Tamper Evident Cap

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. January 31, 2020 International Medical Industries Inc. David Meily Director of Quality & Regulatory Affairs 2981 Gateway Drive Pompano Beach, Florida 33069 #### Re: K193192 Trade/Device Name: Tamper Evident Cap Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 7, 2019 Received: January 8, 2019 #### Dear David Meily: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193192 Device Name Prep-LockTM Tamper Evident Cap for IV Syringes Indications for Use (Describe) Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ # K193192 510(k) Summary | Date Summary Prepared: | November 15, 2019 | |--------------------------|--------------------------------------------------| | Manufacturing Company: | International Medical Industries, Inc. | | Manufacturing Address: | 2981 Gateway Drive, Pompano Beach, Florida 33069 | | Corresponding Official: | David Meily | | | Director of Quality and Regulatory Affairs | | Telephone Number: | 954.917.9570 x 283 | | Fax Number: | 954.917.9244 | | Email Address: | dmeily@imiweb.com | | Trade Name: | Prep-Lock™ Tamper Evident Cap | | | for IV Syringes | | Device 510(k): | K193192 | | Device Common Name: | Tamper Evident Cap | | Regulation Number: | 21 CFR 880.5860 | | Regulation Name: | Piston syringe | | Product Class: | II | | Product Panel: | General Hospital | | Product Code: | FMF | | Predicate Device Name: | Prep-Lock™ Tamper Evident Cap | | | for IV Syringes | | | (Originally cleared as Tamper Proof Cap) | | Predicate Device 510(k): | K861276 cleared May 5, 1986 | | Device Common Name: | Tamper Evident Cap | | Regulation Number: | 21 CFR 880.5860 | | Regulation Name: | Piston syringe | | Product Class: | II | | Product Panel: | General Hospital | | Product Code: | FMF | #### 1. Device Description The Tamper Evident Cap (TEC) is a sterile, single use device which will be used to cover male luer ports on medical devices and provide evidence of access. TEC is offered in multiple colors and all the components used in the device are comprised of polystyrene and polypropylene resin. The TEC device is marketed as a stand-alone device and packaged in bulk. {4}------------------------------------------------ ## 2. Indications for Use | Subject Device IFU: | Predicate Device IFU | |----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | TEC in Bulk Bags<br>Tamper Evident Caps are indicated for use<br>as a sterile tamper evident cap for IV<br>syringes. | TEC in Individual Trays and Blister Packs<br>Tamper Evident Caps are indicated for use<br>as a sterile tamper evident cap for IV<br>syringes. | Discussion of differences in indications for use The Indications For Use remains the same. ## 3. Comparison of Technological Characteristics and Basis for Substantial Equivalence | Parameter | Subject Device | Predicate Device | Comparison | |----------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Proprietary<br>Device Name | Prep-Lock™ Tamper Evident Cap<br>for IV Syringes | Prep-Lock™ Tamper<br>Evident Cap for IV Syringes | Same | | Packaging<br>Configuration | Pouches that contain 100 TEC<br>units. | Individual blister packs and<br>10-up trays. | The packaging<br>configuration has been<br>tested and conforms to<br>the same functional and<br>sterility specifications as<br>the predicate device. The<br>cap itself is unchanged. | | Labeling | Instructions on how to open 100<br>cap packaging | Instructions on how to<br>open 10 cap packaging | Labeling has been slightly<br>modified on how to open<br>the new packaging | | Sterility | Sterile EO (10^-6) | Sterile EO (10^-6) | Same | | Number of<br>Uses | Single Use, Rx only | Single Use, Rx only | Same | | Cap Material | Polypropylene / Polystyrene | Polypropylene /<br>Polystyrene | Same | | Shelf Life | 3 years | 3 years | Same | | Table 5.3.1 - Comparison Between Subject and Predicate Devices | | | |----------------------------------------------------------------|--|--| | | | | {5}------------------------------------------------ | Tamper<br>Evidence<br>Design Feature | Cap separation upon opening | Cap separation upon<br>opening | Same | |--------------------------------------------|----------------------------------------------|----------------------------------------------|------| | Biocompatibili<br>ty Contact /<br>Duration | Indirect blood contact, limited<br>duration. | Indirect blood contact,<br>limited duration. | Same | # Discussion of Technological differences The device is a tamper evident cap used to cover male luer ports on medical devices and provide evidence of access. The device is marketed as a stand-alone device and packaged in bulk. Both the subject device and the predicate device are comprised of the same resin and are manufactured by the same injection molding / assembly process. There are no changes in the cap from the currently marketed predicate device and the subject device. The update is in the packaging configuration in which the caps are provided. The subject device is provided in a new packaging configuration; a carton containing 10 pouches where each pouch contains 100 TEC units. The predicate device was offered in 10-up trays and single unit blisters. The instructions for use have been updated to provide slight modifications to the instructions on how to open the new packaging. The safety and effectiveness of the proposed TEC device is adequately supported by the material information, comparison of design characteristics with the predicate device, testing rationale and data summarized within this premarket notification. This testing supports the equivalence of the TEC in bulk packaging to the predicate TEC device and shows that no new questions of safety and effectiveness have been introduced with the packaging modification. # 4. Non-Clinical Bench Testing The new packaging configuration was assessed and the following performance testing was conducted. Packaging design verification and validation were performed to ensure that the subject TEC device in bulk packaging meets the existing functional specifications and demonstrates equivalence to the predicate device packaging. A summary of the testing conducted is presented below. All pre-determined acceptance criteria were met. The data demonstrates that the subject device is substantially equivalent to the predicate device. | Test Name | Test Description | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterility Assurance 10-6 SAL | Sterilization product adoption for Tamper evident cap<br>in Tyvek Pouch (Bulk Bag) conducted per ANSI/AAMI/<br>ISO 11737-2: 2009/(R)2014 Sterilization of medical<br>devices – Microbiological methods – Part 2: Tests of<br>sterility performed in the definition, validation and<br>maintenance of a sterilization process | | Sterilization Product Adoption | AAMI TIR 28 Product adoption<br>and process equivalence<br>for ethylene oxide sterilization | | Table 5.4.1 – Summary of Performance Testing Conducted on Subject Device | | | |--------------------------------------------------------------------------|--|--| | | | | {6}------------------------------------------------ | Shelf Life | ASTM F1980-16 Standard Guide for<br>Accelerated Aging of Sterile Barrier Systems for Medical<br>Devices1 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EO/ECH Residuals | ISO 10993-1 Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk management<br>process | | Device Function | AAMI ANSI HE75 Human factors engineering—Design of<br>medical devices<br>ISO 80369-7 Small-bore connectors for liquids and<br>gases in healthcare applications – Connectors for<br>intravascular or hypodermic applications<br>Tamper Evident Break Force Test Method (IMI Internal)<br>Simulated Use Test Method (IMI Internal)<br>Weld Strength (IMI Internal) | | Packaging Integrity | Standard Test Method for Determining Integrity of<br>Seals for Flexible Packaging by Visual Inspection (ASTM<br>F 1886) | | Transportation | Minimum Peel Strength (ASTM F 88) | | Transportation | ISTA 3B TEST Over 150 lbs. Pallet Test,<br>Visual on Seal per ASTM F1886, Dye Penetration per<br>F1929, | | Product Validation | Human factors and Usability, limited to assessment of<br>packaging use. | ## Biocompatibility Testinq The packaging material for the subject and predicate devices have no patient contact. Biocompatibility testing of the TEC device was conducted per Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff, Jun 16, 2016 and "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]," July 11, 2008, as recognized by the FDA. Biocompatibility testing was conducted in accordance with the cited guidance and standards as required for an External Communicating Device, Blood Path, Indirect Contact, Limited Duration. ## 5. Clinical Bench Testing Not applicable for this change. ## 6. Conclusion Review of the performance test summaries as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, Tamper Evident Cap in the bulk bag configuration is substantially equivalent to the predicate Tamper Evident Cap in single and 10up packaging configurations. The difference between the subject and the predicate devices do not raise any new questions of safety or effectiveness.