(93 days)
K082801, P980048 S3
Not Found
No
The 510(k) summary describes a physical interbody fusion device made of PEEK and tantalum. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies are biomechanical tests of the physical implant.
Yes
The device is an implantable system designed to facilitate intervertebral body fusion in the cervical spine to treat degenerative disc disease, which qualifies it as a therapeutic device.
No
This device is an intervertebral body fusion system, specifically an implant designed to facilitate fusion in the cervical spine. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a system of wedge-shaped implants made of PEEK and tantalum, which are physical materials, not software. The performance studies also focus on biomechanical testing of the physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a cervical interbody fusion system) used to facilitate fusion in the cervical spine. It is a physical device implanted into the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens.
Therefore, the Spine360 Stingray Cervical Interbody Fusion System falls under the category of a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
ODP
Device Description
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 F560markers for radiographic
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to T1 disc levels
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
Not Found
Summary of Performance Studies
No clinical studies were performed. 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)
Key Metrics
Not Found
Predicate Device(s)
K082801, P980048 S3
Reference Device(s)
Not Found
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.
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510(k) Summary for the
Image /page/0/Picture/2 description: The image shows the logo for "360 Spine". The word "SPINE" is written in bold, sans-serif font. The number "360" is written in a larger font and is placed behind the word "SPINE". The logo is simple and modern.
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.
Image /page/0/Picture/20 description: The image shows a small, square-shaped object with a hollow center. The object appears to be made of a light-colored material, possibly plastic or metal. The object has a ridged or textured surface on one side, and there are small holes or openings on the sides. The object is sitting on a textured surface.
markers for radiographic
1
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 360
Stingray | 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-sterile
Steam sterilized at
hospital | Provided non-sterile
Steam sterilized at
hospital | Provided gamma
sterilized |
| 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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page 3 of 3
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
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top and sides of the circle.
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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Image /page/5/Picture/0 description: The image shows the text "360 SPINE". The number 360 is written in a stylized font, with the word "SPINE" written below it. The text is black and white and appears to be a logo or brand name. The image is slightly blurry and pixelated.
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_________________________________________________________________________________________________________________________________________________________________
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