(51 days)
K111525, P950019
No
The summary describes a physical implant (a cage for spinal fusion) and its material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion cage used to provide support and correction during lumbar interbody fusion surgeries for patients with Degenerative Disc Disease (DDD). Its purpose is to treat a medical condition and is implanted in the body to achieve this therapeutic effect.
No
Explanation: The provided text describes a medical implant (LT Cage System) used for spinal fusion in patients with Degenerative Disc Disease. Its purpose is to provide support and correction during surgery, not to diagnose a condition.
No
The device description explicitly states it consists of "cages of various widths and heights" manufactured from "titanium alloy," indicating a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the LT Cage System is an implantable device used in surgery to support and correct vertebral bodies. It does not involve testing or analyzing biological samples.
- The intended use is for surgical implantation. The device is designed to be placed within the patient's body during a surgical procedure, not to perform diagnostic tests on samples outside the body.
- The performance studies are mechanical tests. The studies listed (Static Compression, Static Torsion, etc.) are evaluating the physical properties and strength of the implant, not its ability to detect or measure substances in biological samples.
The LT Cage System is a surgical implant used for spinal fusion.
N/A
Intended Use / Indications for Use
The LT Cage System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The Medyssey LT Cage System consists of cages of various widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Medyssey LT Cage System is to be used with supplemental fixation.
The device is offered in 64 sizes, with heights ranging from 8 - 15mm, lengths from 25 - 32mm and a width of 11mm. They are also available with 0°, 4° and 8° lordosis. The devices are manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and are supplied non-sterile.
The purpose of this submission is to provide a device that is manufactured from titanium alloy, which is similar to the PEEK device currently available from Medyssey Co. Ltd.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar or lumbrosacral vertebral bodies, L2-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)
The subject and predicate Medyssey Cage devices are identical in indications for use, intended use, performance specifications, and fundamental technological characteristics. Assessment of the design change (alternate material) was completed in accordance with Medyssey design control procedures. The titanium material is stronger than the currently available PEEK material. In addition titanium is used in both spinal and general orthopedic implants and has no biocompatibility issues. No additional testing is required to support this submission. The predicate LP Cage was subjected to the following:
- Static Compression ASTM F2077-03 .
- Static Torsion ASTM F2077-03 .
- Static Compressive Shear F2077-03 .
- Dynamic Compression F2077-03 .
- Subsidence ASTM F2267-04 .
A risk analysis was completed. Based on the risk analysis and additional supporting documentation provided in this premarket notification submission, Medyssey believes that the subject Medyssey LT Cage is substantially equivalent to the Medyssey LP Cage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K111525, P950019
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
510(k) Summary
- Company:
Medyssey Co. Ltd. 722-3, 4F, Science Tower 4F Dongducheon City Gyeonggido, Korea Tel: 82-31-879-0414 FAX: 82-31-879-0415
- Contact:
Michael Kvitnitskv Chief Operating Officer Medyssey Co. Ltd. 8001 N. Lincoln Ave. Suite 401 Skokie, IL 60077 Tel: 847-982-0100 FAX: 888-518-9070
- Proprietary Name:
.
Medyssey LT Cage System
- Classification Name: Intervertebral Body Fusion Device (21 CFR888.3080); Class II, Product Code MAX
Product Description: 5.
The Medyssey LT Cage System consists of cages of various widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Medyssey LT Cage System is to be used with supplemental fixation.
The device is offered in 64 sizes, with heights ranging from 8 - 15mm, lengths from 25 - 32mm and a width of 11mm. They are also available with 0°, 4° and 8° lordosis. The devices are manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and are supplied non-sterile.
The purpose of this submission is to provide a device that is manufactured from titanium alloy, which is similar to the PEEK device currently available from Medyssey Co. Ltd.
6. Indications for Use:
The LT Cage System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
1
7. Summary of Technological Characteristics
The purpose of this special 510(k) is to provide a cage with the same dimension design and implant technique as the Medyssey LP Cage, but manufactured from titanium alloy meeting ASTM F136. The design and fundamental scientific technology of the subject Medyssey LT Cage are identical to the predicate device. The only difference is the material.
8. Identification of Legally Marketed Predicate Device
Documentation was provided, which demonstrates that the subject Medyssey LT Cage is substantially equivalent to the predicate Medyssey LP Cage cleared on April 8, 2011 under K110067. The only difference is the material of manufacture and several lumbar cage devices are manufactured from titanium alloy including the Medtronic PERIMETER Interbody Fusion Device (K111525, Aug. 25, 2011) and the Ray Cage (P950019).
9. Brief Discussion of Non-Clinical Tests Submitted
The subject and predicate Medyssey Cage devices are identical in indications for use, intended use, performance specifications, and fundamental technological characteristics. Assessment of the design change (alternate material) was completed in accordance with Medyssey design control procedures. The titanium material is stronger than the currently available PEEK material. In addition titanium is used in both spinal and general orthopedic implants and has no biocompatibility issues. No additional testing is required to support this submission. The predicate LP Cage was subjected to the following:
- Static Compression ASTM F2077-03 .
- Static Torsion ASTM F2077-03 .
- Static Compressive Shear F207703 .
- Dynamic Compression F2077-03 .
- Subsidence ASTM F2267-04 .
10. Conclusions from Non-Clinical Tests
A risk analysis was completed. Based on the risk analysis and additional supporting documentation provided in this premarket notification submission, Medyssey believes that the subject Medyssey LT Cage is substantially equivalent to the Medyssey LP Cage.
2
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 5 2012
Medyssy Co., Ltd. % Mr. Michael Kvitnitsky Chief Operating Officer 8001 North Lincoln Avenue Skokie, Illinois 60077
Re: K121246
Trade/Device Name: Medyssey LT Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 29, 2012 Received: May 30, 2012
Dear Mr. Kvitnitsky:
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
3
Page 2 -- Mr. Michael Kvitnitsky
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 forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson
Mark N. Melkerson // U Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
K121246 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Medyssey LT Interbody Fusion Cage System
Indications for Use:
The LT Cage System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation: These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Prescription Use × OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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K121246 510(k) Number_