(86 days)
Not Found
No
The summary describes a physical interbody fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is implanted to facilitate fusion and treat degenerative disc disease, which are therapeutic interventions.
No
Explanation: The provided text describes the Varian cage as an interbody fusion device intended for use in spinal fusion surgery, not for diagnostic purposes. Its function is to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states the device is made of titanium alloy and includes various sizes and angles, indicating it is a physical implantable device, not software.
No, 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 Function: The Varian cage is a physical implant designed to be surgically placed in the spine to facilitate fusion. It does not analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating a structural issue in the spine, not a diagnostic test.
- Device Description: The description details the material, size, and shape of a physical implant.
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the implant, not the accuracy of a diagnostic test.
Therefore, based on the provided information, the Varian cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151900, K132505, K140564, K140577, K121246
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
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
2
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 123 | |
| Elk Grove Village, IL 60007, USA | |
| Phone: (847) 427-0200 | |
| Contact: | Mr. Shawn Kim |
| Director | |
| Medyssey USA, Inc. | |
| 1550 E. Higgins Road, Suite 123 | |
| Elk Grove Village, IL 60007, USA | |
| Phone: (847) 427-0200 | |
| Prepared by: | Mr. Justin Eggleton |
| Senior Director, Spine Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: (202) 552-5800 | |
| jeggleton@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 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 |
4
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.