(22 days)
No
The summary describes a passive implant (a PEEK cage) used for spinal fusion. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device is a physical implant with anti-migration features.
Yes
The device is indicated for intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device description clearly states it is an "intervertebral body fusion" cage, a surgical implant used to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states the device is a "PEEK Cage" made from PEEK and Tantalum, which are physical materials, not software.
Based on the provided information, 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: The description clearly states that the Medynus IVA PEEK Cage is an implantable device intended for intervertebral body fusion in the spine. It is a physical cage made of PEEK and Tantalum.
- Intended Use: The intended use is to facilitate fusion between vertebrae in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Medynus IVA (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Medynus IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous 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 radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX, ODP
Device Description
The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine. All the devices are non-sterile, single use - cages of multiple footprints, heights and lordosis options to fit the anatomical needs of a wide variety of patients and are made from PEEK and Tantalum. They have anti-migration features on the superior and inferior surfaces and can be packed with autograft to facilitate fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C3 disc to C7-T1 disc), Lumbar spine (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)
The subject and predicate devices are identical and therefore, no performance testing is necessary to demonstrate substantial equivalence. Submission is only transferring name of a system that has already been cleared under K162220. No new testing was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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September 23, 2021
Medynus Inc. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Drive Collegeville, Pennsylvania 19426
Re: K212792
Trade/Device Name: Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 30, 2021 Received: September 1, 2021
Dear Jeena 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.
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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) 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 medical devices and radiation-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 L. 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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K212792 Page 1 of 1
510(k) Number (if known)
K212792
Device Name
Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage
Indications for Use (Describe)
The Medynius IV A (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Medynis IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S 1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous 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 radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Medynus IVA PEEK Cage
l. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Medynus Inc. 18 Technology Dr. Ste 109 Irvine, CA 92618 Phone: (949) 932-0847 Email: davidshin@medynus.com
II. Contact Person Name and Address:
Jeena Mathai Eerkie Corporation 4027 Runnymeade Dr Collegeville, PA 19426 Phone: (760) 521-58707 Email: mgsharemg@gmail.com
lll. Subject Device:
| Trade Name: | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
|---|---|
| Common Names: | Intervertebral body fusion device |
| Classification: | Class II |
| Classification Name: | Intervertebral Body Fusion Device, Cervical (Product Code ODP) |
| Intervertebral Body Fusion Device, Lumbar (Product Code MAX) | |
| Regulation Number: | 21 C.F.R. §888.3080 |
IV. Predicate Devices:
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K162220)
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V. Device Description:
The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine. All the devices are non-sterile, single use - cages of multiple footprints, heights and lordosis options to fit the anatomical needs of a wide variety of patients and are made from PEEK and Tantalum. They have anti-migration features on the superior and inferior surfaces and can be packed with autograft to facilitate fusion.
Intended Use / Indications for Use
Indications for Use:
The Medynus IVA (ACIF) PEEK Cage is intended to be used for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage
The Medynus IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Technological Characteristics
The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage consists of PEEK+Tantalum which is identical to its predicate devices. The design, material composition and manufacturing are same as the predicate.
VI. Comparison of Technological Characteristics with the Predicate Device: (Substantial
Equivalence)
The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is identical to the predicate device and is as safe and effective as the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage. The Subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. There are no technological differences between the Subject device and its predicate devices resulting in no new issues of safety or effectiveness. Thus, the Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is identical/substantially equivalent.
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VII. Performance Data
The subject and predicate devices are identical and therefore, no performance testing is necessary to demonstrate substantial equivalence. Submission is only transferring name of a system that has already been cleared under K162220. No new testing was provided.
VIII. Conclusion:
The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Thus, the subject device is identical/substantially equivalent to the predicate device.