(28 days)
The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
· Arch Screw will be implanted in patient's bone then autograft will be inserted.
· Locking Screw can be used with washer or can be used on its own
· Self-tapping flute centers screw for easy insertion
The provided document is a 510(k) premarket notification for a medical device called the "PathLoc-SI Joint Fusion System." It describes the device, its intended use, and compares it to a legally marketed predicate device.
Crucially, this document is for a mechanical medical device (bone fixation fastener), not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/SaMD performance metrics (like sensitivity, specificity, AUC, etc.) does not apply.
The performance testing mentioned (ASTM F543-13 Standard and ASTM F2193-14 Standard) relates to the physical and mechanical properties of the bone screws (e.g., torsional strength, axial pullout strength, bending strength). These standards are for assessing the structural integrity and performance of the hardware itself, not for evaluating an AI algorithm's diagnostic or predictive capabilities.
Therefore, I cannot provide the information requested in the prompt because the available text does not describe an AI/SaMD and thus lacks the relevant data concerning:
- A table of acceptance criteria and reported device performance (for an AI/SaMD): The document lists mechanical tests, not AI performance metrics.
- Sample size used for the test set and data provenance: No test set for an AI algorithm is mentioned.
- Number of experts used to establish ground truth: Not applicable for a mechanical device.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document indicates that the device's substantial equivalence is based on its similarity in design, material, and indications for use to a previously cleared predicate device (K153656), along with adherence to established mechanical testing standards for bone fixation devices.
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July 16, 2018
L&K BIOMED Co., Ltd. Ms. Jihyeon Seo Regulatory Affairs Associate #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA
Re: K181600
Trade/Device Name: PathLoc-SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: June 15, 2018 Received: June 18, 2018
Dear Ms. Seo:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -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) K181600
Device Name PathLoc-SI Joint Fusion System
Indications for Use (Describe)
The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X 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 Co., Ltd. #201, 202, 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea Phone: 82-2-6717-1983 e-mail: kate.seo@lnkbiomed.com Contact Person: Jihyeon Seo Date prepared: June 15th, 2018
2. Device Identification
| Trade Name | PathLoc-SI Joint Fusion System |
|---|---|
| Common Name | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Product Code | OUR |
| Regulatory Class | II |
| Classification Name | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener |
3. Purpose of 510(k)
The L&K BIOMED Co. Ltd. hereby submits this special 510(k): to register additional size and additional components of the PathLoc-SI Joint Fusion System
Predicate or legally marketed devices which are substantially equivalent 4.
- Primary Predicate(unmodified device): K153656 PathLoc-SI Joint Fusion System
Description of the Device 5.
PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
- · Arch Screw will be implanted in patient's bone then autograft will be inserted.
- · Locking Screw can be used with washer or can be used on its own
- · Self-tapping flute centers screw for easy insertion
Materials:
| Product | Material | Standard |
|---|---|---|
| Arch Screw | Ti-6Al-4V ELI | ASTM F136 |
| Locking Screw | Ti-6Al-4V ELI | ASTM F136 |
| Washer | Ti-6Al-4V ELI | ASTM F136 |
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Indication for Use 6.
The PathLoc-Sl Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Comparison of the technological characteristics of the subject and 7. predicate devices
The PathLoc-SI Joint Fusion System is considered substantially equivalent to the unmodified device (PathLoc-SI Joint Fusion System, K153656). They are similar in design and have the same material, and the same indications for use.
| Subject Device | Predicate Device(unmodified) | |
|---|---|---|
| Item | PathLoc-SI Joint FusionSystem | PathLoc-SI Joint FusionSystem |
| Manufacturer | L&K BIOMED Co.,Ltd. | L&K BIOMED Co.,Ltd. |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| 510(K) No | K153656 | |
| Product Code | OUR | OUR |
| RegulationNo. | 21CFR888.3040 | 21CFR888.3040 |
| Class | Class II | Class II |
| Intended Use | The PathLoc-SI Joint FusionSystem is intended forsacroiliac joint fusion forconditions including sacroiliacjoint disruptions anddegenerative sacroililtis. | The PathLoc-SI Joint FusionSystem is intended forsacroiliac joint fusion forconditions including sacroiliacjoint disruptions anddegenerative sacroililtis. |
Performance Testing 8.
ASTM F543-13 Standard
- । Torsional test
- Axial pullout test -
- Driving torque test(Insertion/Removal) -
ASTM F2193-14 Standard
- Static and fatigue bending strength of metallic spinal screw -
9. Conclusion
The PathLoc-SI Joint Fusion System is substantially equivalent to the unmodified device (K153656)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.