(272 days)
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No
The summary describes a physical implant (cage) and its mechanical properties and testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is an implantable cage used to treat degenerative disc disease by promoting spinal fusion, which directly treats a medical condition.
No
Explanation: The Medussa-PL Cage is an implantable device used to treat Degenerative Disc Disease, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the device is comprised of implantable components manufactured from titanium alloy and is intended for surgical implantation. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (a cage) for treating Degenerative Disc Disease (DDD) in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the material (titanium alloy), manufacturing process (additive manufacturing), and intended surgical approach (PLIF). This aligns with a medical device intended for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies described (mechanical testing, subsidence, expulsion, abrasion) are typical for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medussa-PL Cage 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Medussa-PL Cage is comprised of a variety of implant sizes and instrumentation to accommodate various patient anatomy and pathology. All implantable components are manufactured with an additive manufacturing technology from medical grade titanium alloy Ti6Al4V-ELI per ASTM F136 and ASTM 3001. The cages are intended to be implanted via a Posterior Lumbar Intervertebral (PLIF) approach. Implants are single use and the system is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
L2-S1 (lumbar spine)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. Abrasion testing was performed per ASTM F1978. Additionally, bone graft volume as compared to the predicate and SEM characterization were conducted. The above pre-clinical testing on the Subject device indicate that the Medussa-PL Cage is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 2, 2017
Medyssey Co., Ltd. % Ms. Cheryl L. Wagoner Principal Consultant/Owner Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K170341
Trade/Device Name: Medussa-PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 2, 2017 Received: October 4, 2017
Dear Ms. Wagoner:
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);
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170341
Device Name Medussa-PL Cage
Indications for Use (Describe)
The Medussa-PL Cage 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
| 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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3
510(k) Summary (as required by 21 CFR 807.92)
| Date Prepared | 10/31/2017 |
|---|---|
| Manufacturer | Medyssey Co., Ltd. |
| Address | 129, Hanbang Expo-ro, Jecheon-si, Chungcheongbuk-do, 27116, |
| Republic of Korea | |
| Telephone | +82 43 716 1014 |
| Fax | +82 43 716 1015 |
| Contact Person | Shawn Kim |
| Address | Medyssey USA |
| 1550 E Higgins Road | |
| Suite#123 | |
| Elk Grove, IL 60007 | |
| Telephone | 847-427-0200 |
| Fax | 888-518-9070 |
| shawn@medyssey.com |
| Trade Name | Medussa-PL Cage |
|---|---|
| Common Name | Intervertebral Body Fusion Device |
| Panel Code | Orthopaedics/87 |
| Classification Name | Intervertebral Body Fusion Device |
| Class | Class II |
| Regulation Number | 21 CFR 888.3080 |
| Product Code | MAX |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Medyssey LP Cage (Primary) | K110067 | Medyssey Co., Ltd |
| 4-WEB ALIF SPINAL TRUSS | ||
| SYSTEM (STS) | K112316 | 4-WEB, INC. |
| Description | The Medussa-PL Cage is comprised of a variety of implant sizes and
instrumentation to accommodate various patient anatomy and pathology.
All implantable components are manufactured with an additive
manufacturing technology from medical grade titanium alloy Ti6Al4V-ELI
per ASTM F136 and ASTM 3001. The cages are intended to be
implanted via a Posterior Lumbar Intervertebral (PLIF) approach.
Implants are single use and the system is provided sterile. |
| ------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Indications and
Intended Use | The Medussa-PL Cage 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated
to be used with autograft bone. |
| --------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Technological
Characteristics and
Substantial
Equivalence | Documentation was provided to demonstrate that the Subject device, Medussa-
PL Cage is substantially equivalent to the Predicate Medyssey LP Cage
(K110067). The Subject device is substantially equivalent to the predicate device
in intended use, indications for use, materials, technological characteristics, and
labeling. |
| -------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
| Performance Data | Static and dynamic axial compression, static and dynamic
compression shear, and static torsion were completed following
ASTM F2077-14. Subsidence was tested following ASTM F2267-
04. Expulsion was tested following a recognized protocol to allow
comparison evaluation of intervertebral body fusion device
assemblies, and characterize their resistance to expulsion.
Abrasion testing was performed per ASTM F1978. Additionally,
bone graft volume as compared to the predicate and SEM
characterization were conducted. The above pre-clinical testing on
the Subject device indicate that the Medussa-PL Cage is
substantially equivalent to the predicate device. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Medussa-PL Cage and its predicate have the same intended use, to provide
mechanical stability in the lumbar disc space to facilitate biologic fusion. The
indications for use of the Medussa-PL Cage are identical to the predicate. The
Subject device is similar in size as its predicate. Minor differences between the
Subject and predicate devices do not raise any new questions of safety or
efficacy. Bench testing demonstrated that the differences do not adversely impact
device mechanical performance. Based on the intended use, indications for use,
technological characteristics, materials, and comparison to predicate devices, the
Subject Medussa-PL Cage (Subject device) has been shown to be substantially
equivalent to legally marketed predicate devices. |