(478 days)
No
The summary describes a mechanical interbody fusion device and its materials. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an interbody fusion device intended for use in patients with degenerative disc disease to provide structural stability and contribute to the fusion process, which are therapeutic interventions.
No
The device is described as an interbody fusion device intended to provide structural stability and is filled with bone graft material and used with supplemental fixation. Its purpose is to treat degenerative disc disease by providing mechanical support, not by diagnosing a condition.
No
The device description explicitly states that the device is manufactured from physical materials (PEEK, titanium alloy, and tantalum markers) and is an implantable cage, indicating it is a hardware device, not software-only.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a physical implant (Spectrum Spine Expandable Cages) used in surgery to provide structural stability in the spine. It is a medical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for spinal fusion in patients with degenerative disc disease, which is a surgical procedure, not a diagnostic test.
The information provided clearly indicates this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
Product codes
MAX
Device Description
The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-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)
The Spectrum Spine Expandable Cages (SSEC) has been tested in the following test modes:
- Static Axial Compression per ASTM F2077
- Static Compressive Shear per ASTM F2077
- Static Subsidence per ASTM F2267 and ASTM F2077
- Static Expulsion
- Dynamic Axial Compression per ASTM F2077
- Dynamic Compressive Shear per ASTM F2077
The results of this non-clinical testing show that the strength of the Spectrum Spine Expandable Cages (SSEC) is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K112095, K123281, K123752, K123231
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.
0
March 7, 2019
Image /page/0/Picture/1 description: The image contains 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The logos are placed side by side.
Spectrum Spine, LLC James Robinson President 4020 Stovall Terrace NE Atlanta, Georgia 30342
Re: K173518
Trade/Device Name: Spectrum Spine Expandable Cages (SSEC) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 7, 2019 Received: February 8, 2019
Dear Dr. Robinson:
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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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,
Melissa Hall -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173518
Device Name Spectrum Spine Expandable Cages (SSEC)
Indications for Use (Describe)
The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
| 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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3
510(K) SUMMARY
| Submitter's Name: | Spectrum Spine |
|---|---|
| Submitter's Address: | 4020 Stovall Terrace NE |
| Atlanta, GA 30342 | |
| Submitter's Telephone: | 404.550.1335 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Consulting, LLC | |
| 719.337.7579 | |
| MMay@EmpiricalConsulting.com | |
| Date Summary was Prepared: | 17 January 2017 |
| Trade or Proprietary Name: | Spectrum Spine Expandable Cages (SSEC) |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 Device Classification |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).
INDICATIONS FOR USE
The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
The indication for use for the Spectrum Spine Expandable Cages (SSEC) is similar to that of the predicate devices.
4
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Identification |
|------------------|---------------------------------------|--------------|----------------|
| K090507 | ROI-A Implant System | LDR | Primary |
| K112095, K123281 | AccuLIFTTM TL-PEEK Cage | CoAlign | Additional |
| K123752 | AccuLIFTTM TL and PL Cage | CoAlign | Additional |
| K123231 | Caliber Spacer | Globus | Additional |
Table 5-1: Predicate Devices
TECHNOLOGICAL CHARACTERISTICS
The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness when compared to the predicate devices. Specifically the following characteristics are identical between the subject and predicates:
- Indications for use ●
- Structural support mechanism ●
- . Principles of operation
PERFORMANCE DATA
The Spectrum Spine Expandable Cages (SSEC) has been tested in the following test modes:
- Static Axial Compression per ASTM F2077 ●
- Static Compressive Shear per ASTM F2077
- Static Subsidence per ASTM F2267 and ASTM F2077 ●
- Static Expulsion
- Dynamic Axial Compression per ASTM F2077 ●
- . Dynamic Compressive Shear per ASTM F2077
The results of this non-clinical testing show that the strength of the Spectrum Spine Expandable Cages (SSEC) is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
5
The overall technology characteristics and mechanical performance data lead to the conclusion that the Spectrum Spine Expandable Cages (SSEC) is substantially equivalent to the predicate device.