(30 days)
Not Found
No
The summary describes a physical implant (intervertebral body fusion device) made of PEEK with tantalum markers. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on substantial equivalence based on size additions, not algorithmic performance.
Yes.
The device is used to treat degenerative disc disease and is implanted to promote spinal fusion, which is a therapeutic intervention.
No
This device is an intervertebral body fusion device (an implant), not a diagnostic tool. Its purpose is to facilitate spinal fusion, not to diagnose a condition.
No
The device description clearly states it is fabricated from PEEK and includes tantalum markers, indicating it is a physical implant, not software.
Based on the provided information, 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: The Plateau Spacer System is an implantable device made of PEEK with tantalum markers, intended for spinal fusion procedures. It is surgically placed within the body.
- Intended Use: The intended use is for spinal fusion in patients with degenerative disc disease, to be used with bone graft and supplemental fixation. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a physical implant used in a surgical procedure, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.
Product codes
MAX
Device Description
The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral 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)
Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario and are therefore substantially equivalent to the predicate devices,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Plateau Spacer System (K080411), Medtronic Capstone (K073291), Orthofix Pillar System (K081177)
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
JUL - 6 2011
510(k) Summary PLATEAU® Spacer System
| Submitted By: | Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 2nd, 2011 |
| Trade Name: | Life Spine Plateau Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, 21 CFR 888.3080, Class II |
| Predicate Device: | Plateau Spacer System (K080411), Medtronic Capstone (K073291),
Orthofix Pillar System (K081177) |
Device Description:
The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.
1
Intended Use of the Device: -
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.
Material:
The PLATEAU Spacer System implants are manufactured according to ASTM F2026 from Polyetheretherketone (PEEK-OPTIMA LT1), which is a biocompatible material manufactured and supplied by Invibio, and either 6-4 Alloy Titanium markers or unalloyed Tantalum markers. PEEK-OPTIMA is a biocompatible radiolucent material, allowing visualization of osteogenesis.
Characteristic Comparison:
The purpose of this submission is to add additional sizes to the offering of the PLATEAU Spacer System. The additional sizes fall within the range of sizes offered in the predicate systems. Additionally they have the same intended use, material, and basic design as the predicate systems.
Performance Data:
Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario and are therefore substantially equivalent to the predicate devices,
Substantial Equivalence:
The Plateau Spacer System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes extending upwards and three wave-like shapes below, representing water.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 6 2011
Life Spine, Inc. % Mr. Randy Lewis 2401 West Hassell Road Suite 1535 Hoffman Estates, Illinois 60169
Re: K111569
Trade/Device Name: PLATEAU® Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 03, 2011 Received: June 06, 2011
Dear Mr. Lewis:
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 - Mr. Randy Lewis
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E. S. Keith
Sr 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): ___K111569
Device Name: PLATEAU® Spacer System
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.
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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign Off
(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KITI 284 510(k) Number ___
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