(197 days)
The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.
The Spinal Fusion Cage System is single component devices used to restore height of disc space via posterior, lateral, anterior, oblique approach and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.
This looks like a 510(k) summary for a medical device (Spinal Fusion Cage System), not an AI/ML device. Therefore, the questions related to acceptance criteria for an algorithm's performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.
The document discusses performance data in the context of mechanical testing for the spinal fusion cages, comparing them to predicate devices. It states:
- Mechanical testing (static axial compression, static compression-shear, static subsidence and dynamic axial compression) was conducted in accordance with ASTM F2077-14 and F2267-04.
- "The subject device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions."
However, specific numerical acceptance criteria (e.g., "subsidence must be less than X mm") and the exact results showing the device meets these criteria are not explicitly detailed in the provided text. The document concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices."
To answer the user's request, I would need a 510(k) summary or similar regulatory document for an AI/ML medical device that includes details about its algorithmic performance evaluation. This document only pertains to a physical implantable device.
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Solco Biomedical Co., Ltd. % Hwi-geun Yu Manager 154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do, 17704, Republic of Korea
Re: K190563
Trade/Device Name: 4CIS® PEEK PLIF Cage, 4CIS® Pebble Beach PEEK PLIF Cage, 4CIS® Torrey Pines PEEK TLIF Cage, 4CIS® Dunes PEEK DLIF Cage, 4CIS® Augusta PEEK ALIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 14, 2019 Received: August 19, 2019
September 18, 2019
Dear Hwi-geun Yu:
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
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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 (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-re-ulatory-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Melissa Hall 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Spinal Fusion Cage System (4CIS® PEEK PLIF Cage, 4CIS® Pebble Beach PEEK PLIF Cage, 4CIS® Torrey Pines PEEK TLIF Cage , 4CIS® Dunes PEEK DLIF Cage, 4CIS® Augusta PEEK ALIF Cage)
Indications for Use (Describe)
The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.
| 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
| Submitter | Solco Biomedical Co., Ltd. |
|---|---|
| 154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do, 17704Republic of Korea | |
| Phone. +82-31-664-4101 | |
| Fax. +82-31-663-8983 | |
| Contact Person | Hwi-geun Yu |
| 154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of Korea | |
| Phone: +82)31-610-4091 | |
| Fax: +82)31-663-8983 | |
| Submission Date | Mar 01, 2019 |
| Trade / Proprietary name | Spinal Fusion Cage System (4CIS® Augusta PEEK ALIF Cage,4CIS® Dunes PEEK DLIF Cage, 4CIS® Torrey Pines PEEK TLIFCage, 4CIS® Pebble Beach PEEK PLIF Cage, 4CIS® PEEK PLIFCage) |
| Common / Usual Name | Spinal Fusion Cage System |
| Classification Name | Intervertebral body fusion device with bone graft, lumbar |
| Classification Code | MAX |
| Regulatory Class | Class II |
| Regulation Number | 888.3080 |
| Predicate Device | 4CIS® PEEK PLIF and TLIF Cage System (K092162, SE01/06/2010) [Solco Biomedical Co., Ltd.] – Primary PredicatePATRIOTTM Spacers (ContinentalTM ALIF Spacer,TransContinentalTM LLIF Spacer) (K072970, SE 01/18/2008)[GLOBUS MEDICAL, INC.] – Additional Predicate |
| ARDIS SPACER (K073202, SE 01/30/2008) [ABBOTT SPINE,INC.] – Additional Predicate | |
| Description of Device | The Spinal Fusion Cage System is single component devices usedto restore height of disc space via posterior, lateral, anterior, obliqueapproach and to facilitate lumbar intervertebral body fusion withmaintaining physiological lordotic angulation of lumbar spine. Toallow maximum preservation and ensure ample contact surfaceswith bony endplate, a variety of shapes and sizes are available andeach device has tantalum (ASTM F560) markers for ease ofvisualization on radiographs. Vertical square teeth on the top andthe bottom surface prevent subsidence of the cage into the vertebralbody while they increase the anchoring and prevent slipping orexpulsion. To make solid fusion of intervertebral body, hollowspace in the implant allows autologous bone graft material to befilled. The implant has safety proven structure and material(Polyetheretherketone, ASTM F2026) to promote biologicalsynostosis and assures mechanical safety against load. |
| Indication for Use | The Spinal Fusion Cage System is an intervertebral body fusiondevices intended for use to skeletally mature patients withDegenerative Disk Disease (DDD) of the lumbar spine with up toGrade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of thedisc confirmed by history and radiographic studies. Spinal FusionCage System is indicated to be used with autologous bone graft tofacilitate fusion and are intended to be used with supplementalfixation. The device is to be used in patients who have had sixmonths of non-operative treatment. |
| Comparison ofTechnologicalCharacteristics with thePredicate Devices | The subject device and all the predicates have the same or similarindications for use statements. The subject device is composed of thesame material as the predicate devices conforming to recognizedindustry standards for permanent implants and surgical orthopedicinstruments. All they have similar basic design features and functionsas well as those dimensions. The subject device and cited predicatedevices are provided non-sterile for single use only. The subjectdevice demonstrated equivalent mechanical performance to the citedpredicate device under the same test conditions. |
| Performance Data | Mechanical testing (static axial compression, static compression-shear, static subsidence and dynamic axial compression) wasconducted in accordance with ASTM F2077-14 and F2267-04.Above non-clinical performance data in the form of a comprehensiveliterature review was provided in support of substantial equivalenceof the subject device. |
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| Conclusion | The overall technology characteristics and mechanical performancedata lead to the conclusion that the subject device is substantiallyequivalent to legally marketed predicate devices. |
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.