(182 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and components of a pedicle screw system, with no mention of AI or ML.
Yes
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various spinal instabilities and deformities, which is a therapeutic purpose.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components such as screws, rods, and accessories made from titanium alloy, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a surgical implant system used for spinal fixation and stabilization in patients with specific spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device components are physical implants (screws, rods, etc.) made of titanium alloy, designed to be surgically implanted into the spine. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies described are mechanical tests (static and fatigue testing) of the device's structural integrity, which are relevant for surgical implants, not diagnostic devices.
In summary, the HAIDER-UCR Spinal System is a surgical implant used for spinal fixation and stabilization, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
- The HAIDER-UCR Spinal System is a pedicle screw system indicated for the . treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
- Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
- . The HAIDER-UCR Spinal System is a pedicle screw system 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:
- degenerative with objective evidence of neurological ● spondylolisthesis impairment,
- . fracture,
- dislocation, ●
- scoliosis, .
- kyphosis.
- spinal tumor, and ●
- failed previous fusion pseudarthrosis). .
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
Device Description
The HAIDER-UCR Spinal System is a pedicle screw system. The system components include: Titanium Pedicle screw (7.0mm dia., Assembled), Pedicle Screw Components (Set Screw, Washer, Cap, Housing), Screw Sub-Assembly (7.0mm X 35mm, 40mm, 45 mm), Crosslink (Cross Link Nut, Cross Link Hook, Cross-link Bar-60mm, 70mm, 80mm), and 5.5 mm Titanium Rods (305mm). Accessories include Hex 3mm Screw Driver and Hex 4mm Screw Driver. The system is made from titanium alloy or 6Al, 4V, Ti titanium alloy. The HAIDER-UCR Spinal System is supplied "NON-STERILE" and must be sterilized prior to use. The recommended sterilization process is high temperature sterilization (Steam Cycle: Gravity, Temperature: 270°F (125°C), Exposure Time: 15 minutes).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar and sacral spine (L3 to sacrum), Thoracic, lumbar, and sacral spine, L5-S1 vertebra, T-10 to Sacrum, L-1 to L-5
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 were conducted. Static tests of compression bending, tension bending and torsion of a typical system configuration indicated design performance was met. All samples were tested according to ASTM F-1717-96, the pedicle screw spinal system quideline. Samples subjected to cyclic fatigue testing also performed according to expectations. Seven constructs were tested and an S/N curve established. At least two run out points exceeded 5.000.000 load cycles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 1 4 2000
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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1. Device Name:
HAIDER-UCR Spinal System
Common Name(s): Pedicle screw spine system
Classification Name(s): Pedicle Screw Spinal System
2. Establishment Information:
| Name: | INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC |
|---|---|
| Number: | 9033791 |
| Address: | 5360 Preserve Parkway, S |
| 909.682.9616 - 909.682.9620 - fax | |
| Greenwood Village, CO 80121 |
3. Classification:
& 888.3070 - Spondylolisthesis Spinal Fixation Device System & 888.3070 - Pedicle Screw Spinal System (Class II Uses)
Device Class: Class II for the requested indications Classification Panel: Orthopaedic and Rehabilitation Devices Panel Product Codels): MNH. MNI respectively
Equivalent Predicate Device: 4.
Synergy™ Spinal System: K974749, Cross Medical Products, Inc. (now Interpore Cross International).
5. Device Description:
Indications for Use: when used as a Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
The HAIDER-UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
The HAIDER-UCR Spinal System is a pedicle screw system 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:
1
- degenerative spondylolisthesis with objective evidence of neurological impairment, .
- . fracture,
- dislocation, ●
- . scoliosis,
- kyphosis, ●
- spinal tumor, and .
- failed previous fusion pseudarthrosis). .
The system components include:
| Component | Catalog Number | Level of Use |
|---|---|---|
| Titanium Pedicle screw | ||
| 7.0mm dia., Assembled | ||
| 7.0mm X 35mm | ||
| 7.0mm X 40mm | ||
| 7.0mm X 45 mm | 40-35 | |
| 40-40 | ||
| 40-45 | T-10 to Sacrum | |
| T-10 to Sacrum | ||
| T-10 to Sacrum | ||
| Pedicle Screw Components | ||
| Set Screw | ||
| Washer | ||
| Cap | ||
| Housing | 60-10 | |
| 60-15 | ||
| 60-20 | ||
| 60-25 | T-10 to Sacrum | |
| T-10 to Sacrum | ||
| T-10 to Sacrum | ||
| T-10 to Sacrum | ||
| Screw Sub-Assembly | ||
| 7.0mm X 35mm | ||
| 7.0mm X 40mm | ||
| 7.0mm X 45 mm | 60-35 | |
| 60-40 | ||
| 60-45 | T-10 to Sacrum | |
| T-10 to Sacrum | ||
| T-10 to Sacrum | ||
| Crosslink | ||
| Cross Link Nut | ||
| Cross Link Hook | ||
| Cross-link Bar-60mm | ||
| Cross-link Bar-70mm | ||
| Cross-link Bar-80mm | 50 | |
| 55 | ||
| 70-60 | ||
| 70-70 | ||
| 70-80 | L-1 to L-5 | |
| L-1 to L-5 | ||
| L-1 to L-5 | ||
| L-1 to L-5 | ||
| L-1 to L-5 | ||
| 5.5 mm Titanium Rods | ||
| 5.5mm X 305mm | 95 | T-10 to Sacrum |
| Accessories | ||
| Hex 3mm Screw Driver | ||
| Hex 4mm Screw Driver | 300 | |
| 400 |
Materials: The system is made from a well known metallic alloy commonly known as titanium alloy or 6Al, 4V, Ti titanium alloy. This material meets or exceeds the quality and composition standards listed in the table below:
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Testing Summary: Static and fatigue testing were conducted. Static tests of compression bending, tension bending and torsion of a typical system configuration indicated design performance was met. All samples were tested according to ASTM F-1717-96, the pedicle screw spinal system quideline. Samples subjected to cyclic fatigue testing also performed according to expectations. Seven constructs were tested and an S/N curve established. At least two run out points exceeded 5.000.000 load cycles.
7. Company Contact:
Todd L. Ackarman Requiatory Affairs IAME, INC.
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
9. Performance Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM. Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.
IAME, INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
10. Special Controls:
Special controls were published in the Federal Register, Vol. 63, No. 143, July 27, 1998 (Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems). The following special controls apply to the marketing of this device when used as a posterior pedicle system:
- (i) Compliance with material standards,
- (ii) Compliance with mechanical testing standard,
- (iii) Compliance with biocompatability standard, and
- (iv) Compliance with specified labeling requirements.
11. Storage, Packaging & Sterilization Information:
The HAIDER-UCR Spinal System is supplied "NON-STERILE" and must be sterilized prior to use.
The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°
The validated cycle is:
Method: Steam Cycle: Gravity Temperature: 270°F (125°C) Exposure Time: 15 minutes
23
3
All packages containing implants or instruments should be intact upon receipt. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.
| FEATURE | HAIDER-UCR Spinal System | Synergy™ Spinal System | SE? |
|---|---|---|---|
| Indications for | |||
| Use: | degenerative spondylolisthesis with objective evidence of | ||
| neurological impairment, | |||
| fracture, | |||
| dislocation, | |||
| scoliosis, | |||
| kyphosis, | |||
| spinal tumor, and | |||
| failed previous fusion pseudarthrosis). | SAME | YES | |
| Materials: | Titanium alloy | SAME | YES |
| Design: | Rod, sacral screw, pedicle screw & cross link system | SAME | YES |
| Sterile: | Supplied Non-sterile | ||
| Autoclave processed by end user | SAME | YES | |
| Sizes: | Rods: 5.5mm dia. X 40-305mm length | ||
| Pedicular screws 7.0mm 35mm, 40mm, 45mm | EQUIVALENT | YES | |
| Manufacturer: | IAME, Inc. | Interpore/Cross | YES |
| Product Code: | MNH, MNI | SAME | YES |
| K - Number: | Pending | K974749 | YES |
12. Summary Comparison Table:
4
Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2000
Mr. David W. Schlerf Buckman Company, Inc. c/o IAME, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K993503 Trade Name: HAIDER-UCR Spinal System Regulatory Class: II Product Code: MNH and MNI Dated: January 10, 2000 Received: February 24, 2000
Dear Mr. Schlerf:
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 control provisions of the Act. The general control 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 (OS) 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.
This letter will allow you to begin marketing your device as described in your 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.
5
Page 2 - Mr. David W. Schlerf
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Danne R. Vochner.
1 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
6
Page 1 of 1
X 493503 510(k) Number :_______________________________________________________________________________________________________________________________________________________________
Device Name(s): HAIDER-UCR Spinal System
Intended Use Statement(s):
-
- Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
- The HAIDER-UCR Spinal System is a pedicle screw system indicated for the . treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
-
- Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
- . The HAIDER-UCR Spinal System is a pedicle screw system 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:
- degenerative with objective evidence of neurological ● spondylolisthesis impairment,
- . fracture,
- dislocation, ●
- scoliosis, .
- kyphosis.
- spinal tumor, and ●
- failed previous fusion pseudarthrosis). .
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmns D. Lochner.
(Division Sig -Off) Division of Ceneral Restorative Devices 510(k) Number_K99350 Z
X Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
UCR.DOC