Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

OsteoCove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. OsteoCove Strip resorbs and is replaced with bone during the healing process. OsteoCove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Device Description

Cove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (β-TCP): Hydroxyapatite (HA) combined with highly purified Type-1 collagen. The collagen scaffold contains ceramic granules throughout, providing osteoconductive substrates that support new bone formation. Cove Strip combined with autograft in a 1:1 ratio, is intended to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a double blister tray configuration.

OsteoCove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (β-TCP): Hydroxyapatite (HA) combined with highly purified Type-1 collagen. The collagen scaffold contains ceramic granules throughout, providing osteoconductive substrates that support new bone formation. OsteoCove Strip combined with autograft in a 1:1 ratio, is intended to be placed in the posterolateral spine. The implant is provided sterile and nonpyrogenic for single use in a double blister tray configuration.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a medical device (Cove Strip, OsteoCove Strip), which are bone void fillers. It states explicitly that no clinical testing was performed and that the determination of substantial equivalence is not based on an assessment of clinical performance data. Therefore, most of the information requested about acceptance criteria and a study proving the device meets them (especially those related to AI/human performance) is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of materials, manufacturing processes, design verification, sterilization, and packaging.

Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable due to the nature of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for a clinical or performance study, as no such study was conducted. The "performance" assessment is based on the subject device being "similar" to the predicate device in terms of components, design, materials, manufacturing, sterility, and packaging.

The non-clinical "verification and validation activities" were evaluated to demonstrate substantial equivalence. These activities and their successful execution serve as the "reported performance" for non-clinical aspects:

Non-Clinical Verification/Validation Activity	Reported Performance
Design Verification	Executed successfully
Ethylene Oxide (EO) Adoption	Executed successfully
Limulus Amebocyte Lysate (LAL) Kinetic Turbidimetric Validation	Executed successfully
Packaging Shipping Validation	Executed successfully
Packaging Shelf Life Validation	Executed successfully
Design (User) Validation	Executed successfully
Process Performance Qualification	Executed successfully
Sterilization Compliance	ISO 11135: SAL of 10^-6
Biocompatibility and In Vivo Safety/Performance	Equivalence to predicate (no new worst-case introduced)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set data is provided or referenced, as no clinical testing was performed. The data provenance would refer to the non-clinical test results for design verification, sterilization, etc., which are presumably internal company data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth establishment was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was conducted.

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. The device is a bone void filler, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical ground truth was established, as no clinical testing was performed. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to the predicate device through non-clinical means and a claim that the subject device does not introduce a new worst case for biocompatibility and in vivo performance compared to the predicate.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As above, no training set or its ground truth establishment is relevant to this device submission.

Summary based on the document:

The K232668 submission for the Cove Strip and OsteoCove Strip devices achieved 510(k) clearance by demonstrating substantial equivalence to an existing predicate device (K230486). This was primarily achieved through non-clinical testing focusing on physical properties, manufacturing processes, and quality control (e.g., sterilization, packaging, design verification). The document explicitly states that no clinical testing was performed, and the substantial equivalence determination was not based on an assessment of clinical performance data. Therefore, all questions pertaining to clinical studies, human readers, AI, or expert ground truth are not applicable to the information provided in this FDA letter.

Summary

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September 27, 2023

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SeaSpine Orthopedics Corporation Cindy Toyama Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K232668

Trade/Device Name: Cove Strip, OsteoCove Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: August 31, 2023 Received: September 1, 2023

Dear Cindy Toyama:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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Indications for Use

510(k) Number (if known) K232668

Device Name Cove Strip

Indications for Use (Describe)

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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Indications for Use

510(k) Number (if known) K232668

Device Name OsteoCove Strip

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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."

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510(k) Summary

K232668

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(949) 855-7175
Fax number:	(760) 683-6874
Contact Person:	Cindy Toyama, Regulatory Affairs Specialist
Date Prepared:	September 26, 2023

Device Name

Device/Trade Name:	Cove Strip, OsteoCove Strip
Common Name:	Bone Void Filler
Classification Name:	Filler, Bone Void, Calcium Compound (21 CFR 888.3045)
Class:	II
Product Code:	MQV

Legally Marketed Predicate Device

510(k) Number	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K230486	MQV	Cove Strip, OsteoCove Strip	IsoTis OrthoBiologics, Inc.

Device Description

Cove Strip:

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to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a double blister tray configuration.

OsteoCove Strip:

Indications for Use

Cove Strip:

OsteoCove Strip:

Summary of Technological Characteristics

The subject device is similar to the cited predicate device in regard to components, device description, indications for use, device characteristics (i.e., design, materials, sterility, manufacturing, packaging, sterility, etc.), and performance. Compared to the predicate device, the subject device is longer; as such, the packaging was scaled accordingly. All materials, designs, and configurations are equivalent.

Summary of Non-Clinical Testing to Support Substantial Equivalence

The subject device is similar to the predicate device in terms of materials, manufacturing process, and intended use. Non-clinical testing was not performed on the subject device, as the subject device does not introduce a new worst case, for the following: biocompatibility and in vivo (animal) safety and performance.

Equivalency was established with the predicate device consisting of similar product sizing and packaging that allowed the adoption of the sterilization validation. Sterilization complies with ISO 11135, Sterilization of health care products-Ethylene Oxide-Requirements to ensure a sterility assurance level (SAL) of 10-6.

The following verification and validation activities were evaluated for the subject device:

1. Design Verification

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1. Ethylene Oxide (EO) Adoption
1. Limulus Amebocyte Lysate (LAL) Kinetic Turbidimetric Validation
1. Packaging Shipping Validation
1. Packaging Shelf Life Validation
1. Design (User) Validation
1. Process Performance Qualification

All activities were executed successfully to demonstrate substantial equivalence.

Clinical Testing

Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.

Conclusions

The submitted data demonstrate that the subject device is substantially equivalent to the cited legally marketed predicate.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.