KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for HK Surgical. The logo features the letters "HK" in a stylized font, with the word "SURGICAL" underneath. Below that is the website "HKSurgical.com". The address "1271 Puerta del Sol San Clemente, CA 92673" is printed below the website. HK Surgical KleinTouch Pump and Tubing Set 510(k) Notification ## 5. 510(k) Summary | Submitter: | HK Surgical, Inc. | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 1271 Puerta del Sol San Clemente, CA 92673 | | Phone number: | 949-369-0101 | | Fax number: | 949-369-9797, email peter@hksurgical.com | | Contact person: | Pejman Farivar | | Date prepared: | 12/10/2012 | | 510(k) Number: | To be Determined | | Trade name: | KleinTouch Pump (KTP) | | Common name: | Infiltration Pump | | Classification name: | Pump, Infusion | | Classification: | Product Code: FRN,<br>Regulation Number: 880.5725<br>Class II | | Substantial equivalence<br>claimed to: | Klein Infiltration Pump - K031432 | | Description: | Device Functionality:<br><br>The KleinTouch Pump is an electrically or battery operated, manually<br>controlled, peristaltic pump using three rollers to create pumping<br>action in a section of sterile tubing.<br>Scientific Concept(s)<br><br>The KTP is designed to specifically function with sterile single use only<br>Klein Touch Tubing (KT20). Tubing must be primed before use.<br>Please refer to the KT20 Instructions for Use for further details.<br>Physical And Performance Characteristics | | | | | | Device Design Display: Color Graphic LCD Dual Foot Switches With Hose - Air Activated Dimensions: 11" x 10 ¾" x 5" Weight: 8.4 lbs. | | | Components Used Motor Fluid Pathway Materials Silicone Inlet Hospital Power Cord Hospital Grade Plugs Barcode Reader Base, Plastic Battery Instrument Foam PCBA - Power Board PCBA, Main Circuit Board Pump, Peristaltic, 3-Roller, Fixed Clamp Switch, Rocker, Lighted | | | Physical Properties The Pump is intended for use in combination with the KT20 tubing. The peristaltic pump using three rollers will create pumping action in KTP20 tubing set | | | specifically designed for the KleinTouch Pump | | Intended use: | The KleinTouch Pump is an infiltration pump used to cause a flow of<br>fluid from an IV bag into a patient in a manner controlled manually by a<br>health care professional. The KleinTouch pump is not intended to be<br>used as an IV infusion pump. | | Safety and Labeling | WARNINGS AND CAUTIONS<br>The device labeling contains cautions and warnings which are<br>considered essential to the safety of personnel, patients, equipment,<br>and property. | | | This device must be used by a trained professional with current<br>knowledge regarding safety of total dosage. Orders for dosage must<br>be by a physician and legible.<br>Protection against electric shock: Class I, Type B<br>Refer to the Instructions for Use for the Pump and Infusion Set for<br>Warnings and cautions. | | Performance Testing | MET LABS tested per UL Standards 2601-1; 2nd ed. Medical<br>Electrical Equipment- Part 1 General Requirements for Safety<br>• CSA C22.2<br>• UL 60601-1<br>• EN/IEC 60601-1 | | | EMC:<br>• IEC/EN 60601-1-2:2007-ED30<br>• JSA-JIS T0601-1-2:2002<br>• AS/NZ 3200.1.2:2005<br>Biocompatibility Testing demonstrates all fluid path materials are<br>biocompatible in accordance with ISO10993-1.<br>Sterilization Validation to SAL 10-6 in accordance with ISO11135.<br>Human Factors evaluation demonstrates the KleinTouch Pump can be<br>used safely with no critical task errors.<br>Performance testing demonstrates the KleinTouch Pump meets the specifications. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo and contact information for HK Surgical. The logo features the letters 'HK' in a stylized font, with the word 'SURGICAL' written below. The website 'HKSurgical.com' is also listed. The address '1271 Puerta del Sol, San Clemente, CA 92673' is provided, indicating the company's location. ## Substantial Equivalence Conclusion: HK has provided test data to assess the technological differences and demonstrate Subject Device is substantially equivalent to the predicate device (K031432) and at least is safe and effective. | Page 15 of 92 | HK Surgical KleinTouch Pump and Tubing Set 510(k) Notification | Confidential | |---------------|----------------------------------------------------------------|--------------| |---------------|----------------------------------------------------------------|--------------| {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 27, 2013 HK Surgical, Inc. Ms. Clare Bennett General Manager 1271 Puerta del Sol SAN CLEMENTE, CA 92673 Re: K123822 Trade/Device Name: KleinTouch Pump (KTP) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 1, 2013 Received: February 1, 2013 Dear Ms. Bennett: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any Federal statutes and regulations administered by other Federal agencies. You must {3}------------------------------------------------ Page 2 - Ms. Clare Bennett comply with all the Act 's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. · Sincerely yours. Mary S. Runner -S Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation -Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for HK Surgical. The logo features the text "HK SURGICAL" in a bold, sans-serif font, with "HKSurgical.com" written below it. The address "1271 Puerta del Sol, San Clemente, CA 92673" is printed below the website address. The logo is simple and professional, and it is likely used to identify the company on its products and marketing materials. K123822 HK Surgical KleinTouch Pump and Tubing Set 510(k) Notification ## 4. Indications for Use Statement The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch pump is not intended to be used as an IV infusion pump. . . Prescription Use (21 CFR 807 Subpart C) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS UNE - CONTINUE ON ANOTHER PAGE IF NEEDED) Cancurrence of CDRH, Office of Dovice Evaluation (ODE) Image /page/4/Picture/10 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is composed of the letters "FDA" in a stylized font. The letters are made up of small, geometric shapes, giving the logo a textured appearance. The logo is black and white. Richard C. Chapman 2013.09.27 15:31:41 -04'00'