(220 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
The provided document is a 510(k) Premarket Notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through clinical studies with performance metrics.
Therefore, the document does not contain the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The "study" mentioned in the document is a mechanical test that demonstrates substantial equivalence:
1. Table of acceptance criteria and the reported device performance:
Not applicable. The document states "Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner." It does not provide specific acceptance criteria or reported performance data for these mechanical tests.
2. Sample sized used for the test set and the data provenance:
Not applicable. The study refers to mechanical testing, not a clinical test set with data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood in the context of clinical studies (e.g., for AI/diagnostic devices) is not relevant for this type of mechanical testing for substantial equivalence.
4. Adjudication method for the test set:
Not applicable.
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. This is for a spinal fixation system, not an AI or diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a spinal fixation system.
7. The type of ground truth used:
Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device.
8. The sample size for the training set:
Not applicable. There is no training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. There is no training set mentioned.
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K070282
Page 1 of 2
SEP - 6 2007
Section 5 - 510(k) Summary
5.1 Statement
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Endius, Inc. chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the modified device, Endius Minit Posterior Cervical and Upper Thoracic Fixation System is provided below.
5.2 Submitter
Endius, Inc. 23 West Bacon Street Plainville, MA. 02762 Establishment Registration #: 1057469
5.3 Company Contact
Regina Wagner Manager, Regulatory Affairs/Quality Assurance
(508) 643-0983 x107 rwagner@endius.com
Christine Kuntz-Nassif Director, Regulatory Affairs/Quality Assurance (508) 643-0983 x114 cnassif(@endius.com
5.4 Device Name
Proprietary Name: Endius Minit Posterior Cervical and Upper Thoracic Fixation
System
Classification Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050
Endius. Inc. 510(k) Premarket Notification Endius Minit PCT Fixation System K070282
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K070282
Page 2 of 2
5.5 Predicate Devices
Device Name(s) & 510(k) Number:
- Endius Minit Posterior Cervical and Upper Thoracic Fixation System, K060683 t
5.6 Device Description
The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
5.7 Device Indications and Intended Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
5.8 Substantial Equivalence
- . Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner.
Endius, Inc. 510(k) Premarket Notification Endius Minit PCT Fixation System K070282
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes. The symbol is oriented diagonally, with the top of the symbol pointing towards the upper right corner of the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endius. Incorporated c/o Ms. Christine Kuntz-Nassif Director, RA/QA and Tissue Banking 23 West Bacon Street Plainville, Massachusetts 02762
K070282 Re:
Trade/Device Name: Endius Minit Posterior Cervical-Thoracic Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: August 21, 2007 Received: August 22, 2007
SEP - 6 2007
Dear Ms. Kuntz-Nassif:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in 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.
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Page 2 - Ms. Christine Kuntz-Nassif
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Aubare Bowen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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070282
Indications for Use
510(k) Number (if known): K070282
Device Name: Endius Minit Posterior Cervical and Upper Thoracic Fixation System
Indications For Use:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to theTiTLE and TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Prescription Use X AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Derice Evaluation (ODE)
and Neurological Devices
510(k) Number K070282
N/A