(12 days)
The SPECTRUM™ Cervical Plating System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/of failed previous fusions.
The SPECTRUM™ Cervical Spinal System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implants for this system are manufactured from Titanium alloy (Ti6Al4V) in conformance with ISO 5832/3 (ASTM F136-98) and are provided non-sterile.
The provided text is a 510(k) summary for the SPECTRUM™ Cervical Spinal System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets acceptance criteria through clinical studies or performance against specific metrics as would be typical for more novel or higher-risk devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of an AI/software device. Specifically:
- No acceptance criteria table or reported device performance for an AI/software component is present.
- No sample size for a test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance study, or ground truth details related to an AI/software evaluation are provided.
- No sample size for a training set or how ground truth was established for a training set is provided.
The "Performance Data" section ([1]Page 2 of 2) explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The modified components conform to ASTM standard F1717, applicable ISO standards, and the CDRH Guidance for Spinal System 510(k)." This indicates that the device's conformity is based on existing mechanical and material standards for spinal systems, not on clinical performance studies proving specific acceptance criteria for functionality like an AI/software device would undergo.
The document discusses substantial equivalence to predicate devices based on design and material conformity to industry standards, not on a detailed analysis of AI performance metrics.
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APR 1 1 2005
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
SPECTRUM™ Cervical Spinal System
March 29, 2005
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Kathy A. Racosky, Regulatory Affairs Associate800-258-1946 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com (e-mail) |
| TRADE NAME: | SPECTRUM™ Cervical Spinal System |
| COMMON NAME: | Plate and Screw Cervical Spinal Fixation System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | KWQ |
| CLASSIFICATION: | 888.3060 - Appliance, Fixation, Spinal Intervertebral Body |
| REVIEW PANEL: | Orthopedic |
| INTENDED USE |
The SPECTRUM™ Cervical Plating System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/of failed previous fusions.
WARNING: This device is not approved for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
DEVICE DESCRIPTION
The SPECTRUM™ Cervical Spinal System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implants for this system are manufactured from Titanium alloy (Ti6Al4V) in conformance with ISO 5832/3 (ASTM F136-98) and are provided non-sterile.
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Page 2 of 2
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The modified components conform to ASTM standard F1717, applicable ISO standards, and the CDRH Guidance for Spinal System 510(k).
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the modified SPECTRUM™ Cervical Spinal System is substantially equivalent to our current SPECTRUM™ Cervical Spinal System (K022997) and to the following competitor's predicate device.
- Sofamor Danek Atlantis™ Anterior Cervical Plate System (K993855) .
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 】 2005
Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K050804
Trade/Device Name: SPECTRUM™ Cervical Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 29, 2005 Received: March 30, 2005
Dear Ms. Racosky:
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 - Ms. Kathy A. Racosky
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
Styph Rhode
Z. Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting 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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K050804
Device Name: SPECTRUMTM Cervical Spine System
Indication for Use:
The SPECTRUM™ Cervical Plating System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/of failed previous fusions.
WARNING: This device is not approved for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use × or Over-the-Counter Use
(per 21 CFR 801.109)
(Optional Format 3-10-98)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
ice of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number
Image /page/4/Picture/16 description: The image contains the number 3 in bold font. The number is centered in the image. The background is white, but there are some dark spots around the number.
§ 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.