(167 days)
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No
The description focuses on the mechanical design and intended use of a spinal implant, with no mention of AI or ML capabilities.
Yes
The device is an Anterior Lumbar Interbody Fusion (ALIF) device intended to facilitate fusion in patients with Degenerative Disc Disease, which is a therapeutic intervention.
No.
The device is an Interbody Fusion Device used for surgical correction of Degenerative Disc Disease, rather than for diagnosing conditions.
No
The device description clearly states it is an "Interbody Fusion Device" made of titanium with integrated fixation plates, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Camber Spine Technologies ENZA™-A Titanium ALIF is an implantable medical device used in spinal fusion surgery. It is surgically placed within the body to facilitate the fusion of vertebrae.
- Intended Use: The intended use is to treat Degenerative Disc Disease by providing structural support and a space for bone graft to promote fusion. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The provided information clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by pairent history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Camber Spine Technologies ENZA™-A Titanium ALIF is an Interbody Fusion Device that has a hollow chamber to permit packing with autogenous graft material to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior and inferior anchoring plates. These implants may be implanted via a laparoscopic or an open anterior approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed indicate that the ENZA ™ - A Titanium ALIF is as mechanically soundas predicate devices. Testing included static compression, static compression-shear, dynamiccompression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
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.
Not Found
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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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Camber Spine Technologies % Paul Speidel Lead Regulatory Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913 April 18, 2018
Re: K173432
Trade/Device Name: ENZA™-A Titanium ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 6, 2018 Received: March 16, 2018
Dear Mr. Speidel:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173432
Device Name
ENZATM-A Titanium ALIF
Indications for Use (Describe)
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by pairent history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
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
Camber Spine Technologies ENZA™-A Titanium ALIF
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087 Phone: 484.318.8031
Contact Person: Mr. Damian Heinz Engineering Support Manager The Institute for Musculoskeletal Science and Education 418 E. LancasterAve. Wayne, PA 19087 Phone: 484.420.4286 Fax: 484.318.8031 Email: dheinz@imseinstitute.org
Date Prepared: April 18, 2018
Name of Device and Name/Address of Sponsor
Trade Name: ENZA™-A Titanium ALIF Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087
Common or Usual Name
Device Type: Intervertebral Fusion Device with Bone Graft, Lumbar
Classification Name
Intervertebral body fusion device (21 CFR 888.3080) (Product Code: OVD)
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Predicate Devices
The subject ENZA™-A Titanium ALIF device was demonstrated to be substantially equivalent to predicates Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device (K153720) and Camber Spine SPIRA Open Matrix ALIF Device (K162986) with respect to indications, design, materials, function, manufacturing, and/or performance.
The primary predicate device is ENZAZero-Profile Anterior Interbody Fusion Device (K153720).
Device Description
The Camber Spine Technologies ENZA™-A Titanium ALIF is an Interbody Fusion Device that has a hollow chamber to permit packing with autogenous graft material to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior and inferior anchoring plates. These implants may be implanted via a laparoscopic or an open anterior approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.
Intended Use / Indications for Use
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discoqenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
Technological Characteristics
The Camber Spine Technologies ENZA™-A Titanium ALIF is an Interbody Fusion Device that has spiral supportarches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.
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Performance Data
Testing performed indicate that the ENZA ™ - A Titanium ALIF is as mechanically soundas predicate devices. Testing included static compression, static compression-shear, dynamiccompression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Substantial Equivalence
The ENZA ™-A Titanium ALIF is as safe and effective as the Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device (K153720) and Camber Spine SPIRA Open Matrix ALIF Device (K162986). The ENZA™-A Titanium ALIF has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technologicaldifferencesbetweentheENZA™-A Titanium ALIF anditspredicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that ENZA™-A Titanium ALIF is as safe and effective as Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device (K153720)and Camber Spine SPIRA Open Matrix ALIF Device (K162986). The ENZA™-A Titanium ALIF is substantially equivalent.