Mini Spike Plus 6/8R

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below. December 9, 2020 B. Braun Medical Inc. Angela Caravella Sr. Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109 Re: K201469 Trade/Device Name: Mini Spike Plus 6/8R Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: November 12, 2020 Received: November 13, 2020 Dear Angela Caravella: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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, CAPT Alan Stevens Director (acting) 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) K201469 Device Name Mini Spike Plus 6/8R Indications for Use (Describe) An IV additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R). 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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Submitter Information | Name: | B. Braun Medical Inc. | |-------------------|----------------------------------------------------------| | Address: | 901 Marcon Boulevard<br>Allentown, PA 18109-9341 | | Contact Person: | Angela J. Caravella<br>Sr. Regulatory Affairs Specialist | | Telephone Number: | (610) 596 2966 | | Fax Number: | (610) 266-4962 | | Email | angela.caravella@bbraunusa.com | | Date Prepared: | 09 December 2020 | ## 2. Device Name and Classification | Device Trade Name: | Mini Spike Plus 6/8 R | |----------------------|---------------------------------------------------| | Common Name: | Vial Adapter / IV Fluid Transfer Set | | Classification Name: | Intravascular Administration Set; 21 CFR 880.5440 | | Regulatory Class | Class II (non-exempt) | | Product Code: | LHI | #### 3. Predicate Device | Device Trade Name: | Mini-Spike Plus | |----------------------|---------------------------------------------------| | Common Name: | Vial Adapter / IV Fluid Transfer Set | | Classification Name: | Intravascular Administration Set; 21 CFR 880.544c | | 510(k) Number: | K983794 | The predicate device 510(k) clearance for K983794 covers three models of the device Mini-Spike Plus. Substantial equivalence is demonstrated with the following two models which are covered by K983794: - Mini-Spike Plus, #04550242 - - Chemo Mini-Spike Plus, #412011 - No reference devices were used in this submission. {4}------------------------------------------------ #### 4. Device Description The Mini Spike Plus 6/8 R is an IV additive dispensing pin for aspiration from single-dose containers with the size 6R* or 8R*. It is intended for withdrawal and injection from/in vials. The Mini Spike Plus 6/8 R transfer device is used for the preparation of medications contained in vials with a 20 mm vial closure diameter and a 22mm vial body diameter. The device is for single use and to only be used with single use drug dose vials. The device is configured with a snap cap covering a luer lock female access, a grip plate which features an integrated air filter (0.45 um) and a standard plastic piercing spike. The device provides two separate internal channels: - One for injection and withdrawal of fluids - One for the pressure equalization between the vial and the environment When the device's spike is pierced into a rubber stopper of a drug vial, these channels enable a fluid transfer between a syringe (that is connected with the device's luer connector on the top) and the vial. The vial adapter enables a permanent connection between the Mini Spike Plus 6/8 R and the vial. During the pressure equalization process there is an air exchange with the environment. In order to prevent any contamination of drugs being stored in the vials the air passes a 0.45um bacteria retentive air filter. * The container sizes 6R and 8R are related to the size definitions set out in ISO 8362-1 Injection Containers and accessories-Part 1: Injection vials made of glass tubing. # 5. Indications for Use / Intended Use #### Indications for Use: An IV additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R). #### Intended Use: Withdrawal and injection from/in vials. {5}------------------------------------------------ ## 6. Substantial Equivalence #### Intended Use/Indications for Use - Discussion of differences The intended use of the proposed and the predicate device are identical. The indications for use of the proposed and the predicate device are equivalent and do not create a new intended use: - Both devices are intended for aspiration from and injection into vials. - The proposed device indications for use are limited to vials with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R). - . The indications for use of the proposed device fall within the intended use of the predicate device and, therefore, the two devices have the same intended use. * The differences in wording of the intended use and indications for use between proposed device and predicate device do not affect safety and effectiveness and do not alter the intended use of the proposed device: - The indications for use of the proposed device are a subset compared to the predicate ● device indications for use. - . Both devices are used by the same type of healthcare professionals under the same conditions of use. - Both devices have an identical principle of operation as well as mechanism of action. ● - The differences in wording in the indications for use statements do not introduce new ● questions regarding safety or effectiveness due to their similarities in purpose, function and conditions of use. *Refer to Section IV.D.1. of the Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", issued July 28, 2014. #### Technological Characteristics - Discussion of differences The technological characteristics of the proposed device are substantially equivalent to the predicate device in regards to the technological characteristics as compared in Section 7 below. #### Conclusion on Substantial Equivalence The proposed device Mini Spike Plus 6/8 R has the same intended use and equivalent indications for use as the predicate device. The proposed device has similar technological characteristics to the predicate, and the descriptive and performance information provided within this premarket notification demonstrates that: - any differences do not raise different questions of safety and effectiveness that the . predicate device; and - . the proposed device is at least as safe and effective as the legally marketed predicate device. Based on the comparison of the intended use and the technological characteristics the proposed Mini Spike Plus 6/8 R is substantially equivalent to the currently marketed predicate Mini-Spike Plus. {6}------------------------------------------------ # 7. Comparison with Technological Characteristics with the Predicate Device The technological characteristics of the proposed Mini Spike Plus 6/8 R are substantially equivalent to the predicate Mini-Spike Plus in regards to the following technological characteristics: - . Principle of operation, mechanism of action and conditions of use are identical between proposed device and predicate device. - Material Composition is equivalent. Material composition of proposed device does not ● raise new questions of safety and effectiveness, as demonstrated by performance testing and biocompatibility evaluation. - . Physical Specifications are identical, except the proposed devices new component Vial Adapter. The Vial Adapter does not raise new questions on safety and effectiveness, as demonstrated by performance testing. - Design Features & Interfaces are identical, except the proposed devices new component ● Vial Adapter. Additional performance verification of the proposed device with Vial Adapter does not raise new questions on safety and effectiveness. - Sterilization method, SAL Level and sterilization cycle are equivalent between proposed ● device and predicate device. Differences do not raise new questions on safety and effectiveness. - . Packaging configuration and labeling are equivalent. Differences do not raise new questions on safety and effectiveness. | Intended Use / Indications for Use Comparison | | | | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Characteristic | Proposed Device:<br>Mini Spike Plus 6/8 R<br>#4550315-02 | Predicate Device:<br>K983794; Mini-Spike Plus<br>Models:<br>Mini-Spike Plus, #04550242<br>(Model 1)<br>Chemo Mini-Spike Plus,<br>#412011 (Model 2) | Comparison | | Product Code<br>and Regulation | LHI<br>21 CFR 880.5440 | LHI<br>21 CFR 880.5440 | Identical | | Classification | Class II (non-exempt) | Class II (non-exempt) | Identical | | Review Panel | General Hospital | General Hospital | Identical | | Type of Use | Prescription use only | Prescription use only | Identical | | Conditions of Use | Single Use | Single Use | Identical | | Sterility | Sterile using Ethylene Oxide | Sterile using Gamma Radiation | Equivalent | | Shelf Life | 5 years | 5 years | Identical | | Indications for Use | An IV additive dispensing pin for<br>aspiration from single-dose<br>containers with the size 6R or 8R. | An IV additive dispensing pin for<br>aspiration from multi-dose<br>containers or injection into IV<br>Systems (IV Bags) | Equivalent | | Intended Use | Withdrawal and injection from/in<br>vials. | Withdrawal and injection from/in<br>multidose vials. | Identical<br>Limitations of<br>indicates for use for<br>proposed device fall | {7}------------------------------------------------ | Technological Characteristic Comparison | | | within the intended<br>use of the predicate<br>device, therefore the<br>two devices have the<br>same intended use. | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Characteristics | | | | | Principle of<br>Operation /<br>Mechanism of<br>Action | The device provides two separate<br>channels:<br>- One for injection and withdrawal<br>of fluids<br>- One for the pressure equalization<br>between the vial and the<br>environment<br>When the device's spike is pierced<br>into a rubber stopper of a drug vial,<br>these channels enable a fluid<br>transfer between a syringe (that is<br>connected with the device's luer<br>connector on the top) and the vial. | The device provides two separate<br>channels:<br>- One for injection and withdrawal<br>of fluids<br>- One for the pressure equalization<br>between the vial and the<br>environment<br>When the device's spike is pierced<br>into a rubber stopper of a drug vial,<br>these channels enable a fluid transfer<br>between a syringe (that is connected<br>with the device's luer connector on<br>the top) and the vial. | Identical | | Conditions of Use | Single Use | Single Use | Identical | | Material Composition | | | | | Grip Piece | Material:<br>SAN/ABS (Styrene-Acrylonitrile /<br>Acrylonitrile-Butadiene-Styrene) | Material:<br>SAN/ABS (Styrene-Acrylonitrile /<br>Acrylonitrile-Butadiene-Styrene) | Identical | | Piercing Spike | Material:<br>SAN/ABS (Styrene-Acrylonitrile /<br>Acrylonitrile-Butadiene-Styrene) | Material:<br>SAN/ABS (Styrene-Acrylonitrile /<br>Acrylonitrile-Butadiene-Styrene) | Identical | | Snap Cap | Material:<br>PP (Polypropylene) | Material:<br>PP (Polypropylene) | Identical | | Air Filter | Material:<br>AVC on PA 6 (Acrylonitrile-<br>Vinylchloride Copolymer on<br>Polyamide) | Material:<br>AVC on PA 6 (Acrylonitrile-<br>Vinylchloride Copolymer on<br>Polyamide) | Identical | | Protective Cap | N/A for proposed device. | Material:<br>PE-LD (Low-Density Polyethylene) | N/A for proposed<br>device. | | Vial Adapter | Material:<br>Polystyrene | N/A | New component.<br>As demonstrated by<br>performance testing<br>vial adapter does not<br>raise new questions<br>on safety and<br>effectiveness. | | Piercing Spike<br>Lubricant | Material:<br>Silicone Oil | Material:<br>Silicone Oil | Identical | | Physical Specifications | | | | | Dimensions | Mini Spike<br>(entire device without Vial<br>Adapter):<br>Height: 54.7 mm<br>Length: 34 mm<br>Width: 30 mm | Mini Spike<br>(entire device without Protective<br>Cap):<br>Height: 54.7 mm<br>Length: 34 mm<br>Width: 30 mm | Identical for Mini<br>Spike and Piercing<br>Spike<br>Vial adapter<br>dimensions do not<br>raise questions on | | | Piercing Spike:<br>Length: 21 ± 0.2 mm<br>Diameter: 3.98 +0.2/-0.3 mm<br><br>Vial Adapter:<br>Height: 64 mm<br>Length: 38 mm<br>Width: 30 mm | Piercing Spike:<br>Length: 21 ± 0.2 mm<br>Diameter: 3.98 +0.2/-0.3 mm | safety and<br>effectiveness. | | Connector Type | Luer Lock | Luer Lock | Identical | | Color | Snap Cap: Green<br>Grip Piece & Piercing Spike: White<br>Vial Adapter: Transparent | Snap Cap: Green (Model 1)<br>Grip Piece & Piercing Spike: White<br>Protective Cap: Green | Identical<br>(Snap Cap; Grip<br>Piece & Piercing<br>Spike) | | Vial Adapter | Vial adapter keeps proposed device<br>connected to a vial with the size 6R<br>or 8R. | N/A | Transparent vial<br>adapter does not<br>raise questions on<br>safety and<br>effectiveness.<br>New component.<br>As demonstrated by<br>performance testing<br>vial adapter does not<br>raise new questions<br>on safety and<br>effectiveness. | | Design Features & Interfaces | | | | | Luer Connector<br>Cover | Snap Cap | Snap Cap | Identical | | Device User<br>Interface | Grip Piece | Grip Piece | Identical | | Interface to Syringe | Luer Lock Connector | Luer Lock Connector | Identical | | Interface to Vial | Piercing spike with dimensions:<br>Length: 21 ± 0.2 mm<br>Diameter: 3.98 +0.2/-0.3 mm | Piercing spike with dimensions:<br>Length: 21 ± 0.2 mm<br>Diameter: 3.98 +0.2/-0.3 mm | Identical | | Air Filter | 0.45µm | 0.45µm (Model 1) | Identical | | Protective Cap | N/A for proposed device | Pull Off Cap that prevents piercing<br>of sterile barrier system during<br>transport; needs to be removed prior<br>to product usage | Functionally<br>Equivalent | | Vial Adapter | Vial adapter keeps proposed device<br>connected to vial. | N/A | New component.<br>Vial adapter keeps<br>proposed device<br>connected to vial.<br>As demonstrated by<br>performance testing<br>vial adapter does not<br>raise new questions<br>on safety and<br>effectiveness | | Sterilization | | | | | Sterilization Method | Ethylene Oxide | Gamma Radiation | Equivalent | | | | | | | Sterility Assurance<br>Level (SAL) | 10-6 | 10-6 | sterilization<br>validation the<br>sterilization method<br>does not raise new<br>questions on safety<br>and effectiveness<br>Identical | | Sterilization Cycle | 90% EO / 10% CO2 | Isotope: Cobalt 60<br>Minimum Dose 18.0 KGy<br>Maximum Dose: 30.0 KGy | Equivalent<br>As demonstrated by<br>sterilization<br>validation the<br>sterilization method<br>does not raise new<br>questions on safety<br>and effectiveness | | Packaging | | | | | Packaging - Sterile<br>Barrier System | Thermoformed film sealed with<br>printed medical grade paper | Thermoformed film sealed with<br>printed medical grade paper | Equivalent<br>As demonstrated by<br>packaging validation<br>the packaging does<br>not raise new<br>questions on safety<br>and effectiveness | {8}------------------------------------------------ B. Braun Medical Inc. 510(k) Premarket Notification Mini Spike Plus 6/8 R {9}------------------------------------------------ # 8. Performance Testing # Performance Testing Bench Functional performance bench testing was conducted to demonstrate that the Mini Spike Plus 6/8R device performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. {10}------------------------------------------------ B. Braun Medical Inc. 510(k) Premarket Notification Mini Spike Plus 6/8 R The following performance tests were conducted in support of the substantial equivalence determination: | Standard | Test Performed | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | ISO 22413:2010 | Particle Contamination Fragmentation Air Tightness Free Flow Penetration Force Tensile Load Visual Inspection Chemical Analysis | | ISO 80369-7:2016 | Luer Connector Leakage, Stress Cracking & Resistance Testing Dimensional Accuracy | | ISO 11607-1: 2006/Amd1:2014<br>ASTM F 1980-16<br>ASTM F1886/F1886M-16<br>ASTM D4169-16<br>ASTM D4332-14<br>ASTM F88/F88M-15<br>ASTM F1929-15<br>ASTM F2096-11<br>ASTM F2252/F2252M-13<br>DIN 58953-6:2016<br>ISO 11607-2: 2006/Amd:2014 | Sterile Barrier System Validation | | USP <85>, USP <161> | Bacterial Endotoxin (LAL Gel Clot Test) | | Internal device performance test methods | Fluid burst pressure of air filter membrane Dynamic tensile load between Mini Spike and Vial Adapter | | USP <788> | Particulate Contamination | {11}------------------------------------------------ # Biocompatibility Testing The final finished Mini Spike Plus 6/8R was evaluated according to ISO 10993-1:2009. The following biocompatibility testing was performed with the reference standard utilized: | Standard | Test Performed | |-------------------------------------------|-------------------------------------------------------------| | ISO 10993-5:2009 | • Cytotoxicity | | ISO 10993-10:2010 | • Sensitization<br>• Intracutaneous Reactivity / Irritation | | ISO 10993-11:2006 | • Acute Systemic Toxicity | | ISO 10993-4:2002/Amd1<br>ASTM F756 (2013) | • Hemolysis | | ISO 10993-11:2006<br>USP 38 <151> | • Material Mediated Pyrogenicity | #### 9. Conclusion The proposed Mini Spike Plus 6/8R has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the Mini Spike Plus 6/8R device demonstrate that the proposed device supports a substantial equivalence determination to the predicate device as described in Section 6.