DISPOSABLE TEMPORARY PACING WIRE

{0}------------------------------------------------ # JUN 1 1 2003 ### Summary of Safety and Effectiveness In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed RIVER Medical RIVER-WIRE component device. | Manufacturer: | RIVER Medical, Inc.<br>836 NE 24th Avenue<br>Portland, OR 97232<br>PHONE: (503) 230-1280<br>FAX: (503) 233-1152 | |-------------------|-----------------------------------------------------------------------------------------------------------------| | Contact Person: | Mary Ann Greenawalt, Vice President<br>Legal & Regulatory Affairs | | Device Name: | | | Trade Name: | Disposable Temporary Pacing Wire | | Common Name: | Component to diagnostic or physiological<br>monitoring devices | | Proprietary name: | RIVER Wire™ | | Classification: | Cable, Transducer and Electrode, Patient (including<br>Connector), Cardiovascular, LDF, Class II | | Date Prepared: | September 19, 2002 | Device Description: The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities. The predicate and proposed devices are manufactured in compliance with special controls/performance standards as dictated by 21 CFR 898; 62 FR 25497 26 USP <871> Sutures - Needle Attachment, <881> Tensile Strength - Surgical sutures, <71> Sterility Tests, <861> Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1; Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1. Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6. {1}------------------------------------------------ - Intended Use: The RIVER Medical Temporary Cardiac Pacing Wire is a nonabsorbable surqical cardiac pacer lead with dual needle intended to be used for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is SINGLE USE ONLY. The device is supplied nonsterile on OEM basis only. Indications: The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery. Comparison of Technological Characteristics: The proposed device, the disposable temporary pacing wire, comprises the same or similar material as the predicate device. Manufacture of this device, and QC testing, is in substantial compliance with current 21 CFR 898; 62 FR 2549726 USP <871> Sutures - Needle Attachment, <881> Tensile Strength - Surgical sutures. <71> Sterility Tests. <861> Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1, Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1, Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6. end {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUN 1 1 2003 RIVER Medical, Inc. c/o Ms. Mary Ann Greenawalt Vice President Legal & Regulatory Affairs 836 NE 24th Avenue Portland, OR 97232 Re: K023174 Trade Name: Disposable Temporary Pacing Wire Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode. Regulatory Class: Class II (two) Product Code: LDF Dated: April 28, 2003 Received: May 5, 2003 Dear Ms. Greenawalt: 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. 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 {3}------------------------------------------------ #### Page 2 - Ms. Mary Ann Greenawalt 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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, NoQalettun Bram D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page __ 1 __ of____ 1 __ #### INDICATIONS FOR USE 510(k) (if known): K023174 DEVICE Name: Disposable Temporary Pacing Wire Indications for Use: The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ 510(k) Num Concurrence of CDRH, Office of Device Evaluation (ODE)