(31 days)
Not Found
Not Found
No
The summary describes a physical implantable device (interbody fusion device) and its components. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on substantial equivalence to existing devices based on physical characteristics and intended use, not on algorithmic performance.
Yes
The device is indicated for the treatment of cervical disc disease and degenerative disc disease, which are conditions that cause pain, and therefore, it aims to treat or alleviate these conditions.
No
The device is an interbody fusion device, indicated for treating cervical and lumbar disc disease by facilitating fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of "plates, bone screws and screw covers," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the InterPlate™ as an implantable medical device used for intervertebral body fusion of the spine. It is a physical device surgically placed within the body.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is structural support and facilitating bone fusion.
Therefore, based on the provided information, the InterPlate™ Interbody Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InterPlate™ IFD is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
The InterPlate™ I. and I.GC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, OVE, OVD
Device Description
The InterPlate™ IFD System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C3 to T1; lumbar spine, from L2 to 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K08/1994
7. 510(k) Summary
.
MAY 2 9 2008
| Sponsor: | RSB Spine, LLC
3030 Superior Ave., Suite 703
Cleveland, OH 44114
Phone: 216.241.2804
Fax: 216.241.2820 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James M. Moran, D. Eng.
Vice President of Engineering and Chief Technical Officer |
| Proposed Trade Name: | InterPlate™ IFD |
| Classification: | Class II |
| Classification Name: | Spinal Intervertebral Body Fusion Device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX, ODP |
| Device Description: | The InterPlate™ IFD System consists of plates, bone screws and screw
covers. Various plate sizes are available to accommodate individual patient
anatomy and graft material size. Screw covers are individually matched to
the plate size. |
| Intended Use: | The InterPlate™ IFD is indicated for intervertebral body fusion of the spine
in skeletally mature patients. The device system is designed for use with
autograft to facilitate fusion. One device is used per intervertebral space.
The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are
intended for use at one level in the cervical spine, from C3 to T1, for the
treatment of cervical disc disease (defined as neck pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic
studies). The cervical device is to be used in patients who have had six
weeks of non-operative treatment.
The InterPlate™ I. and I.GC Systems are intended for use at either one level
or two contiguous levels in the lumbar spine, from L2 to S1, for the
treatment of degenerative disc disease (DDD) with up to Grade I
spondylolisthesis. DDD is defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies. The
lumbar device is to be used in patients who have had six months of non-
operative treatment. |
| Materials: | The InterPlate™ C, CGC, L and LGC components are manufactured from
Ti-6Al-4V titanium alloy (ASTM F136). The InterPlate™ PEEK OPTIMA®
Cervical IFD components are manufactured from polyetheretherketone
(PEEK-OPTIMA® LTI, Invibio™) and Ti-6Al-4V titanium alloy as
described by ASTM F2026 and ASTM F136, respectively. Radiographic
markers within the InterPlate™ PEEK Cervical IFD are manufactured from
Ti-6Al-4V titanium alloy (ASTM F136). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the InterPlate™ to be
substantially equivalent to previously cleared devices. The substantial
equivalence is based upon equivalence in intended use, indications,
anatomic sites, performance and material of manufacture. |
·
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RSB Spine, LLC % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Rd. Chesterland, OH 44026
SEP 12 2011
Re: K081194
Trade/Device Name: InterPlate™ Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, OVD Dated: April 28, 2008 Received: April 28, 2008
Dear Dr. Warden:
This letter corrects our substantially equivalent letter of May 29, 2008.
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 (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.
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
2
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
6. Indications for Use Statement
510(k) Number: KD81194
Device Name: InterPlate™ Interbody Fusion Device
Indications for Use:
The InterPlate™ Interbody Fusion Device (IFD) is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are intended for usc at onc level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Prescription Use X (Per 21 CFR 801.109) OR Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel Rooden forimer
Division S. 1869
Division of General, Restorative, and Neurological Devices
510(k) Number K081194