(86 days)
The Varian cage 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. 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. Varian cage is designed to be implanted bi-laterally via a posterior (PLIF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.
The Medyssey Varian cage is an interbody fusion device utilized to achieve fusion in the lumbosacral spine. The system is made of titanium alloy and includes seven sizes, ranging from 9 mm to 15 mm in height and 24 mm or 27mm in length with 8° or 10° lordotic angle versions.
The provided text describes a medical device, the "Varian cage," and its FDA 510(k) clearance, which attests to its substantial equivalence to previously marketed devices. However, the document does not describe a study that establishes acceptance criteria for performance metrics (such as sensitivity, specificity, or AUC) and then proves the device meets those criteria, as typically seen in AI/ML device submissions.
Instead, the "acceptance criteria" discussed are related to the mechanical and functional performance of the intervertebral body fusion device. The study described is a series of engineering tests designed to demonstrate the device's structural integrity and equivalence to predicate devices, not a study involving human readers or AI.
Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI performance studies that are not present in this document.
Here's the breakdown of what can be extracted:
Acceptance Criteria and Device Performance (Mechanical/Functional)
| Acceptance Criteria (Test Standard) | Reported Device Performance (Demonstrated Compliance) |
|---|---|
| ASTM F2077 (Static Compression, Static Compression-Shear, Dynamic Compression, Dynamic Compression-Shear, Subsidence) | Studies designed to address risks and demonstrate substantial equivalent performance to predicate devices. (Specific quantitative results are not provided in the summary.) |
| ASTM F2267 (Expulsion Testing) | Studies designed to address risks and demonstrate substantial equivalent performance to predicate devices. (Specific quantitative results are not provided in the summary.) |
| FEA Worst Case Verification | Verification performed. (Specific quantitative results are not provided in the summary.) |
1. A table of acceptance criteria and the reported device performance
(See table above)
The document states that testing was performed in accordance with ASTM F2077 and ASTM F2267, which are standards for intervertebral body fusion device testing. The acceptance criterion is implicitly meeting the requirements of these standards and demonstrating substantial equivalence to predicate devices in these mechanical performance aspects. The reported device performance is that these studies were designed to address risks and demonstrate substantial equivalent performance to predicate devices. Specific numerical results are not provided in this 510(k) summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a physical device, not a study with a "test set" of clinical data. The "samples" would be the physical devices tested according to the ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes mechanical testing of a physical device. Ground truth is not established by experts in a clinical context for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes mechanical testing of a physical device. Adjudication methods are not relevant here.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral cage, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral cage, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" relates to the physical properties and performance characteristics of the material and device design as per engineering standards, not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This document describes mechanical testing, not a machine learning study with a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes mechanical testing, not a machine learning study.
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December 8, 2017
Image /page/0/Picture/1 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medyssey USA, Inc. % Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K172756
Trade/Device Name: Varian cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 11, 2017 Received: September 14, 2017
Dear Mr. Eggleton:
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 (QS) regulation (21 CFR Part 820);
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Page 2 - Justin Eggleton
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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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Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K172756
Device Name Varian cage
Indications for Use (Describe)
The Varian cage 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. The device is intended for use 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 radios.
Varian cage is designed to be implanted bi-laterally via a posterior (PLF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.
| 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) |
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510(k) Summary
| Device Trade Name: | Varian cage |
|---|---|
| Manufacturer: | Medyssey, Co., Ltd.1550 E. Higgins Road, Suite 123Elk Grove Village, IL 60007, USAPhone: (847) 427-0200 |
| Contact: | Mr. Shawn KimDirectorMedyssey USA, Inc.1550 E. Higgins Road, Suite 123Elk Grove Village, IL 60007, USAPhone: (847) 427-0200 |
| Prepared by: | Mr. Justin EggletonSenior Director, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5800jeggleton@mcra.com |
| Date Prepared: | December 4, 2017 |
| Classification: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
| Primary Predicate Device: | Wenzel Spine, Inc., VariLift®-L Interbody Fusion Device(K151900) |
| Additional Predicates: | CoAlign Innovations AccuLIF TL and PL Cage (K132505)K093669)Medyssey BN Cage (K140564)INNESIS PEEK TL Cage (K140577)Medyssey LT Cage (K121246) |
| Indications For Use: | The Varian cage is indicated for intervertebral body fusion of thelumbar spine, from L2 to S1, in skeletally mature patients who havehad six months of non-operative treatment. The device is intendedfor use at either one level or two contiguous levels for the treatment |
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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. Varian cage is designed to be implanted bi-laterally via a posterior (PLIF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion. Device Description: The Medyssey Varian cage is an interbody fusion device utilized to achieve fusion in the lumbosacral spine. The system is made of titanium alloy and includes seven sizes, ranging from 9 mm to 15 mm in height and 24 mm or 27mm in length with 8° or 10° lordotic angle versions. Predicate Device: Varian cage was shown to be substantially equivalent to previously cleared predicate devices and has the same indications for use, design, function, and materials used. These devices are the Wenzel Spine VariLift®-L Interbody Fusion Device (K151900), CoAlign AccuLIF TL and PL Cage (K132505), Medyssey BN Cage (K140564), INNESIS PEEK TL Cage (K140577), and Medyssey LT Cage (K121246) Testing performed on this includes FEA worst case verification, Performance Testing: Static Compression, Static Compression-Shear, Dynamic Compression, Dynamic Compression-Shear, Subsidence and Expulsion Testing. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Each of these studies were designed to address risks and demonstrate substantially equivalent performance to predicate devices. Substantial Equivalence: The subject Varian cage is substantially equivalent to the primary predicate, the Wenzel Spine VariLift®-L Interbody Fusion Device (K151900), and the additional predicates CoAlign AccuLIF TL and PL Cage (K132505), Medyssey BN Cage (K140564), INNESIS PEEK TL Cage (K140577), and Medyssey LT Cage (K121246) with respect to indications, design, materials, function, and performance. Conclusion: The Varian cage is substantially equivalent to predicate devices with respect to safety and effectiveness.
§ 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.