(202 days)
The HOURGLASSTM Vertebral Body Spacer is intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of turnor or trauma (i.e., fracture). The HOURGLASS™ device is to be used with supplemental fixation. Specifically, the HOURGLASS™ device is to be used with the Medtronic Sofamor Danek ZPLATE-II® Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, and/or the GDLH® Spinal System, or their successors. Additionally, the HOURGLASS™ device is intended to be used with bone graft.
The HOURGLASS™ device is a PEEK spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The HOURGLASS™ device is fabricated and manufactured from Polyetheretherketone (PEEK OPTIMA LT) as described by ASTM F-2026. The Tantalum markers used for this product are made to the voluntary standard of ASTM F-560.
The HOURGLASS™ device must be used with additional anterior and/or posterior spinal instrumentation to augment stability
The provided text is a 510(k) premarket notification for the HOURGLASS™ Vertebral Body Spacer, primarily focusing on its substantial equivalence to previously cleared devices rather than a detailed study demonstrating performance against specific acceptance criteria. This type of document generally establishes equivalence based on design, materials, and intended use.
Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text. The document does not describe a study that proves the device meets acceptance criteria in the manner one would expect for an AI/CADe device. Instead, it relies on substantial equivalence to predicate devices.
However, I can extract the available information:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, not on specific performance metrics or acceptance criteria for the device itself in a clinical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the document. The document describes a premarket notification based on substantial equivalence, not a clinical study with a test set of data.
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)
This information is not present in the document. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the document. No test set or adjudication method is described.
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
This information is not present in the document. This is not a study of an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the document. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not present in the document. No ground truth is mentioned.
8. The sample size for the training set
This information is not present in the document. No training set is mentioned as this device is not an AI/CADe.
9. How the ground truth for the training set was established
This information is not present in the document. No training set or ground truth establishment process is described.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
OCT 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K033926
Trade/Device Name: HOURGLASS™ Vertebral Body Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 8, 2004 Received: June 9, 2004
Dear Dr. Treharne:
This letter corrects our substantially equivalent letter of July 7th, 2004 regarding the attachment of incorrect Indications for Use statement page. The correct Indications for Use page is attached.
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 (QS) 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 - Richard Treharne, Ph.D.
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millhusan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
March 2004
510(k) Number (if known): K033926
Device Name: HOURGLASS™ Vertebral Body Spacer
Indications for Use!
The HOURGLASSTM Vertebral Body Spacer is intended to be used in partial corpectorny procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of turnor or trauma (i.e., fracture). The HOURGLASS™ device is to be used with supplemental fixation. Specifically, the HOURGLASS™ device is to be used with the Medtronic Sofamor Danek ZPLATE-II® Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, and/or the GDLH® Spinal System, or their successors. Additionally, the HOURGLASS™ device is intended to be used with bone graft.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millenn
(Division of General, Restorative, and Neurological Devices
510(k) Number
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K033926 (Pg 1/1)
JUL - 7 2004 HOURGLASS™ Vertebral Body Spacer 510(k) Summary December 2003
- Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proprietary Trade Name: HOURGLASS™ Vertebral Body Spacer II.
III. Product Description
The HOURGLASS™ device is a PEEK spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The HOURGLASS™ device is fabricated and manufactured from Polyetheretherketone (PEEK OPTIMA LT) as described by ASTM F-2026. The Tantalum markers used for this product are made to the voluntary standard of ASTM F-560.
The HOURGLASS™ device must be used with additional anterior and/or posterior spinal instrumentation to augment stability
IV. Indications
The HOURGLASS™ Vertebral Body Spacer is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). The HOURGLASS™ device is to be used with supplemental fixation. Specifically, the HOURGLASS™ device is to be used with the Medtronic Sofamor Danek ZPLATE-II® Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System or their successors. Additionally, the HOURGLASS™ device is intended to be used with bone graft.
V. Substantial Equivalence
Documentation was provided which demonstrates the HOURGLASS™ Vertebral Body Spacer to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K030736 and K031780) and the ZPLATE-II® Anterior Fixation System in terms of its size, indications for use and use with supplemental fixation.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.