(62 days)
No
The summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for spinal fusion procedures to treat degenerative disc disease, which involves mitigating a medical condition, thereby qualifying it as a therapeutic device.
No
The device is an interbody fusion system intended for spinal fusion procedures, acting as an implant to aid in stabilization and fusion, not to diagnose a condition.
No
The device description explicitly states that the device is manufactured from Commercially Pure (Unalloyed) Titanium and includes instruments made from polymer and stainless steel, indicating it is a physical implant and associated hardware, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the CancelleX Porous Titanium Lumbar Interbody System is an implantable device intended for spinal fusion procedures. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Lack of IVD-related information: The text does not mention any testing of biological samples, analysis of biomarkers, or any other activities typically associated with IVDs.
Therefore, the CancelleX Porous Titanium Lumbar Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>=20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: Analysis was performed according to ISO 10993-1:2009 and biological effects were considered based on FDA Guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."
Bench Testing: Substantial equivalence of the CancelleX Porous Titanium Interbody Device was supported by evaluation for static and dynamic axial compression and compression shear testing per ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), subsidence testing per ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression), and Expulsion testing.
Animal Study: Animal performance data was not required to determine substantial equivalence.
Clinical Studies: Clinical performance data was not required to determine substantial equivalence.
Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent.
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.
K180373, K143158, K150481, K152011
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.
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Xenco Medical, LLC. - CancelleX Porous Titanium Lumbar Interbody Device
510(k) SUMMARY
K190364 Page 1 of 3
l. SUBMITTER
Xenco Medical, LLC.
9930 Mesa Rim Road San Diego, CA 92121 USA Phone: 858-202-1505 Fax: 858-202-1549
Contact at Xenco Medical: Jason Haider, CEO Email: jhaider@xencomedical.com
Official Correspondent
Korina A. Akhondzadeh KARA & Associates - Regulatory Consultant to Xenco Medical 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009
760-798-9642 Phone: Fax: 760-798-9643 korina@kara2a.com Email:
Date Prepared: 04/16/2019
Establishment Registration: 3011181154
II. DEVICE
SUBJECT DEVICE
Trade Name: CancelleX Porous Titanium Lumbar Interbody System Common Name: Intervertebral fusion device with bone graft, lumbar Classification Name: Intervertebral body fusion device Regulation: 21 CFR 888.3080 Device Class: Class II Product Code: MAX Review Panel: Orthopedic
PREDICATE DEVICES
| Type | 510(k) # | Trade Name | Manufacturer | Product
Code |
|---------|----------|----------------------------------|----------------|-----------------|
| Primary | K180373 | CancelleX Porous Titanium Lumbar | Xenco Medical, | MAX |
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Xenco Medical, LLC. - CancelleX Porous Titanium Lumbar Interbody Device
| Predicate | Interbody Device | LLC. | ||
|---|---|---|---|---|
| Additional Predicates | ||||
| Predicate | K143158 | Xenco Medical Lumbar Interbody System | Xenco Medical, LLC. | MAX |
| Predicate | K150481 | Cascadia Interbody System | K2M | MAX |
| Predicate | K152011 | Lucent XP Ti-Bond® | Spinal Elements, Inc. | MAX |
| Reference Predicates | ||||
| Reference | K102019 | Restoration Acetabular Wedge Augments | Howmedica / Stryker Orthopedic | LPH |
III. DEVICE DESCRIPTION
CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.
IV. INDICATIONS FOR USE
CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.
V. TECHNOLOGICAL CHARACTERISTICS
The subject device is substantially equivalent to the cited legally marketed predicate devices. The subject device has equivalent technological characteristics including design, materials, operating principle and indications for use.
VI. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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Biocompatibility Testing
Analysis was performed according to ISO 10993-1:2009 and biological effects were considered based on FDA Guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."
Bench Testing
Substantial equivalence of the CancelleX Porous Titanium Interbody Device was supported by evaluation for static and dynamic axial compression and compression shear testing per ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), subsidence testing per ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression), and Expulsion testing.
Animal Study
Animal performance data was not required to determine substantial equivalence.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
VII. CONCLUSIONS
Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent.
3
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.
Page 1 of 1
510(k) Number (if known) K190364
Device Name
CancelleX Porous Titanium Lumbar Interbody Device
Indications for Use (Describe)
CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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April 18. 2019
Xenco Medical, LLC % Korina A. Akhondzadeh Sr. Regulatory Consultant to Xenco Medical KARA & Associates 6965 El Camino Real Suite 105-428 Carlsbad, California 92009
Re: K190364
Trade/Device Name: CancelleX Porous Titanium Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 14, 2019 Received: February 19, 2019
Dear Ms. Akhondzadeh:
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.
5
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure