(55 days)
No
The device description and performance studies focus on the material properties and biological function of a bone graft putty, with no mention of AI or ML technologies.
Yes
The device is intended to fill voids and gaps in the skeletal system and support new bone formation, which directly treats or alleviates a medical condition.
No
Cove Putty is a bone graft extender intended to fill voids and gaps in the skeletal system, not to diagnose medical conditions.
No
The device description clearly states it is a "putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Cove Putty is to fill voids and gaps in the skeletal system and act as a bone graft extender. This is a therapeutic and structural function within the body.
- Device Description: The device is a physical implant (putty) made of collagen, ceramic granules, and a polymer carrier. It is designed to be placed directly into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease. IVDs are typically used to test blood, urine, tissue, etc., outside of the body.
The device is clearly intended for surgical implantation and bone regeneration, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use. When used in intervertebral body fusion procedures, Cove Putty must be used as a bone graft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Product codes
MQV
Device Description
Cove Putty is formulated into a putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout. The combined collagen and ceramic provide osteoconductive substrates that support new bone formation. Cove Putty 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 standard syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, posterolateral spine, pelvis, intervertebral body space
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 originally submitted as part of 510(k) K231030 was performed on the subject device to establish biocompatibility bacterial endotoxin safety. A sterilization for the subject device was submitted as part of 510(k) K231030 to ensure a sterility assurance level (SAL) of 10-6. An in vivo animal study for safety and performance submitted as part of 510(k) K231030 demonstrated Cove Putty functions as intended in terms of resorption, remodeling, and rates of fusion when compared to a legally marketed predicate. Expansion of the Cove Putty Indications for Use statement to employ the subject device in the intervertebral body space is supported by a clinical rationale included in the subject submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2024
SeaSpine Orthopedics Corporation Patrick Hughes Regulatory Affairs Program Manager 5770 Armada Drive Carlsbad, California 92008
Re: K242273
Trade/Device Name: Cove Putty, OsteoCove Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: July 31, 2024 Received: August 1, 2024
Dear Mr. Hughes:
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 (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"
1
(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
JESSE MUIR - Digitally signed by JESSE
- MUIR - MUIR - MUIR - S Date: 2024.09.25
10:59:17 -04'00' S 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
3
Indications for Use
510(k) Number (if known) K242273
Device Name Cove Putty, OsteoCove Putty
Indications for Use (Describe)
Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use. When used in intervertebral body fusion procedures, Cove Putty must be used as a bone graft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
| 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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
4
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA 92008 |
| Phone number: | (352) 359-7940 |
| Fax number: | (760) 683-6874 |
| Contact: | |
| Date Prepared: | Patrick Hughes, Regulatory Affairs Program Manager |
| September 24, 2024 |
Subject Device
| Device/Trade Name: | Cove Putty, OsteoCove Putty |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name: | Filler, Bone Void, Calcium Compound (21 CFR 888.3045) |
| Class: | II |
| Product Code: | MQV |
Predicate Devices
-
- NuVasive AttraX Putty cleared per 510(k) submission K203714
Reference Devices
Device Description
Cove Putty is formulated into a putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout. The combined collagen and ceramic provide osteoconductive substrates that support new bone formation. Cove Putty 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 standard syringe.
Indications for Use
Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use. When used in intervertebral body fusion procedures, Cove Putty must be used as a bone graft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Summary of Technological Characteristics
The subject device is identical to Cove Putty cleared per 510(k) submission K231030. The subject device is similar to the cited predicate NuVasive AttraX Putty and reference SIGNAFUSE Putty in regard to intended use, indications, and key technological characteristics (i.e., design, materials, manufacturing, labeling, sterility, etc.).
5
Summarv of Non-Clinical Testing
Non-clinical testing originally submitted as part of 510(k) K231030 was performed on the subject device to establish biocompatibility bacterial endotoxin safety. A sterilization for the subject device was submitted as part of 510(k) K231030 to ensure a sterility assurance level (SAL) of 10 °. An in vivo animal study for safety and performance submitted as part of 510(k) K231030 demonstrated Cove Putty functions as intended in terms of resorption, remodeling, and rates of fusion when compared to a legally marketed predicate. Expansion of the Cove Putty Indications for Use statement to employ the subject device in the intervertebral body space is supported by a clinical rationale included in the subject submission.
Conclusions
Subject Cove Putty is the same device as Cove Putty cleared per 510(k) submission K231030. Subject Cove Putty is substantially equivalent to cited predicate AttraX Putty as well as reference SIGNAFUSE Putty. Per testing previously submitted as part of 510(k) K231030, any differences in technological characteristics between the subject device, predicate AttraX Putty, and reference SIGNAFUSE Putty do not raise questions of safety and effectiveness. Based on the clinical rationale included in this submission and the establishment of substantial equivalence to cited predicates, Cove Putty may be indicated for use in intervertebral body fusion procedures as a bone graft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler.