(17 days)
No
The document describes a mechanical spinal implant system and its components, with no mention of AI or ML technology.
Yes
The device is indicated for conditions such as scoliosis, vertebral fracture or dislocation, spondylolisthesis, degenerative disc disease, spinal tumor, and failed fusions, all of which are medical conditions that require treatment. It is a component of a spinal system designed to provide structural support and aid in spinal fusion.
No
The device, Diapason Combo, is a component of a spinal system intended for surgical implantation to treat various spinal conditions like scoliosis, fractures, and degenerative disc disease. Its purpose is therapeutic, not diagnostic. While its use can involve "radiographic studies," these are mentioned in the context of confirming degeneration for degenerative disc disease, not as an output of the device itself.
No
The device description clearly states it is a "design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker," which are physical components used in spinal surgery. The submission also covers the use of "Xia 6 mm diameter Rods," which are also physical components. The performance studies involve "Static and fatigue testing," which are tests performed on physical devices. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that this device is a component of a Spinal System used for posterior spinal fixation. Its intended uses are for various spinal conditions like scoliosis, fractures, spondylolisthesis, etc. This involves direct surgical implantation into the body.
- Lack of Specimen Handling: There is no mention of the device being used with any specimens taken from the human body.
- Focus on Mechanical Properties: The performance studies focus on the mechanical properties (static and fatigue testing) of the device, which is typical for implantable surgical devices, not IVDs.
Therefore, the Diapason Combo, as described, is a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- Vertebral fracture or dislocation .
- Spondylolisthesis .
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor .
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
Product codes
MNH, MNI, KWP
Device Description
The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T4-S2 spine, non-cervical posterior spine, L5-S1 joint, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
Static and fatigue testing demonstrates the comparable mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap.
Static and fatigue testing demonstrates the acceptable mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
FEB 1 4 2002
Special 510(k): Device Modification for the Osteonics® Spinal System Summary of Safety and Effectiveness
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp
59 Route 17
Allendale, NJ 07401-1677 |
| -------------------------------------------------------------- | --------------------------------------------------------------------- |
|---|
Contact Person:
Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:
January 25, 2002
Device Identification
Proprietary Name: Common Name: Classification Name and Reference:
Osteonics® Spinal System Spinal Fixation Appliances Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 Pedicle Screw Spinal System 21 CFR 888.3070
Predicate Device Identification
The features of the subject device are substantially equivalent to features of the Osteonics® Spinal System (OSS) Combination Screw Ring/Blocker which was determined substantially equivalent via 510(k) K990158 and to the OSS Screw Blocker and Cap which were determined substantially equivalent via 510(k) K951725. The modified device shall be referred to here in as the Diapson Combo. The Xia 6 mm diameter rods were determined substantially equivalent via K984251.
Description of Device Modification
The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.
Intended Use
The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:
1
20293 Plz
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- Vertebral fracture or dislocation .
- Spondylolisthesis .
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor .
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
Statement of Technological Comparison:
Static and fatigue testing demonstrates the comparable mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap.
Static and fatigue testing demonstrates the acceptable mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with its head tilted upwards. The figure is composed of three overlapping profiles, creating a sense of depth and dimension. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2002
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401
Re: K020293
Trade Name: Osteonics® Spinal System Regulatory Number: 21 CFR 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP Dated: January 25, 2002 Received: January 28, 2002
Dear Ms. Ariemma:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin marketing your device to a legally marketed notification. The PDA inding of substantial equiveland 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 and If you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in This allegitestions on the promotion and advertising of your device, (201) 594-4639. Rudinonary, 12. quese at (301) 594-4639. Also, please note the regulation prease contact the Office or Comphanes et notification" (21 CFR 807.97). Other general emined, "Misoranuming of relection to permanel from the Act may be obtained from the Division of Small information on your responsionnes and its not no nover (800) 638-2041 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
uriam 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
510(k) Number (if known): Kクスリ29 3
Device Name: Modification to the Osteonics® Spinal System
The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.
The uses for the legally marketed Osteonics® Spinal System are as follows:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis
- Vertebral fracture or dislocation
- Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
(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)
Miriam C. Provost
Over-The-Counter Use Division of General, Restorative Division of Golleral, Restorative Format 1-2-96)
K020293 510(k) Number_