The NeoSci Medical Endoluminal Brush is intended to collect a sample, which is suitable for microbiological analysis, from the inner lumen surface of an indwelling central venous catheter. The proximal nitinol shaft is encased in a polytetrafluoroethylene sheath with a hydrophilic coating applied to reduce friction.

The device is contraindicated for patients with known, or suspected, allergies to nitinol, PTFE Teflon®, Nylon, stainless steel, gold, or hydrophilic coatings.

Device Description

The NeoSci Medical (NSM) Endoluminal Brush (EB) is a device similar to a very small diameter bottlebrush that can be inserted into the lumen of partially obstructed central venous catheters to collect a sample. The distal end of the device consists of a flexible tip equivalent to that of a floppy guide wire tip. Immediately proximal to the flexible tip is a segment of bristles wound into flexible. twisted (braided) stainless steel wires. The outer diameter of the bristle is selected by the user. Instructions for use recommend that the EB size be 1.2 to 2.0 times the inner diameter of the lumen to be sampled. The stainless steel wires are bonded to a nitinol shaft that extends to the proximal end of the device. The proximal nitinol shaft is encased in a polvtetrafluoroethylene sheath with a hydrophhilic coating applied to reduce friction.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Tensile Strength	Suitable for intended use	Suitable
Torque Strength	Suitable for intended use	Suitable
Torqueability	Suitable for intended use	Suitable
Tip Flexibility	Suitable for intended use	Suitable
Coating Adherence / Integrity	Suitable for intended use	Suitable
Catheter Compatibility	Suitable for intended use	Suitable
Biocompatibility	Suitable for intended use	Suitable
Fracture and Flex Resistance	Suitable for intended use	Suitable
Effectiveness of Sampling (Microbiological)	Suitable for intended use	Effectively collects a sample suitable for microbiological analysis.
Compliance with ISO 11070	Meets relevant requirements	Meets relevant requirements
Substantial Equivalence to Predicate	Equivalent to predicate device in safety and efficacy	Substantially equivalent
No New Safety/Efficacy Issues	No new issues raised	No new issues raised

Note: The document states that "Results indicate that NSM EB Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence / Integrity, Catheter Compatibility, Biocompatibility, Fracture and Flex Resistance, and Effectiveness of Sampling are suitable for the EB's intended use." The acceptance criteria are therefore implicitly "suitable for its intended use" for each of these performance aspects.

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

The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data is summarized in a general statement without detailing the specific studies or cohort sizes.

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

The document does not mention the use of experts to establish ground truth for any test set, nor does it specify the number or qualifications of any such experts. The evaluation appears to be based on engineering and performance testing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. This type of methodology is not typically mentioned in a 510(k) summary for this kind of device, which focuses on physical and material performance rather than diagnostic accuracy or human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done or is not mentioned in this document. This type of study is more common for diagnostic imaging or interpretation devices where human readers are involved in assessing output with and without AI assistance. This device is a mechanical sampling tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a physical, mechanical sampling tool, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed/mentioned. The "effectiveness of sampling" would be evaluated in terms of its ability to physically collect a sample suitable for downstream microbiological analysis, which is an inherent function of the device itself rather than an AI algorithm.

7. Type of Ground Truth Used

Based on the nature of the device and the tests mentioned:

Engineering/Physical Testing: For metrics like Tensile Strength, Torque Strength, Tip Flexibility, etc., the "ground truth" would be established by objective measurements against defined engineering specifications or industry standards (e.g., ISO 11070).
Effectiveness of Sampling: For "Effectiveness of Sampling," the ground truth would likely be established by microbiological analysis of the samples collected by the brush, demonstrating that the collected material is indeed suitable for such analysis (e.g., sufficient quantity, viable microbes if present).

8. Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical medical instrument, not a machine learning algorithm that requires a training set.

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

As there is no training set, this question is not applicable.

Summary

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DEC 22 2004

510(K) Summary Preparation Date: August 28, 2003

1.0 Submitter Name and Address Matt Longson, VP Product Development NeoSci Medical Inc. 1192 E. Draper Parkway Suite #442 Draper, Utah 84020

2.0 Contact Person/ Prepared By Phil Triolo, PhD Phil Triolo and Associates LC 148 S. 1200 E. Salt Lake City, UT 84102-1643 801.328.1996 phone / 801.328.2399 fax philt@philt.com

3.0 Device Identification Trade Name Common Name
Endoluminal Brush Endoluminal Brush Central Venous Catheter Biopsy Brush Intravascular Catheter Accessory

Classification Name

4.0 Predicate Device(s) Predicate Device Manufacturer / Name FAS Endoluminal Brush

Digene Cervical Brush Guidant Hi-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating AngioDynamics Continuous Flush Catheter of its Pulse Spray Infusion System

Galt Medical Guide Wire

5.0 Device Description

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6.0 Intended Use

The NeoSci Medical Endoluminal brush is intended to collect a sample, which is suitable for microbiological analysis, from the inner lumen surface of an indwelling central venous catheter.

The device is contraindicated for patients with known, or suspected allergies to nitinol, PTFE Teflon®, Nylon, stainless steel, gold or hydrophilic coatings.

7.0 Summary of Technological Characteristics in relation to Predicate Device(s)

DeviceComponent	NeoSci Medical EB	FAS EndoluminalBrush
Distal Tip	Gold-coated tungsten wirewrapped around a centralnitinol core	Twisted stainless steelwire loop
Brush Segment	Nylon bristles wound intotwisted stainless steel wires	Same design, with differentdiameter Nylon bristles
Proximal Shaft	Nitinol encased in sheath withhydrophilic coating	Twisted stainless steelwire
Proximal End	Same as proximal shaft	Stainless steel tubebonded to the twistedstainless steel wire, witha loop at the end
Sterile Sheath	None	Clear polymer with PVCLuer lock hubs

Assessment of Performance Data used to justify Substantial Equivalence Claim 8.0 Results indicate that NSM EB Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence / Integrity, Catheter Compatibility, Biocompatibility, Fracture and Flex Resistance, and Effectiveness of Sampling are suitable for the EB's intended use. Tests were carried out according to protocols based on those identified in ISO 11070, where applicable.

9.0 Conclusion

Performance and safety of the NSM EB meets the relevant requirements for guide wires identified in ISO 11070, and / or are substantially equivalent to the safety and efficacy of the predicate endoluminal brush, and no new issues of safety and efficacy are raised by use of the NSM EB.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2004

Mr. Matt Longson Vice President Research and Development NeoSci Medical, Incorporated 1192 E. Draper Parkway Draper, Utah 84020

Re: K030400

Trade/Device Name: NeoSci Medical Endoluminal Brush Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 8, 2004 Received: December 9, 2004

Dear Mr. Longson:

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 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. Triolo

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 your device to proceed to the market.

If vou 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/dsma/dsmamain.html

Sincerely yours,

Anthony D. Aster for

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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Indications for Use

510(k) Number (if known): K030400

Device Name: NeoSci Medical Endoluminal Brush

Indications for Use:

The device is contraindicated for patients with known, or suspected, allergies to nitinol, PTFE Teflon®, Nylon, stainless steel, gold, or hydrophilic coatings.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D, hme

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: JCD) 4449

Page 1 of _ 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.”