(174 days)
Not Found
Not Found
No
The summary describes a physical implant device made of PEEK with tantalum markers for visualization. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies mentioned are mechanical testing, not related to algorithmic performance.
Yes
The device is intended to facilitate fusion and treat Degenerative Disk Disease, which aligns with the definition of a therapeutic device.
No
This device is an intervertebral body device, an implant used in surgery to facilitate fusion in patients with Degenerative Disk Disease, not a tool for diagnosing medical conditions.
No
The device description explicitly states the device is a "PEEK PLIF Cage System" made of physical components (PEEK-OPTMA LT1 material) and includes mechanical testing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion in patients with Degenerative Disk Disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of PEEK material with features for anchoring and visualization. This is consistent with a surgical device.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Input Imaging Modality: While radiographs are mentioned, they are used for visualization of the implanted device, not as the primary input for a diagnostic test performed by the device itself.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
The 4CIS PEEK PLIF IBF Device is an intervertebral body device intended for use 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 pack pain with degeneration of the disk confirmed by history and radiographic studies. 4CIS Peek PLIF IBF devices are intended to be used with autologous bone graft to facilitate fusion. The device is to be used in patients who have had six months of non-operative treatment.
The 4CIS PEEK PLIF IBF devices are to be implanted via a direct posterior approach. The device is implanted singly or in pairs, with supplemental fixation.
Product codes
MAX
Device Description
The subject device, 4CIS® PEEK PLIF Cage System is made of devices for fixation of spine. This system allows maximum preservation of bony endplate and vertical square teeth ensure enough contact surfaces with bony endplate, which prevents "sinking-in" of cage into the vertebral body, while vertical teeth increase the anchoring and prevent slipping. It has two tantalum markers for ease of visualization on radiographs.
The components are manufactured from PEEK-OPTMA LT1 (Polyetheretherketone, ASTM F2026) material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2-S1
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
Mechanical testing as listed in APPENDIX 10
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KO42.162
JAN - 62010
510(k) SUMMARY
The following 510(k) summary is being submitted as required by
| Submission Information | |
|---|---|
| Contact: | Seayoung Ahn |
| 155 Gibbs Street Suite 510 Rockville, MD 20850 | |
| saeyounga@yahoo.com (301) 279-5453(o); (301) 646-6602 | |
| Sponsor: | 34-6 Keumam-ri, Seotan-myeon, |
| Pyeongtaek, Gyeonggi-do, 451-852 | |
| Republic of Korea | |
| Date Prepared: | May 5, 2009 |
| Device Identification | |
| Trade Name: | 4CIS® PEEK PLIF Cage System |
| Common/Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device - lumbar |
| 21 CFR Section 888.3080 | |
| MAX | |
| Class II |
Substantially Equivalent Predicate Legally Marketed Devices
Device Description
The subject device, 4CIS® PEEK PLIF Cage System is made of devices for fixation of spine. This system allows maximum preservation of bony endplate and vertical square teeth ensure enough contact surfaces with bony endplate, which prevents "sinking-in" of cage into the vertebral body, while vertical teeth increase the anchoring and prevent slipping. It has two tantalum markers for ease of visualization on radiographs.
The components are manufactured from PEEK-OPTMA LT1 (Polyetheretherketone, ASTM F2026) material.
Indications for Use
The 4CIS PEEK PLIF IBF Device is an intervertebral body device intended for use 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 pack pain with degeneration of the disk confirmed by history and radiographic studies. 4CIS Peek PLIF IBF devices are intended to be used with autologous bone graft to facilitate fusion. The device is to be used in patients who have had six months of non-operative treatment.
1
The 4CIS PEEK PLIF IBF devices are to be implanted via a direct posterior approach. The device is implanted singly or in pairs, with supplemental fixation.
:
.
Performance Data
Mechanical testing as listed in APPENDIX 10
70
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN - 62010
Solco Biomedical Co., Ltd. % Solco USA, Inc. Mr. Saeyoung Ahn Official Correspondent 155 Gibbs Street, Suite 510 Rockville, Maryland 20850
Re: K092162
Trade/Device Name: 4CIS® PEEK PLIF Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MAX Dated: December 23, 2009 Received: December 24, 2009
Dear Mr. Ahn:
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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical
3
Page 2 - Mr. Saeyoung Ahn
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark 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
510(k) Number (if known): __ K092162
4CIS PEEK PLIF Cage System Device Name:
Indications For Use:
The 4CIS® PEEK PLIF is intervertebral body fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 4CIS® PEEK PLIF ™ IBF device is intended to be used with autologous bone graft to facilitate fusion. The 4CIS® PEEK PLIF ™ IBF device is to be used in patients, who have had six months of non-operative treatment. The device is to be implanted via a direct posterior approach. The 4CIS® PEEK PLIF ™ device may be implanted singly or in pairs in the lumbosacral spine with supplemental fixation.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division/Sign-Off) | Page 1 of | ||
|---|---|---|---|
| Division of Surgical, Orthopedic, | |||
| and Restorative Devices |
| 510(k) Number | K092162 |
|---|---|
| --------------- | --------- |