(23 days)
No
The document describes a spinal implant system and its components, focusing on materials, sizes, and intended use for spinal fusion. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a spinal system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction for various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is a spinal system intended for fusion and treating various spinal conditions; it is not described as being used for diagnosis.
No
The device description explicitly states it includes physical components like screws, surgical instruments, and cases, and is made from titanium alloy. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fusion and stabilization. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details surgical screws, rods, and instruments, all components of a surgical system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device is used directly on the patient's spine during surgery. IVDs are used to test samples from the patient, not implanted in the patient.
Therefore, this device falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput - T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discoqenic origin with deqeneration of the disc as . confirmed by patient history and radiographic studies)
- spondylolisthesis ●
- spinal stenosis .
- fracture/dislocation ●
- . atlanto/axial fracture with instability
- . occipitocervical dislocation
- revision of previous cervical spine surgery .
- tumors ●
The occipital bone screws are limited to occipital fixation only.
The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Product codes
MNI, KWP
Device Description
The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.
The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, occipito-cervico-thoracic junction (occiput -T3), upper thoracic spine (T1-T3), posterior cervical spine, occipital fixation
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)
Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002733, K010681, K013222, K022190
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
K030103 p 1/2
IX. 510(k) Summary
FEB 0 5 2003
| SUBMITTER: | DePuy AcroMed, Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02780 |
Lisa A. Gilman CONTACT PERSON:
DATE PREPARED: January 10, 2003
CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation
PROPRIETARY NAME: Summit OCT Spinal System Minipolyaxial Screws
Summit OCT Spinal System (K002733, K010681, PREDICATE DEVICES: K013222, K022190)
DEVICE DESCRIPTION: The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.
The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The indications for use for the modified devices INTENDED USE: described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- · ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · spondylolisthesis
- · spinal stenosis
- · fracture/dislocation
- · atlanto/axial fracture with instability
1
- · occipitocervical dislocation
- · revision of previous cervical spine surgery
- tumors
The occipital bone screws are limited to occipital fixation only.
The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System can also be linked to the ISOLA, TiMX. MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
- Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
FEB 0 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa A. Gilman Regulatory Affairs Associate DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K030103
Trade/Device Name: Summit Occipito-Cervico-Thoracic (OCT) Spinal System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: MNI, KWP Dated: January 10, 2003 Received: January 13, 2003
Dear Ms. Gilman:
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.
3
Page 2 - Ms. Lisa A. Gilman
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 vour 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) 594-4639. 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 n Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
III. Indications for Use
510(k) Number (if known): KO30 |03
Modified Summit OCT Spinal System Minipolyaxial Screws Device Name:
Indications For Use:
The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput - T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discoqenic origin with deqeneration of the disc as . confirmed by patient history and radiographic studies)
- spondylolisthesis ●
- spinal stenosis .
- fracture/dislocation ●
- . atlanto/axial fracture with instability
- . occipitocervical dislocation
- revision of previous cervical spine surgery .
- tumors ●
The occipital bone screws are limited to occipital fixation only.
The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109)
OR Over-The-Counter Use:
(Per 21 CFR 801.109)
OR Over-The-Counter Use:
DePuy AcroMed, Inc. Special 510K