K Number
K230486
Device Name
Cove Strip
Date Cleared
2023-08-21

(179 days)

Product Code
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 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 process. Cove 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 (B-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.
More Information

Not Found

No
The description focuses on the material composition and intended use as a bone graft extender, with no mention of AI or ML technologies. The performance study is an in vivo animal study, not a study of an AI/ML algorithm's performance.

No.
The device is described as an implant used to fill bony voids or gaps and support new bone formation, rather than treating or preventing a disease or condition.

No

The device description indicates that Cove Strip is an implant intended to fill bony voids or gaps as a bone graft extender, and its composition is ceramic granules combined with highly purified Type-1 collagen. This functionality aligns with therapeutic or reconstructive purposes rather than diagnostic ones.

No

The device description clearly states it is an implant comprised of ceramic granules and collagen, which are physical materials, not software.

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

Here's why:

  • Intended Use: The intended use clearly states that Cove Strip is an implant intended to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function within the body.
  • Device Description: The description details the composition of the implant (ceramic granules and collagen) and its physical form (strip). This aligns with a medical device intended for implantation.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples and provide diagnostic information. Cove Strip is used inside the body as a structural implant.

N/A

Intended Use / Indications for Use

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 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 process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Product codes

MQV

Device Description

Cove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (B-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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

posterolateral spine and pelvis

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

Non-clinical testing performed on the subject device includes tests for biocompatibility and bacterial endotoxin to establish safety. Biocompatibility was performed in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Bacterial endotoxin testing complies with AAMI ST72 Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing, USP Bacterial Endotoxin Test, and USP, Medical Devices – Bacterial Endotoxin and Pyrogen Tests, and has been validated ensure a BET limit of

§ 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.

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

August 21, 2023

SeaSpine Orthopedics Corporation Cindy Toyama Regulatory Affairs Specialist 2 Goodyear Irvine, California 92618

Re: K230486

Trade/Device Name: Cove Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV Dated: July 22, 2023 Received: July 24, 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 (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

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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 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 (QS) 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,

Image /page/1/Picture/5 description: The image shows the name "Jesse Muir-S" in a large, bold, sans-serif font. The text is black and stands out against a white background. There is a faint, light blue watermark in the background, partially obscuring the text.

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

Enclosure

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Indications for Use

510(k) Number (if known) K230486

Device Name Cove Strip

Indications for Use (Describe)

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 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 process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

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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510(k) Summary

K230486

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:June 21, 2023

Device Name

Device/Trade Name:Cove 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) NumberProduct CodeTrade NameManufacturer
Primary Predicate Device
K140375MQVMASTERGRAFT PuttyMedtronic Sofamor
Danek USA, Inc.
Additional Predicate Device
K063124MQVIntegra MOZAIK™ Bone
Regeneration Matrix — Strip*Integra LifeSciences
Corporation

*Since the most recently cleared 510(k) for the predicate device, Integra MOZAK™ Osteoconductive Scaffold – Strip (K063124), under contractual agreements between IsoTis OrthoBiologics, Inc. and Integra LifeSciences Corporation, the device has been rebranded under a new trade name for IsoTis OrthoBiologics, Inc., and will herein be referred to as "IsoTis Mozaik Strip". IsoTis Mozaik Strip is legally manufactured by IsoTis OrthoBiologics, Inc.

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Device Description

Cove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (B-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.

Indications for Use

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.

Summary of Technological Characteristics

The subject device is identical or similar to the cited predicate devices in regard to intended use/indications for use, device description, technological characteristics (i.e. design, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., in vivo performance (animal) study).

Summary of Non-Clinical Testing to Support Substantial Equivalence

Non-clinical testing performed on the subject device includes tests for biocompatibility and bacterial endotoxin to establish safety. Biocompatibility was performed in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Bacterial endotoxin testing complies with AAMI ST72 Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing, USP Bacterial Endotoxin Test, and USP, Medical Devices – Bacterial Endotoxin and Pyrogen Tests, and has been validated ensure a BET limit of ≤20 EU/Device.

Equivalency was established with a predicate device consisting of identical product sizing and packaging that allowed us to adopt 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.

An in vivo (animal) study for safety and performance demonstrated comparable resorption, remodeling and rates of fusion when compared to a legally marked predicate. The study employed various analyses and endpoints were assessed at several time points. The subject device was also assessed per ISO 10993-6:2016 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation.

Clinical Testing

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

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Conclusions

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