(22 days)
No
The summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is an interbody fusion cage used to facilitate fusion in the lumbar spine for patients with Degenerative Disc Disease, which directly addresses a medical condition and aims to restore physiological function.
No
The device is an interbody fusion cage used to facilitate the fusion process in the lumbar spine, specifically for treating Degenerative Disc Disease, not for diagnosing it.
No
The device description explicitly states that the Medussa-PL Cage is an interbody fusion device additively manufactured from Titanium Alloy, indicating it is a physical hardware implant.
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 Description and Intended Use: The provided information clearly describes a surgical implant (an interbody fusion cage) used to facilitate spinal fusion in the lumbar spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
The Medussa-PL Cage is a medical device, specifically a surgical implant.
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 I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The Medussa-PL Cage is additively manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001 and is available in a range of sizes to accommodate different patient anatomies, and pathologies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the engineering analysis and the performance testing result including comparison of device dimensions and materials concluded that based on the similarities in device design, the subject device is substantially equivalent and/or better with respect to performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medussa-PL Cage (K170341), LP Cage (K110067)
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.
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December 28, 2022
Medyssey USA, Inc. % Ms. Jeena Mathai President Eerkie Corp 4027 Runnymeade Dr Collegeville, Pennsylvania 19426
Re: K223654
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: November 29, 2022 Received: December 6, 2022
Dear Ms. Mathai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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 I 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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5. 510(k) Summary
| Device Name: | Medussa-PL Cage |
|---|---|
| Manufacturer: | Medyssey, Co., Ltd. |
| 129, Hanbang expo-ro, Jechoen-si, | |
| Chungcheongbuk-do, 27116, Republic of Korea | |
| Contact: | Mr. Youngsu Jang |
| Director | |
| Medyssey USA, Inc. | |
| 1302 Busch Pkwy | |
| Buffalo Grove, IL 60089, USA | |
| 847-427-0200 | |
| ysjang@medyssey.com | |
| Data Prepared: | November 29, 2022 |
| Prepared by: | Ms. Jeena Mathai |
| President | |
| Eerkie Corp | |
| 4027 Runnymeade Dr | |
| Collegeville, PA 19426 | |
| 760-521-5870 | |
| mgsharemg@gmail.com | |
| Regulation Number: | 21 CFR 888.3080 |
| Classification Product Code: | MAX |
| Device Classification Name: | Intervertebral body fusion device |
| Device Class: | II |
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 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.
Device Description:
The Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The Medussa-PL Cage is additively manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001 and is available in a range of sizes to accommodate different patient anatomies, and pathologies.
Performance Testing Summary:
Based on the engineering analysis and the performance testing result including comparison of device dimensions and materials concluded that based on the similarities in device design, the subject device is substantially equivalent and/or better with respect to performance.
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Predicate Device:
The primary predicate device is the Medussa-PL Cage (K170341). The additional predicate device is the LP Cage (K110067).
Substantial Equivalence Conclusion:
The subject Medussa-PL Cage is substantially equivalent to the primary predicate, the Medussa-PL Cage (K170341), with respect to indications, design, materials, function, and performance.