BD Surgiphor Antimicrobial Irrigation System

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March 23, 2022 Becton, Dickinson and Company Shellev Wilcox Staff Regulatory Affairs Specialist 75 N Fairway Dr Vernon Hills, Illinois 60061 Re: K213616 Trade/Device Name: BD Surgiphor Antimicrobial Irrigation System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FOH, FRO Dated: February 15, 2022 Received: February 16, 2022 Dear Shelley Wilcox: 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). 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Sincerely, Julie Morabito Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Submission Number (if known) K213616 Device Name BD Surqiphor™ Antimicrobial Irrigation System (910100) Indications for Use (Describe) BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds. 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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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}------------------------------------------------ # 510(k) SUMMARY | Preparation Date: | 22 MAR 2021 | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K213616 | | Applicant: | BD<br>75 N Fairway Dr<br>Vernon Hills, IL 60061 | | Contact Person: | Shelley Wilcox<br>Staff Specialist, Regulatory Affairs<br>Tel: (303) 324-3816 | | Device Trade Name: | BD Surgiphor™ Antimicrobial Irrigation System | | Classification Name: | Jet Lavage | | Device Classification: | Class II (21 CFR 880.5475)<br>Unclassified (Pre-amendment) | | Product Code: | FQH; FRO | | Primary Predicate Device: | Irrisept® Antimicrobial Wound Lavage Product<br>System Product Code: FQH (Jet Lavage); Class II<br>(21 CFR 880.5475)<br>Product Code FRO (Dressing, Wound,<br>Drug); Unclassified (pre-amendment)<br>Applicant: Irrimax Corporation<br>K210536 | | Secondary Predicate Device: | Surgiphor™ Wound Irrigation System<br>Product Code: FQH (Jet Lavage); Class II<br>(21 CFR 880.5475)<br>Applicant: Orthophor LLC<br>K202071 | | Reference Device: | Atteris Antimicrobial Skin and Wound Cleanser<br>Product Code: FRO (Dressing, Wound,<br>Drug); Unclassified (pre-amendment)<br>Applicant: Rochal Industries, LLC<br>K160192 | {4}------------------------------------------------ #### Device Description: The BD Surgiphor™ Antimicrobial Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of Surgiphor™ Solution (0.5% Povidone Iodine) which is used first to loosen wound debris, and one bottle of SurgiRinse™ Solution (saline solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, and foreign materials, including microorganisms, from wounds. The BD Surgiphor™ Antimicrobial Irrigation System is provided as a two-part terminally sterilized system with 450 mL of each solution. The povidone in the Surgiphor™ Solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open. ### Indications for Use: BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds. ## Comparison of Technological Characteristics: The subject BD Surgiphor™ Antimicrobial Irrigation System is substantially equivalent to its secondary predicate, predecessor Surgiphor Wound Irrigation System (K202071), primary predicate Irrisept® Antimicrobial Wound Lavage (K210536) and reference device, Atteris Antimicrobial Skin and Wound Cleanser (K160192). The Surgiphor solution comprises 0.5% povidone iodine in sterile saline while the Irrisept solution comprises 0.05% chlorhexidine gluconate and the Atteris solution, polyaminopropyl biguanide (PHMB) in purified water. The composition of all three solutions acts as a preservative to inhibit microbial growth in the respective solutions. The mechanism of action is the same between the proposed and the predicates, specifically, the mechanical action of fluid across the wound removes wound debris, including microorganisms. The mechanism of action is defined by the fluid pressure of the solution, dispensed upon a wound. which is demonstrated by testing provided in this 510(k). The BD Surgiphor™ Antimicrobial Irrigation System is unchanged from the legally marketed predicate Surgiphor™ Wound Irrigation System (K202071) in its intended use, performance, and technological characteristics except as noted in subsequent comparison of technological characteristics table. The removal of wound debris and foreign materials, including microorganisms, is consistent with the primary predicate Irrisept® Antimicrobial Wound Lavage (K210536) and reference predicate device Atteris Antimicrobial Skin & Wound Cleanser (K160192). All three predicate devices have intended use and apply a solution to the wound for removal of wound debris and foreign materials, including microorganisms. This 510(k) is to specify the removal of microorganisms through mechanical cleansing action within the indications for use statement of the BD Surgiphor™ Antimicrobial Irrigation System consistent with predicates Irrisept Antimicrobial Wound Lavage and the Atteris Antimicrobial Skin & Wound Cleanser. {5}------------------------------------------------ | Comparison of Technological Characteristics | | | | | 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| Comparison Feature | Proposed Device | Primary Predicate Device | Secondary Predicate Device | Reference Device | | | BD Surgiphor™ Antimicrobial<br>Irrigation System | Irrisept® Antimicrobial<br>Wound Lavage | Surgiphor™ Wound Irrigation<br>System | Atteris Antimicrobial Skin<br>& Wound Cleanser | | 510(K) Number | TBD | K210536 | K202071 | K160192 | | Product Code | FQH, Jet Lavage<br>FRO, Dressing, Wound, Drug | FQH, Jet Lavage<br>FRO, Dressing, Wound, Drug | FQH, Jet Lavage | FRO, Dressing, Wound, Drug | | Product Classification | Class II (21 CFR 880.5475)<br>Unclassified (Pre-Amendment) | Class II (21 CFR 880.5475)<br>Unclassified (Pre-Amendment) | Class II (21 CFR 880.5475) | Unclassified (Pre-Amendment) | | Intended Use | Intended for wound cleansing<br>and removal of wound debris | Intended for wound cleansing<br>and removal of wound debris | Intended for wound cleansing<br>and removal of wound debris | Intended for wound cleansing<br>and removal of wound debris | | Indications For Use | BD Surgiphor™ Antimicrobial<br>Irrigation System is intended to<br>mechanically loosen and remove<br>debris, and foreign materials,<br>including microorganisms, from<br>wounds. | Irrisept® Antimicrobial Wound<br>Lavage is intended for<br>mechanical cleansing and<br>removal of debris, dirt and<br>foreign materials, including<br>microorganisms from wounds. | The Surgiphor™ Wound<br>Irrigation System is a wound<br>cleansing delivery system<br>intended to loosen and remove<br>wound debris. | (Rx Use) Atteris Antimicrobial<br>Skin & Wound Cleanser is<br>intended for mechanical<br>cleansing and removal of debris,<br>dirt and foreign materials,<br>including microorganisms from<br>wounds such as stage I-IV<br>pressure ulcers, diabetic foot<br>ulcers, post-surgical wounds, first<br>and second-degree burns, grafted<br>and donor sites.<br><br>(OTC Use) Atteris Antimicrobial<br>Skin & Wound Cleanser is<br>intended for physical cleaning<br>and removal of dirt and debris,<br>from skin scrapes, cuts,<br>lacerations, minor irritations, exit<br>sites and unbroken skin. | | Type Of Use | Prescription use only | Prescription use only | Prescription use only | Both prescription use and over-<br>the-counter use | | Comparison of Technological Characteristics | | | | | | Comparison Feature | Proposed Device | Primary Predicate Device | Secondary Predicate Device | Reference Device | | | BD Surgiphor™ Antimicrobial<br>Irrigation System | Irrisept® Antimicrobial<br>Wound Lavage | Surgiphor™ Wound Irrigation<br>System | Atteris Antimicrobial Skin<br>& Wound Cleanser | | Mechanism Of Action | The mechanical action of fluid<br>across the wound removes wound<br>debris, including<br>microorganisms.<br><br>The change in the indications for<br>use to include removal of<br>microorganisms as a type<br>of wound debris does not change<br>the intended use of the device<br>and does not raise new<br>safety and effectiveness<br>concerns. Substantial equivalence<br>has been confirmed through<br>performance testing of the fluid<br>pressure. | The mechanical action of fluid<br>across the wound removes wound<br>debris. | The mechanical action of fluid<br>across the wound removes wound<br>debris. | The mechanical action of fluid<br>across the wound removes wound<br>debris. | | Solution | 1 bottle of Surgiphor Solution<br>0.5% povidone iodine plus<br>vitamin E TPGS in 0.9% saline,<br>pH 4.6 – 7.0<br><br>1 bottle of sterile saline, USP,<br>pH 4.0 – 7.0 | 0.05% chlorhexidine gluconate in<br>99.95% sterile water for<br>irrigation, USP | 1 bottle of Surgiphor Solution<br>0.5% povidone iodine plus<br>vitamin E TPGS in 0.9% saline,<br>USP, pH 4.6 – 6.4<br><br>1 bottle of sterile saline, USP,<br>pH 4.0 – 6.5 | Purified water, poloxamer 407,<br>sodium chloride,<br>ethylhexylglycerin,<br>hypromellose, octane-1,2-diol,<br>polyaminopropyl biguanide<br>[PHMB] | | Solution<br>Antimicrobial<br>Preservative | 0.5% Povidone Iodine | 0.05% Chlorhexidine Gluconate | 0.5% Povidone Iodine | Polyaminopropyl Biguanide<br>[PHMB] | | How Supplied | 1 – 450 mL bottle of Surgiphor<br>Solution 0.5% povidone iodine<br>plus vitamin E TPGS in 0.9%<br>saline, USP; 1 – 450 mL bottle of<br>sterile saline, USP; packed within<br>a PETG tray heat-sealed with a<br>Tyvek® cover and sterilized by<br>gamma irradiation to achieve a<br>SAL of 10-6. IFU are included<br>with the system. | Provided for single use. A 450<br>mL bottle of Irrisept is double<br>wrapped in CSR and sealed<br>within an outer Tyvek® pouch.<br>The bottle exterior, CSR wraps,<br>and applicator are sterilized by<br>EO gas. The bottle contains<br>aseptically processed Irrisept<br>solution. | 1 – 450 mL bottle of Surgiphor<br>Solution 0.5% povidone iodine<br>plus vitamin E TPGS in 0.9%<br>saline, USP; 1 – 450 mL bottle of<br>sterile saline, USP; packed within<br>a PETG tray heat-sealed with a<br>Tyvek® cover and sterilized by<br>gamma irradiation to achieve a<br>SAL of 10-6. IFU are included<br>with the system. | Provided Non-Sterile In 8 Fluid<br>Ounce Bottle with Sprayer. | | Comparison of Technological Characteristics | | | | | | Comparison Feature | Proposed Device | Primary Predicate Device | Secondary Predicate Device | Reference Device | | | BD Surgiphor™ Antimicrobial<br>Irrigation System | Irrisept® Antimicrobial<br>Wound Lavage | Surgiphor™ Wound Irrigation<br>System | Atteris Antimicrobial Skin<br>& Wound Cleanser | | Applicator | Polycarbonate cap with a spike<br>threads onto a polypropylene<br>bottle. The user squeezes the<br>bottle to dispense the solution<br>onto the wound. | Multiport applicator that threads<br>onto the Irrisept bottle. | Polycarbonate cap with a spike<br>threads onto a polypropylene<br>bottle. The user squeezes the<br>bottle to dispense the solution<br>onto the wound. | Sprayer Attachment | | Sterilization | The BD Surgiphor™<br>Antimicrobial Irrigation System<br>is provided terminally sterile to a<br>SAL of 10-6 by gamma<br>irradiation. The system is<br>validated in accordance with<br>ANSI/AAMI/ISO TIR13004:<br>Sterilization of health care<br>products- Radiation -<br>Substantiation of a selected<br>sterilization dose: Method<br>VDmaxSD | Bottle exterior, CSR wraps, and<br>outer packaging conforms to ISO<br>11135-7 for EO sterilization and<br>ISO 10993-7 for EO residuals<br>whereas the solution is<br>aseptically processed. | The Surgiphor Sterile Wound<br>Irrigation System is provided<br>terminally sterile to a SAL of<br>10-6 by gamma irradiation. The<br>system is validated in accordance<br>with ANSI/AAMI/ISO TIR13004:<br>Sterilization of health care<br>products- Radiation -<br>Substantiation of a selected<br>sterilization dose: Method<br>VDmaxSD | Provided non-sterile | | Biocompatibility | Biocompatible per ISO 10993-1<br>Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process, Annex A (informative)<br>Biological evaluation tests as a<br>surface device (breached or<br>compromised) with limited<br>contact (≤ 24 hours).<br>Added Teflon coating to the mold<br>to manufacture the cap. The<br>components of the mold that are<br>Teflon coated do not come into<br>contact with the fluid-contacting<br>portions of the cap. | Biocompatible per ISO 10993<br>testing for a surface device with<br>breached or compromised surface<br>contact and a limited duration (≤<br>24 hours) | Biocompatible per ISO 10993-1<br>Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process, Annex A (informative)<br>Biological evaluation tests as a<br>surface device (breached or<br>compromised) with limited<br>contact (≤ 24 hours).<br>No Teflon Coating on the mold to<br>manufacture the cap. | Biocompatible per ISO 10993<br>testing | | Preservative<br>Effectiveness over<br>Shelf-Life | Demonstrated per USP <51><br>testing. | Demonstrated per USP <51><br>testing. | Demonstrated per USP <51><br>testing. | Demonstrated per USP <51><br>testing. | | Storage Temperature | Store at room temperature. Avoid<br>freezing and excessive heat<br>above 40°C (104°F) | 10°C to 30°C | 10°C to 30°C | Unknown | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## Performance Testing There are no technological differences between the two versions of the Surgiphor System. The change to the BD labeled indication for use to include removal of "microorganisms" as a type of wound debris does not change the intended use of the device and does not raise new safety and effectiveness concerns. Substantial equivalence has been confirmed through performance testing as summarized below. The following tests were submitted under K202071 and remain valid for the subject device: - Preservative Antimicrobial Effectiveness ● - o USP <51> Antimicrobial Effectiveness Testing - . Endotoxins and Pyrogens - o USP <85> Bacterial Endotoxins Test - 0 USP <151> Pyrogen Test (USP Rabbit Test) - o USP <161> Medical Devices- Bacterial Endotoxin and Pyrogen Tests - Biocompatibility ● - ISO 10993-1 Biological Evaluation of Medical Devices o - Fluid Pressure Testing ● - Nonclinical Wound Healing Study ● The following tests were conducted to support the transfer of the Surgiphor System to BD: - Sterilization ● - o ANSI/AAMI/ISO TIR13004:2013, Sterilization of Health Care Products -Radiation - Substantiation of a Selected Sterilization Dose: Method VDmax® - ANSI/AAMI/ISO 11137:2006/ (R) 2015 & A1:2013 & A2:2019. Sterilization O of Health Care Products - Radiation - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices - ANSI/AAMI/ISO 11137-1:2018/: Sterilization of Health Care Products - O Microbiological methods - Part 1: Determination of the population of microorganisms on product - ANSI/AAMI/ISO 11137-2:2019/: Sterilization of medical devices - O Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process - ANSI/AAMI/ISO 11137-2:2013/ (R) 2019, Sterilization of Health Care O Products - Radiation - Part 2: Establishing the sterilization dose. - (AAMI) ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, O Routine Monitoring, and Alternatives to Batch Testing - . Packaging and Shelf-Life - ISO 11607 Packaging for Terminally Sterilized Medical Devices O - ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier O Systems for Medical Devices - ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in O Packaging by Internal Pressurization (Bubble Test) - ASTM D4169-16 Standard Practice for Performance Testing of Shipping O Containers and Systems {9}------------------------------------------------ - Stability Testing ● - ICH Q1A(R2) Stability Testing of New Drug Substances and Products O - USP <51> Antimicrobial Effectiveness Testing O - Free Iodine Determination o - % Available Iodine Determination o - o Osmolality Determination - USP <791> pH Determination o - Biocompatibility ● - ISO 10993-1:2018 Biological evaluation of medical devices Part 1: o Evaluation and testing within a risk management process ## Substantial Equivalence Conclusion The performance testing conducted demonstrates that the subject BD Surgiphor™ Antimicrobial Irrigation System is substantially equivalent to the primary predicate, Irrisept device and the secondary predicate, Surgiphor Wound Irrigation System in intended use and technological characteristics and this premarket notification supports the addition of "microorganisms" as a type of wound debris removed by the device in the labeled indications for use.