Codman Surgical Patties & Strips

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November 20, 2020 Integra LifeSciences Corporation Alyssa Woodcock Regulatory Affairs Product Manager 11 Cabot Boulevard Mansfield, Massachusetts 02048 ## Re: K193346 Trade/Device Name: Codman Surgical Pattie & Strip Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical Paddie Regulatory Class: Class II Product Code: HBA Dated: October 19, 2020 Received: October 21, 2020 # Dear Alyssa Woodcock: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 medical devices and radiation-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, Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193346 Device Name Codman Surgical Patties and Strips Indications for Use (Describe) The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery. 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 | Integra LifeSciences Corporation<br>11 Cabot Boulevard<br>Mansfield, MA 02048<br><br>Contact: Alyssa Woodcock<br>Phone: (508) 615-7426<br><br>Establishment Registation: 3014334038 | | | II. Device | Device Proprietary Name | Codman® Surgical Pattie and Strip | | | Common Name | Pattie and Strip | | | Classification Name | Neurosurgical Paddie (21 CFR 882.4700) | | | Regulatory Classification | II | | | Product Code | HBA | | | Review Panel | Neurology | | III. Predicate<br>Device | The predicate device for this submission is the Codman® Surgical Pattie<br>(K880402), which was cleared on March 2, 1988. | | | IV. Device<br>Description | The Codman Surgical Patties and Strips are single use, sterile devices indicated<br>for the use in protection of tissue, including brain and other tissues of the central<br>nervous system, during surgery.<br><br>The Surgical Patties are comprised of 3 main components: Cottonoid Material,<br>String and X-ray detectable monofilament.<br><br>The Strips are comprised of 2 main parts: Cottonoid Material and X-ray<br>detectable monofilament. | | | V. Indications<br>for Use | The Surgical Patties and Surgical Strips are indicated for the use in protection of<br>tissue, including brain and other tissues of the central nervous system, during<br>surgery. | | {4}------------------------------------------------ VI. The proposed Codman Surgical Patties & Strips are identical to the currently Comparison to marketed Codman Surgical Patties and Strips (K880402) with the exception that Predicate this submission proposes to use a non-phthalate PVC Resin instead of PVC Device Resin containing phthalates for the x-ray detectable monofilament affixed to the Surgical Patties and Strips. > The indications for use, design, principle of operation, manufacturing process, clinical utility, packaging, and sterilization will remain unchanged and identical to the predicate device. > Accelerated shelf-life testing has been completed to for 2 years and will be updated to 5 years once testing has been completed. The current marketed Codman Surgical Patties and Strips (K880402) has a 5-year shelf-life; therefore, the proposed Surgical Patties and Strips will be tested to a 5-year shelf-life. | Comparison of the Predicate and Subject Device | | | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device:<br>Codman Sugical Patties<br>& Strips<br>(K880402) | Subject Device:<br>Codman Patties &<br>Strips<br>(This Submission) | Difference and<br>Justification | | FDA Product<br>Code | HBA | Same as predicate | No difference | | Classification | Class II - 21 CFR<br>882.4700 | Same as predicate | No difference | | Classification<br>Name | Neurosurgical Paddie | Same as predicate | No difference | | Intended Use | The surgical patties and<br>surgical strips are<br>indicated for the use in<br>protection of tissue,<br>including brain and other<br>tissues of the central<br>nervous system, during<br>surgery. | Same as predicate | No difference | | Single Use | Yes | Same as predicate | No difference | | Radiopaque | Yes | Same as predicate | No difference | | Material | Pattie/Strip: Cottonoid<br>String: braided, textured<br>Polyester<br>X-ray Monofilament:<br>Phthalate containing PVC<br>material for x-ray<br>detection | Same materials as<br>predicate except a<br>similar PVC material<br>without phthalate will<br>be used for the x-ray<br>monofilament. | The testing (i.e.<br>Visual Inspection,<br>Functional,<br>Mechanical, Shelf<br>Life, Sterility and<br>Biocompatibility<br>testing) performed<br>verified that the<br>performance and<br>safety of the<br>proposed device is<br>substantially<br>equivalent to that of<br>the predicate device<br>and does not<br>introduce any new<br>questions of safety<br>and effectiveness. | | Sterile | Yes, ETO Sterilized | Same as predicate | No difference | | Sterility<br>Assurance<br>Level (SAL) | 10-6 | Same as predicate | No difference | {5}------------------------------------------------ | Comparison of the Predicate and Subject Device | | | | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device:<br>Codman Sugical Patties<br>& Strips<br>(K880402) | Subject Device:<br>Codman Patties &<br>Strips<br>(This Submission) | Difference and<br>Justification | | Packaging | <b>Patties:</b><br>Packaging using Form<br>Fill Seal to create Sterile<br>Barrier, placed in a<br>Pouch with Tyvek Lid,<br>(Pouch – plastic film, Lid<br>– Tyvek) and then placed<br>in a Carton and Labeled<br>(Carton - Single walled<br>cardboard)<br><br><b>Strips:</b><br>Packaged using Ceratek<br>Pouch Sealer to create<br>Sterile Barrier, placed in<br>a Pouch with Tyvek for<br>sterilization (Pouch –<br>Plastic Film and Tyvek)<br>and then placed in Carton<br>and Labeled (Carton –<br>Single walled cardboard) | Same as predicate | No difference | | Shelf Life | 5 years | 2 years | The 2-year shelf life<br>does not raise new<br>questions of safety<br>and effectiveness<br>because testing was<br>performed per FDA<br>recognized standard,<br>ASTM F640 and the<br>results met the<br>acceptance criteria. | VII. There were no changes made that affect the Codman Surgical Patties and Strips Performance indications for use, principle of operation, manufacturing process, clinical utility, Data packaging, shelf life and sterilization. The difference between the predicate and proposed device is the use of a non-phthalate PVC Resin instead of PVC Resin that contains phthalates for the construction of the x-ray detectable monofilament. In addition, the proposed device has been tested to 2-year shelf life and testing is ongoing to 5-year shelf life to match the currently marketed Codman Surgical Patties and Strips shelf life of 5 years. Below is a summary of the testing performed to support the substantial equivalence between the proposed and predicate devices: | Test | Test Method Summary | Results | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Visual Inspection<br>(Patties) | Evaluated the following pattie specifications:<br>1. String and X-ray isolation<br>2. X-ray weld strength<br>3. X-ray flash | All samples passed the acceptance criteria demonstrating that the proposed patties meet the same performance specification as the predicate device. This supports that | | | | | | Visual Inspection<br>(Strips) | Evaluated the following parameters of the strips:<br>1. X-ray weld strength<br>2. X-ray flash | All samples passed the acceptance criteria demonstrating that the proposed strips meet the same specifications as the predicate strips. This supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device. | | Radiopacity<br>(Patties and<br>Strips) | Evaluated the visibility of the finished good<br>under X-ray per FDA recognized standard,<br>ASTM F640-12 | All samples passed the qualitative acceptance criteria. This supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device. | | Sterilization<br>Validation<br>(Cottonoid and<br>X-ray Strip) | Testing was conducted to achieve a 10-6 sterility assurance level using the overkill process per FDA recognized standard, ISO 11135:2014 with a reference product load that included "worst case" product. | The test results met the EO/ECH residual and bioburden acceptance criteria and achieved a sterility assurance level of 10-6. The acceptance criteria is the same as the predicate device, supporting substantial equivalence between the proposed and predicate devices. | | Shelf-Life (2-<br>years) | The following test methods were used to evaluate the product after 2-years accelerated aging:<br>• X-ray shall not proture<br>• ASTM F640<br>• X-ray shall exhibit adequate adherence<br>• X-ray shall not overlap string. | All product tested passed the acceptance criteria. The proposed device has been tested to 2-year shelf life which is within the current shelf life claim for the predicate device. | | Biocompatibility Testing | | | | Cytotoxicity<br>Testing | Determine the potential of a test article extract to cause cytotoxicity per ISO 10993-5 Tests for in vitro cytotoxicity (Less than or equal to grade 2 reactivity on the 0 to 4 reactivity scale) | All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device. | | ISO<br>Intracutaneous<br>Study in Rabbits | Evaluate the local dermal irritation of a test article extract following intracutaneous injection in rabbits per ISO 10993-10 Tests for irritation and skin sensitization (Difference between test article extract overall mean score and control group score is 1.0 or less) | All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device. | | USP Rabbit<br>Pyrogen Study,<br>Material<br>Mediated | Determine whether an extract of the test article induced a pyrogenic response following intravenous injection in rabbits per ISO 10993-11 Tests for Systemic Toxicity (No single animal shows a rise of 0.5 °C above its baseline temperature) | All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device. | | ISO Acute<br>Systemic Toxicity<br>Study in Mice | Evaluate the acute systemic toxicity of a test article extract following injection in mice per ISO 10993-11 Tests for Systemic Toxicity (No single animal treated with the individual test extract exhibits a significantly greater reaction | All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device. | | | | | | <b>ISO Guinea Pig<br/>Maximization<br/>Sensitization Test</b> | than the control animals: no more than two<br>animal deaths; no abnormal behavior such as<br>convulsions or prostration occurs in two or more<br>animals; no final body weight loss greater than<br>10% occurred in three or more animals) | All product tested passed the<br>acceptance criteria demonstrating<br>that the device is biocompatible and<br>therefore is substantially equivalent<br>to the predicate device. | | Evaluate the potential of the test article to cause | | | | delayed dermal contact sensitization in the | | | | guinea pig maximization test per ISO 10993-10 | | | | Tests for irritation and skin sensitization (A<br>grade of 0 on a patch test reaction scale of 0-3) | | | | <b>ASTM Hemolysis<br/>Study</b> | Evaluate the potential to cause hemolysis. This<br>study was conducted based on ASTM F756 and<br>ISO 10993-4 (Acceptance criteria of hemolytic<br>index for the test article extract to be 0.1% and<br>non-hemolytic.) | All product tested passed the<br>acceptance criteria demonstrating<br>that the device is biocompatible and<br>therefore is substantially equivalent<br>to the predicate device. | {6}------------------------------------------------ {7}------------------------------------------------ Codman® Surgical Pattie & Strip ### Bench Testing Visual Inspection, Functional Testing (Radiopacity Testing), Mechanical Testing (Weld Strength), Shelf Life testing, Sterility testing and Biocompatibility testing were performed to verify that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the current device, which uses PVC Resin containing phthalates). #### Animal Studies No animal studies were performed as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, sterilization, shelf-life and biocompatibility testing. #### Clinical Studies No clinical studies were performed as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, sterilization, shelf-life and biocompatibility testing. Based upon the intended use, design, operating principles, patient/user VIII. Conclusion interface, comparison to the predicate device, and testing conducted, it is concluded that the subject device, Codman Surgical Pattie and Strip is substantially equivalent to the predicate device.