The CRS 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 CRS Endoluminal Brush product line is an accessory to central venous catheters. Each single use Endoluminal Brush kit contains 2 pairs of latex free gloves, 1- 70% isopropyl alcohol cleaning agent, 1 fibrin brush in transport bag, 1- 10 cc syringe, 2 patient labels, 1 medical drape, 1 over wrap, and Instructions for Use. The brush consists of nylon bristles wound into a flexible stainless steel wire, which is further wound into a tubular, metal, rigid handle. The Brush is enclosed within a no ratiner would at the distal end and is attached to a standard luer lock at its proximal end. The luer lock fitting complies with catheter manufacturers' requirement that only luer-lock connections be used with catheters. The various CRS Endoluminal Brush products defined by the product codes differ mainly in the length of the flexible wire and the diameter of the Brush bristles.

AI/ML Overview

The provided text describes a 510(k) submission for the "CRS Endoluminal Brush" (K050889), which claims substantial equivalence to the "FAS Endoluminal Brush" (K993614). The core of the submission argues that the new device is "identical" to the predicate device. Therefore, the device's "performance" is implicitly considered to be the same as the predicate, and the "study" is a comparison to the predicate rather than a new clinical trial with specific performance metrics.

Here's an analysis based on the provided documents:

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

The submission does not define explicit "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device's intended function (collecting biofilm or fibrin samples). Instead, the acceptance criterion appears to be the demonstrate substantial equivalence to a predicate device.

The reported device performance, therefore, is its alleged identicality to the predicate device.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Claimed)
Intended Use	Identical to predicate	Same
Instructions for Use	Identical to predicate	Same
Target Population	Identical to predicate	Same
Anatomical Size	Identical to predicate	Same
Area of Use	Identical to predicate	Same
Design	Identical to predicate	Same (Per patent 5,405,755)
Standards Met	Identical to predicate	Same (ANSI/AAMI, Biocompatibility, Non-pyrogenic)
Materials	Identical to predicate	Same (Nylon bristles wound into a stainless steel flexible wire)
Electrical Safety	Identical to predicate	Same (N/A)
Chemical Safety	Identical to predicate	Same (N/A)
Energy Used/Delivered	Identical to predicate	Same (N/A)
Supplied items	Substantially similar to predicate	Different in specific items, but overall functionality not deemed to affect equivalence.
Sterility	Similar method of sterilization and single-use	Provided packaged and sterile, EO (Predicate uses Gamma)

2. Sample size used for the test set and the data provenance

The documents do not describe a specific "test set" or a clinical study conducted with human subjects or a defined sample size for the CRS Endoluminal Brush to evaluate its performance characteristics like sample collection efficacy.

The "testing" mentioned is bench and clinical testing to show the new device is "as safe and effective as the predicate devices," but specific details on sample sizes or data provenance (country of origin, retrospective/prospective) are not provided. The emphasis is on the substantial equivalence argument, which suggests that extensive new primary clinical data might not have been generated for this specific device, assuming its identicality to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no independent test set or clinical study with the CRS Endoluminal Brush is detailed with performance metrics, there is no mention of experts establishing ground truth for such a study. The "ground truth" for this submission would be the regulatory approval of the predicate device.

4. Adjudication method for the test set

Not applicable, as no described test set requiring expert adjudication.

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

Not applicable. This device is a physical medical tool (a brush for collecting samples), not an AI or imaging diagnostic device. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this submission.

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

Not applicable. This device is a physical medical tool and does not involve any algorithms.

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

The "ground truth" for this 510(k) submission is the regulatory clearance of the predicate device (FAS Endoluminal Brush, K993614). The CRS Endoluminal Brush is asserting that it is "identical" to this already cleared device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for a physical device.

Summary

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AUG 26 2005

K050889 page

EXHIBIT 2

510(k) Summary CRS Medical Diagnostics, Inc. 662 Capitol Drive Pewaukee Wisconsin 53072 Tel 262-264-0047 Fax 262-264-0051 August 19, 2005 Contact: Robert S. Brewer, Chairman of the Board

1. Identification of the Device: Proprietary-Trade Name: CRS Endoluminal Brush Catheter, intravascular, therapeutic, long-term greater than 30 Classification Names: days, product code LJS Common/Usual Name: Endoluminal Brush
1. Equivalent legally marketed devices The CRS Endoluminal Brush is IDENTICAL to the FAS Endoluminal Brush, K993614
1. Indications for Use (intended use) The CRS 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
1. Description of the Device: The CRS Endoluminal Brush product line is an accessory to central venous catheters. Each single use Endoluminal Brush kit contains 2 pairs of latex free gloves, 1- 70% isopropyl alcohol cleaning agent, 1 fibrin brush in transport bag, 1- 10 cc syringe, 2 patient labels, 1 medical drape, 1 over wrap, and Instructions for Use. The brush consists of nylon bristles wound into a flexible stainless steel wire, which is further wound into a tubular, metal, rigid handle. The Brush is enclosed within a no ratiner would at the distal end and is attached to a standard luer lock at its proximal end. The luer lock fitting complies with catheter manufacturers' requirement that only luer-lock connections be used with catheters. The various CRS Endoluminal Brush products defined by the product codes differ mainly in the length of the flexible wire and the diameter of the Brush bristles.
1. Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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K050889
page 2 of 2

Characteristic	Predicate FAS Endoluminal Brush K993614	CRS Endoluminal Brush K050889
Intended Use:	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	Same
Instructions for Use:	Provided with illustrations	Same
Target Population:	Patients with indwelling catheters.	Same
Anatomical Size:	Patient catheter	Same
Area of Use:	Hospital	Same
Design:	Per patent 5,405,755	Same
Standards Met:	ANSI/AAMIBiocompatibility;Non-pyrogenic	Same
Materials:	Nylon bristles wound into a stainless steel flexible wire	Same
Supplied items:	Measuring tape, patient drape, instructions for use, wire clippers, specimen container with cap, patient identification label	2 Pair Latex-free GlovesEndoluminal Brush InTransparent SheathCleaning Agent1 10cc Syringe1 Overwrap Drape1 Medical Drape2 Patient Identification LabelsPackage insert
Sterility:	Provided packaged and sterile, GammaSingle Use Only	Provided packaged and sterile, EOSingle Use Only
Electrical Safety:	N/A	N/A
Chemical Safety:	N/A	N/A
Energy Used and/or Delivered:	N/A	N/A

6. Substantial Equivalence Chart, CRS Endoluminal Brush

7. Conclusion

The CRS Endoluminal Brush does not raise any issues of safety or effectiveness compared to the predicate device because it is in fact the predicate device..

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Indications for Use

510(k) Number K050889

Device Name: CRS Endoluminal Brush

Indications For Use:

The CRS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is The CNS Endoluminal Brain is inter lumen surface of an in-dwelling central venous catheter

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR AND/OR AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Page 1 of 1

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the perimeter of the circle.

AUG 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CRS Medical Diagnostics, Incorporated C/O Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K050889

Trade/Device Name: CRS Endoluminal Brush Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular catheter Regulatory Class: II Product Code: LJS Dated: June 22, 2005 Received: June 27, 2005

Dear Mr. Kamm:

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 aga\inst 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 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.

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Page 2 - Mr. Kamm

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); 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.

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Punno
for Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050889

Indications for Use

510(k) Number K050889

Device Name: CRS Endoluminal Brush

Indications For Use:

The CRS 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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Page 1 of 1

Anton Vm

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Ancotheolorsion of Antal Devices

510(k) Number _

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.”