(59 days)
NKB, KWQ
No
The device description focuses on the physical components of a spinal fixation system (screws, rods, set screws) and mentions standard mechanical performance testing. There is no mention of software, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes
The device is described as a "spinal fixation system" and is "intended for use as a posterior pedicle screw fixation system" to treat various spinal conditions like degenerative disc disease, trauma, and scoliosis. This indicates its use in treating a medical condition and restoring normal function, which aligns with the definition of a therapeutic device.
No
This device is an implantable pedicle screw fixation system used as an adjunct to fusion for various spinal conditions; it is not used to diagnose a medical condition.
No
The device description clearly states it is a titanium alloy implant device consisting of rods, screws, and set screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The OrthoCircle Spine Pedicle Screw System is a titanium alloy implant device designed to be surgically implanted into the spine. It is a physical device used for structural support and fixation.
- Intended Use: The intended use is as a posterior pedicle screw fixation system to stabilize the spine in skeletally mature patients with various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for in vitro testing of biological samples.
N/A
Intended Use / Indications for Use
The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and/or failed previous fusion (pseudoarthrosis).
Product codes
NKB, KWQ
Device Description
The OrthoCircle Spine Pedicle Screw System is a titanium alloy implant device to be implanted from the posterior approach. The system consists of rods, poly-axial screws and set screws. The screws are available in diameters from Ø4.50mm to Ø7.50mm and in lengths of 20mm to 60mm. Standard and Reduction Pedicle Screws are available in these sizes. Titanium rods are available in Ø5.50mm diameter straight and pre-contoured. Set screws are used to fasten the rods and poly-axial screws. Implants are provided sterile in individual packaging.
Special instruments are used to implant the pedicle system. Instruments used to implant the pedicle screw system are provided as non-sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbosacral (T1-S1)
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
The OrthoCircle Spine Pedicle Screw System has been tested in the following test modes:
- Static compression bending per ASTM F1717-18
- Static torsion per ASTM F1717-18
- Dynamic compression bending per ASTM F1717-18 o
The results of this non-clinical testing show that the strength of the OrthoCircle Spine Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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February 13, 2020
OrthoCircle Spine % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K193472
Trade/Device Name: OrthoCircle Spine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ Dated: December 13, 2019 Received: December 16, 2019
Dear Nathan Wright:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number (if known)
K193472 | |
| Device Name
OrthoCircle Spine Pedicle Screw System | |
| Indications for Use (Describe) | |
The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and/or failed previous fusion (pseudoarthrosis).
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.510(K) SUMMARY
| Submitter's Name: | OrthoCircle Spine |
|---|---|
| Submitter's Address: | 15 East Montgomery Crossroads, Suite 3 |
| Savannah, GA 31406 | |
| Submitter's Telephone: | 888-463-5803 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | 13-Dec-2019 |
| Trade or Proprietary Name: | OrthoCircle Spine Pedicle Screw System |
| Common or Usual Name: | thoracolumbosacral pedicle screw system |
| Classification: | Class II per 21 CFR §888.3070 |
| Product Code: | NKB, KWQ |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OrthoCircle Spine Pedicle Screw System is a titanium alloy implant device to be implanted from the posterior approach. The system consists of rods, poly-axial screws and set screws. The screws are available in diameters from Ø4.50mm to Ø7.50mm and in lengths of 20mm to 60mm. Standard and Reduction Pedicle Screws are available in these sizes. Titanium rods are available in Ø5.50mm diameter straight and pre-contoured. Set screws are used to fasten the rods and poly-axial screws. Implants are provided sterile in individual packaging.
Special instruments are used to implant the pedicle system. Instruments used to implant the pedicle screw system are provided as non-sterilization prior to use.
INDICATIONS FOR USE
The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and/or failed previous fusion (pseudoarthrosis).
TECHNOLOGICAL CHARACTERISTICS
The OrthoCircle Spine Pedicle Screw System implants are made from Ti-6Al-4V ELI conforming to ASTM F1472. The subject and predicate devices have nearly identical technological characteristics and the minor difference do not raise any new issues of safety and
4
effectiveness. Specifically, the following characteristics are similar between the subject and predicates:
- Indications for Use ●
- Materials of manufacture ●
- Structural support mechanism ●
- Sizes
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|--------------------------|-------------------|
| K171170 | M.U.S.T. Pedicle Screw System | Medacta International SA | Primary |
| K191576 | Mercury® Spinal System | Spinal Elements, Inc. | Additional |
PERFORMANCE DATA
The OrthoCircle Spine Pedicle Screw System has been tested in the following test modes:
- Static compression bending per ASTM F1717-18 ●
- Static torsion per ASTM F1717-18
- Dynamic compression bending per ASTM F1717-18 o
The results of this non-clinical testing show that the strength of the OrthoCircle Spine Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the OrthoCircle Spine Pedicle Screw System is substantially equivalent to the predicate device.