(63 days)
Not Found
No
The device description and intended use focus on a mechanical brush for cleaning catheters and collecting samples. There is no mention of AI or ML in the provided text.
Yes
The device is intended to collect and remove obstructing material from a central venous catheter to restore or improve its flow rate, which is a therapeutic intervention.
Yes
The device's intended use explicitly states one of its purposes is "to provide a biofilm or fibrin sample which is suitable for microbiological analysis." Collecting samples for analysis is a diagnostic function.
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 hardware device.
Based on the provided information, the FAS Endoluminal Brush is not primarily an In Vitro Diagnostic (IVD) device.
Here's why:
- Primary Intended Use: The main purpose of the device is to collect and remove obstructing material from a central venous catheter to restore or improve flow. This is a therapeutic or procedural function performed in vivo (within the patient's body).
- Secondary Function: While it can provide a sample for microbiological analysis (which is an in vitro process), this is a secondary function and not the primary reason for using the device. The device itself is not performing the diagnostic test. It's a tool for sample collection.
- Device Description: The description focuses on the physical components and how it's used to access and clean the catheter lumen.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any components that would perform a diagnostic test on the collected sample. The diagnostic analysis happens after the sample is collected, using separate laboratory procedures.
Think of it this way: A swab used to collect a throat culture is not an IVD device itself, even though the collected sample will be used for an in vitro diagnostic test. The swab is a sample collection tool. Similarly, the FAS Endoluminal Brush is a tool for collecting a sample from the catheter lumen.
Therefore, while the device facilitates an in vitro diagnostic process by providing a sample, it is not classified as an IVD device itself based on its primary intended use and function.
N/A
Intended Use / Indications for Use
The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
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 is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to catheter lumens in a sterile environment.
The FAS Endoluminal Brush kit also contains accessory items including a 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
internal lumen surface of an indwelling 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.”
0
OCT 1 5 2001
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
Thomas Kroenke, Senior Consultant phone (303) 956-4232 fax: (419) 858-9171
Manufacturer Name and Address
FAS Medical Limited Unit E4. Brooklands Close Sunbury, Middlesex TW16 7DX United Kingdom
Manufacturer Contact Person
Laura Garcia, COO Phone 44 1932 780333 Fax 44 1932 771488
Common Classification & Proprietary Names
| Common Name: | Central Venous Catheter Biopsy Brush |
|---|---|
| Classification Name: | Intravascular Catheter, Accessory to |
| Proprietary Name: | FAS Endoluminal Brush |
Predicate Devices
| K993613 | FAS Endoluminal Brush |
|---|---|
| K963925 | Thrombolytic Brush Catheter |
| K993816 | Fogarty Adherent Clot Catheter |
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 is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to catheter lumens in a sterile environment.
1
The FAS Endoluminal Brush kit also contains accessory items including a patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.
Indications for Use
The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
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. Additionally, the FAS Endoluminal Brush removes obstructing material from the internal lumen surface of an indwelling central venous catheter and restores or improves catheter flow rate.
The FAS Endoluminal Brush and its predicates are constructed in a similar way, with brush bristles wound around 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 general device safety.
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.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines that appear to be flowing in the same direction.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2001
FAS Medical Limited C/O Mr. Thomas Kroenke Senior Consultant Morningstar Consulting Group, Incorporated P.O. Box 219 Indian Hills, Colorado 80454
Re: K012641
Trade/Device Name: FAS Endoluminal Brush Regulation Number: 880.5970 Regulation Name: Accessory to, Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: August 10, 2001 Received: August 13, 2001
Dear Mr. Kroenke:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
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
3
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouclar states requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Part 807), adolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Susan Ruaves
Erika A. Ulatawski
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): KO 12 6 Y
FAS Endoluminal Brush Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The FAS Endoluminal Brush is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter intornal lamon banded of biofilm or fibrin sample which is suitable for microbiological analysis.
(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
Ann Nemecek for PxC
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 1510(k) Number Kolace
(Optional Format 1-2-96)