(44 days)
The ChoiceSpine Harrier-SATM 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.
The ChoiceSpine Harrier-SATM Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. 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 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. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6AI-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6AI-4V ELI plate and screws per ASTM F136.
The provided text focuses on the FDA 510(k) clearance of the ChoiceSpine Harrier-SA™ Lumbar Interbody System, specifically for a modification to make the use of anterior components optional. This document is a regulatory submission, not a clinical study report or a detailed performance and acceptance criteria document for AI/software-based medical devices.
Therefore, the information required to answer your request (acceptance criteria, study details of AI algorithms, sample sizes, expert ground truthing, MRMC studies, standalone performance, etc.) is not present in the provided text.
The document describes a mechanical testing comparison to predicate devices, not a study involving AI or human reader performance.
To reiterate, the provided text does not contain any of the following:
- A table of acceptance criteria and reported device performance related to an AI/software.
- Sample sizes for a test set or data provenance for AI/software.
- Number of experts for ground truth establish for AI/software, nor their qualifications.
- Adjudication method for a test set of AI/software.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI data (expert consensus, pathology, outcomes).
- Sample size for training set for an AI algorithm.
- How ground truth for a training set for an AI algorithm was established.
This document pertains to a physical medical device (spinal interbody system) and its mechanical equivalence to existing predicate devices, not an AI/software medical device.
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ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37922
Re: K191367
Trade/Device Name: Harrier-SATM Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 6, 2019 Received: June 7, 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
July 5, 2019
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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)
K191367
Device Name
ChoiceSpine Harrier-SATM Lumbar Interbody System
Indications for Use (Describe)
The ChoiceSpine Harrier-SATM 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.
The ChoiceSpine Harrier-SATM Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. 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.
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:Sponsor: | May 21, 2019ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919 |
|---|---|
| Phone:Fax:Contact Person: | 865-246-3333865-246-3334Kim Finch, Director of Regulatory Affairs |
| ProposedProprietary TradeName: | ChoiceSpine Harrier-SA™ Lumbar Interbody System |
| Product Class: | Class II |
| ClassificationName: | ChoiceSpine Harrier-SA™ Lumbar Interbody System888.3080 - Spinal Intervertebral Body Fusion Device• |
| Device ProductCode: | ChoiceSpine Harrier-SA™ Lumbar Interbody System•MAX |
| Purpose of Submission: | The purpose of this submission is to modify the surgical technique guide (STG)to make the use of the anterior components optional for the Harrier-SATMLumbar Interbody System. The intended use remains the same. |
| Device Description: | The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in varioussizes 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. The implant spacer components are made from two materials:Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6AI-4V ELI Titanium per ASTMF3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6AI-4V ELI plateand screws per ASTM F136. |
| Indications for Use: | The Choice Spine HARRIER-SAT™ Lumbar Interbody System is indicated forintervertebral body fusion of the lumbar spine, from L2 to S1, in skeletallymature patients who have had six months of non-operative treatment. Thisdevice is intended for use at either one level or two contiguous levels for thetreatment of degenerative disc disease (DDD) with up to Grade Ispondylolisthesis. DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies. Thisdevice is designed to be used with autogenous bone graft and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bone graft.The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone deviceintended to be used with four bone screws. Supplemental fixation, cleared by theFDA for use in the lumbosacral spine, must be used with implants ≥20°.Supplemental fixation must also be used whenever fewer than four bone screws. |
| Materials: | The implant spacer components are made from two materials:1.Invibio PEEK-OPTIMA™ HA Enhanced2.Ti-6Al-4V ELI Titanium per ASTM F3001, Class CTantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws perASTM F136. All implants except for the screws and plates will be providedsterile. Screws and plates will be provided non-sterile but will be steamsterilized 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 F2077Static Compression Shear - Per ASTM F2077Dynamic Compression - Per ASTM F2077Dynamic Compression Shear - Per ASTM F2077Expulsion - N/ASubsidence - per ASTM E2267 |
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Summary of technological characterstics of the subject and predicate(s):
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 difference includes the subject device is designed for use without an accompanying coverplate. However, this embodiment is similar to the additional predicate in omitting coverplate utilization. The subject device is identical to the ChoiceSpine Harrier-SA predicate aside from the required utilization of a coverplate.
Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices. Dynamic Compression Shear testing of the worst-case implant construct is the standardized test that was determined to most aggressively challenge the functional performance of the device without the additional coverplate. Testing results confirm that utilization of the Harrier SA interbody and screws with or without usage of the coverplate results in equivalent functional performance. 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.
§ 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.