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.

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.

AI/ML Overview

The provided information for K993614, the FAS Endoluminal Brush, does not contain a detailed study proving the device meets specific performance acceptance criteria. The submission states, "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." However, it does not provide the concrete acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific metric for collecting biofilm/fibrin samples), nor does it present the study data, sample sizes, or methods used to establish ground truth.

Therefore, many of the requested details cannot be extracted from the given text.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document	"Actual device performance satisfies the design intent."
Not explicitly stated in the document	"Actual device performance as tested internally and by a third party conforms to the device performance specifications."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document globally refers to "Testing" but does not give specific numbers of cases or samples.
Data Provenance: Not specified. It mentions testing was done "internally and by a third party," but it does not detail the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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 device is a physical medical device (brush for sample collection), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Study: No, this device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed. The performance described relates to the physical characteristics and function of the brush.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not specified. Given the device's function (collecting biofilm or fibrin for microbiological analysis), the ground truth would likely involve laboratory confirmation of successful sample collection and microbiological analysis of those samples. However, the document does not detail how this was established or what metrics were used to define "successful collection" or "suitable for microbiological analysis."

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable in the context of this physical device. This device is not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable for this physical device.

Summary of available information regarding testing:

The 510(k) summary for the FAS Endoluminal Brush focuses on demonstrating substantial equivalence to predicate devices (Digene Cervical Brush, Mill-Rose Microbiology Brush) for its intended use: collecting biofilm or fibrin samples from central venous catheters for microbiological analysis. The review indicates that "Testing was performed according to international standards to assure biocompatibility, sterility assurance, and clinical safety of the device." The conclusion is that "Test results support the conclusion that actual device performance satisfies the design intent" and "conforms to the device performance specifications," based on internal and third-party testing. However, the specific details of these performance specifications, the exact test protocols, the data obtained, and the statistical analysis are not provided in this summary.

Summary

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K993614

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

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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)

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

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.”