(93 days)
The Spine360 Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervical spondylosis. Stingray is a system of wedge-shaped implants and instruments designed for anterior cervical interbody fusion (ACF). In the lateral view, the implant has a 3.5° lordotic form. The Stingray Cervical Cage has a flat top and bottom. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Spine 360 Cervical Interbody Fusion System (K122085), framed according to your requested information.
Please note that this is a medical device submission, not an AI/software device. Therefore, many of the requested fields related to AI performance, human readers, training sets, and ground truth in the context of an algorithm will not be applicable or will need to be reinterpreted in the context of a physical device.
Acceptance Criteria and Study for Spine 360 Cervical Interbody Fusion System (K122085)
This device is a physical medical implant (interbody fusion system) and not an AI or software-based medical device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material properties, not algorithmic accuracy or human reader improvement. The "study" refers to non-clinical (mechanical) testing based on ASTM standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on demonstrating mechanical equivalence or superiority to predicate devices and meeting established biomechanical tissue tolerances for the cervical spine. The performance is reported as meeting or exceeding these criteria.
| Acceptance Criteria Category | Specific Test Standard (Criteria Definition) | Reported Device Performance (Spine360 Stingray) | Notes |
|---|---|---|---|
| Material Equivalence | ASTM F2026 (PEEK-OPTIMA LT1) | Compliant | Material is PEEK-OPTIMA LT1, identical to predicate, meeting the standard for surgical implant applications. |
| Biomechanical Performance | ASTM F2077-11 (Static Compression) | Exceeded pre-determined test criteria | Demonstrated mechanical strength under static compression. |
| ASTM F2077-11 (Static Compression Shear) | Exceeded pre-determined test criteria | Demonstrated mechanical strength under static compression shear. | |
| ASTM F2077-11 (Static Compression Torsion) | Exceeded pre-determined test criteria | Demonstrated mechanical strength under static compression torsion. | |
| ASTM F2267-04 (Subsidence) | Exceeded pre-determined test criteria | Demonstrated resistance to subsidence, indicating stability when implanted. | |
| (Not specified standard) (Expulsion) | Exceeded pre-determined test criteria | Demonstrated resistance to expulsion from the intervertebral space. | |
| ASTM F2077-11 (Dynamic Compression) | Exceeded pre-determined test criteria | Demonstrated mechanical strength under dynamic (cyclic) compression, important for long-term stability in a physiological environment. | |
| ASTM F2077-11 (Dynamic Compression Shear) | Exceeded pre-determined test criteria | Demonstrated mechanical strength under dynamic (cyclic) compression shear. | |
| ASTM F2077-11 (Dynamic Torsion) | Exceeded pre-determined test criteria | Demonstrated mechanical strength under dynamic (cyclic) torsion. | |
| Overall Performance | Equivalence/Superiority to Predicates | Equivalent or superior to predicates tested | Direct comparison of test results showed the Stingray performed as well as or better than the US Spine Phantom Plus Cage (K082801) and Zimmer BAK/C Vista Interbody Fusion (P980048 S3). |
| Biomechanical Tissue Tolerances (Cervical FSU) | Exceeded biomechanical tissue tolerances | The device demonstrated performance beyond the mechanical limits expected for a cervical spinal functional unit. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of devices tested for each mechanical test. However, standards like ASTM F2077-11 typically require a minimum number of samples for statistically valid testing (e.g., 5-6 samples per test group). The tests are conducted on manufactured devices, not human data.
- Data Provenance: The data is generated from non-clinical (laboratory) mechanical testing of the physical device. It is not patient data, nor does it have a country of origin in that sense. It's a prospective testing design to evaluate the device against established engineering standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable to a physical medical device. "Ground truth" in this context refers to established engineering standards (ASTM standards) and biomechanical properties of the human spine. The "experts" would be the engineers and scientists who developed these standards and conducted the testing, not clinical experts establishing ground truth from patient data.
4. Adjudication Method for the Test Set
- This question is not applicable as there is no human interpretation or adjudication of test results in the clinical sense. The results of the mechanical tests are quantitative measurements against predefined criteria in the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- This device is a physical medical implant, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- This device is a physical medical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance relies on established engineering standards (ASTM F2077-11, F2267-04) and recognized biomechanical properties and tolerances of the human cervical spine. The objective is to ensure the device's mechanical integrity and safety when implanted.
8. The Sample Size for the Training Set
- This device is a physical medical implant, not an AI with a training set. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established
- This device is a physical medical implant, not an AI with a training set. Therefore, this question is not applicable.
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510(k) Summary for the
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Spine 360 Cervical Interbody Fusion System
OCT 17 2012
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Spine 360 Interbody Fusion System. Date Prepared: July 12, 2012
Submitter: Spine 360 5000 Plaza on the Lake, Suite 305 Austin, TX 78746
Contact Person:
Dave Lamb Spine360 5000 Plaza on the Lake Suite 305 Austin, TX 78746 Telephone: 512-327-6400 ext. 24 3005841736 ·
Establishment Registration Number
- Trade name: Common Name: Classification Name: Spine 360 Cervical Interbody Fusion System intervertebral body fusion device intervertebral body fusion device - cervical 21 CFR section 888.3080 ODP Class II
3. Predicate or legally marketed devices which are substantially equivalent:
Spine 360 Interbody Fusion System is substantially equivalent to the following devices.
- US Spine Phantom Plus Cage (K082801) .
- Zimmer BAK/C Vista Interbody Fusion (P980048 S3)
4. Description of the device:
The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervical spondylosis. Stingray is a system of wedge-shaped implants and instruments designed for anterior cervical interbody fusion (ACF). In the lateral view, the implant has a 3.5° lordotic form. The Stingray Cervical Cage has a flat top and bottom.
Materials:
PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.
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markers for radiographic
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5. Substantial equivalence claimed to predicate devices
Spine 360 Cervical Interbody Fusion is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the Spine 360 Cervical Interbody Fusion System to these predicate devices.
| Device | Spine 360Stingray | Phantom Plus Cage | BAKc |
|---|---|---|---|
| 510(k) number | -- | K082801 | P980048 S3 |
| Intended use | Per 888.3080 | Per 888.3080 | Per 888.3080 |
| Bone graft cavity | Yes | Yes | Yes |
| Ridges | Yes | Yes | Yes |
| X-ray markers | Yes | Yes | Yes |
| Raw material | PEEK Optima LT1 | PEEK Optima LT1 | Ti-6Al-4Vd |
| Sterility | Provided non-sterileSteam sterilized athospital | Provided non-sterileSteam sterilized athospital | Provided gammasterilized |
| Sizes -Height | 5-12mm | 6-12mm | 6-12mm |
| Sizes-Depth | 12mm | 11mm | 12mm |
| Sizes-Width | 12mm-14mm | 14mm | 10mm-17mm |
6. Intended Use:
The Spine 360 Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation . · Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
7. Non-clinical Test Summary:
The following tests were conducted:
| Static Compression | F2077-11 | |
|---|---|---|
| Static Compression Shear | F2077-11 | |
| Static Compression Torsion | F2077-11 | |
| Subsidence | F2267-04 | |
| Expulsion | ||
| Dynamic Compression | F2077-11 | |
| Dynamic Compression Shear | F2077-11 | |
| Dynamic Torsion | F2077-11 |
8. Clinical Test Summary
No clinical studies were performed
-
- Conclusions from Non-clinical tests
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A direct comparison of test results of the Spine360 Stingray and predicate devices demonstrated the Stingray was equivalent or superior to the predicates tested. The Spine360 Stingray Cervical Interbody Fusion Device exceeded pre-determined test criteria as well as the biomechanical tissue tolerances of the cervical spine FSU. ( see report OKT_TR380-0811-13596)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
Omni Surgical, LP DBA Spine360 % Mr. Dave Lamb Ouality and Regulatory Affairs 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746
OCT 17 2012
Re: K122085
Trade/Device Name: Spine360 Stingray Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 17, 2012 Received: September 17, 2012
Dear Mr. Lamb:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Dave Lamb
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Melkerson
Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ K122085
Device Name: Spine360 Stingray Cervical Interbody Fusion System
The Spine360 Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use _ 'X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cal-of-
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
il
§ 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.