(156 days)
No
The device description and performance studies focus on the material composition and biological performance of a bone graft putty, with no mention of AI or ML technology.
Yes
The product is intended to fill voids and gaps in the skeletal system, supporting new bone formation, which directly aids in healing and restoring physiological function to an injured or defective area of the body.
No
The device, Cove Putty, is intended to fill voids and gaps in the skeletal system as a bone graft extender, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical putty formulated with collagen, ceramic granules, and a polymer carrier, intended to be implanted in the skeletal system. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 putty made of collagen, ceramic granules, and a polymer carrier, designed to be implanted into the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the body. IVDs are used to perform tests on samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
This device is clearly intended for surgical implantation and bone regeneration, which falls outside the scope of In Vitro Diagnostics.
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 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.
OsteoCove 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. OsteoCove Putty is hydrated with saline at the point-of-use.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
A sterilization validation was performed and complies with ISO 11137, Sterilization of Health Care Products – Radiation 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.
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
September 14, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
SeaSpine Orthopedics Corporation Cindy Toyama Regulatory Affairs Specialist 2 Goodyear Irvine, California 92618
Re: K231030
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: August 9, 2023 Received: August 11, 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 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
1
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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K231030
Device Name Cove Putty
Indications for Use (Describe)
Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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."
3
Indications for Use
510(k) Number (if known) K231030
Device Name OsteoCove Putty
Indications for Use (Describe)
OsteoCove 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. OsteoCove Putty is hydrated with saline at the point-of-use.
| 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
K231030
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: | August 9, 2023 |
Device Name
| 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 |
Legally Marketed Predicate Device
| 510(k) Number | Product Code | Trade Name | Manufacturer | |
|---|---|---|---|---|
| Primary Predicate Device | ||||
| K140375 | MQV | MASTERGRAFT Putty | Medtronic Sofamor | |
| Danek USA, Inc. | ||||
| Additional Predicate Devices | ||||
| K062353 | MQV | Integra MOZAIK™ Bone | ||
| Regeneration Matrix — Putty* | Integra LifeSciences | |||
| Corporation | ||||
| K212135 | MQV, MBP | Torrent/Torrent C** | IsoTis OrthoBiologics, | |
| Inc.*** |
5
*Since the most recently cleared 510(k) for the predicate device, Integra MOZAK™ Osteoconductive Scaffold – Putty (K062353), 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 Putty". IsoTis Mozaik Putty is legally manufactured by IsoTis OrthoBiologics, Inc.
**Since the most recently cleared 510(k) for the predicate device, Dry DBM-A Putty (K212135), the device has been rebranded under a new trade name and will herein be referred to as "Torrent/Torrent C".
***soTis OrthoBiologics, Inc. is a subsidiary of SeaSpine Orthopedics Corporation. The subject and predicate device, Torrent/Torrent C, are both manufactured by IsoTis.
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-ofuse.
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.
A sterilization validation was performed and complies with ISO 11137, Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 10°.
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.
6
Clinical Testing
Not applicable; 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.