(89 days)
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No
The provided text describes a physical medical device (a cervical spacer system) and its materials, intended use, and predicate devices. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
Yes
The device is intended for the treatment of degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is a cervical spacer system intended for spinal fusion, which is used for treatment, not diagnosis. It is an implant used with bone graft and supplemental fixation to facilitate fusion in patients with degenerative disc disease.
No
The device description clearly details physical implants made from titanium alloy or PEEK, along with surgical instruments. This indicates a hardware-based medical device, not a software-only one.
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 about a person's health.
- Device Description: The ChoiceSpine Stealth™ Cervical Spacer System is an implantable device designed to be surgically placed in the spine to facilitate fusion. It is a physical device used in the body, not a test performed on samples from the body.
- Intended Use: The intended use is for anterior cervical spine intervertebral body fusion, which is a surgical procedure.
Therefore, based on the provided information, the ChoiceSpine Stealth™ Cervical Spacer System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ChoiceSpine Stealth™ 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 sketally 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 Stealth™ 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.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The ChoiceSpine Stealth™ Cervical Spacer System's implants have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.
The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Materials Class C) or polyetheretherketone (PEEK-OPTIMA® polymer, Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. Both 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 and 17-4 SS per ASTM F899.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, C2-C3 disc space to the C7-T1 disc
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
0
Image /page/0/Picture/0 description: The image shows the logo for 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.
March 6. 2019
ChoiceSpine, LP Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37922
Re: K183397
Trade/Device Name: ChoiceSpine Stealth™ Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 5, 2019 Received: February 6, 2019
Dear Kim 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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)
K183397
Device Name
ChoiceSpine Stealth™ Cervical Spacer System
Indications for Use (Describe)
The ChoiceSpine Stealth™ 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 sketally 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 Stealth™ 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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7. 510(k) Summary
| Date | February 5, 2019 |
|---|---|
| Sponsor | ChoiceSpine, LP |
| 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 Stealth™ Cervical Spacer System |
| Product Class | Class II |
| Classification Name | ChoiceSpine Stealth™ Cervical Spacer System |
| 888.3080 - Spinal Intervertebral Body Fusion Device | |
| ● | |
| Device Product Code | ChoiceSpine Stealth™ Cervical Spacer System: |
| ODP | |
| Purpose of | |
| Submission | The purpose of this submission is to gain clearance for the updated ChoiceSpine |
| Stealth™ Cervical Spacer System. Updates to the system include new material and | |
| manufacturing (Ti-6Al-4V ELI per ASTM F3001 Class C), how supplied (sterile packed), | |
| and the addition of allogenic bone graft. | |
| Device Description | The ChoiceSpine Stealth™ Cervical Spacer System's implants have a basic oval shape |
| with a hollow center for placement of bone graft. The superior and inferior surfaces | |
| have angled ridges, or "teeth," for resisting migration. The spacers are available in an | |
| assortment of heights and in multiple angles of lordosis to accommodate different | |
| anatomic requirements. | |
| Indications for Use | The ChoiceSpine Stealth™ 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 STEALTH™ 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. |
4
The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Materials Class C) or polyetheretherketone (PEEK-OPTIMA® polymer, Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. Both 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 and 17-4 SS per ASTM F899.
Primary predicate: Choice Spine Cervical Interbody Spacer System (K091531), Predicate Device Additional Predicate: Choice Spine Tiger Shark System (K172816) Additional Predicate:NuVasive Modulus-C Interbody System (K172676)
The implants proposed in this submission are similar to the predicate devices in Substantial principle of operation, indications for use, stabilization method, anatomic location Equivalence Conclusion and 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 spacer proposed made of Titanium (Ti-6Al-4V ELI per ASTM F3001, Class C) is identical in geometry and footprint as the PEEK spacer offered in the Stealth Cervical Spacer System. The only difference between the spacers is the material and manufacturing method which are shared with the additional predicate. The difference between the mechanical properties confirmed that the PEEK spacer is the worst-case compared to the Titanium spacer which is previously tested and cleared under K091531.
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 ° and the package system remained intact while also maintaining the hermetic barrier.