NEOSCI MEDICAL ENDOLUMINAL BRUSH

{0}------------------------------------------------ K\$\phi\$3\$\phi\$4\$\phi\$\$\phi\$ (F. / cf 2) 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 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. {1}------------------------------------------------ \$\kappa \psi 3 \phi 4 \psi \psi (f.2 \text{ or } 3)\$ #### 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) | Device<br>Component | NeoSci Medical EB | FAS Endoluminal<br>Brush | |---------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Distal Tip | Gold-coated tungsten wire<br>wrapped around a central<br>nitinol core | Twisted stainless steel<br>wire loop | | Brush Segment | Nylon bristles wound into<br>twisted stainless steel wires | Same design, with different<br>diameter Nylon bristles | | Proximal Shaft | Nitinol encased in sheath with<br>hydrophilic coating | Twisted stainless steel<br>wire | | Proximal End | Same as proximal shaft | Stainless steel tube<br>bonded to the twisted<br>stainless steel wire, with<br>a loop at the end | | Sterile Sheath | None | Clear polymer with PVC<br>Luer 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K030400 Device Name: NeoSci Medical Endoluminal Brush Indications for 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 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. 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