ 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).