(85 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or any related computational techniques.
No.
The device is intended to collect a sample for microbiological analysis, not to treat, mitigate, or cure a disease or condition. Its purpose is diagnostic, not therapeutic.
No
The device is intended to collect a sample for microbiological analysis, not to perform the analysis itself. It is a sample collection tool, not a diagnostic device.
No
The device description clearly outlines physical components such as nylon bristles, stainless steel wire and handle, a plastic sheath, and accessory items, indicating it is a physical medical device, not software-only.
Based on the provided information, the FAS Endoluminal Brush is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to collect a sample (biofilm or fibrin) from the inner lumen surface of a catheter. The sample is then suitable for microbiological analysis, but the device itself is not performing the analysis.
- Device Description: The device is a brush designed for physical sample collection. It does not contain reagents, assays, or components that would be used to perform a diagnostic test on the sample.
- Lack of Diagnostic Function: The device's function is limited to obtaining the sample. The diagnostic process (microbiological analysis) happens after the sample is collected using this device.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The FAS Endoluminal Brush is a tool for sample collection, which is a step prior to the diagnostic process.
N/A
Intended Use / Indications for Use
The FAS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter.
Product codes
LJS
Device Description
The FAS Endoluminal Brush is a single use, sterile disposable medical device. The device itself consists of nylon bristles wound into a stainless steel flexible wire, which is further wound into a stainless steel tubular handle. The brush is enclosed in a plastic sterile sheath that is heat sealed at the proximal end and is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to the catheter lumen in a sterile environment.
The FAS Endoluminal Brush kit also contains accessory items including a measuring tape, patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inner lumen surface of an in-dwelling central venous catheter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing was performed according to international standards to assure biocompatibility, sterility assurance, and clinical safety of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
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510(k) Summary FAS Endoluminal Brush
Submitter (Consultant) Name and Address
Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454
Submitter (Consultant) Contact Person
Lynne Aronson, Senior Consultant (303) 697-8198 phone: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: (303) 697-7907
Manufacturer Name and Address
FAS Medical Limited Unit E4. Brooklands Close Sunbury-on-Thames. Middlesex TW16 7DX England
Manufacturer Contact Person
Laura Garcia, COO 011 44 1932 780333 phone: 011 44 1932 771488 fax:
Common, Classification & Proprietary Names
Common Name: Central Venous Catheter Biopsy Brush Intravascular Catheter Classification Name: Proprietary Name: FAS Endoluminal Brush
Predicate Devices
Digene Cervical Brush (K971586) Mill-Rose Microbiology Brush (K960880)
Device Description
The FAS Endoluminal Brush is a single use, sterile disposable medical device. The device itself consists of nylon bristles wound into a stainless steel flexible wire, which is further wound into a stainless steel tubular handle. The brush is enclosed in a plastic sterile sheath that is heat sealed at the proximal end and is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to the catheter lumen in a sterile environment.
The FAS Endoluminal Brush kit also contains accessory items including a measuring tape, patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.
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Indications for Use
The FAS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter.
Technological Characteristics Comparison
The FAS Endoluminal brush is an accessory to a central venous catheter. The purpose of the FAS Endoluminal Brush is to collect a biosample for subsequent microbiological analysis in much the same way as intended for a cytology brush and a microbiology brush, both described as predicates. The FAS Endoluminal Brush and its predicates are constructed in a similar way, with brush bristles wound the distal end of a flexible or rigid stainless steel wire.
Test Discussion
Testing was performed according to international standards to assure biocompatibility, sterility assurance, and clinical safety of the device.
Test Conclusions
Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the device performance specifications.
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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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them that could represent water or movement. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Ms. Lynne Aronson Senior Consultant Morningstar Consulting Group, Inc. Requlatory & QA Consultants to the Medical Device Industry PO Box 219 Indian Hills, Colorado 80454
K993614 Re : Fas Endoluminal Brush Trade Name: Requlatory Class: Unclassified Product Code: LJS October 19, 1999 Dated: Received: October 25, 1999
Dear Ms. Aronson:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
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Page 2 - Ms. Aronson
obligation you might have under sections 531 through 542 of obligation you magas under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in your in your device 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) 594-4692. 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 premation 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.pov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K993614 |
|---|---|
| --------------------------- | --------- |
FAS Endoluminal Brush Device Name:
Indications for Use:
The FAS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter.
(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_
(Optional Format 1-2-96)
Patrizia Crescenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _
G-1