(88 days)
No
The summary describes a physical implant and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for intervertebral body fusion of the lumbar spine in patients with degenerative disc disease, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is an implantable lumbar cage system designed to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description explicitly states it is composed of implants and instruments, which are physical hardware components, not software.
Based on the provided text, the CarboClear® Lumbar Cage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the CarboClear® Lumbar Cage System is an implantable device used for intervertebral body fusion in the lumbar spine. It is a physical device implanted into the body, not a device that analyzes samples taken from the body.
- Lack of IVD-related information: The text does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD device.
Therefore, the CarboClear® Lumbar Cage System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
CarboClear® Lumbar Cage System is composed of implants of various sizes, and instruments.
The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2 to S1
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 included static and dynamic axial compression tests according to ASTM F2077; static and dynamic compression-shear tests according to ASTM F2077; wear evaluation; subsidence test according to ASTM F2267; expulsion test; and endplate shear test according to ASTM F1044. Test results demonstrated that the device is substantially equivalent to the identified predicates.
In addition, bacterial endotoxin testing was conducted for the CarboClear® Lumbar Cage.
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
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March 2, 2020
CarboFix Orthopedics Ltd. Ms. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'hoshlim St. Herzeliya 4672411 Israel
Re: K193378
Trade/Device Name: CarboClear® Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 3, 2019 Received: December 5, 2019
Dear Ms. Wachsler-Avrahami:
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.
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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 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 L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal 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)
K193378
Device Name CarboClear® Lumbar Cage System
Indications for Use (Describe)
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
| 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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K193378 510(K) Summary
CarboFix Orthopedics Ltd. CarboClear®Lumbar Cage System
Applicant Name
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Hila Wachsler-Avrahami CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
December 3, 2019
Trade/Proprietary Name
CarboClear® Lumbar Cage System
Common Name
Intervertebral Body Fusion Device
Regulation Number and Device Class
21 CFR §888.3080; Class II
Product Code and Review Panel
MAX; Orthopedic
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Predicate Devices
Primary Predicates
- CONCORDE® Bullet Lumbar Interbody System (DePuy Spine, Inc.; K151773, and . more)
Additional Predicates
- FORZA® PTC Spacer System (Orthofix Inc.; K152475) .
- icotec Interbody Cage System (icotec ag; K172480) .
Reference Devices
With regards to the materials incorporated into the system components, comparison is also made to the following cleared products by the Company:
- " CarboClear VBR System (CarboFix Orthopedics Ltd.; K192214)
- CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377)
Indications for Use
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
5
System Description
CarboClear® Lumbar Cage System is composed of implants of various sizes, and instruments.
The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.
Performance Data and Substantial Equivalence
The CarboClear® Lumbar Cage System intended use, design, dimensions, material, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
Performance characteristics included static and dynamic axial compression tests according to ASTM F2077; static and dynamic compression-shear tests according to ASTM F2077; wear evaluation; subsidence test according to ASTM F2267; expulsion test; and endplate shear test according to ASTM F1044. Test results demonstrated that the device is substantially equivalent to the identified predicates.
In addition, bacterial endotoxin testing was conducted for the CarboClear® Lumbar Cage.
Conclusion
Based on the information provided in this Premarket Notification, the subject CarboClear® Lumbar Cage System is substantially equivalent to its predicate devices.