The Codman Surgical Patties and Strips are single use, sterile devices indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

The Surgical Patties are comprised of 3 main components: Cottonoid Material, String and X-ray detectable monofilament.

The Strips are comprised of 2 main parts: Cottonoid Material and X-ray detectable monofilament.

AI/ML Overview

This document describes the acceptance criteria and study results for the Integra LifeSciences Corporation's Codman Surgical Pattie & Strip (K193346).

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Visual Inspection (Patties)	1. String and X-ray isolation 2. X-ray weld strength 3. X-ray flash (Demonstrates that proposed patties meet the same performance specification as the predicate device)	All samples passed the acceptance criteria.
Visual Inspection (Strips)	1. X-ray weld strength 2. X-ray flash (Demonstrates that proposed strips meet the same specifications as the predicate strips and that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device)	All samples passed the acceptance criteria.
Radiopacity (Patties and Strips)	Qualitative acceptance criteria (as per FDA recognized standard ASTM F640-12). (Supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device)	All samples passed the qualitative acceptance criteria.
Sterilization Validation	Achieve a 10⁻⁶ sterility assurance level (SAL) using the overkill process per FDA recognized standard, ISO 11135:2014, with a reference product load that included "worst case" product, and meet EO/ECH residual and bioburden acceptance criteria. (Same as predicate device, supporting substantial equivalence)	Test results met the EO/ECH residual and bioburden acceptance criteria and achieved a sterility assurance level of 10⁻⁶.
Shelf-Life (2-years)	• X-ray shall not protrude • Meets ASTM F640 • X-ray shall exhibit adequate adherence • X-ray shall not overlap string. (Within the current shelf life claim for the predicate device, does not raise new questions of safety and effectiveness as per FDA recognized standard ASTM F640)	All product tested passed the acceptance criteria.
Biocompatibility - Cytotoxicity	Less than or equal to grade 2 reactivity on the 0 to 4 reactivity scale (per ISO 10993-5). (Demonstrates biocompatibility and substantial equivalence to predicate device)	All product tested passed the acceptance criteria.
Biocompatibility - Intracutaneous Study	Difference between test article extract overall mean score and control group score is 1.0 or less (per ISO 10993-10). (Demonstrates biocompatibility and substantial equivalence to predicate device)	All product tested passed the acceptance criteria.
Biocompatibility - USP Rabbit Pyrogen Study	No single animal shows a rise of 0.5 °C above its baseline temperature (per ISO 10993-11). (Demonstrates biocompatibility and substantial equivalence to predicate device)	All product tested passed the acceptance criteria.
Biocompatibility - Acute Systemic Toxicity	No single animal treated with the individual test extract exhibits a significantly greater reaction than the control animals; no more than two animal deaths; no abnormal behavior such as convulsions or prostration occurs in two or more animals; no final body weight loss greater than 10% occurred in three or more animals (per ISO 10993-11). (Demonstrates biocompatibility and substantial equivalence to predicate device)	All product tested passed the acceptance criteria.
Biocompatibility - Guinea Pig Maximization Sensitization Test	A grade of 0 on a patch test reaction scale of 0-3 (per ISO 10993-10). (Demonstrates biocompatibility and substantial equivalence to predicate device)	All product tested passed the acceptance criteria.
Biocompatibility - ASTM Hemolysis Study	Hemolytic index for the test article extract to be 0.1% and non-hemolytic (as per ASTM F756 and ISO 10993-4). (Demonstrates biocompatibility and substantial equivalence to predicate device)	All product tested passed the acceptance criteria.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the exact sample size for each test. However, it indicates "All samples" passed the acceptance criteria for most tests, suggesting an appropriate number of samples were tested to demonstrate substantial equivalence. The data provenance is derived from bench testing conducted by Integra LifeSciences Corporation, as stated under "Bench Testing" and "Performance Data." This is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin for the data is not specified, but the submission is to the U.S. FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical medical instrument (surgical pattie and strip), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance evaluation relies on objective physical, chemical, and biological tests.

4. Adjudication method for the test set:

Not applicable. As described in point 3, this is not an AI/imaging device subject to expert adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical medical instrument and does not involve AI assistance or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical instrument.

7. The type of ground truth used:

The "ground truth" for this device's performance evaluation is established through adherence to recognized industry standards (e.g., ASTM, ISO standards) and meeting predefined objective specifications for physical, chemical, and biological properties. This includes measurements of weld strength, X-ray visibility, sterility assurance levels, and biocompatibility endpoints.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument and does not involve AI models or training sets.

9. How the ground truth for the training set was established:

Not applicable. As described in point 8, this device does not involve AI models or training sets.

Summary

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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

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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

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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)

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Codman® Surgical Pattie & Strip

510(k) Summary

Date:	November 20, 2020
Submissionnumber:	K193346
I. Submitter	Integra LifeSciences Corporation11 Cabot BoulevardMansfield, MA 02048Contact: Alyssa WoodcockPhone: (508) 615-7426Establishment 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. PredicateDevice	The predicate device for this submission is the Codman® Surgical Pattie(K880402), which was cleared on March 2, 1988.
IV. DeviceDescription	The Codman Surgical Patties and Strips are single use, sterile devices indicatedfor the use in protection of tissue, including brain and other tissues of the centralnervous system, during surgery.The Surgical Patties are comprised of 3 main components: Cottonoid Material,String and X-ray detectable monofilament.The Strips are comprised of 2 main parts: Cottonoid Material and X-raydetectable monofilament.
V. Indicationsfor Use	The Surgical Patties and Surgical Strips are indicated for the use in protection oftissue, including brain and other tissues of the central nervous system, duringsurgery.

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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:Codman Sugical Patties& Strips(K880402)	Subject Device:Codman Patties &Strips(This Submission)	Difference andJustification
FDA ProductCode	HBA	Same as predicate	No difference
Classification	Class II - 21 CFR882.4700	Same as predicate	No difference
ClassificationName	Neurosurgical Paddie	Same as predicate	No difference
Intended Use	The surgical patties andsurgical strips areindicated for the use inprotection of tissue,including brain and othertissues of the centralnervous system, duringsurgery.	Same as predicate	No difference
Single Use	Yes	Same as predicate	No difference
Radiopaque	Yes	Same as predicate	No difference
Material	Pattie/Strip: CottonoidString: braided, texturedPolyesterX-ray Monofilament:Phthalate containing PVCmaterial for x-raydetection	Same materials aspredicate except asimilar PVC materialwithout phthalate willbe used for the x-raymonofilament.	The testing (i.e.Visual Inspection,Functional,Mechanical, ShelfLife, Sterility andBiocompatibilitytesting) performedverified that theperformance andsafety of theproposed device issubstantiallyequivalent to that ofthe predicate deviceand does notintroduce any newquestions of safetyand effectiveness.
Sterile	Yes, ETO Sterilized	Same as predicate	No difference
SterilityAssuranceLevel (SAL)	10-6	Same as predicate	No difference

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Comparison of the Predicate and Subject Device
	Predicate Device:Codman Sugical Patties& Strips(K880402)	Subject Device:Codman Patties &Strips(This Submission)	Difference andJustification
Packaging	Patties:Packaging using FormFill Seal to create SterileBarrier, placed in aPouch with Tyvek Lid,(Pouch – plastic film, Lid– Tyvek) and then placedin a Carton and Labeled(Carton - Single walledcardboard)Strips:Packaged using CeratekPouch Sealer to createSterile Barrier, placed ina Pouch with Tyvek forsterilization (Pouch –Plastic Film and Tyvek)and then placed in Cartonand Labeled (Carton –Single walled cardboard)	Same as predicate	No difference
Shelf Life	5 years	2 years	The 2-year shelf lifedoes not raise newquestions of safetyand effectivenessbecause testing wasperformed per FDArecognized standard,ASTM F640 and theresults met theacceptance 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(Patties)	Evaluated the following pattie specifications:1. String and X-ray isolation2. X-ray weld strength3. 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(Strips)	Evaluated the following parameters of the strips:1. X-ray weld strength2. 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(Patties andStrips)	Evaluated the visibility of the finished goodunder X-ray per FDA recognized standard,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.
SterilizationValidation(Cottonoid andX-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-years)	The following test methods were used to evaluate the product after 2-years accelerated aging:• X-ray shall not proture• ASTM F640• X-ray shall exhibit adequate adherence• 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
CytotoxicityTesting	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.
ISOIntracutaneousStudy 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 RabbitPyrogen Study,MaterialMediated	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 AcuteSystemic ToxicityStudy 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.

ISO Guinea PigMaximizationSensitization Test	than the control animals: no more than twoanimal deaths; no abnormal behavior such asconvulsions or prostration occurs in two or moreanimals; no final body weight loss greater than10% occurred in three or more animals)	All product tested passed theacceptance criteria demonstratingthat the device is biocompatible andtherefore is substantially equivalentto 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 (Agrade of 0 on a patch test reaction scale of 0-3)
ASTM HemolysisStudy	Evaluate the potential to cause hemolysis. Thisstudy was conducted based on ASTM F756 andISO 10993-4 (Acceptance criteria of hemolyticindex for the test article extract to be 0.1% andnon-hemolytic.)	All product tested passed theacceptance criteria demonstratingthat the device is biocompatible andtherefore is substantially equivalentto the predicate device.

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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.

Regulation Number and Section

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).