(307 days)
No
The summary describes a physical implant device (cervical cage and VBR system) made of CFR-PEEK and titanium. There is no mention of software, algorithms, image processing, or any terms related to AI/ML in the intended use, device description, or performance studies.
Yes
The device is intended for intervertebral body fusion procedures and to replace diseased or damaged vertebral bodies, which are therapeutic interventions aimed at treating medical conditions.
No
Explanation: This device is a cervical cage and vertebral body replacement system, designed for intervertebral body fusion and to replace diseased or damaged vertebral bodies. It is an implantable medical device used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the device is composed of implants and instruments made of physical materials (CFR-PEEK and titanium alloy), indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the CarboClear Cervical Cage System and VBR System are implants designed for surgical procedures within the cervical spine. They are physical devices intended to replace or support vertebral bodies.
- Lack of Mention of Biological Samples or Testing: The text does not mention any analysis of biological samples or any diagnostic testing being performed by the device.
Therefore, the CarboClear Cervical Cage System and VBR System are medical devices intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 – T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Patients should receive at least six (6) weeks of non-operative treatment with the CarboClear Cervical Cage System.
The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 - T1).
The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems).
When used at more than two levels, supplemental fixation should include posterior fixation. The use of allograft or autograft with the CarboClear Cervical VBR device is optional.
Product codes (comma separated list FDA assigned to the subject device)
ODP, PLR
Device Description
-
CarboClear Cervical Cage System is composed of implants of various sizes, and of instruments. Cage is is made of of carbon CarboClear Cervical fiber-reinforced The polyetheretherketone (CFR-PEEK), with titanium alloy endplates.
-
The CarboClear Cervical VBR System is composed of implants (spacers) in various sizes, and of instruments. The CarboClear Cervical VBR spacers are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2 – T1
Indicated Patient Age Range
skeletally mature patients
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)
Performance characteristics, including static and dynamic axial compression tests (according to ASTM F2077); static and dynamic compression-shear tests (according to ASTM F2077); static and dynamic torsion tests (according to ASTM F2077); wear debris evaluation; and subsidence test (according to ASTM F2267), as applicable to each of the devices, are comparable to those of predicate devices (where applicable), thus demonstrating that the devices are safe and effective for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
July 26, 2023
CarboFix Orthpedics Ltd. Yael Rubin Director of Regulatory Affairs 11 Ha'Hoshlim Street Herzeliya, 4672411 Israel
Re: K222874
Trade/Device Name: CarboClear® Cervical Cage System, CarboClear® Cervical VBR System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, PLR Dated: June 14, 2023 Received: June 14, 2023
Dear Yael Rubin:
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
1
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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Page 1 of 2
510(k) Number (if known) K222874
Device Name
CarboClear® Cervical Cage System
Indications for Use (Describe)
The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 – T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Patients should receive at least six (6) weeks of non-operative treatment with the CarboClear Cervical Cage System.
| 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
K222874 Page 2 of 2
510(k) Number (if known)
Device Name CarboClear® Cervical VBR System
Indications for Use (Describe)
The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 - T1).
The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems).
When used at more than two levels, supplemental fixation should include posterior fixation. The use of allograft or autograft with the CarboClear Cervical VBR device is optional.
| 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
CarboFix Orthopedics Ltd.
CarboClear® Cervical Cage System; CarboClear® Cervical VBR System
Applicant Name
CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Yael Rubin CarboFix Orthopedics, Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
September 2022
Trade/Proprietary Name
-
- CarboClear® Cervical Cage System
-
- CarboClear® Cervical VBR System
Common Name
-
- Intervertebral Body Fusion Device Cervical
-
- Spinal Vertebral Body Replacement Device Cervical
5
Regulation Number and Device Class
-
- 21 CFR §888.3080; Class II
-
- 21 CFR $888.3060; Class II
Product Code and Review Panel
-
- ODP; Orthopedic
-
- PLR; Orthopedic
Predicate Devices
Primary
-
- For CarboClear Cervical Cage System ALTA Cervical Interbody Spacer (Astura Medical; K160154, and more)
-
- For CarboClear Cervical VBR System HAWKEYE™ Vertebral Body Replacement (VBR) System (Choice Spine; K183588)
Additional
-
- CarboClear VBR System (CarboFix Orthopedics Ltd.; K192214)
Indications for Use
CarboClear Cervical Cage System
The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 - T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
6
The implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the CarboClear Cervical Cage System.
CarboClear Cervical VBR System
The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 – T1).
The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems).
When used at more than two levels, supplemental fixation should include posterior fixation.
The use of allograft or autograft with the CarboClear Cervical VBR device is optional.
7
System Description
-
- CarboClear Cervical Cage System is composed of implants of various sizes, and of instruments.
Cage is is made of of carbon CarboClear Cervical fiber-reinforced The polyetheretherketone (CFR-PEEK), with titanium alloy endplates.
- CarboClear Cervical Cage System is composed of implants of various sizes, and of instruments.
-
- The CarboClear Cervical VBR System is composed of implants (spacers) in various sizes, and of instruments.
The CarboClear Cervical VBR spacers are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.
- The CarboClear Cervical VBR System is composed of implants (spacers) in various sizes, and of instruments.
Performance Data
Performance characteristics, including static and dynamic axial compression tests (according to ASTM F2077); static and dynamic compression-shear tests (according to ASTM F2077); static and dynamic torsion tests (according to ASTM F2077); wear debris evaluation; and subsidence test (according to ASTM F2267), as applicable to each of the devices, are comparable to those of predicate devices (where applicable), thus demonstrating that the devices are safe and effective for their intended use.
Substantial Equivalence
The CarboClear Cervical Cage and Cervical VBR Systems intended use, design, dimensions, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
8
Conclusion
Based on the information provided in this 510(k) Premarket Notification, the subject CarboClear Cervical Cage and Cervical VBR Systems are substantially equivalent to their predicate devices.