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.

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.

AI/ML Overview

The provided text describes the 510(k) submission for the FAS Endoluminal Brush. However, it does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device's performance against those criteria in a quantitative manner.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated: The document does not provide a table or clear bullet points outlining specific, measurable acceptance criteria for the device's main functions (collecting and removing obstructing material, providing a biosample suitable for microbiological analysis).	"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."
Implied Criteria: - Biocompatibility - Sterility Assurance - General Device Safety	"Testing was performed according to international standards to assure biocompatibility, sterility assurance, and general device safety."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "Testing was performed" but does not give any numbers for samples or cases.
Data Provenance: Not specified. It mentions "tested internally and by a third party," but no geographical origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, this is not an AI/imaging device. The FAS Endoluminal Brush is a physical medical device. Therefore, an MRMC study is not applicable.
Effect Size of AI Improvement: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Study: Not applicable, as this is a physical medical device and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not explicitly stated. The "design intent" and "device performance specifications" are mentioned, suggesting that performance was evaluated against these internal benchmarks, but the specific nature of the "ground truth" (e.g., specific measurements of flow rate improvement, microbiological culture results, etc.) is missing.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical device, not an algorithm that requires a training set in the machine learning sense.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable.

Summary of Device and Study Information from the Text:

The FAS Endoluminal Brush is a single-use, sterile disposable device composed of nylon bristles wound into a stainless steel wire and handle. It's used to:

Collect and remove obstructing material from indwelling central venous catheters to restore or improve flow rate.
Provide a biofilm or fibrin sample suitable for microbiological analysis.

The document indicates that "Testing was performed according to international standards to assure biocompatibility, sterility assurance, and general device safety." It concludes that "Test results support the conclusion that actual device performance satisfies the design intent" and "conforms to the device performance specifications."

Conclusion:

The provided 510(k) summary for the FAS Endoluminal Brush is very high-level regarding performance testing. It asserts that testing was done and met specifications, but it lacks the specific quantitative details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment that would typically be found in a detailed study report. This kind of summary focuses on demonstrating substantial equivalence to predicates rather than providing exhaustive performance data for novel devices, which would be typical for a 510(k) submission for a Class II device of this nature.

Summary

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K012641

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

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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

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.

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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

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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)

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)

Regulation Number and Section

§ 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.”