Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and basic functional tests, with no mention of AI/ML algorithms or data processing.

Therapeutic

No
The device, Codman Surgical Patties and Strips, is described as being used for the "protection of tissue" during surgery, not for treating any specific disease, injury, or condition in a therapeutic manner. It acts as a protective barrier or absorbent material rather than providing a therapeutic intervention.

Diagnostic

No
The device is described as a surgical aid (patties and strips) used for tissue protection during surgery, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is comprised of physical components (Cottonoid Material, String, X-ray detectable monofilament) and is a single-use, sterile device, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the protection of tissue during surgery, specifically in the central nervous system. This is a direct surgical intervention and not a diagnostic test performed in vitro (outside the body).
Device Description: The device is a physical object (patties and strips) made of cottonoid material, string, and X-ray detectable monofilament. These are used for physical manipulation and protection during surgery, not for analyzing biological samples.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze biological samples (like blood, urine, or tissue samples), or provide information about a patient's health status through in vitro testing.
Performance Studies: The performance studies focus on physical and functional characteristics (visual inspection, radiopacity, weld strength, shelf life, sterility, biocompatibility), which are relevant to a surgical device, not a diagnostic one.

IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery.

Product codes

HBA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

brain and other tissues of the central nervous system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench Testing:

Study Type: Visual Inspection (Patties)
Sample Size: Not specified
Key Results: All samples passed the acceptance criteria demonstrating that the proposed patties meet the same performance specification as the predicate device. This supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device.
Study Type: Visual Inspection (Strips)
Sample Size: Not specified
Key Results: 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.
Study Type: Radiopacity (Patties and Strips)
Sample Size: Not specified
Key Results: 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.
Study Type: Sterilization Validation (Cottonoid and X-ray Strip)
Sample Size: Not specified
Key Results: 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.
Study Type: Shelf-Life (2-years)
Sample Size: Not specified
Key Results: 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:

Study Type: Cytotoxicity Testing
Sample Size: Not specified
Key Results: All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device.
Study Type: ISO Intracutaneous Study in Rabbits
Sample Size: Not specified
Key Results: All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device.
Study Type: USP Rabbit Pyrogen Study, Material Mediated
Sample Size: Not specified
Key Results: All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device.
Study Type: ISO Acute Systemic Toxicity Study in Mice
Sample Size: Not specified
Key Results: All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device.
Study Type: ISO Guinea Pig Maximization Sensitization Test
Sample Size: Not specified
Key Results: All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device.
Study Type: ASTM Hemolysis Study
Sample Size: Not specified
Key Results: All product tested passed the acceptance criteria demonstrating that the device is biocompatible and therefore is substantially equivalent to the predicate device.

Animal Studies: No animal studies were performed.
Clinical Studies: No clinical studies were performed.

Key Metrics

Not Found

Predicate Device(s)

K880402

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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
Submission
number:	K193346
I. Submitter	Integra LifeSciences Corporation
11 Cabot Boulevard
Mansfield, MA 02048

Contact: Alyssa Woodcock
Phone: (508) 615-7426

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. | |
| V. Indications
for Use | The Surgical Patties and Surgical Strips are indicated for the use in protection of
tissue, including brain and other tissues of the central nervous system, during
surgery. | |

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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 and
Justification
FDA Product
Code	HBA	Same as predicate	No difference
Classification	Class II - 21 CFR
882.4700	Same as predicate	No difference
Classification
Name	Neurosurgical Paddie	Same as predicate	No difference
Intended Use	The surgical patties and
surgical strips are
indicated for the use in
protection of tissue,
including brain and other
tissues of the central
nervous system, during
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
String: braided, textured
Polyester
X-ray Monofilament:
Phthalate containing PVC
material for x-ray
detection	Same materials as
predicate except a
similar PVC material
without phthalate will
be used for the x-ray
monofilament.	The testing (i.e.
Visual Inspection,
Functional,
Mechanical, Shelf
Life, Sterility and
Biocompatibility
testing) performed
verified that the
performance and
safety of the
proposed device is
substantially
equivalent to that of
the predicate device
and does not
introduce any new
questions of safety
and effectiveness.
Sterile	Yes, ETO Sterilized	Same as predicate	No difference
Sterility
Assurance
Level (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 and
Justification
Packaging	Patties:
Packaging using Form
Fill Seal to create Sterile
Barrier, placed in a
Pouch with Tyvek Lid,
(Pouch – plastic film, Lid
– Tyvek) and then placed
in a Carton and Labeled
(Carton - Single walled
cardboard)

Strips:
Packaged using Ceratek
Pouch Sealer to create
Sterile Barrier, placed in
a Pouch with Tyvek for
sterilization (Pouch –
Plastic Film and Tyvek)
and then placed in Carton
and Labeled (Carton –
Single walled cardboard) | Same as predicate | No difference |
| Shelf Life | 5 years | 2 years | The 2-year shelf life
does not raise new
questions of safety
and effectiveness
because testing was
performed per FDA
recognized standard,
ASTM F640 and the
results met the
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
(Patties)	Evaluated the following pattie specifications:

String and X-ray isolation
X-ray weld strength
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:
X-ray weld strength
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 and
Strips) | Evaluated the visibility of the finished good
under 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. |
| Sterilization
Validation
(Cottonoid and
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-
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 | | |
| Cytotoxicity
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
Intracutaneous
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
Pyrogen Study,
Material
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
Systemic Toxicity
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. |
| | | |
| ISO Guinea Pig
Maximization
Sensitization Test | 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) | All product tested passed the
acceptance criteria demonstrating
that the device is biocompatible and
therefore is substantially equivalent
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
grade of 0 on a patch test reaction scale of 0-3) | | |
| ASTM Hemolysis
Study | Evaluate the potential to cause hemolysis. This
study was conducted based on ASTM F756 and
ISO 10993-4 (Acceptance criteria of hemolytic
index for the test article extract to be 0.1% and
non-hemolytic.) | All product tested passed the
acceptance criteria demonstrating
that the device is biocompatible and
therefore is substantially equivalent
to 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.