(440 days)
Not Found
No
The document describes a standard intervertebral fusion cage made of PEEK with tantalum markers. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies listed are mechanical and sterilization tests, not algorithm validation.
Yes.
The device is an intervertebral body fusion cage intended to treat degenerative disc disease and facilitate fusion, which is a therapeutic purpose.
No
Explanation: The device, EDEN Peek Cage, is an intervertebral body fusion device used for treating degenerative disc disease. Its purpose is to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states the device is made of polyether ether ketone (PEEK) and contains tantalum markers, indicating it is a physical implantable device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The EDEN Peek Cage is an implantable medical device designed for intervertebral body fusion procedures in the spine. It is a physical device used within the body to provide structural support and facilitate bone fusion.
- Lack of Diagnostic Testing: The description focuses on the physical characteristics of the cage, its material, and its surgical application. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the EDEN Peek Cage falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The EDEN Peek Cage - PLIF Type is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EDEN Peek Cage - ACIF Type is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP, MAX
Device Description
The EDEN Peek Cage is offered in various device configurations based on based on surgical approach and patient anatomy, and consist of:
Cervical Interbody Fusion Device (ACIF Type) which may be implanted as a single device via an anterior approach.
Lumbar Interbody Fusion Device (PLIF Type) which can be implanted Bi-laterally via a posterior approach.
- · As a single device via an Anterior approach;(ACIF Type)
- · Bi-laterally via a posterior approach:(PLIF Type)
The EDEN Peek Cage is made of polyether ether ketone (VESTAKEEP® i4 R) that conforms to ASTM F2026 and they have tantalum markers (ASTM F560) to assist the surgeon for proper placement of the device. The subject devices are offered gamma sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, lumbar spine (L2-S1, C2-C3 disc to C7-T1 disc)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
- Sterilization validating testing has been performed in accordance with ISO 11137 .
- . 36-month shelf life validation
- . Mechanical test (static and dynamic axial compression, static and dynamic torsion per ASTM F2077 and subsidence per ASTM F2267)
Key Results: The results support that the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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September 13, 2021
JMT Co., Ltd Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K201793
Trade/Device Name: EDEN Peek Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: July 13, 2021 Received: July 15, 2021
Dear Priscilla Chung:
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.
1
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) 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 medical devices and radiation-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.
for Brent Showalter, Ph.D. 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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Indications for Use
510(k) Number (if known) K201793
Device Name EDEN Peek Cage
Indications for Use (Describe)
The EDEN Peek Cage - PLIF Type is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EDEN Peek Cage - ACIF Type is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment with an intervertebral cage.
| 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
(K201793)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 9/3/2021
1. Submitter
JMT Co., Ltd (11517) 70-39, Gwonyul-ro 1203 beon-gile, Baekseok-eup, Yangju-si Gyeonggi-do, Republic of Korea Tel. +82-31-868-0951
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: EDEN Peek Cage
- Common Name: Intervertebral Body Fusion System ●
- Classification:
- Product Code: ODP (888.3080, Intervertebral Fusion Device With Bone Graft, Cervical, Class II, 510k)
- Product Code: MAX (888.3080, Intervertebral Fusion Device With Bone Graft, Lumbar, Class II, 510k)
4. Predicate Devices:
- LnK Lumbar Interbody Fusion Cage System by L&K BIOMED Co., Ltd. ●
- (K181380) Velofix™ Interbody Fusion System by U & I Corporation (K171749) .
5. Device Description:
The EDEN Peek Cage is offered in various device configurations based on based on surgical approach and patient anatomy, and consist of:
4
Cervical Interbody Fusion Device (ACIF Type) which may be implanted as a single device via an anterior approach.
Lumbar Interbody Fusion Device (PLIF Type) which can be implanted Bi-laterally via a posterior approach.
- · As a single device via an Anterior approach;(ACIF Type)
- · Bi-laterally via a posterior approach:(PLIF Type)
The EDEN Peek Cage is made of polyether ether ketone (VESTAKEEP® i4 R) that conforms to ASTM F2026 and they have tantalum markers (ASTM F560) to assist the surgeon for proper placement of the device. The subject devices are offered gamma sterile.
6. Indication for use:
The EDEN Peek Cage - PLIF Type is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EDEN Peek Cage - ACIF Type is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
7. Basis for Substantial Equivalence
The subject device is substantially equivalent to LnK Lumbar Interbody Fusion Cage System (K181380) by L&K BIOMED Co., Ltd. and VelofixTM Interbody Fusion System (K171749) by U & I Corporation.
They have the same indications for use and use the same materials with very similar designs. We have conducted the performance tests and the results support that the subject device is substantially equivalent to the predicate devices.
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8. Non-Clinical Testing
- Sterilization validating testing has been performed in accordance with ISO 11137 .
- . 36-month shelf life validation
- . Mechanical test (static and dynamic axial compression, static and dynamic torsion per ASTM F2077 and subsidence per ASTM F2267)
9. Conclusion
The subject device and the predicate devices have the same intended use and have the same technological characteristics. Based on the similarities and the test results, we conclude that the EDEN Peek Cage is substantially equivalent to the predicate devices.