(17 days)
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No
The device description and intended use clearly describe a mechanical implant (plates and screws) for spinal fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing, not algorithmic performance.
Yes
The device is described as an "anterior cervical fixation system" used to treat various medical conditions like degenerative disc disease, trauma, and tumors, indicating its use in treating or alleviating a disease or injury.
No
This device is a cervical plate system used for surgical fixation in the spine, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of plates and screws manufactured from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The Quantum Anterior Cervical Plate System is a physical implant (plates and screws) used for surgical fixation in the spine. It is not used to analyze biological samples.
- Intended Use: The intended use describes a surgical procedure to stabilize the cervical spine, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the Quantum Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (kyphosis, lordosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The Quantum Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine (C2-C7). Plates and screws are available in a variety of sizes to suit the individual pathology and unatomic condition of the patient. The device is manufactured from titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
anterior cervical spine (C2-C7)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing indicates that the Quantum Anterior Cervical Plate is capable of performing in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Quantum Orthopedics, Inc. Premarket Notification - Quantum Anterior cal Plate System પ્રદેશના પ
510(k) Summary Quantum Anterior Cervical Plate System 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Manufacturer Identification | |
|---|---|
| Submitted by: | Quantum Orthopedics. Inc. |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-0121 | |
| Contact Information: | Jason Blain |
| Chief Technology Officer | |
| Quantum Orthopedics. Inc. | |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-0121 | |
| jblain@quantumorthopedics.com | |
| Date Prepared: | February 21, 2006 |
| Device Indentification | |
| Proprietary Name: | Quantum Anterior Cervical Plate System |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Classification: | 21 CFR 888.3060: Appliance. Fixation. Spinal, Intervertebral Body |
Device Description
The Quantum Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine (C2-C7). Plates and screws are available in a variety of sizes to suit the individual pathology and unatomic condition of the patient. The device is manufactured from titanium alloy.
Intended Use of the Device
The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic only with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (lordosis, kyphosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.
1
KCC-491
Substantial Equivalence
The Quantum Anterior Cervical Plate System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
Performance Data
:
Mechanical testing indicates that the Quantum Anterior Cervical Plate is capable of performing in accordance with its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS emblem, which consists of a stylized caduceus with three lines representing health, services, and people. The emblem is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
ﻬﺎ ﻓﻬ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2006
Ouantum Orthopedics, Incorporated c/o Mr. Jason Blain Chief Technology Officer 2744 Loker Avenue W. Suite 100 Carlsbad, California 92010
Re: K060491
Trade/Device Name: Quantum Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Il Product Code: KWQ Dated: February 21, 2006 Received: February 24, 2006
Dear Mr. Blain:
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 mav 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
3
Page 2 -- Mr. Jason Blain
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. 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/dsma/dsmamain.html
Sincerely yours,
Heckert Semen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KOGO491 510(k) Number (if known):
Device Name: Quantum Anterior Cervical Plate System
Indications For Use:
The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (kyphosis, lordosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.
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)
Helene Lewis
Division of General, Restorative and Neurological Devices
Page 1 of 1
510(k) Number.