(56 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The performance studies are mechanical tests.
No.
The device is described as an implantable system (screws, rods, set screws) intended to provide immobilization and stabilization of spinal segments, often used as an adjunct to fusion. It is not designed to provide a direct therapeutic effect or treatment itself, but rather to aid in the healing process by providing mechanical support.
No
The document describes a spinal system (screws, rods, and set screws) used for stabilization and fusion of spinal segments. Its purpose is therapeutic (to treat instabilities or deformities) rather than diagnostic (to identify or characterize a medical condition).
No
The device description explicitly states it consists of physical components like screws, rods, and set screws made from titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PathLoc-L MIS Spinal System is a surgical implant used to provide immobilization of spinal segments as an adjunct to fusion. This is a therapeutic and structural function within the body.
- Device Description: The device is described as consisting of screws, rods, and set screws made from titanium alloy. These are physical implants designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The PathLoc-L MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach.
The PathLoc-L MIS Spinal System is intended for the following indications:
· Degenerative disc disease (defined as back pain of discogenic origin 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, lordosis)
- · Tumor
- Pseudarthrosis
- · Failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
PathLoc-L MIS System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are made from titanium alloy (ASTM F136). The implants will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Pullout testing per ASTM F543-13 was performed on the subject screws and compared to a legally marketed predicate device. Results of the testing demonstrate substantially equivalent performance.
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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2016
L&K BIOMED Company, Limited Ms. Yerim An Regulatory Affairs Specialist #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, Gyeonggi-do 446-916 KOREA
Re: K161766
Trade/Device Name: Pathloc-L MIS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: June 20, 2016 Received: June 27, 2016
Dear Ms. An:
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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vincent J. Devlin -S
for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161766
Device Name PathLoc-L MIS Spinal System
Indications for Use (Describe)
The PathLoc-L MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach.
The PathLoc-L MIS Spinal System is intended for the following indications:
· Degenerative disc disease (defined as back pain of discogenic origin 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, lordosis)
- · Tumor
- Pseudarthrosis
- · Failed previous fusion
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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510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
- Submitter: L&K BIOMED Company, Limited 1. #201, 202 16-25, Dongbaekjungang-ro 16 beon-qil Giheung-gu, Yongin-si, Gyeonggi-do, 446-916, Korea Phone. 82-2-6717-1985 e-mail: yerim2706@gmail.com Contact Person: Yerim An Date prepared Aug, 12, 2016
Device Identification 2.
| Trade Name | PathLoc-L MIS Spinal System |
|---|---|
| Regulatory Class | Class III |
| Regulation Name/Common Name | Pedicle Screw Spinal System |
| Panel | Orthopaedic |
| Product Codes | NKB, MNH, MNI |
3. Purpose of 510(k)
L&K BIOMED Co. Ltd., hereby submits this 510(k) proposing the addition of new screw types to the PathLoc-L MIS Spinal System.
Predicate Device 4.
- Primary Predicate Device: K120140 LnK MIS Spinal System
Description of the Device 5.
PathLoc-L MIS System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are made from titanium alloy (ASTM F136). The implants will be provided non-sterile.
Indication for Use 6.
The PathLoc-L MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the
4
thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach.
The PathLoc-L MIS Spinal System is intended for the following indications:
- · Degenerative disc disease (defined as back pain of discogenic origin 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, lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
Comparison of the technological characteristics of the subject and 7. predicate devices
The PathLoc-L MIS Spinal System is considered substantially equivalent to the legally marketed LnK MIS Spinal System (K120140). The systems have similar design, material, scientific technology, and indications for use. The only difference is the addition of different screw types which have been evaluated via mechanical testing.
8. Performance Testing
Pullout testing per ASTM F543-13 was performed on the subject screws and compared to a legally marketed predicate device. Results of the testing demonstrate substantially equivalent performance.
Conclusion 9.
The PathLoc-L MIS Spinal System is substantially equivalent to a legally marketed predicate.