(188 days)
The Tiger Shark Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TiGER SHARK Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/ or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.
The ChoiceSpine Tiger Shark™ Cervical Spacer System consists of intervertebral body fusion devices comprised of titanium alloy (Ti-6AI-4V ELI per ASTM F3001, Class C). The spacers have a basic oval shape that coincides with the shape of vertebral bodies and a hollow center for placement of bone graft. They are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.
The provided text describes a 510(k) premarket notification for a medical device cleared by the FDA, the ChoiceSpine Tiger Shark™ Cervical Spacer System. This type of submission focuses on proving substantial equivalence to a predicate device, rather than extensive de novo clinical studies with acceptance criteria for AI performance. Therefore, the requested information about acceptance criteria, study design for AI models, expert adjudication, MRMC studies, and ground truth establishment for AI performance is not applicable to this document.
The document primarily details:
- Device Name: ChoiceSpine Tiger Shark™ Cervical Spacer System
- Regulation Number/Name: 21 CFR 888.3080, Intervertebral Body Fusion Device (Class II)
- Product Code: ODP
- Indications for Use: Anterior cervical spine intervertebral body fusion for degenerative disc disease (DDD) at one level (C2-C3 to C7-T1), in skeletally mature patients after 6 weeks of non-operative treatment, used with supplemental fixation and autogenous/allogenic bone graft.
- Device Description: Intervertebral body fusion devices made of titanium alloy, available in various heights and lordosis angles, manufactured using Electron Beam Melting (EBM) additive manufacturing.
- Predicate Devices: Genesys Spine Apache Cervical Interbody Fusion System (K150812) and ChoiceSpine Tiger Shark Cervical Spacer System (K183397).
- Purpose of Submission: To gain clearance for an additional titanium implant footprint (18x15mm) and instruments.
- Substantial Equivalence Conclusion: The device is similar to predicate devices in principle of operation, indications for use, stabilization method, anatomic location, approach, product code, classification, and biocompatibility. Minor differences (e.g., allogenic bone graft use, sterile provision) do not alter intended use or create a new worst case. Sterilization validation was performed.
To directly answer the prompt's request for acceptance criteria and study proving device meets them, based solely on the provided text, the information is not present as this is a traditional medical device clearance, not an AI/ML software clearance.
Therefore, the table and detailed points regarding AI/ML performance acceptance criteria cannot be fulfilled from this document.
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December 22, 2020
ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K201643
Trade/Device Name: ChoiceSpine Tiger Shark™ Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 2, 2020 Received: December 3, 2020
Dear Ms. Finch:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201643
Device Name
ChoiceSpine Tiger Shark™ Cervical Spacer System
Indications for Use (Describe)
The Tiger Shark Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TiGER SHARK Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/ or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date | June 15, 2020 |
|---|---|
| Sponsor | ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919 |
| Phone | 865-243-3969 |
| Fax | 865-246-3334 |
| Contact Person | Kim Finch, Director of Regulatory Affairs |
| Proposed ProprietaryTrade Name | ChoiceSpine Tiger Shark™ Cervical Spacer System |
| Product Class | Class II |
| Classification Name | ChoiceSpine Tiger Shark™ Cervical Spacer System• 888.3080 - Spinal Intervertebral Body Fusion Device |
| Device Product Code | ChoiceSpine Tiger Shark™ Cervical Spacer System:• ODP |
| Purpose ofSubmission | The purpose of this submission is to gain clearance for adding an additional titaniumimplant footprint in 18x15mm size and instruments to the ChoiceSpine Tiger Shark™Cervical Spacer System. This device has been previously submitted as ChoiceSpineStealth™ Cervical Spacer System, (K183397) and has undergone additional technicalupgrades per ChoiceSpine design control including porous titanium regions and aslight change in profile within the scope of K183397. It has since been trade markedas Tiger Shark™ Cervical Spacer System. |
| Device Description | The ChoiceSpine Tiger Shark™ Cervical Spacer System consists of intervertebral bodyfusion devices comprised of titanium alloy (Ti-6AI-4V ELI per ASTM F3001, Class C).The spacers have a basic oval shape that coincides with the shape of vertebral bodiesand a hollow center for placement of bone graft. They are available in an assortmentof heights and in multiple angles of lordosis to accommodate different anatomicrequirements. The devices are manufactured using the Electron Beam Melting (EBM)additive manufacturing method. |
| Indications for Use | The Tiger Shark™ Cervical Spacer System is intended for anterior cervical spineintervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc forthe treatment of degenerative disc disease (DDD) in skeletally mature patients whohave had six (6) weeks of non-operative treatment. DDD is defined as neck pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographic |
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studies. The Tiger Shark™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion. The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class Materials C). Implants will be provided sterile. Instruments will be provided non-sterile but will be steam sterilized before use. The instrumentation is made from 455/465 SS per ASTM A564, 17-4 SS per ASTM F899 and 6061 T6 Aluminum per ASTM B209/B221. Predicate Device Primary predicate: Genesys Spine Apache Cervical Interbody Fusion System (K150812) Additional Predicate: ChoiceSpine Tiger Shark Cervical Spacer System (K183397) The implants proposed in this submission are similar to the predicate devices in Substantial Equivalence principle of operation, indications for use, stabilization method, anatomic location and Conclusion approach, product code and classification, and biocompatibility. The indications for use were compared; the differences include the primary predicate is cleared for use with autograft while the subject device and additional predicate are intended to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. The addition of the allogenic bone graft material does not alter the device intended use. The additional footprint spacer is within the size range of the primary predicate, Genesys Spine Apache Cervical Interbody Fusion System (K150812). The larger footprint does not make a new worse case when compared to the worse case cleared in the additional predicate, ChoiceSpine Tiger Shark Cervical Spacer System (K183397). The subject device and additional predicate are both provided sterile while the primary predicate is provided non-sterile. ChoiceSpine's sterilization process has been validated through gamma validation and distribution testing and the results demonstrate that the predetermined acceptance criteria were met. The minimum radiation dose of 25kGy was sufficient to meet a sterilization assurance level (SAL) of 10-6 and the package system remained intact while also maintaining the hermetic barrier.
§ 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.