(175 days)
When used as an intervertebral body fusion device, Choice Spine lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L 2 - S 1 , in skeletally mature patients who have had six months of nonoperative treatment. The 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. The device system is designed for use with supplemental fixation systems such as (ORIA Claris, ORIA Spinal Clip System, etc.).
When used as a vertebral body replacement device, Choice Spine lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5 , for the replacement of a collapsed or unstable vertebral body resulting from a turnor or traumatic injury. The device system is designed for use with supplemental fixation (ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft bone to facilitate fusion.
The 9mm width spacer system (SABRE, SHARK, HORNET, HARPOON) has a rectangular shape, a hollow center for placement of autograft bone, and a smooth anterior surface (nose). It is available in a variety of heights, length, and lordosis combinations with and without medial-lateral curvature to accommodate many different anatomic requirements.
The provided text describes the Choice Spine Lumbar Spacer System, which is a medical device. The information details the device's indications for use, materials, and a declaration of substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.
Therefore, many of the requested categories are not applicable to the provided document. The document describes a traditional medical device (spinal spacer), not an AI or algorithm-based device.
Here's a breakdown based on the information provided, highlighting what is and isn't available:
Acceptance Criteria and Study for Choice Spine Lumbar Spacer System
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Testing Standards) | Device Performance (Results) |
|---|---|
| Static Axial Compression Bending (ASTM F2077-11) | Substantially equivalent to predicate devices |
| Static Torsion (ASTM F2077-11) | Substantially equivalent to predicate devices |
| Dynamic Axial Compression Bending (ASTM F2267-04) | Substantially equivalent to predicate devices |
| Dynamic Torsion (ASTM F2267-04) | Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes mechanical performance testing of the physical device (spinal spacer) rather than a test set for an AI/algorithm. The "test set" in this context would refer to the physical spacers subjected to the performance tests. The specific number of devices tested is not provided, but the testing was conducted by an "independent laboratory."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and "ground truth" for mechanical performance is established by standardized testing methods, not expert consensus interpretation of data.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a physical implant; it does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the performance testing, the ground truth is established by physical measurement against the requirements of the ASTM standards (ASTM F2077-11 and ASTM F2267-04) and comparison to the performance of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of the Study:
The "study" described in the provided text is a series of mechanical performance tests conducted on the Choice Spine Lumbar Spacer System. These tests were performed by an independent laboratory according to established ASTM standards (ASTM F2077-11 and ASTM F2267-04). The tests covered static axial compression bending, static torsion, dynamic axial compression bending, and dynamic torsion.
The overall conclusion of these tests was that the device's performance was "substantially equivalent to those of the predicate devices." This "substantial equivalence" is the basis for the FDA 510(k) clearance, indicating that the device is as safe and effective as legally marketed predicate devices. The document does not provide raw data, specific pass/fail values, or detailed performance metrics beyond stating substantial equivalence.
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K140142 page 1 of 2
JUL 1 6 2014
510(k) Summary for the 9 mm Wide Choice Spine Lumbar Spacer System
Date Prepared: July 14, 2014
Submitter Contact: Choice Spine, LP. 400 Erin Drive, Knoxville, TN 37919 Tel: 865.246.3333 Fax: 865.246.3334
Regulatory Contact: Kim Finch, Manager of Regulatory Affairs kfinch@choicespine.net
Device Name: Spinal Vertebral Body Replacement Device Intervertebral Fusion Device with Bone Graft, Jumbar
TradeName: Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)
Product Class: Class II
Requlation Number 888.3080 Intervertebral Body Fusion Device
888.3060 Spinal Intervertebral body fixation orthosis
Product Codes: MAX, MQP
Panel Code: 87
Indications for Use:
When used as an intervertebral body fusion device, Choice Spine lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L 2 - S 1 , in skeletally mature patients who have had six months of nonoperative treatment. The 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. The device system is designed for use with supplemental fixation systems such as (ORIA Claris, ORIA Spinal Clip System, etc.).
When used as a vertebral body replacement device, Choice Spine lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5 , for the replacement of a collapsed or unstable vertebral body resulting from a turnor or traumatic injury. The device system is designed for use with supplemental fixation (ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft bone to facilitate fusion.
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K140142 page 2 of 2
Device Descriptions:
The 9mm width spacer system (SABRE, SHARK, HORNET, HARPOON) has a rectangular shape, a hollow center for placement of autograft bone, and a smooth anterior surface (nose). It is available in a variety of heights, length, and lordosis combinations with and without medial-lateral curvature to accommodate many different anatomic requirements.
Materials:
The 9mm width spacers are manufactured from PEEK OPTIMA LT1(Invibio) per ASTM F2026. The spacer includes tantalum marking pins per ASTM F560 for radiographic assistance. These technological characteristics and materials are identical to the predicate devices.
The 9mm width trials are manufactured from 17-4 Stainless Steel per ASTM F899 and are biocompatible.
Predicate Device(s):
K2M, LLC Aleutian Spacer System K051454, K130699 Innovasis, Inc., Box Peek VBR System K062151 Choice Spine Lumbar Spacer System, K073669
Performance Standards:
Performance testing was completed by an independent laboratory following ASTM F2077-11 and ASTM F2267-04. The tests included static axial compression bending, static torsion, dynamic axial compression bending and dynamic torsion testing. The test methods and results are substantially equivalent to those of the predicate devices.
Conclusion:
The 9 mm wide spacer has the same technological characteristics, intended use, comparable performance data, and is manufactured using the same processes as the predicate devices. The sterilization method and parameters remain the same. In conclusion, the 9 mm wide devices are substantially equivalent to the listed predicates and do not raise new questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2014
Choice Spine, LP Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K140142
Trade/Device Name: Choice Spine Lumbar Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: June 13, 2014 Received: June 16, 2014
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kim Finch
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -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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Indications for Use Statement K140142
The Company's Indications for Use Statement for Choice Spine Lumbar Spacer System is provided.
Indications for Use:
When used as an intervertebral body fusion device, Choice Spine Lumbar Spacers are 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. The 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. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
When used as a vertebral body replacement device, Choice Spine Lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
n E. Dmitrie Division of
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.