(117 days)
Not Found
No
The document describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
This device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for treating various spinal instabilities and deformities, which categorizes it as a therapeutic device.
No
This device is a spinal fixation system, used for immobilization and stabilization of spinal segments. It is a treatment device, not a diagnostic one.
No
The device description clearly indicates it is a physical spinal fixation system consisting of screws and other components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this is a "Spinal Fixation Device System" and a "Pedicle Screw Spinal System." Its intended use is to provide "immobilization and stabilization of spinal segments" and "spinal fixation" in patients with various spinal conditions.
- Mechanism of Action: The device is a physical implant used to mechanically support and stabilize the spine. It does not involve testing biological samples.
The information provided focuses on the mechanical properties, fatigue performance, and surgical application of the spinal screws and system, which are characteristic of a surgical implant rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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. Also 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 the thoracic, lumbar, and sacral spine:
- . degenerative spondylolisthesis with objective evidence of neurological impairment,
- . fracture.
- dislocation,
- . scoliosis,
- kyphosis.
- l spinal tumor, and
- I failed previous fusion (pseudarthrosis)
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
Device Description
The new 5.5mm screw will be used in all UCR Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical properties and fatigue performance are important. The remainder of the UCR Spinal System components will remain unchanged. Other than the major and minor diameter of the cancellous portion of the shaft and threads, the new 5.5mm screws are similar to the existing screws. Spinal rod attachment method are the same as cleared previously.
The new 8.0mm Spinal Screws expand the options for screw insertion by providing an alternative to the smaller 6, 6.5 or 7.0mm pedicle screws of the available UCR Spinal System. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the large size of the pedicle makes use of smaller diameter screws less desirable. The larger diameter of the 8.0mm Spinal Screws permits the surgeon to address the needs of an expanded patient population.
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
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)
Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. Both the 505mm and the 8.0mm pedicular screws carry clinically useful loads out to the five-million cycle asymptotic endurance limit.
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
K021623 1/3
SEP 1 0 2002
| Summary of Safety and Effectiveness Information
| Premarket Notification, Section 510(k) | SEASPINE, INC. |
|---|---|
| AUGUST 23, 2002 |
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
| 1. Device Name: | |
|---|---|
| ----------------- | -- |
| Trade Name: | UCR Spinal System |
|---|---|
| Common Name(s): | pedicle screw |
| Classification Name(s): | Pedicle Screw Spinal System (Class II Uses) |
2. Establishment Name & Registration Number:
Name: SEASPINE, INC. Number:
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 Code(s): | MNH, MNI, respectively |
4. Equivalent Predicate Device:
The 5.5mm Spinal Screws may be directly contrasted with the larger diameter cleared spinal screws of UCR Spinal System, K983353. Other than the reduced major screw diameter, the new Spinal Screws are essentially the same as the cleared spinal screws in the existing UCR Spinal System. The basic design, dimensional tolerances, materials and intended use are identical.
5. Device Description:
The new 5.5mm screw will be used in all UCR Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical properties and fatigue performance are important. The remainder of the UCR Spinal System components will remain unchanged. Other than the major and minor diameter of the cancellous portion of the shaft and threads, the new 5.5mm screws are similar to the existing screws. Spinal rod attachment method are the same as cleared previously.
The new 8.0mm Spinal Screws expand the options for screw insertion by providing an alternative to the smaller 6, 6.5 or 7.0mm pedicle screws of the available UCR Spinal System. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the large size of the pedicle makes use of smaller diameter screws less desirable. The larger diameter of the 8.0mm Spinal Screws permits the surgeon to address the needs of an expanded patient population.
Testing Summary:
Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. Both the 505mm and the 8.0mm pedicular screws carry clinically useful loads out to the five-million cycle asymptotic endurance limit.
Indications for Use:
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. Also 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 the thoracic, lumbar, and sacral spine:
1
- . degenerative spondylolisthesis with objective evidence of neurological impairment,
- . fracture.
- dislocation,
- . scoliosis,
- kyphosis.
- l spinal tumor, and
- I failed previous fusion (pseudarthrosis)
6. Applicant Name & Address:
SEASPINE, INC. 6276 River Crest Drive Riverside, CA 92507.0754 909.413.0200 (v) 909.653.5680 (f)
7. Company Contact:
Regulatory Affairs 6276 River Crest Drive Riverside, CA 92507.0754 909.413.0200 (v) 909.653.5680 (f)
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, LLC. 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 procedures, Quality Systems Regulations. ISO materials standards and ISO 9000 series quality regulations. SEASPINE, INC. In addition, meets appropriate general controls authorized under Sections 501, 502, 510, 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. Special Guidance Document Information:
The 510(k) was prepared in accordance with:
- "Guidance for Spinal System 510(k)'s," May 7, 1999. l
- "The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Premarket 트 Notifications - Final Guidance, March 20, 1998.
12. Storage, Packaging & Sterilization Information:
The UCR Spinal System is supplied "NON-STERILE" and must be sterilized before use. The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°.
2
The validated sterilization cycle is:
| Method: | Steam |
|---|---|
| Cycle: | Gravity |
| Temperature: | 270°F (134°C) |
| Exposure Time: | 30 minutes |
13. Summary Comparison Table:
| FEATURE | SeaSpine UCR Spinal Screws | UCR Spinal System | SE? |
|---|---|---|---|
| Indications | |||
| for | |||
| Use: | 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. Also 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 spondylolisthesis with objective evidence of neurological impairment, | |||
| fracture, | |||
| dislocation, | |||
| scoliosis. | |||
| kyphosis, | |||
| spinal tumor, and | |||
| failed previous fusion pseudarthrosis) | Identical | YES | |
| Design: | Cancellous thread pedicle screw, vertebral screws, sacral screws, Polyaxial | SAME | YES |
| Sterile: | Non-sterile | SAME | YES |
| Sizes: | 5.5 & 8.0mm diameter in 35, 40 and 45mm lengths | EQUIVALENT | YES |
| Material: | Titanium alloy | Identical | YES |
| Manufacturer: | SeaSpine, Inc. | IAME, Inc. | YES |
| Product Code: | MNH, MNI | SAME | YES |
| K - Number: | K021623 | K993503 | YES |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.
Public Health Service
SEP 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523
Re: K021623
Trade/Device Name: UCR Spinal System Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system, Regulatory Class: II Product Code: MNH, MNI Dated: August 15, 2002 Received: August 16, 2002
Dear Mr. Schlerf:
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. Iisting 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.
4
Page 2 -- Mr. David W. Schlerf
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 and additionally 21 CFR Part 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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
A. Salim M. Witta, Ph.D., M.D.
elia 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
5
Page
K021623 510(k) Number :
Device Name(s):
5.5mm, 8.0mm Spinal Screws and Instruments (Haider UCR Spinal System)
Intended Use(s) of the Device:
-
- 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 2. 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 spondylolisthesis with objective evidence of neurological 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)
Hipt Qurlse
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K021623
Prescription Use CFR 801.109) OR
Over-The-Counter Use (Per 21 (Optional format 1-2-96)