(165 days)
The ChoiceSpine TigerShark™ M, Modular Interbody System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The device system is designed for use with autograft bone and/or allogenic bone grafts composed of cancellous bone grafts, and with supplemental internal fixation systems (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.
The ChoiceSpine TigerShark™ M, Modular Interbody System, consists of implants with components that are both additively and traditionally manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C and Ti-6Al-4V ELI per ASTM F136 respectively). The device is provided in lengths of 24-32mm and final heights of 9-17mm with 6° and 12° lordotic options and contains a hollow core to receive autogenous and / or allogenous bone graft.
The provided text is a 510(k) summary for a medical device (ChoiceSpine TigerShark™ M, Modular Interbody System). Such summaries primarily focus on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., mechanical, material, biocompatibility) rather than clinical studies evaluating AI-driven performance.
Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-based device.
The questions you've asked (about sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance, training data, etc.) are highly relevant for the FDA's review of artificial intelligence and machine learning (AI/ML)-enabled medical devices. This document, however, describes a traditional orthopedic implant, an intervertebral body fusion device.
Without information specific to an AI/ML component, I cannot fulfill the request.
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September 13, 2022
ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K220953
Trade/Device Name: ChoiceSpine TigerShark™M, Modular Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 22, 2022 Received: August 23, 2022
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,
for
Brent 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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Indications for Use
510(k) Number (if known)
Device Name
ChoiceSpine TigerShark™ M, Modular Interbody System
Indications for Use (Describe)
The ChoiceSpine TigerShark™ M, Modular Interbody System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The device system is designed for use with autograft bone and/or allogenic bone grafts composed of cancellous bone grafts, and with supplemental internal fixation systems (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral 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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7.0 510(k) Summary
| Date: | March 31, 2022 |
|---|---|
| Sponsor: | ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| ProposedProprietary TradeName: | ChoiceSpine TigerShark™ M, Modular Interbody System |
| Product Class: | Class II |
| ClassificationName: | ChoiceSpine TigerShark™ M, Modular Interbody System888.3080 - Intervertebral Fusion Device with Integrated Fixation, Lumbar• |
| Device ProductCode: | ChoiceSpine TigerShark™ M, Modular Interbody System• MAX |
| Purpose of Submission: | The purpose of this submission is to gain clearance for the new ChoiceSpineTigerShark™ M, Modular Interbody System. |
| Device Description: | The ChoiceSpine TigerShark™ M, Modular Interbody System, consists ofimplants with components that are both additively and traditionallymanufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C and Ti-6Al-4V ELI per ASTM F136 respectively). The device is provided in lengths of 24-32mm and final heights of 9-17mm with 6° and 12° lordotic options and containsa hollow core to receive autogenous and / or allogenous bone graft. |
| Indications for Use: | The ChoiceSpine TigerShark™ M, Modular Interbody System, is anintervertebral body fusion device intended for spinal fusion procedures at oneor two contiguous levels in the lumbar spine from L2 to S1 in patients withDegenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). DDD is defined as back pain of discogenicorigin, with degeneration of the disc confirmed by history and radiographicstudies. Patients should be skeletally mature and have had at least six (6)months of non-operative treatment. The device system is designed for use withautograft bone and/or allogenic bone grafts composed of cancellous and /orcorticocancellous bone grafts, and with supplemental internal fixation systems(i.e., posterior pedicle screw and rod systems, anterior plate systems, andanterior screw and rod systems) cleared for use in the lumbosacral spine. |
| Materials: | The ChoiceSpine TigerShark™ M, Modular Interbody System, implants arecomposed of a titanium alloy (Ti-6Al-4V ELI per ASTM F136 and ASTM F3001,Class C). The instrumentation is made from 17-4 Stainless Steel (ASTM |
| F899/A693), 465 Stainless Steel (ASTM F899), medical grade silicone, andpolyphenylsulfone (Radel R5000 Series). | |
| Predicate Devices: | Primary Predicate:ChoiceSpine Octane Elevate re-branded to Octane-M (K123607)Additional Predicates:ChoiceSpine TigerSharkTM System (K172816) |
| Non-clinical Testing: | Static Compression - per ASTM F2077Static Compression Shear - per ASTM F2077Dynamic Compression - per ASTM F2077Dynamic Compression Shear - per ASTM F2077Subsidence - per ASTM F2267 |
| Substantial EquivalenceConclusion: | The implants proposed in this submission are similar to the predicate devicesin the principle of operation, indications for use, biocompatibility, stabilizationmethod, sterilization method, anatomic location and approach, product codeand classification.The implants proposed are similar to the predicate devices in material,manufacturing, post-processing steps, and locking mechanism. Mechanical andfunctional testing was conducted to demonstrate substantial equivalence tothe predicate devices in safety, effectiveness, and performance. The subjectdevice has components made from wrought titanium alloy (Ti-6Al-4V ELI) perASTM F136, which the predicates do not. The system components wereassessed in accordance with ISO 10993-1 and found substantially equivalent tothe predicate devices. |
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§ 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.