(127 days)
No
The summary describes a mechanical interbody fusion device with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is implanted to treat degenerative disc disease and facilitate fusion between vertebrae, which is a therapeutic intervention.
No
This device is an interbody fusion device, designed to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose a condition.
No
The device description clearly states it is an "Interbody Fusion Device" with a "hollow chamber," "superior and inferior surfaces with a pattern of teeth," and a "built-in fixation mechanism," all of which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is an implantable surgical device designed to be placed between vertebrae to facilitate spinal fusion. It is a structural device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for treating degenerative disc disease and facilitating fusion, not for diagnosing a condition based on in vitro testing.
- Device Description: The description details its physical structure and how it functions mechanically within the body, not how it analyzes biological samples.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is an Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device has a built-in fixation mechanism that is manually deployed into the vertebral bodies by the operating surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies.
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Testing performed indicate that the ENZA Zero-Profile Anterior Interbody Fusion is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. Wear testing was also performed to evaluate wear particulate. Additionally, blade deployment testing was conducted to evaluate blade performance. 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.
LDR ROI-A (K110327), Theken Spine Vu aPOD (K101310)
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.
Renovis S128 PEEK ALIF (K131122), Centinel Spine STALIF TT (K073109), Alphatec Spine Solus Zero Profile Cage (K123993)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and support. The profiles are black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
Camber Spine Technologies % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K153720
Trade/Device Name: ENZA Zero-Profile Anterior Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: April 1, 2016 Received: April 4, 2016
Dear Mr. Eggleton:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
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)
Device Name
ENZA Zero-Profile Anterior Interbody Fusion
Indications for Use (Describe)
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).
| 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)
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510(k) Summary
| Device Trade Name: | ENZA Zero-Profile Anterior Interbody Fusion |
|---|---|
| Manufacturer: | Camber Spine Technologies |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact: | Mr. Michael Black |
| Director of Engineering | |
| Phone: (855) 899.9869 | |
| Prepared by: | Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | April 1, 2016 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | OVD |
| Primary Predicate: | LDR ROI-A (K110327) |
| Additional Predicate: | Theken Spine Vu aPOD (K101310) |
| Reference Devices: | Renovis S128 PEEK ALIF (K131122), Centinel Spine STALIF TT |
| (K073109), Alphatec Spine Solus Zero Profile Cage (K123993) |
Indications For Use:
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
4
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).
Device Description:
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is an Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device has a built-in fixation mechanism that is manually deployed into the vertebral bodies by the operating surgeon.
Predicate Device:
The subject ENZA Zero-Profile Anterior Interbody Fusion device is substantially equivalent to predicates Theken Spine Vu aPOD (K101310) and LDR ROI-A (K110327) with respect to indications, design, function, and performance.
Non-Clinical Performance Testing and Substantial Equivalence:
Testing performed indicate that the ENZA Zero-Profile Anterior Interbody Fusion is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. Wear testing was also performed to evaluate wear particulate. Additionally, blade deployment testing was conducted to evaluate blade performance. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Conclusion:
Camber Spine Technologies provided sufficient information to demonstrate the ENZA Zero-Profile Anterior Interbody Fusion is substantially equivalent to predicates Theken Spine Vu aPOD (K101310) and LDR ROI-A (K110327) with respect to indications, design, function, and performance.