(105 days)
The DIO Medical IVA (ACIF) 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 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 DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) 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 or two contiguous 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.
The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage consists of PEEK+Tantalum which is identical to its predicate devices. All of the heights, lengths, and widths are within range covered by its predicate devices.
The provided text describes a medical device, the DIO Medical IVA Cage, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to acceptance criteria, device performance, sample size, ground truth, expert adjudication, MRMC studies, and training/test sets are not applicable to this document. These questions are typically relevant for evaluating AI/ML models in medical imaging or diagnostics.
The document focuses on the mechanical and material properties of an intervertebral body fusion device and its comparison to existing devices to demonstrate substantial equivalence for regulatory approval.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Device Performance:
- Acceptance Criteria: The device underwent testing according to specific ASTM standards:
- ASTM F2077: Static and dynamic axial compression testing, static and dynamic torsion testing, static compression shear testing.
- ASTM F2267: Subsidence testing.
- Reported Device Performance: The document states that "Performance data demonstrate that the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as [list of predicate devices]." However, specific quantitative performance metrics (e.g., exact load limits, displacement values, or fatigue life) from these tests are not provided in this summary. The summary only confirms that the testing was performed and deemed sufficient to show substantial equivalence.
2-9. Not Applicable (AI/ML Device):
The following questions are not applicable as the document describes a physical medical implant, not an AI/ML software device:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Summary of Relevant Information:
The DIO Medical IVA Cage is an intervertebral body fusion device. Its acceptance criteria are based on compliance with established ASTM standards for mechanical properties (ASTM F2077 and ASTM F2267). The study performed was a series of mechanical tests to demonstrate that the device performs equivalently to previously approved predicate devices in terms of safety and effectiveness. The specific numerical results of these tests and the test sample sizes are not detailed in this 510(k) summary but are implied to have met the necessary thresholds for substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2016
DIO Medical Co., Ltd % Mr. Paul Speidel Senior Regulatory and Quality Consultant ROMIS Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913
Re: K162220
Trade/Device Name: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 9, 2016 Received: September 12, 2016
Dear Mr. Speidel:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162220
Device Name
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) Cage
Indications for Use (Describe)
The DIO Medical IVA (ACIF) 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 radio raphic 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 with an intervertebral cage.
The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) 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-overative treatment. The device is intended for use at one or two contiguous 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.
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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510(k) SUMMARY
DIO Medical Co., Ltd's IVA Cage
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
DIO Medical Co., Ltd Sung Hee-Lee 101-105 Megacenter, SK Technopark 124 Sagimakgol-ro, Jungwon-gu Seongnam-si Gyeonggi-do, South Korea
Phone: 82-31-776-3690 Fax: 82-31-776-3691
Contact Person: Sung Hee-Lee
Date Prepared: November 10, 2016
Name of Device and Name/Address of Sponsor
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) Cage
DIO Medical Co., Ltd Sung Hee-Lee 101-105 Megacenter, SK Technopark 124 Sagimakgol-ro, Jungwon-gu Seongnam-si Gyeonggi-do, South Korea
Common or Usual Name
Intervertebral Body Fusion Device
Classification Name, Product Code, Regulation Number and Class
Intervertebral Body Fusion Device, Cervical (Product Code ODP) 21 CFR 888.3080 Class II Intervertebral Body Fusion Device, Lumbar (Product Code MAX) 21 CFR 888.3080 Class II
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Predicate Devices
- o Primary
- K122872 Galaxy PEEK Cage (Dio Medical Co., Ltd)
- · Additional
Intended Use / Indications for Use
Indications for Use:
The DIO Medical IVA (ACIF) 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 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 DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) 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 or two contiguous 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.
Intended Use:
The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage are intended for intervertebral body fusion in skeletally mature patients. The intended operation of this device is concentrated around the C2-C3, C7-Tl, and L2-S1 region of the spine. The device is designed for use with supplemental fixation and with autograft to facilitate fusion in the vertebrae.
Technological Characteristics
The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage consists of PEEK+Tantalum which is identical to its predicate devices. All of the heights, lengths, and widths are within range covered by its predicate devices.
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Performance Data
The DIO Medical IVA (ACIF) Cage device underwent testing according to ASTM F2077, specifically static and dynamic axial compression testing, static and dynamic torsion testing, static compression shear testing; and subsidence testing according to ASTM F2267.
The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage device underwent testing according to ASTM F2077. specifically static and dynamic axial compression testing. static torsion testing, static compression shear testing; and subsidence testing according to ASTM F2267.
Substantial Equivalence
The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as the Galaxy PEEK Cage (DIO Medical Co., Ltd), SYNSTER Caqe (BM Korea Co., Ltd), VENUS Lumbar Intervertebral Body Fusion Cage System (L&K Biomed Co.), the Innesis PEEK Cage (BK Meditech Co.) and the AnyPlus PEEK Cage (GS Medical Co., Ltd.). The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as the Galaxy PEEK Cage (DIO Medical Co., Ltd), SYNSTER Cage (BM Korea Co., Ltd), VENUS Lumbar Intervertebral Body Fusion Cage System (L&K Biomed Co.), the Innesis PEEK Cage (BK Meditech Co.) and the AnyPlus PEEK Cage (GS Medical Co., Ltd.). Thus, the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is substantially equivalent.
§ 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.