PREPARE CARTRIDGE

{0}------------------------------------------------ K023890 、 # 510(k) SUMMARY | Date: | November 19, 2002<br>FEB 07 2003 | |-------------------------|------------------------------------------------------------------------------------------------| | Manufacturing Facility: | APPRO Healthcare, Inc.<br>847 Main Street<br>Buffalo, NY 14203 | | Telephone: | (716) 855-1068 | | Contact Person: | John R. Semler<br>Vice President, RD&E<br>Extension 309<br>Email: jrsemler@approhealthcare.com | | Device Trade Name: | Prepare™ Cartridge | | Device Common Name: | Accessory to an Infusion Pump | | Classification Name: | Accessories, Pump, Infusion | | Regulatory Reference: | MRZ | | Predicate Device | CADD® 1 Medication Cassette Reservoir | Registered trademark of SIMS Deltec, Inc. l {1}------------------------------------------------ ## Description: Prepare™ Cartridge is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides a reservoir for holding up to 100ml of prepared drug and interfaces with various models of SIMS Deltec infusion pumps to provide a pathway from the reservoir to the patient's access site. ## Intended Use / Indications for Use: Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets. For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare. #### Physical/Technical Comparison Prepare™ Cartridge can be used in place of Medication Cassette Reservoir. Physical and technical characteristics, including materials used in construction, size, intended use, and ability to interface with specified CADD® pumps are comparable. #### Performance Summary: The device and the predicate were subjected to various bench tests to demonstrate comparable performance characteristics. Prepare™ Cartridge capacity, accuracy of delivery, volume delivered per pump cycle, and fit to pump are substantially equivalent to the CADD® Administration Set. #### Biocompatibility Testing: Prepare™ Cartridge was subjected to biocompatibility testing as recommended by ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The device is certified as non-irritating, non-cytotoxic, non-toxic, non-hemolytic, and nonsensitizing. #### Sterilitv: Prepare™ Cartridge is sterilized by ethylene oxide gas in a validated sterilization process. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 0 7 2003 Mr. John R. Semler Vice President, RD & E APPRO Healthcare Incorporated 847 Main Street Buffalo, New York 14203 Re: K023890 Trade/Device Name: Prepare™ Cartridge Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: November 19, 2002 Received: November 21, 2002 Dear Mr. Semler: 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. Semler 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 (OS) 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 (301) 594-4618. 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, Susan Russer Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ | 510(k) Number, if known: | Not yet assigned M023890 | |--------------------------|---------------------------------| | Device Name: | Prepare ^TM Cartridge | Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets. For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare. Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | / | |------------------|---| |------------------|---| OR Over-the-Counter Use (Per 21CFR 801,109) Patina Cucente (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number: _