(26 days)
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 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
- 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.
Addition of 3.5mm rod to the Summit OCT Spinal System.
The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document describes a 510(k) submission for an addition of a 3.5mm rod to the Summit OCT Spinal System. This is a submission for a modified medical device, not for a novel diagnostic device or AI algorithm. As such, the information typically expected for acceptance criteria and studies proving performance for AI/diagnostic devices (such as sample sizes, expert ground truth, MRMC studies, standalone performance) is not applicable in this context.
The "PERFORMANCE DATA" section simply states: "Performance data were submitted to characterize the modified Summit OCT Spinal System." The FDA's response confirms that the device is "substantially equivalent" to predicate devices, meaning it meets the same safety and effectiveness standards, likely through engineering analyses and mechanical testing, rather than clinical studies with human subjects that establish diagnostic performance metrics.
Therefore, many of the requested fields cannot be filled as they pertain to a different type of medical device submission.
Here's the closest interpretation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Structural and Material Integrity (for 3.5mm rod) | "Performance data were submitted to characterize the modified Summit OCT Spinal System." |
| Biocompatibility (for 3.5mm rod) | "Manufactured from ASTM F-136 implant grade titanium alloy." |
| Functional Equivalence to Predicate Devices | Considered "Substantially Equivalent" to the predicate Summit OCT Spinal System (K022190). |
| Maintenance of Indicated Uses | The indications for use for the modified device are the same as the predicate (K022190). |
Explanation: In the context of a 510(k) for a modified implantable device like this, acceptance criteria typically revolve around demonstrating that the new component (the 3.5mm rod) does not compromise the safety and effectiveness of the overall system and that it meets established mechanical and material standards. The "reported device performance" here is the conclusion that these criteria were met, leading to the substantial equivalence determination.
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a modified implantable device. "Test set" and "data provenance" (in the context of clinical or AI data) are not relevant here. Performance data for such devices usually involves mechanical testing (e.g., fatigue, static strength), which doesn't involve clinical "test sets" in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of clinical/AI data is not relevant for this type of device submission. Device performance is evaluated against engineering specifications and material standards.
4. Adjudication method for the test set
- Not Applicable. See notes above.
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
- Not Applicable. This is an implantable surgical device, not a diagnostic AI tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an implantable surgical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a spinal fixation system, performance is established through engineering principles, material specifications, and potentially mechanical testing, rather than ground truth from medical diagnoses or outcomes data in the way an AI diagnostic would.
8. The sample size for the training set
- Not Applicable. This is an implantable surgical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This is an implantable surgical device, not an AI algorithm.
{0}------------------------------------------------
JUN - 2 2004 IX. 510(k) Summary
- SUBMITTER: DePuy Spine, Inc. 325 Paramount Drive Ravnham, MA 02780
- CONTACT PERSON: Lisa A. Gilman
- DATE PREPARED: May 6, 2004
- CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation
- PROPRIETARY NAME: Summit OCT Spinal System
- PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103)
- DEVICE DESCRIPTION: Addition of 3.5mm rod to the Summit OCT Spinal System.
The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
-
INTENDED 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 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
-
· occipitocervical dislocation
{1}------------------------------------------------
| 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.
MATERIALS: Manufactured from ASTM F-136 implant grade titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the modified Summit OCT Spinal System.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2004
Ms. Sharon Starowicz Regulatory Affairs Director Depuy Spine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K041203
Trade Name: Modified Summit OCT Spinal System - Additional Components Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: Class I1 Product Code: MNI, KWP Dated: May 6, 2004 Received: May 7, 2004
Dear Ms. Starowicz:
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.
{3}------------------------------------------------
Page 2 – Ms. Sharon Starowicz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Drimas made a assoc regulations administered by other Federal agencies. You must or uny 1 odetar buttor and 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. product ladiation come of provesin marketing your device as described in your Section 510(k) I mis letter will and in yourse finding of substantial equivalence of your device to a legally prematics notification " 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 rryou don't 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 other general 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/cdrb/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
for 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
{4}------------------------------------------------
Indications for Use III.
K041203 510(k) Number (if known):
Device Name:
Modified Summit OCT Spinal System
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 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 ◆
- 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) | |
|---|---|
| Miriam C. Provost | |
| Prescription Use: (Per 21 CFR 801.109) | X (Division Sign-Off) Counter Use: ______ |
| Division of General, Restorative,and Neurological Devices | |
| DePuy Spine, Inc.Special 510K | Page 5 |
§ 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.