Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with three intertwined figures, representing health, services, and humanity. The text reads "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 8, 2017 ConceptoMed AS Marit Martinsen Director QA & Regulatory Hattvikveien 2 Ballstad N-8373 NORWAY Re: K171805 Trade/Device Name: Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: August 3, 2017 Received: August 10, 2017 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. Isting 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 (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 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/Resourcesfor You/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 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, # Tara A. Ryan -S for Lori A. Wiggins, MPT, CLT 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}------------------------------------------------ ## Change Control Table, Change History ## Change Control Table | Version | Document Author | Document Approver | Date Approved | |---------|---------------------|---------------------|---------------| | 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY | Complete Change Control Table (all versions) retained in SWIFT Docs. {3}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) ## K171805 Device Name LuerJack Slip 3 ml. 5 ml. 20 ml LuerJack Lock 10 ml ## 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 of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ # 510(K) Summary K171805 | 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<br>DATE OF SUBMISSION: | | marit.martinsen@conceptomed.no<br>July 31, 2017 | | | 1. Subject Device | | Trade Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | Subject Device 1 – LuerJack Slip 3 ml<br>Subject Device 2 – LuerJack Slip 5 ml<br>Subject Device 3 – LuerJack Slip 20 ml<br>Subject Device 4 – LuerJack Lock 10 ml<br>LuerJack Slip/ LuerJack Lock<br>21 CFR §880.5860<br>Piston syringe<br>II<br>FMF<br>General Hospital | | 2. Predicate<br>Devices | | Predicate Device:<br>Trade Name:<br>510(k) Reference:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | ConceptoMed Luer-Jack Slip 10 ml<br>K162057<br>Luer-Jack Slip 10 ml<br>21 CFR §880.5860<br>Piston syringe<br>II<br>FMF<br>General Hospital | {5}------------------------------------------------ | Reference Device | | |-----------------------|-----------------------------------| | Trade Name: | BD Single use, Hypodermic Syringe | | 510(k) Reference: | K110771 | | Common Name: | BD Single use, Hypodermic Syringe | | Regulation Number: | 21 CFR §880.5860 | | Regulation Name: | Piston syringe | | Regulatory Class: | II | | Product Code: | FMF | | Classification Panel: | General Hospital | ### Description of the Device 3. The LuerJack is a five-piece, single use syringe without needle, with a male 6% (Luer) connector in 3 ml, 5 ml, 10ml, 20 ml Luer Slip and 10 ml Luer Lock syringe sizes. The device includes a three-piece slip syringe (the Reference Device) with a barrel with graduated volume scale, a stopper and a plunger rod. Onto the barrel is a single-handed hub release system in two pieces monunted. The hub release system provides a single-handed connector release system for all Subject Devices and the additional locking function for the LuerJack Lock syringe. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. The LuerJack is delivered sterilized by irradiation) in a syringe only configuration. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection of an attached connector, the hub release system mounted onto the barrel is used. ### 4. Indications for use The LuerJack device is a sterile syringe without needle intended for single use by healthcare 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 connectors. ### 5. Technological characteristics; comparison to predicate device The Subject Devices are equivalent to the Predicate Device (K162057) in intended use and performance characteristics. The Subject Devices are assembled and sterilized under the same conditions as the Predicate Device. Disconnection of attached devices is identical for both the Subject Devices and the Predicate Device. Subject Device 1. 2 and 3 are equivalent to the Predicate Device in materials and design. Subject Device 4 (LuerJack Lock 10 ml) is different from the Predicate in terms of materials. The difference is the added Petrolatum between the collar and lever. Subject Device 4 (LuerJack Lock 10 ml) is different from the Predicate in terms of design. The difference in design is the added 205° protrusion with an integrated {6}------------------------------------------------ locking mechanism. | Element of<br>Comparison | Subject Device | Primary Predicate Device<br>(PD1) | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Indications for<br>Use/ Intended Use | The LuerJack is a sterile<br>syringe without needle<br>intended for single use by<br>healthcare professionals for<br>general purpose aspiration or<br>injection of fluids immediately<br>after filling. The device is<br>intended to be used only in<br>combination with female 6%<br>Luer connectors. | The LuerJack is a sterile<br>syringe without needle<br>intended for single use by<br>healthcare professionals for<br>general purpose aspiration or<br>injection of fluids immediately<br>after filling. The device is<br>intended to be used only in<br>combination with female 6%<br>Luer slip connectors. | | | Barrel size | 3 ml, 5 ml, 20 ml slip –<br>identical to reference device<br>K110771<br>10 ml – identical to predicate<br>device K162057 | 10 ml slip – identical to subject<br>device | | | Syringe materials | Barrel | Polypropylene | Polypropylene | | | Barrel<br>Lubricant | Silicone | Silicone | | | Plunger Rod | Polypropylene | Polypropylene | | | Stopper | Rubber | Rubber | | | Stopper<br>Lubricant | Silicone | Silicone | | | Only Subject<br>Device 4 –<br>Outside<br>Barrel<br>Lubricant | Petrolatum (Vaseline) | N/A | | | Sterilization Method | E-Beam | E-Beam | | SAL | 10-6 | 10-6 | | Reference device K110771 used for comparison to the different syringe barrel sizes 3 ml, 5 ml, 20 ml slip - which are identical to the additional sizes of the subject device. ### 6. Summary of performance testing. Design Verification tests were performed based on the risk analysis. The results of these tests demonstrate that the Subject Device performed in an equivalent manner to the Predicate Devices and is safe and effective when used as intended. {7}------------------------------------------------ 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 | | | Catch mechanism | Functional catch mechanism | | Connector compatibility | Designed to fit female 6% Luer connectors | | Functional testing | | | Sustaining Force (ISO 7886-1:1997 - Annex G) | Per ISO 7886-1:1997 | | Break-Out Force (ISO 7886-1:1997 - Annex G) | Per ISO 7886-1:1997 | | Pump Sticktion/ Force (ISO 7886-2:1996 - Annex C) | Per ISO 7886-2:1997 | | Stopper Seal (ISO 7886-1:1997 - Annex D) | Per ISO 7886-1:1997 | | Autoclavability (ISO 7886-1:1997 - Annex D) | Per ISO 7886-1:1997 | | Chemical testing (Extractables) | | | Zinc | Per ISO 7886-1:1997 | | Lead, Tin, Iron | Per ISO 7886-1:1997 | | Cadmium | Per ISO 7886-1:1997 | | pH shift | Per ISO 7886-1:1997 | | Biocompatibility | | | Cytotoxicity | Conformance to EN ISO 10993-5:2009 | | Sensitization | Conformance to EN ISO 10993-10:2010 | | Irritation or Intra cutaneous reactivity | Conformance to EN ISO 10993-10:2010 | | Acute Systemic Toxicity | Conformance to EN ISO 10993-11:2009 | | Material-Mediated Pyrogenicity | Conformance to EN ISO 10993-11:2009 | | Packaging safe for sterilization | 1) Existence of Packaging and labelling specification. Compliance with Packforsk Std-<br>40-101 2001 Transport tests (including air<br>transportation)<br>2) Packaging material intended for irradiation sterilization | | Lifetime and reliability | | | Shelf life | Valid shelf life on blister and device | | Mechanical requirements | | | Drop test | No damage of the packages and full | {8}------------------------------------------------ | | | functionality of device | |---------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------| | Mechanical strength | | a) Full function of the Lever after 15 full cycles<br>b) A mechanical report shall conclude sufficient<br>mechanical strength | | Initial force level before | | Initial force of 2N needed before click and | | Lever press down | | release activation | | Complete functional<br>performance requirements<br>from ISO 80369-7 | | Leakage, separation force, unscrewing and<br>overriding torque | The Device will be marketed as a piston syringe with one-handed disconnection option. ### 7. Substantial Equivalence The LuerJack Slip 3 ml, 5 ml and 20 ml and the LuerJack Lock 10 ml are equivalent to that of the Predicate ConceptoMed Luer-Jack Slip 10 ml in intended use, principles of operation, technology, materials and performance characteristics. ### 8. Conclusion The LuerJack Slip 3 ml, 5 ml and 20 ml and the LuerJack Lock 10 ml has been verified to meet the established performance criteria above. The LuerJack Slip 3 ml, 5 ml and 20 ml and the LuerJack Lock 10 ml performs as intended and comparably to the legally marketed Predicate Device.