(22 days)
When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput -- T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System and the Mountaineer 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 .
- atianto/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 and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System and the Mountaineer OCT Spinal System can also be linked to the ISOLA, TIMX, MONARCH, MOSS MIAMI, and EXPEDIUM Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Addition of components to the Summit OCT Spinal System and Mountaineer OCT Spinal System.
The Summit OCT Spinal System and Mountaineer OCT Spinal Systems also contain Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document is a 510(k) summary for the Summit OCT Spinal System and Mountaineer OCT Spinal System, specifically for an addition of components. It does not describe a study related to an AI/ML powered device, nor does it provide acceptance criteria or performance data in the typical sense of a clinical or performance study for such a device. Rather, it focuses on the substantial equivalence of additional components for an existing spinal fixation system.
Therefore, many of the requested elements for describing an AI/ML device study are not applicable or cannot be extracted from the provided text.
Here is an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or reported device performance in the context of an AI/ML device study. This submission is for an addition of components to an existing spinal fixation system. The "Performance Data" section states: "Performance data were submitted to characterize the additional components of the Summit OCT Spinal System and Mountaineer OCT Spinal System." However, the details of this performance data and the specific acceptance criteria are not included in the provided 510(k) summary. These would typically involve mechanical testing, material characterization, and compliance with ASTM standards, not clinical performance metrics for an AI system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device for which a "test set" of data would be used to evaluate algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.
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 a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system. The "ground truth" for such devices typically involves established engineering principles, material science, and mechanical testing standards.
8. The sample size for the training set
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.
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| IX. | 510(k) Summary | OCT 7 - 2004 | K042508 |
|---|---|---|---|
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 | ||
| CONTACT PERSON: | Jennifer Mooney | ||
| DATE PREPARED: | September 14, 2004 | ||
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation | ||
| PROPRIETARY NAME: | Summit OCT Spinal SystemMountaineer OCT Spinal System | ||
| PREDICATE DEVICES: | Summit OCT Spinal System (K002733, K010681,K013222, K022190, K030103, and K041203) | ||
| SYNTHES Spine CerviFix System (K984377) | |||
| DEVICE DESCRIPTION: | Addition of components to the Summit OCT SpinalSystem and Mountaineer OCT Spinal System. | ||
| The Summit OCT Spinal System and MountaineerOCT Spinal Systems also contain Class 1 manualsurgical instruments and cases that are consideredexempt from premarket notification. | |||
| INTENDED USE: | When intended to promote fusion of the cervicalspine and occipito-cervico-thoracic junction (occiput –T3), the Summit Occipito-Cervical-Thoracic (OCT)Spinal System and Mountaineer OCT Spinal Systemis intended for: | ||
| • ddd (neck pain of discogenic origin withdegeneration of the disc as confirmed by patienthistory and radiographic studies)• spondylolisthesis• spinal stenosis• fracture/dislocation• atlanto/axial fracture with instability• occipitocervical dislocation |
Page 28
Page 1 of 2
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| revision of previous cervical spine surgerytumors | |
|---|---|
| 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 and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine. | |
| The Summit OCT Spinal System and the Mountaineer OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH, MOSS MIAMI, and EXPEDIUM 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 additional components of the Summit OCT Spinal System and Mountaineer OCT Spinal System
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
OCT 7 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jennifer Mooney Regulatory Affairs Associate DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K042508
. K042500
Trade/Device Name: Summit OCT Spinal System and Mountaineer OCT Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWP Dated: September 14, 2004 Received: September 15, 2004
Dear Ms. Mooney:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in the 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
{3}------------------------------------------------
Page 2 -- Ms. Jennifer Mooney
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,
/ Mach N Mulkerson
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 lll.
510(k) Number (if known): ____ K042508________________________________________________________________________________________________________________________________________
Summit OCT Spinal System and Mountaineer OCT Spinal System Device Name:
Indications For Use:
When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput -- T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System and the Mountaineer 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 .
- atianto/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 and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System and the Mountaineer OCT Spinal System can also be linked to the ISOLA, TIMX, MONARCH, MOSS MIAMI, and EXPEDIUM Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(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 General, Restorative, and Neurological Devices
| 510(k) Number | K042508 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.