(165 days)
Not Found
No
The 510(k) summary describes a physical intervertebral body fusion device and its mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is an intervertebral body fusion device used in spinal fusion procedures to treat Degenerative Disc Disease, which makes it a therapeutic device.
No
The device is described as an intervertebral body fusion device intended for spinal fusion procedures, specifically an implant. It is used for treatment (fusion) and not for diagnosing a condition.
No
The device description explicitly states it consists of implants and components manufactured from titanium alloy, indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion device intended for spinal fusion procedures". This describes a surgical implant used in the body, not a test performed on a sample taken from the body.
- Device Description: The description details the physical characteristics of the implant (materials, dimensions, hollow core for bone graft). This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information about a patient's condition
The device is a surgical implant used to facilitate spinal fusion, which is a therapeutic procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to 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)
Non-clinical Testing:
Static Compression - per ASTM F2077
Static Compression Shear - per ASTM F2077
Dynamic Compression - per ASTM F2077
Dynamic Compression Shear - per ASTM F2077
Subsidence - per ASTM F2267
Mechanical and functional testing was conducted to demonstrate substantial equivalence to the predicate devices in safety, effectiveness, and performance. The system components were assessed in accordance with ISO 10993-1 and found substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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, LLC |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed | |
| Proprietary Trade | |
| Name: | ChoiceSpine TigerShark™ M, Modular Interbody System |
| Product Class: | Class II |
| Classification | |
| Name: | ChoiceSpine TigerShark™ M, Modular Interbody System |
| 888.3080 - Intervertebral Fusion Device with Integrated Fixation, Lumbar | |
| • | |
| Device Product | |
| Code: | ChoiceSpine TigerShark™ M, Modular Interbody System |
| • MAX | |
| Purpose of Submission: | The purpose of this submission is to gain clearance for the new ChoiceSpine |
| TigerShark™ M, Modular Interbody System. | |
| Device Description: | 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. | |
| Indications for Use: | 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 and /or | |
| corticocancellous 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. | |
| Materials: | The ChoiceSpine TigerShark™ M, Modular Interbody System, implants are |
| composed 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, and | |
| polyphenylsulfone (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 F2077 |
| Static Compression Shear - per ASTM F2077 | |
| Dynamic Compression - per ASTM F2077 | |
| Dynamic Compression Shear - per ASTM F2077 | |
| Subsidence - per ASTM F2267 | |
| Substantial Equivalence | |
| Conclusion: | The implants proposed in this submission are similar to the predicate devices |
| in the principle of operation, indications for use, biocompatibility, stabilization | |
| method, sterilization method, anatomic location and approach, product code | |
| and classification. |
The implants proposed are similar to the predicate devices in material,
manufacturing, post-processing steps, and locking mechanism. Mechanical and
functional testing was conducted to demonstrate substantial equivalence to
the predicate devices in safety, effectiveness, and performance. The subject
device has components made from wrought titanium alloy (Ti-6Al-4V ELI) per
ASTM F136, which the predicates do not. The system components were
assessed in accordance with ISO 10993-1 and found substantially equivalent to
the predicate devices. |
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