(135 days)
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.
The Medyssey, Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The cage is additively manufactured from titanium alloy (ASTM F136 and ASTM F3001) and is available in a range of sizes to accommodate different patient anatomies and pathologies.
The provided document is a 510(k) summary for the Medussa-PL Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance studies with human readers or clinical outcomes.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding study design, sample sizes, expert involvement, multi-reader studies, and ground truth establishment cannot be answered from the provided text, as this information is not typically part of a 510(k) summary for a spinal implant device unless specific clinical or performance studies were required.
Here's the information that can be extracted or deduced from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or inter-reader agreement, which are common for AI/diagnostic devices. Instead, for this type of implantable medical device, the "acceptance criteria" are implicitly related to demonstrating substantial equivalence to a previously cleared predicate device. This is primarily done through engineering analysis comparing design, materials, function, and performance.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The subject device must be substantially equivalent to the predicate device in terms of indications, design, materials, function, and performance. | "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." |
| Engineering Performance | Based on accepted engineering principles and testing (e.g., mechanical testing, material characterization, CAD analysis). | "Engineering CAD analyses including a comparison of device dimensions and materials concluded that based on the similarities in device design, the subject and predicate devices are substantially equivalent with respect to performance since both products have the same dimensions, material, area and bone graft lumen capacity." (Note: The document implies these analyses were performed and support the equivalence claim, but doesn't detail the specific results numbers). |
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 is not a study involving a "test set" of patient data for evaluating diagnostic performance. The evaluation is based on engineering analyses and comparison to a predicate device.
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. No ground truth for a test set was established in the context of a diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was used.
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
Not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The evaluation is based on engineering and material standards, and comparison to a predicate device, not on clinical efficacy measured against a ground truth from patient outcomes or pathology, which would typically be part of a PMA (Premarket Approval) submission rather than a 510(k). For a 510(k), the "truth" is established by demonstrating equivalence to a legally marketed device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that "proves" the device meets the acceptance criteria (i.e., is substantially equivalent to a predicate) is described as Engineering CAD analyses and a comparison of device dimensions and materials. This analysis concluded that the subject device (Medussa-PL Cage) and the predicate device (Medussa-PL Cage K170341) have the "same dimensions, material, area and bone graft lumen capacity." This demonstration of equivalence across key design and material components, along with the same Indications for Use, is considered sufficient for 510(k) clearance for this type of implantable device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 18, 2020
Medyssey USA, Inc. % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K200283
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: March 29, 2020 Received: April 29, 2020
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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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, Ph.D. Acting 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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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5. 510(k) Summary
| Device Trade Name: | Medussa-PL Cage |
|---|---|
| Manufacturer: | Medyssey USA, Inc.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, USA |
| Prepared by: | Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001(202) 552-5800jeggleton@mcra.com |
| Date Prepared: | February 4, 2020 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
| Primary Predicate: | The subject devices are substantially equivalent to theMedyssey Medussa-PL Cage (K170341). |
Indications for Use 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.
Device Description:
The Medyssey, Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The cage is additively manufactured from titanium alloy
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(ASTM F136 and ASTM F3001) and is available in a range of sizes to accommodate different patient anatomies and pathologies.
Performance Testing Summary:
Engineering CAD analyses including a comparison of device dimensions and materials concluded that based on the similarities in device design, the subject and predicate devices are substantially equivalent with respect to performance since both products have the same dimensions, material, area and bone graft lumen capacity.
Substantial Equivalence:
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.
§ 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.