(195 days)
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Latitude-C Interbody Spacer is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.
DeGen Medical Latitude-C Cervical Interbody Spacer is a cervical interbody fusion device for anterior cervical fusion procedures. The Latitude-C spacer has teeth on its superior and inferior surfaces to prevent migration. The Latitude-C spacer comes in 5 different size footprints, and different heights ranging from 5mm to 14mm.
This document describes the DeGen Medical Latitude-C Cervical Interbody Spacer System, a medical device, and its substantial equivalence to predicate devices, rather than a study on an AI/ML device. Therefore, the requested information regarding AI/ML device performance, ground truth, and expert adjudication cannot be extracted from this document.
However, I can provide information about the non-clinical performance testing conducted for the Latitude-C Cervical Interbody Spacer System, which demonstrates its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):
The document states that non-clinical testing was performed in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007. The results of these studies showed that the subject device meets or exceeds the performance of the predicate devices.
While specific numerical acceptance criteria and reported performance values are not detailed in this summary, the following tests were performed to demonstrate substantial equivalence:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Static Compression (ASTM F2077) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Dynamic Compression (ASTM F2077) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Static Torsion (ASTM F2077) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Dynamic Torsion (ASTM F2077) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Subsidence (ASTM F2267) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Expulsion Testing | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Wear Testing (ASTM F1877) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Static Tensile Strength (Coating) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Static Shear Strength (Coating) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Abrasion Resistance (Coating) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
| Shear Fatigue (Coating) | Meet or exceed performance of predicate devices | Met or exceeded performance of predicate devices |
2. Sample size used for the test set and the data provenance:
- This document describes non-clinical performance testing of a physical medical device, not an AI/ML model. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not applicable here. The testing involved various mechanical tests on physical samples of the device. The specific number of samples for each test is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device and does not involve ground truth established by experts for a test set. The "ground truth" for these tests would be the established engineering standards and predicate device performance.
4. Adjudication method for the test set:
- Not applicable as this is not an AI/ML device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering specifications, performance standards outlined in ASTM and FDA guidance documents, and the performance characteristics of the legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device and therefore no training set was involved.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2015
DeGen Medical % Linda Braddon, Ph.D. President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K151496
Trade/Device Name: Latitude-C Cervical Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 12, 2015 Received: November 16, 2015
Dear Dr. Braddon:
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
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forth in the quality systems (QS) 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) K151496
Device Name Latitude-C Cervical Interbody Spacer System
Indications for Use (Describe)
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Latitude-C Interbody Spacer is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.
| 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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Image /page/3/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left, resembling three curved lines emanating from three blue circles. To the right of the design is the text "DeGen" in a larger, bolder blue font, with the word "Medical" underneath in a smaller, gray font. The overall design is clean and professional.
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical LATITUDE-C is provided below.
| Date Summary Prepared | November 12, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | DeGen Medical1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681LGB@SecureBME.com |
| Trade Name | Latitude-C Cervical Interbody Spacer SystemLatitude-C PEEK Cervical Interbody SpacerLatitude-C Porous Ti Cervical Interbody SpacerLatitude-C HA PEEK Cervical Interbody SpacerLatitude-C CFR Cervical Interbody SpacerLatitude-C Ti Cervical Interbody Spacer |
| Common Name | Intervertebral body fusion device |
| Code -Classification | ODP21 CFR 888.3080 : Class II |
| Primary Predicate | K142152 – CONSTRUX Mini PEEK Spacer System |
| Reference Devices | K133967 - Aurora Spine Interbody Fusion SystemK142026 - Arena-C® HA PEEK Cervical Intervertebral Body Fusion DeviceK103488 – Depuy Spine Bengal Spine SystemP980048 - BAK/Cervical Interbody Fusion System |
| Device Description | DeGen Medical Latitude-C Cervical Interbody Spacer is a cervicalinterbody fusion device for anterior cervical fusion procedures. TheLatitude-C spacer has teeth on its superior and inferior surfaces toprevent migration. The Latitude-C spacer comes in 5 different sizefootprints, and different heights ranging from 5mm to 14mm. |
| Indications for Use | The Latitude-C Interbody Spacer is indicated for spinal fusion proceduresat one level in the cervical spine (C2-T1), in skeletally mature patientswith degenerative disc disease. Degenerative disc disease is defined asneck pain of discogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies.The Latitude-C Interbody Spacer is intended for use with autograft and/orallograft comprised of cancellous and/or corticocancellous bone graftand supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C InterbodySpacer in the cervical spine. |
| Technological Characteristics | As was established in this submission, the subject Latitude-C CervicalInterbody Spacer is substantially equivalent to other predicate devicescleared by the FDA for commercial distribution in the United States. Thesubject device was shown to be substantially equivalent and has the sametechnological characteristics to its predicate devices through comparisonin areas including design, intended use, material composition, function,and range of sizes. |
| Non-Clinical Performance Testing Conclusion | Non-clinical testing was performed to demonstrate the DeGen MedicalLatitude-C Cervical Interbody Spacer is substantially equivalent to otherpredicate devices in accordance with “Guidance for Industry and FDAStaff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II SpecialControls Guidance Document: Intervertebral Body Fusion Device, June 12,2007.The following tests were performed:Static and dynamic compression testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 Subsidence testing via ASTM F2267 Expulsion Testing Wear testing per ASTM F1877 Additional tests were included on the coating:Static Tensile Strength Static Shear Strength Abrasion Resistance Shear Fatigue The results of these studies show the subject DeGen Medical Latitude-CCervical Interbody Spacer meets or exceeds the performance of thepredicate devices, and the device was therefore found to be substantiallyequivalent. |
| Substantial EquivalenceSummary (Conclusion) | Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject DeGen Medical Latitude-C Cervical Interbody Spacer has been shown to be substantially equivalent to legally marketed predicate devices. |
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Image /page/4/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left and the words "DeGen Medical" on the right. The word "DeGen" is in a larger, bolder, blue font, while the word "Medical" is in a smaller, lighter gray font.
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Image /page/5/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left and the words "DeGen Medical" on the right. The abstract design features three curved lines with circles at the end, and the words "DeGen Medical" are written in blue, with "Medical" in a smaller font size.
§ 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.