(78 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for intervertebral body fusion of the lumbar spine to treat degenerative disc disease, which involves addressing a medical condition.
No
Explanation: The device is an intervertebral body fusion system designed for the surgical treatment of degenerative disc disease, not for diagnosing conditions.
No
The device description clearly states it is a physical implant system made of materials like PEEK and Titanium, intended for surgical implantation. It also includes bone screws and a cover plate, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Choice Spine HARRIER-SA™ Lumbar Interbody System is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Choice Spine HARRIER-SA™ Lumbar Interbody System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.
Product codes
OVD, MAX
Device Description
The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with (4) bone screws provided and the accompanying anterior cover plate assembly. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136.
The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.
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 patients
Intended User / Care Setting
Prescription Use
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
Expulsion
Subsidence - per ASTM F2267
Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102090, K153782, K170953, K172816
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
May 16, 2018
Choice Spine, LP Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K180519
Trade/Device Name: Choice Spine HARRIER-SA™ Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: April 11, 2018 Received: April 12, 2018
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180519
Device Name
Choice Spine HARRIER-SA™ Lumbar Interbody System
Indications for Use (Describe)
The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date:
Sponsor: | April 9, 2018
Choice Spine, LP
400 Erin Drive
Knoxville, TN 37919 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:
Fax:
Contact Person: | 865-246-3333
865-246-3334
Kim Finch, Manager of Regulatory Affairs |
| Proposed
Proprietary Trade
Name: | Choice Spine HARRIER-SA™ Lumbar Interbody System |
| Product Class:
Classification
Name: | System Class II |
| | 888.3080 - Intervertebral Body Fusion Device |
| Device Product
Code: | OVD, MAX |
| | Purpose of Submission: The purpose of this submission is to gain clearance for the new the Choice Spine
HARRIER-SA™ Lumbar Interbody System. |
| Device Description: | The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various
sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-
SA™ Lumbar Interbody System is a stand-alone device intended to be used with
(4) bone screws provided and the accompanying anterior cover plate assembly.
The implant spacer components are made from two materials:
Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM
F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate
and screws per ASTM F136. |
| | The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone
device intended to be used with four bone screws and the accompanying
anterior cover plate. Supplemental fixation, cleared by the FDA for use in the
lumbosacral spine, must be used with implants ≥20°. Supplemental fixation
must also be used whenever fewer than four bone screws are used. The
anterior cover plate must be utilized whenever the device is implanted. |
| Indications for Use: | The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for
intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally
mature patients who have had six months of non-operative treatment. This
device is intended for use at either one level or two contiguous levels for the
treatment of degenerative disc disease (DDD) with up to Grade I
spondylolisthesis. DDD is defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies. This
device is designed to be used with autogenous bone graft and/or allogenic bone
graft comprised of cancellous and/or corticocancellous bone graft. |
| Materials: | The implant spacer components are made from two materials:
1.Invibio PEEK-OPTIMA™ HA Enhanced
2.Ti-6Al-4V ELI Titanium per ASTM F3001, Class C
Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per
ASTM F136. All implants except for the screws will be provided sterile. Screws
will be provided non-sterile but will be steam sterilized before use.
Instruments will be provided non-sterile but will be steam sterilized before use.
The instrumentation is made from 455 SS and 17-4 SS, 465 SS per ASTM A564. |
| 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
Expulsion
Subsidence - per ASTM F2267 |
| Substantial
Equivalence: | The implants included in this submission are equivalent to the Spine Smith
Cynch Spinal System - Visualif Interbody Fusion Implant System (K102090,
primary predicate), NuVasive Lumbar Interbody Implants (K153782, additional
predicate), Choice Spine TOMCAT™ Cervical Spinal System (K170953, additional
predicate), and the Choice Spine TiGer Shark™ (K172816, additional predicate). |
| Substantial
Equivalence
Conclusion" | The implants proposed in this submission are similar to the predicate devices in:
principle of operation, material, indications for use, biocompatibility,
manufacturing and post-processing steps, stabilization method, sterilization
method, anatomic location and approach, product code and classification. The
indications for use were compared, the differences include the subject device is
designed to use four screws for stabilization while the primary predicate utilizes
two and is cleared for use with autograft while the subject device and other
predicates are intended to be used with autogenenous bone graft and /or
allogenic bone graft comprised of cancellous and/or corticocancellous bone
graft.
Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™
Lumbar Interbody System design is equivalent when compared to the predicate
devices. After considering all similarities and differences to the predicate
devices, the subject device has shown to be equivalent when compared to the
predicate devices in safety, effectiveness, and performance. |
4