FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH

{0}------------------------------------------------ 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 - 2. Equivalent legally marketed devices The CRS Endoluminal Brush is IDENTICAL to the FAS Endoluminal Brush, K993614 - 3. 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 - 4. 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. - 5. 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. {1}------------------------------------------------ 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/AAMI<br>Biocompatibility;<br>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 Gloves<br>Endoluminal Brush In<br>Transparent Sheath<br>Cleaning Agent<br>1 10cc Syringe<br>1 Overwrap Drape<br>1 Medical Drape<br>2 Patient Identification Labels<br>Package insert | | Sterility: | Provided packaged and sterile, Gamma<br>Single Use Only | Provided packaged and sterile, EO<br>Single 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.. {2}------------------------------------------------ ## 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 {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 _