(190 days)
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Not Found
No
The provided text describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is a spinal fixation system indicated for the treatment of severe spondylolisthesis and for providing immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal instabilities and deformities, which are therapeutic interventions.
No
The device is described as a "pedicle screw fixation system" intended for "immobilization and stabilization of the spinal segments as an adjunct to fusion." Its purpose is to physically fix and stabilize the spine, not to diagnose conditions.
No
The device description is not provided, but the intended use clearly describes a "pedicle screw fixation system" and "implants attached to the lumbar and sacral spine," 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided information describes a spinal fixation system, which is a surgical implant used to stabilize the spine within the body.
- Intended Use: The intended use clearly states the system is for treating spinal conditions and providing immobilization and stabilization of spinal segments. This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
Therefore, based on the provided information, the Outologous Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Outologous Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Outologous Spinal Fixation System is intended to provide immobilization and stabilization of the 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 spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusions (pseudoarthrosis).
Product codes
MNH, MNI
Device Description
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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
LS-S1 vertebra, lumbar and sacral spine, thoracic, lumbar, and sacral spines.
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
| 510(k) Summary | Outologous Spinal Fixation System | Pa |
|---|---|---|
| ADMINISTRATIVE INFORMATION | SEP - 3 2004 | |
| Manufacturer Name: | Orthopedic Sciences, Inc. | |
| 6080 Center Drive, 6th Floor | ||
| Los Angeles, CA 90045 | ||
| Official Contact: | James K. Brannon, M.D. | |
| President/CEO | ||
| Telephone (310) 242-6643 | ||
| FAX (310) 242-6603 | ||
| Representative/Consultant: | Floyd G. Larson | |
| PaxMed International | ||
| 4329 Graydon Road | ||
| San Diego, CA 92130 | ||
| Telephone (858) 792-1235 | ||
| FAX (858) 792-1236 | ||
| DEVICE NAME | ||
| Classification Name: | Pedicle Screw System (MNI [Class II uses]) per 21 CFR | |
| Part 888.3070 | ||
| Spondylolisthesis Spinal Fixation Device (MNH) Per | ||
| 21 CFR Part 888.3070 | ||
| Trade/Proprietary Name: | OutologousTM Spinal Fixation System | |
| Common Name: | Pedicle Screw Fixation System | |
| DEVICE CLASSIFICATION |
Pedicle screw fixation systems are assigned to Class II by FDA. The product codes for the Outologous Spinal Fixation System are MNI (Class II uses) and MNH.
INTENDED USE
The Outologous Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Outologous Spinal Fixation System is intended to provide immobilization and stabilization of the 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 spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusions (pseudoarthrosis).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a bird or a stylized human figure.
Public Health Service
SEP - 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthopedic Sciences, Inc. C/o Mr. Floyd G. Larson PAXMED International 4329 Graydon Road San Diego, California 92130
Re: K040493
Trade/Device Name: Outologous™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: August 26, 2004 Received: August 27, 2004
Dear Mr. Larson:
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.
2
Page 2 – Mr. Floyd G. Larson
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 (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 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 vours.
Ce
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
3
Indications for Use
510(k) Number: K040493
Device Name: Outologous™ Spinal Fixation System
Indications for Use:
The Outologous" Spinal Fixation System is a pedicle screw fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Outologous" Spinal Fixation System is intended to provide immobilization and stabilization of the 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 spines: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture of the vertebral body, dislocation, scoliosis, spinal tumor, and failed fusions (pseudoarthrosis).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Derice Evaluation (ODE)
Mark N. Mulbinson
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
46493