(108 days)
Not Found
No
The 510(k) summary describes a passive interbody fusion device and does not mention any AI or ML capabilities. The performance studies focus on mechanical testing, not algorithmic performance.
Yes
This device is an interbody fusion device intended to treat cervical disc degeneration and/or cervical spinal instability, and degenerative disc disease, which are therapeutic indications.
No
The device, eCarbon IBDs, is an implant used for spinal fusion procedures. It is a therapy device, not a diagnostic device. The imaging studies mentioned (radiographs, CT, MRI) are used to confirm the patient's condition, not as outputs of the device itself.
No
The device description clearly states that the eCarbon IBDs are a collection of interbody devices, which are physical implants. The performance studies also describe mechanical testing of these implants. This indicates the device is hardware, not software only.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The eCarbon IBDs are physical implants designed to be surgically placed in the spine to facilitate fusion. They are not used to analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The description details the physical characteristics of the implants, not a diagnostic assay or testing system.
The device is a surgical implant used in the treatment of spinal conditions, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
Product codes
ODP, MAX
Device Description
The eCarbon IBDs are a collection of interbody devices. The cervical implants (eCarbon-C) have basic keystone shape in a columnar form while the lumbar devices (eCarbon-P) are essentially rectangular. All have a central cavity for bone graft and are offered in a variety of height, length, width and lordotic angulation combinations are available to accommodate the anatomic requirements of individual patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 - T1 (Cervical), L2-S1 (Lumbar)
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)
Mechanical testing of the worst case eCarbon cervical implant included static and dynamic compression and static and dynamic torsion according to ASTM F2077. Mechanical testing of the worst case eCarbon lumbar implant included static and dynamic compression according to ASTM F2077. In addition, both worst case eCarbon implants were evaluated for subsidence according to ASTM F2267 and expulsion testing.
The test results demonstrated equivalent mechanical performance of the eCarbon cervical and lumbar IBDs compared to the cited predicate devices under the same test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160125, K111792, K043479/K091088
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 26, 2019
Back 2 Basics Direct, LLC % Karen Warden, PhD President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026
Re: K191537
Trade/Device Name: eCarbon IBDs Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 2, 2019 Received: September 4, 2019
Dear Dr. Warden:
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
1
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 (OS) 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,
for Ronald P. Jean, PhD Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name eCarbon IBDs
Indications for Use (Describe)
The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
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
| Date: | 7 June 2019 |
|---|---|
| Sponsor: | Back 2 Basics Direct, LLC |
| 6701 Rockside Road, Suite 200 | |
| Independence, OH 44131 | |
| Office: 216.447.5205 | |
| Fax: 216.447.6071 | |
| Sponsor Contact: | Scot Miller, DO, Principal |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | eCarbon IBDs (eCarbon-C and eCarbon-P) |
| Common Name: | Cervical and lumbar interbody fusion devices |
| Device Classification: | Class II |
| Regulation Names, | |
| Regulation Numbers, | |
| Product Codes: | Intervertebral fusion device with bone graft, 888.3080, cervical, ODP |
| Intervertebral fusion device with bone graft, 888.3080, lumbar, MAX | |
| Device Description: | The eCarbon IBDs are a collection of interbody devices. The cervical |
| implants (eCarbon-C) have basic keystone shape in a columnar form while | |
| the lumbar devices (eCarbon-P) are essentially rectangular. All have a | |
| central cavity for bone graft and are offered in a variety of height, length, | |
| width and lordotic angulation combinations are available to accommodate | |
| the anatomic requirements of individual patients. | |
| Indications for Use: | The eCarbon-C is intended for anterior intervertebral body fusion in |
| skeletally mature patients who have had at least six weeks of non-operative | |
| treatment. The eCarbon-C is indicated to treat cervical disc degeneration | |
| and/or cervical spinal instability, as confirmed by imaging studies | |
| (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or | |
| pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to | |
| be used with supplemental fixation. The implants are designed for use with | |
| autogenous and/or allogeneic bone graft comprised of cancellous and/or | |
| corticocancellous bone to facilitate fusion. | |
| The eCarbon-P is intended for spinal fusion procedures in skeletally mature | |
| patients with degenerative disc disease (defined as discogenic back pain | |
| with degeneration of the disc confirmed by history and radiographic studies) | |
| at one or two contiguous spinal levels from L2-S1. These patients should | |
| have had six months of nonoperative treatment. These patients may have | |
| had a previous non-fusion spinal surgery and/or may have up to Grade 1 | |
| spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, | |
| the eCarbon-P can be used as an adjunct to fusion in patients diagnosed | |
| with degenerative scoliosis. The eCarbon-P is to be used with autograft | |
| and/or allograft comprised of cancellous and/or corticocancellous bone graft | |
| and with supplemental fixation indicated for lumbar spinal fusion | |
| procedures. | |
| Materials: | The eCarbon IBDs are manufactured from PEEK-OPTIMA Ultra Reinforced |
| polymer (PEEK-OPTIMA per ASTM F2026 and carbon fibers). Integral | |
| markers are manufactured from gold wire (per ASTM B562). | |
| Primary Predicate: | Cascadia Interbody System (K2M Inc. - K160125) |
| Additional Predicates: | KIMBA® and KIMBA® Mini (SIGNUS Medizintechnik GmbH – K111792), |
| MC+ (LDR Holding – K043479/K091088) | |
| Performance Data: | Mechanical testing of the worst case eCarbon cervical implant included |
| static and dynamic compression and static and dynamic torsion according | |
| to ASTM F2077. Mechanical testing of the worst case eCarbon lumbar | |
| implant included static and dynamic compression according to ASTM | |
| F2077. In addition, both worst case eCarbon implants were evaluated for | |
| subsidence according to ASTM F2267 and expulsion testing. |
The test results demonstrated equivalent mechanical performance of the
eCarbon cervical and lumbar IBDs compared to the cited predicate
devices under the same test conditions. |
| Technological
Characteristics: | The eCarbon IBDs possess the same technological characteristics as one
or more of the predicate devices. These include:
• intended use (as described above)
• basic design (structural column),
• material (reinforced polymer) and
• sizes (dimensions are comparable to those offered by the predicate
systems)
Therefore the fundamental scientific technology of the eCarbon IBDs is the
same as previously cleared devices. |
| Conclusion: | The eCarbon IBDs possess the same intended use and technological
characteristics as the predicate devices. Therefore the eCarbon IBDs are
substantially equivalent for their intended use. |
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