(22 days)
The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.
- 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
This document is a 510(k) summary for the PathLoc SI Joint Fusion System, a Class II medical device. It's important to understand that a 510(k) submission primarily demonstrates "substantial equivalence" to existing legally marketed devices, rather than proving novel effectiveness or safety through extensive clinical trials.
The provided text focuses on the device's design, materials, and substantial equivalence to predicate devices, but does not contain information regarding studies that prove the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, which would typically be found for AI/ML-driven devices or diagnostics.
Therefore, I cannot provide a response filling the requested sections as the document describes a traditional mechanical medical device, not one with performance characteristics that would be evaluated with the type of study design you're asking about (e.g., AI/ML performance, diagnostic accuracy etc.).
The document explicitly states:
- "A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. And the results of the risk assessment were confirmed, and that there were no problems with safety and effectiveness. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing."
- "Therefore, we substitute mechanical test data of PathLoc SI Joint Fusion System for additional components with the predicate device data (K153656/K181600)."
This indicates that the "performance testing" was primarily a risk assessment and Finite Element (FE) analysis, comparing the new components to previously cleared predicate devices based on mechanical properties and safety, not a clinical study evaluating diagnostic or therapeutic accuracy against a ground truth.
To directly answer your prompt, the information about acceptance criteria and study proving device performance as you've outlined (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in this 510(k) summary because it's not relevant for this type of device submission. This is a mechanical implant, not an AI or diagnostic device that would require such performance evaluations.
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July 14, 2023
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L & K Biomed Co., Ltd. Katherine Kim RA #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Gyeonggi-do 17015 Korea, South
Re: K231841
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 20, 2023 Received: June 22, 2023
Dear Katherine Kim:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 mediation-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,
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Colin O'Neill, M.B.E. Assistant Director 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
510(k) Number (if known)
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) |
|---|
| ☑ 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):
1. MANUFACTURER
| Submitter's Name: | L&K Biomed Co., Ltd. |
|---|---|
| Submitter's Address: | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gilGiheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea. |
| Submitter's Telephone: | 82-2-6717-1983 |
| Contact Person: | Katherine Kimkhkim@lnkbiomed.com |
| Prepared Date: | June 20, 2023 |
2. DEVICE IDENTIFICATION
| Device Trade Name | PathLoc SI Joint Fusion System |
|---|---|
| Common/Usual Name | Sacroiliac Joint Fixation, Bone Screw |
| Regulation Class /Number | Class II / 21 CFR 888.3040 |
| Regulation Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | OUR |
| Classification Panel | Spinal Devices (DHT6B) |
PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT. 3.
The subject devices are identical to the predicate devices in all characteristics.
| Subject Device Name | 510K NO. | Trade or Proprietary or Model Name | Predicate Type |
|---|---|---|---|
| PathLoc SI JointFusion System | K153656 | PathLoc SI Joint Fusion System | Primary |
| K181600 | PathLoc SI Joint Fusion System | Additional | |
| K210035 | Zespin SI Joint Fusion System | Additional | |
| K223521 | Zespin SI Joint Fusion System | Additional |
The design feature, indications for use, material and manufacturing process for the subject devices are substantially equivalent to the predicate devices.
4. MATERIALS
| PATHLOC SI Joint Fusion System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
|---|---|
| -------------------------------- | ------------------------------------------ |
And the additional components material is the same material used in the predicate devices (K 153656/K181600).
5. DESCRIPTION OF THE DEVICE
The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.
- 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
6. INDICATION FOR USE
The PATHLOC SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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7. PERFORMANCE TESTING
PATHLOC SI Joint Fusion System
A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. And the results of the risk assessment were confirmed, and that there were no problems with safety and effectiveness. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing.
Therefore, we substitute mechanical test data of PathLoc SI Joint Fusion System for additional components with the predicate device data (K153656/K181600).
8. SUMMARY OF TECHNOLOGY CHARACTERISTICS
Subject devices are identical to the predicate devices in all (Material, Indication for use, Design, Manufacturing process, Surgical approach) characteristics.
| 510K no. | Indication foruse | Design | Surgical approach | Material | |
|---|---|---|---|---|---|
| Subject Device | Same | Same | Same | Ti-6Al-4V ELI(ASTM F136) | |
| PathLoc SI JointFusion System | K153656/K181600 | Same | Same | Same | Same |
| Zespin SI JointFusion System | K210035K223521 | Same | Same | Same | Same |
9. SUBSTANTIAL EQUIVALENCE
Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, function and materials used.
10. CONCLUSION
The overall technology characteristics lead to the conclusion that the PathLoc SI Joint Fusion System is substantially equivalent to the predicate devices(K153656/K181600).
§ 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.