(109 days)
Not Found
No
The summary describes a standard spinal fixation system with mechanical components and does not mention any AI/ML capabilities or related performance metrics.
Yes
The device is a spinal fixation system intended to provide immobilization and stabilization of specific spinal segments as an adjunct to fusion, treating various acute and chronic instabilities or deformities, which constitutes a therapeutic purpose.
No
Explanation: The SmartLoc™ is a spinal fixation system designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is treatment, not diagnosis.
No
The device description explicitly lists physical components like rods, screws, hooks, and connectors, indicating it is a hardware-based spinal fixation system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- SmartLoc™ Description: The description clearly states that the SmartLoc™ is a spinal fixation system consisting of rods, screws, hooks, and connectors. These are implants designed to be surgically placed within the body to provide structural support and stabilization to the spine.
- Intended Use: The intended use describes the surgical application of the device for immobilizing and stabilizing spinal segments as an adjunct to fusion. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
Therefore, the SmartLoc™ is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
Product codes
MNI, MNH, KWP
Device Description
The SmartLoc™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spinal segments; L5-S1 vertebra; non-cervical posterior spine (T1 to S2); non-cervical
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
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 compression bending and torsion, and dynamic compression bending of the worst case SmartLoc™ construct was performed according to ASTM F1717. The mechanical test results demonstrated that SmartLoc™ performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CD HORIZON® (K031655), Moss Miami (K992168), Synergy VLS (K950099), Optima™ (K024096), flamenco (K102853)
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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K111883 Page 1 of 2
OCT 1 8 2011
Image /page/0/Picture/2 description: The image contains the logo for A-Spine. The logo features a stylized letter "A" with the word "spire" written in cursive within the letter. To the right of the "A" is the text "A-SPINE" in a bold, sans-serif font. The logo has a professional and modern look.
| 510(k) Summary | |
|---|---|
| Date: | 28 June 2011 |
| Sponsor: | A-SPINE ASIA CO., LTD. |
| 11F., No. 1, Aly. 30, Ln. 358, Ruiguang Rd., Neihu District, | |
| Taipei, Taiwan | |
| Phone: +886 (2)2627-2977 | |
| Fax: +886 (2)6606-5955 | |
| Contact Person: | Frank Hsu |
| A-SPINE ASIA CO., LTD. | |
| 11F., No. 1, Aly. 30, Ln. 358, Ruiguang Rd., Neihu District, | |
| Taipei, Taiwan | |
| frank@aspine.com.tw | |
| Phone: +886 (2)2627-2977 | |
| Fax: +886 (2)6606-5955 | |
| Proposed Trade Name: | SmartLoc™ spinal fixation system |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system & Spinal interlaminal fixation |
| orthosis | |
| Regulation: | 888.3070 & 888.3050 |
| Device Product Code: | MNI/MNH & KWP |
| Device Description: | The SmartLoc™ consists of rods, monoaxial and polyaxial |
| pedicle screws, hooks and transverse connectors with locking | |
| set screws. The components are available in various sizes to | |
| accommodate differing patient anatomy. Rods are available in | |
| one diameter and a variety of lengths. Monoaxial and polyaxial | |
| screws are available in a variety of diameter-length | |
| combinations. Hooks are offered in a variety shapes and | |
| sizes. | |
| Intended Use: | The SmartLoc™ is a spinal fixation system intended to provide |
| immobilization and stabilization of thoracic, lumbar, and sacral | |
| spinal segments as an adjunct to fusion. When used as | |
| posterior, pedicle screw fixation, the system is intended for the | |
| treatment of severe spondylolisthesis (grades 3 and 4) of the | |
| L5-S1 vertebra in skeletally mature patients. In addition, when | |
| used as a pedicle screw fixation system in the noncervical | |
| posterior spine (T1 to S2), the system is intended for the | |
| treatment of the following acute and chronic instabilities or |
SmartLoc™
8-2
1
. .
| | deformities: degenerative spondylolisthesis with objective
evidence of neurologic impairment, fracture, dislocation,
spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor,
pseudarthrosis and failed previous fusion in skeletally mature
patients. When used as a posterior, non-cervical, hook and/or
sacral/iliac fixation system (i.e., non-pedicle screw), the
SmartLoc™ is intended for the treatment of the following acute
and chronic instabilities or deformities: degenerative disc
disease (as conformed by patient history and radiographic
studies), spondylolisthesis, fracture, dislocation, scoliosis,
kyphosis, lordosis, spinal stenosis, spinal tumor,
pseudarthrosis and failed previous fusion. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | The SmartLoc™ components are manufactured from titanium
alloy (Ti-6Al-4V) as described by ISO 5832-3 / ASTM F136. |
| Predicate Devices: | CD HORIZON® (K031655/K041460)
Moss Miami (K992168/K022623)
Synergy VLS (K950099/K974749)
Optima™ (K024096/K031585/K051971)
flamenco (K102853) |
| Technological
Characteristics: | The SmartLoc™ possesses the same technological
characteristics as the predicate devices. These include basic design (rod-based fixation system having monoaxial
and polyaxial pedicle screws and various hook shapes and
sizes), material (titanium alloy), sizes (rod and screw sizes are encompassed by those offered by the predicate systems) and intended use (as described above). The fundamental scientific technology of the SmartLoc™ is
the same as previously cleared devices. |
| Performance Data: | Static compression bending and torsion, and dynamic
compression bending of the worst case SmartLoc™ construct
was performed according to ASTM F1717. The mechanical
test results demonstrated that SmartLoc™ performs as well as
or better than the predicate devices. |
.
.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol resembling a bird or abstract human figure with outstretched arms.
OCT 1 8 2011
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
A-Spine Asia, Co., LTD. % Mr. Frank Hsu 11F., No. 1, Aly. 30, Ln. 358 Ruiguang Rd., Neihu District, Taipei Taiwan
Re: K111883
Trade/Device Name: SmartLoc" spinal fixation system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal ssytem Regulatory Class: II Product Code: MNI, MNH, KWP Dated: September 14, 2011 Received: September 15, 2011
Dear Mr. Hsu:
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. 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
3
Page 2 - Mr. Frank Hsu
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunel Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:_K111883
Device Name: SmartLoc™ spinal fixation system Indications for Use:
The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, fordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
SmartLoc™
KIII883 510(k) Number___
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