(111 days)
Not Found
No
The device description and performance metrics focus solely on the physical filtration properties of the device, with no mention of AI or ML technologies.
No.
The device is a filter for ventilators and anesthesia machines, not a direct therapeutic device for a patient's medical condition. It supports the function of therapeutic devices by filtering gases.
No
Explanation: The device is a filter designed for gas filtration in respiratory circuits, not for diagnosing medical conditions. Its function is to prevent the spread of bacteria and viruses, which is a therapeutic/preventative function, not diagnostic.
No
The device description clearly describes a physical filter with connectors and electrostatic media, indicating it is a 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 for filtering inspired and/or expired gases in respiratory circuits. This is a mechanical function related to patient breathing, not the analysis of biological samples to diagnose a condition.
- Device Description: The description focuses on the physical characteristics, filtration mechanism (electrostatic capture), and performance metrics related to filtration efficiency (bacterial, viral, HEPA). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts with gases, not biological samples for diagnostic purposes.
- Predicate Devices: The predicate devices listed are also respiratory filters, not IVD devices.
Therefore, this device falls under the category of a respiratory accessory or filter, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml.
May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.
Product codes
CAH
Device Description
The Bact-Trap™ HEPA Midi filter incorporates standard 15 / 22 mm connectors with a gas sampling luer port. It utilizes an electrostatic media for the filtration function. The "HEPA" performance was tested in accordance to DOE 3020-97 and ASTM D2986 - 95a DOP at 30 Ipm.
The filter functions by electrostatic capture.
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
Home, Hospital, Sub-acute Institutions, Emergency services
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.)
Bacterial filtration - BFE - Nelson Lab. 99.9999%
Viral filtration - VFE - Nelson Lab. 99.9999%
HEPA Filtration >99.97%
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
FEB 2 2 2010
510(k) Summary Page 1 of 2 11-Feb-10
| Pharma Systems AB | Tel - 011 46 18 34 95 00 | |
|---|---|---|
| Rubanksgatan 9 | Fax - 011 46 18 34 95 30 | |
| S741 71 Knivsta Sweden | ||
| Official Contact: | Viljar Salumaa, Product Manager | |
| Proprietary or Trade Name: | Bact-Trap™ HEPA Midi | |
| Common/Usual Name: | Bacterial / Viral Filter | |
| Classification Name: | Filter, Bacterial, Breathing Circuit, | |
| CAH - 21 CFR 868.5260 | ||
| Predicate Devices: | ARC Medical - FilterFlo™ HEPA – K063125 | |
| Air Safety - Model 6500/01 - K033008 |
Device Description
The Bact-Trap™ HEPA Midi filter incorporates standard 15 / 22 mm connectors with a gas sampling luer port. It utilizes an electrostatic media for the filtration function. The "HEPA" performance was tested in accordance to DOE 3020-97 and ASTM D2986 - 95a DOP at 30 Ipm.
The filter functions by electrostatic capture.
Indications for Use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is intended for patients with Tidal Volumes > 150 ml.
May be positioned at the machine end of the expiratory limb of the circuit, or at the patient end of the circuit.
Environment of Use
Home, Hospital, Sub-acute Institutions, Emergency services
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1
510(k) Summary Page 2 of 2 11-Feb-10
General Technical Characteristics
| Attribute | Proposed devices |
|---|---|
| Indications for use - To filter inspired and / or | |
| expired gases. | Yes |
| Intended for single patient use | Yes |
| Prescription | Yes |
| Intended population | > 150 ml tidal volume |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 46 ml for straight, 48 ml for angled |
| Resistance to flow | 99.97% |
| Weight (gm) | 32 gm |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Electrostatic |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| DOE 3020-97 and ASTM D2986 - 95a DOP | Yes |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
2
Image /page/2/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 on the right side, which is composed of three curved lines. To the left of the caduceus is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
FEB 2 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Pharma Systems AB C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K093426
Trade/Device Name: Bact-Trap™ HEPA Midi Regulation Number: 21CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Regulatory Class: II Product Code: CAH Dated: February 11, 2010 Received: February 16, 2010
Dear Mr. Dryden:
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.
3
Page 2- Mr. Dryden
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Critthon V. Nim
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
4
Indications for Use Statement
Page 1 of 1
510(k) Number: K093426 (To be assigned)
Device Name: Bact-Trap™ HEPA Midi
Indications for Use:
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml.
May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.
| Prescription Use XX | or | Over-the-counter use _ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arbuthno
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
11093426 510(k) Number: