ConceptoMed Luer-Jack Slip 10ml

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 11, 2017 ConceptoMed AS Marit Martinsen OA Manager Hattvikveien 2 Ballstad, N-8373 NORWAY Re: K162057 Trade/Device Name: ConceptoMed Luer-Jack Slip 10ml Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 8, 2016 Received: October 14, 2016 Dear Marit Martinsen: 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. {1}------------------------------------------------ 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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang" written in a simple, sans-serif font. Below the name, there is a small "-s". The signature is a complex, looping design with several curves and overlaps, positioned to the left of the name. Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K162057 Device Name ConceptoMed Luer-Jack Slip 10ml ## Indications for Use (Describe) Indications and Intended Use: The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer slip connectors. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) EF PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ConceptoMed. The logo consists of a blue abstract shape on the left, resembling a stylized water droplet or leaf. To the right of the shape is the company name, "ConceptoMed", written in a blue sans-serif font. ## 510(k) SUMMARY ## Summary of Safety and Effectiveness For Luer-Jack Slip In accordance with 21 CFR 807.92, the following information constitutes the ConceptoMed AS summary for the Luer-Jack Slip 10ml. | SUBMITTER'S NAME: | ConceptoMed AS | | | |---------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | ADDRESS: | Hattvikveien 2<br>8373 Ballstad<br>Norway | | | | CONTACT PERSON: | Marit Martinsen, Director QA & Regulatory,<br>ConceptoMed AS | | | | TELEPHONE NUMBER: | +47 905 14 690 | | | | E-MAIL | | marit.martinsen@conceptomed.no | | | DATE OF SUBMISSION: | | January 4, 2017 | | | 1. | Subject Device | Trade Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | ConceptoMed Luer-Jack Slip 10ml<br>Luer-Jack Slip 10ml<br>21 CFR §880.5860<br>Piston syringe<br>II<br>FMF<br>General Hospital | | 2. | Predicate<br>Device | Trade Name: | BD Single use, Hypodermic Syringe | | | | 510(k) Reference:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | K110771<br>BD Single use, Hypodermic Syringe<br>21 CFR §880.5860<br>Piston syringe<br>II<br>FMF<br>General Hospital | #### 3. Description of the Device The Luer-Jack Slip 10ml is a five-piece, single use syringe without needle, with a 6% (Luer) male slip connector. The device includes a three-piece syringe with a plastic barrel with graduated scale, a stopper and a plastic plunger rod. Upon the barrel is a single-handed needle hub release system in two pieces. The Luer-Jack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. {4}------------------------------------------------ ## ConceptoMed For disconnection the hub release system mounted upon the barrel is used. The Luer-Jack will be delivered sterilized by irradiation) in a hard blister pack (the Steri-Tilt™). #### Indications for use 4. The ConceptoMed AS Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer slip connectors. #### 5. Technological characteristics, comparison to predicate device. The subject is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The subject is intended to be used only in combination with female 6% Luer slip connectors. The Device is claimed to be Substantially Equivalent (SE) to the device BD Single Use, Hypodermic Syringe, manufactured by Becton, Dickinson and Company (Predicate Device). The syringe used in the Luer-Jack is manufactured under the same conditions as the predicate device (K110771) apart from packaging and sterilization as the syringe is delivered in bulk to ConceptoMed. Based on the intended use, the Luer-Jack Slip 10 ml is considered Substantially Equivalent to the predicate device, given that: - a) The Luer-Jack Slip 10 ml has the same similar intended use as the predicate device, the only minor difference is the addition of the Luer-Jack component designed to aid the clinician with one-handed removal. - b) The Luer-Jack Slip 10 ml barrel and plunger rod (including rubber piston) use the identical design and identical materials as the predicate device. - c) The Luer-Jack Slip 10 ml and the predicate device meet the requirements for manual use as defined by ISO 7886-1. - d) The Luer-Jack Slip 10 ml and the predicate device component materials comply with ISO 10993-1 as applicable to the intended use of the device. - e) The Luer-Jack Slip 10 ml and the predicate device are sterilized to an SAL of 10° via an E-Beam irradiation process. But differs when it comes to: - be of similar design; । The Luer-Jack Slip 10 ml has an integrated hub release system. - be of similar material; i The Luer-Jack Slip 10ml integrated hub release system is manufactured from biocompatible MABS-polymer. - । have similar principles of operation The subject and the predicate device are both operated as general syringes. The subject may be disconnected from female hubs with a traditional two-handed operation. However, the integrated hub release system may also be used for a one-handed disconnection. {5}------------------------------------------------ # ConceptoMed #### Summary of performance testing. 6. Design Verification tests were performed based on the risk analysis. The results of these tests demonstrate that the Luer-Jack Slip 10ml performed in an equivalent manner to the predicate device and is safe and effective when used as intended. Design Verification testing included the following performance testing with "PASS" on all criteria: | Performance Characteristic | Acceptance Criteria | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System use | | | Sterilization | Valid sterilization documentation | | Manufacturing and assembly in cleanroom | Cleanroom for ISO-class 8 | | Safety functions | | | Connector compatibility | 1. Designed for Luer connections<br>2. Designed with connectors with 6% female Luer fittings | | Catch mechanism | Functional catch mechanism | | Usability | | | One-hand handling and usability of blister | A Use of gloves during handling<br>B Use in combination with a PVC | | Regulatory | | | Standard for syringes | Conformance to EN ISO 7886-1:1993 | | Biocompatibility | Conformance to EN ISO 10993-1:2009/AC:2010 | | Packaging safe for sterilization | 1) Existence of Packaging and labelling<br>specification. Compliance with Packforsk Std-40-101<br>2001 Transport tests (including air transportation)<br>2) Packaging material intended for irradiation<br>sterilization | | Lifetime and reliability | | | Shelf life | Shelf life of 4 years | | Mechanical requirements | | | Drop test | No damage of the packages, and<br>full functionality of device | | Press fit test | Withstand a pulling force of 20 N | | Mechanical strength | a) Full function of the Lever after 15 full cycles<br>b) A mechanical report shall conclude sufficient<br>mechanical strength | | No interference when connected | Functionality after 70N push force | | Surface contact | Ability to use with a PVC | | Functionality | | | Transparency of Lever and Collar | Visual control of graduation lines | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo for ConceptoMed. The logo consists of a stylized, abstract shape in blue on the left, resembling a water droplet or a stylized leaf. To the right of the shape is the company name "ConceptoMed" in a sans-serif font, also in blue. The color of the text transitions from a darker blue on the left to a lighter blue on the right. The Device will be marketed as a piston syringe with one-handed disconnection option only. #### 7. Conclusion The Luer-Jack has been verified to meet the established performance criteria above. The predicate device is a well known and well documented device, the Luer-Jack performs comparably to the predicate device that is currently marketed for the same intended use. Based on the clinical performance as well as biocompatibility characteristics, the Luer-Jack was found substantially equivalent to the predicate device.