(219 days)
P950002, P950019, P960025, K082262
Not Found
No
The summary describes a passive PEEK implant for spinal fusion and does not mention any AI or ML capabilities.
Yes
The device is described as an "Interbody Fusion Device" intended for "interbody fusion procedures" to provide "mechanical support to the lumbar spine while biologic fusion takes place," indicating a direct therapeutic purpose.
No
The device is an implantable interbody fusion device, designed to provide mechanical support for bone fusion, not to diagnose a condition.
No
The device description explicitly states it is a PEEK implant, which is a physical hardware component. The performance studies also describe mechanical testing of this physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "interbody fusion procedures" in the lumbar spine. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of PEEK designed to provide mechanical support and facilitate bone fusion. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion.
The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Static axial compression, static compression shear, static torsion, dynamic axial compression and dynamic torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Epicage Interbody Fusion Device indicated that the Epicage Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P950002, P950019, P960025, K082262
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
4. 510(k) Summary according to 807.92(c)
APR 2 8 2010
| Contact: | Jay Finster |
|---|---|
| R Tree Innovations, LLC | |
| 5956 Timber Ridge Drive | |
| Suite 101 | |
| Prospect, KY 40059 | |
| 502-689-4483 | |
| Trade Name: | Epicage Interbody Fusion Device |
| Product Class: | Class II |
| Classification: | 21 CFR $888.3080 Orthosis, intervertebral fusion device |
| Product Codes: | MAX |
| Panel Code: | 87 |
Indications for Use:
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Device Description:
The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion.
The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.
Predicate Device(s):
The Epicage Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), the Ray Threaded Fusion Cage (P950019), the Brantigan Lumbar I/F Cage (P960025) and the ROI-T device from LDR (K082262)
1
Performance Testing:
Static axial compression, static compression shear, static torsion, dynamic axial compression and dynamic torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Epicage Interbody Fusion Device indicated that the Epicage Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.
Summary:
The Epicage Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Epicage Interbody Fusion Device contain no new language that is not already included in at least one of the predicate devices. Moreover, the device is very similar in its size to the predicate devices. The materials used are also the same as in some predicate devices. There are no significant differences in technological characteristics compared to the predicates, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, bench testing demonstrates that these differences do not adversely impact device performance, as discussed below.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle, with its wings spread, symbolizing protection and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 2 8 2010
R Tree Innovations, LLC % Dr. Richard Jansen Silver Pine Consulting 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K092901
Trade/Device Name: Epicage Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 17, 2010 Received: April 20, 2010
Dear Dr. Jansen:
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
3
Page 2 – Dr. Richard Jansen
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbace Buchud
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3. Statement of Indications for Use
510(k) Number (if known): _K092901
Indications for Use:
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
h
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
K092901 510(k) Number_
Concurrence of CDRH, Office of Device Evaluation (ODE)