(181 days)
Not Found
No
The description focuses solely on the mechanical design and materials of a physical implant for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion device indicated for anterior cervical interbody fusion procedures to treat degenerative disc disease, which is a medical condition. Its purpose is to facilitate bone fusion and provide stability in the cervical spine.
No
The Blackhawk™ Ti Cervical Spacer System is an interbody fusion device intended for use in anterior cervical interbody fusion procedures, not for diagnosing conditions.
No
The device description explicitly details physical components made of titanium alloy and nitinol, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Blackhawk™ Ti Cervical Spacer System is an implantable device designed to be surgically placed in the cervical spine to facilitate bone fusion. Its purpose is structural support and to promote bone growth, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, or the generation of diagnostic information from biological specimens.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blackhawk™ Ti Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Blackhawk™ Ti Cervical Spacer System is an anterior cervical interbody device consisting of a titanium alloy (Ti-4Al-6V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al- 4V ELI) anchors per ASTM F136, and a titanium alloy (Ti-6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal anchors that lock on deployment and provide additional fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, one disc level from C2-T1
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
Static subsidence per ASTM F2267-04
Expulsion (standard N/A)
Dynamic axial compression per ASTM F2077-18
Dynamic compression-shear per ASTM F2077-18
Dynamic torsion per ASTM F2077-18
Key Results: The mechanical strength and stabilization performance are equivalent as demonstrated through ASTM F2077 and ASTM F2267 testing. The proposed device is shown to be equivalent to the predicate devices in safety, effectiveness, and performance.
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.
K191621, K171489, K170953, K132582, K201643
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.
0
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.
May 10, 2021
ChoiceSpine, LLC Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K203311
Trade/Device Name: ChoiceSpine Blackhawk™ Ti Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: April 20, 2021 Received: April 22, 2021
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K203311
Device Name
Blackhawk™ Ti Cervical Spacer System
Indications for Use (Describe)
The Blackhawk™ Ti Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
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: | March 19, 2021 |
|---|---|
| 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 Blackhawk™ Ti Cervical Spacer System |
| Product Class: | Class II |
| Classification | |
| Name: | ChoiceSpine Blackhawk™ Ti Cervical Spacer System |
| 888.3080 - Intervertebral Fusion Device with Integrated Fixation, Cervical | |
| • | |
| Device Product | |
| Code: | ChoiceSpine Blackhawk™ Ti Cervical Spacer System |
| OVE | |
| • | |
| Purpose of Submission: | The purpose of this submission is to gain clearance for the new ChoiceSpine |
| Blackhawk™ Ti Cervical Spacer System, which consists of implant spacers made | |
| of Ti-6Al-4V ELI per ASTM F3001 (Class C). The subject implant devices & | |
| instrumentation will be used with additional previously cleared instrumentation. | |
| The subject implant introduces material, design, and manufacturing method | |
| changes to the previously cleared ChoiceSpine Blackhawk Cervical Spacer | |
| System. | |
| Device Description: | The Blackhawk™ Ti Cervical Spacer System is an anterior cervical interbody |
| device consisting of a titanium alloy (Ti-4Al-6V ELI) implant cage per ASTM | |
| F3001, nitinol internal locking components per ASTM F2063, two internal | |
| titanium alloy (Ti-6Al- 4V ELI) anchors per ASTM F136, and a titanium alloy (Ti- | |
| 6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody | |
| fusion devices and offered in a variety of heights, footprints, and lordotic angles | |
| to accommodate varying anatomical conditions. The device features a chamber | |
| intended to be filled with autogenous bone and/or allogenic bone graft | |
| material. The Blackhawk™ Ti Cervical Spacer System is used with two internal | |
| anchors that lock on deployment and provide additional fixation. | |
| Indications for Use: | The Blackhawk™ Ti Cervical Spacer System is indicated for anterior cervical |
| interbody fusion procedures in skeletally mature patients with degenerative disc | |
| disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined | |
| as discogenic pain with degeneration of the disc confirmed by history and | |
| radiographic studies. These patients should have had six weeks of non-operative | |
| treatment. The Blackhawk™ Ti Cervical Spacer System is to be used with | |
| autogenous bone and/or allogenic bone graft composed of cancellous and /or | |
| corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical | |
| plate), and is implanted via an open, anterior approach. | |
| Materials: | The Blackhawk™ Ti Cervical Spacer System implants are composed of a titanium |
| alloy (Ti-6Al-4V ELI per ASTM F3001, Class C) implant spacer, nitinol (per ASTM | |
| F2063) internal locking clips, titanium alloy (Ti-6Al-4V ELI per ASTM F136) | |
| anchors, and a titanium alloy (Ti-6Al-4V ELI per ASTM F136) locking cam. The | |
| implant body, cam, and anchors are composed of Titanium alloy Ti-6Al-4V per | |
| either ASTM F136 or ASTM 3001, which has a long history of safe and effective | |
| use in orthopedic implants. The locking clips are composed of nitinol per ASTM | |
| F2063, which has a long history of safe and effective use in orthopedic | |
| implants. The Blackhawk™ Ti Cervical Spacer System implants will be provided | |
| sterile. Instruments will be provided non-sterile but will be steam sterilized | |
| before use. The instrumentation is made from 17-4 Stainless Steel (ASTM | |
| F899/A693), 465 Stainless Steel (ASTM F899), titanium alloy (Ti-6Al-4V ELI | |
| Grade 5 per ASTM F136), and polyphenylsulfone (Radel R5000 Series). | |
| Predicate Devices: | Primary Predicate: |
| ChoiceSpine Blackhawk™ Cervical Spacer System (K191621 and K171489) | |
| Additional Predicates: | |
| ChoiceSpine Tomcat™ Cervical Spacer System (K170953) | |
| Exactech Acapella One Cervical Spacer System (K132582) | |
| ChoiceSpine Tiger Shark C™ Cervical Spacer System (K201643) | |
| Non-clinical Testing: | Static subsidence per ASTM F2267-04 |
| Expulsion (standard N/A) | |
| Dynamic axial compression per ASTM F2077-18 | |
| Dynamic compression-shear per ASTM F2077-18 | |
| Dynamic torsion per ASTM F2077-18 |
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Substantial Equivalence Conclusion:
The implants proposed in this submission are similar to the predicate devices in principle of operation, indications for use, stabilization method, anatomic location and approach, product code and classification, and biocompatibility.
The subject device has similar geometry and identical footprints as the primary predicate (Blackhawk Cervical Spacer System). The subject device's spacer component is made out of titanium alloy whereas the primary predicate's spacer component is made out of PEEK. The anchor components of the subject and primary predicate devices are made out of the same titanium alloy material and are deployed in an equivalent fashion. The locking mechanism of the subject device utilizes a new cam component whereas the primary predicate utilized pins and clips. While the designs are different, the mechanical strength and stabilization performance are equivalent as demonstrated through ASTM F2077 and ASTM F2267 testing.
The subject device's spacer component and predicate Tiger Shark Cervical Spacer (K201643) are both manufactured at the same supplier using identical additive and traditional manufacturing processes.
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The subject device and predicates are all provided sterile and are processed at the same supplier. 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° and the package system remained intact while also maintaining the hermetic barrier.
The worst-case device among the proposed system was identified and mechanical testing was conducted to prove the new design is substantially equivalent to the predicates. Therefore, after including all other similarities and performing mechanical testing, the proposed device is shown to be equivalent to the predicate devices in safety, effectiveness, and performance.