(218 days)
No
The device description and performance studies focus on the mechanical properties and comparison to predicate devices, with no mention of AI or ML.
Yes.
The device is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with various spinal conditions, indicating its use in treating medical conditions.
No
Explanation: The device is a cervical plating system used for immobilization and stabilization of the spine as an adjunct to fusion, treating various spinal conditions. It is a surgical implant system, not a device used to diagnose medical conditions.
No
The device description explicitly states it consists of "dynamic and semi-constrained plate, screws and associated instruments" manufactured from "Titanium/ Titanium Alloy," which are physical hardware components.
Based on the provided information, the Quintex Cervical Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "immobilization and stabilization of the spine as an adjunct to fusion." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a "dynamic and semi-constrained plate, screws and associated instruments" made of Titanium/Titanium Alloy. This is a physical implant.
- Anatomical Site: The device is intended for the "cervical spine; C2-T1," which is a part of the human anatomy.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The Quintex Cervical Plating System does not perform this function.
The information provided describes a surgical implant used for spinal fusion, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:
- Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with 0 degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis, ●
- Trauma (i.e. fracture or dislocation), 0
- Spinal Stenosis,
- Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
- . Tumors and instability associated with major reconstructive surgery related to tumor excision,
- Pseudoarthrosis as a result of failed spine surgery, .
- . Failed previous fusions.
- Symptomatic cervical spondylosis, .
- . Instability following surgery for the above indications.
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS 3G Cervical Plating System is manufactured from Titanium/ Titanium Alloy and will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where relevant. Testing results demonstrate the AIS Quintex Cervical Plating System is safe and effective comparable to other predicate systems currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050813, K040017, K000486, K974706, K953720, K936269, K913730, K022997, K050804
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K100243
Page 1 of 1
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Quintex Cervical Plating System January 26, 2010
SEP - 2 2010
COMPANY: Aesculap Implant Systems, Inc. 3773 Corporate Parkwav Center Valley, PA 18034 Establishment Registration Number: 3005673311
CONTACT: Lisa M. Boyle 800-258-1946 (phone) 610-791-6882 (fax)
TRADE NAME: Quintex Cervical Plating System
COMMON NAME: Anterior Cervical Screw Spinal Fixation System
CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis (87KWQ)
REGULATION NUMBER: 888.3060
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems (AIS), Inc., believes that the Quintex Cervical Plating System is substantially equivalent to the AIS ABC Cervical Plating Systems (K050813/K040017 /K000486/K974706), AIS Caspar Plate & Screw System (K953720/K936269/K913730) and the AIS Spectrum Cervical Spinal System (K022997/K050804).
DEVICE DESCRIPTION
The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS 3G Cervical Plating System is manufactured from Titanium/ Titanium Alloy and will be provided non-sterile.
INDICATIONS FOR USE
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:
- Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with 0 degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis, ●
- Trauma (i.e. fracture or dislocation), 0
- Spinal Stenosis,
- Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
1
- . Tumors and instability associated with major reconstructive surgery related to tumor excision,
- Pseudoarthrosis as a result of failed spine surgery, .
- . Failed previous fusions.
- Symptomatic cervical spondylosis, .
- . Instability following surgery for the above indications.
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The AIS Quintex Cervical Plating System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where relevant. Testing results demonstrate the AIS Quintex Cervical Plating System is safe and effective comparable to other predicate systems currently on the market.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines, suggesting movement or flight. Encircling the bird is text, which appears to be part of the logo. The text is arranged in a circular fashion, following the contour of the bird and adding to the overall design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
SEP - 2 19 1
Aesculap Implant Systems, LLC % Ms. Lisa M. Boyle Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K100243
Trade/Device Name: Quintex Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 30, 2010 Received: August 31, 2010
Dear Ms. Boyle:
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
3
Page 2 - Ms. Lisa M. Boyle
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 of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbara Buchen
Mark N. Mell Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
SEP = 2 200
510(k) Number:_
Device Name: Quintex Cervical Plating System
Indications for Use:
The Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with:
- . Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis,
- Trauma (i.e. fracture or dislocation), ●
- Spinal Stenosis,
- . Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
- . Tumors.
- Pseudoarthrosis as a result of failed spine surgery,
- Failed previous fusions, .
- Symptomatic cervical spondylosis
- . Instability following surgery for the above indications.
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use X
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
K100243 510(k) Number_