(90 days)
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Not Found
No
The summary describes a physical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an intervertebral body fusion device used for spinal fusion procedures to treat degenerative disc disease, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device is an implant for spinal fusion procedures, not a diagnostic tool. Its intended use is to treat degenerative disc disease, not to diagnose it, although diagnosis is mentioned as a prerequisite for its use.
No
The device description clearly states it is an implant fabricated from PEEK-OPTIMA LT1 with titanium markers, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Plateau Spacer System is an implantable medical device designed to be surgically placed in the spine to facilitate fusion. It is not used to test samples taken from the body.
- Intended Use: The intended use describes a surgical procedure for spinal fusion, not a diagnostic test performed on a specimen.
- Input Imaging Modality: While radiographic studies are used to assess the patient's condition, the device itself does not perform the diagnostic imaging. It is a treatment device used in conjunction with diagnostic information.
Therefore, based on the provided information, the Plateau Spacer System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative 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 either analonical considered one (PEEK-OPTIMA LT1) with titanium markers. The implant is hollow to I oryeneredier with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to as in the interface with the vertebral endplates to prevent rotation and/or migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies
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)
Biomechanical testing in accordance with ASTM standards was conducted to demonstrate substantial equivalence to the predicate intervertebral body fusion devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line appears below the words, adding a subtle design element to the logo. A registered trademark symbol is present to the right of the word "Spine".
510(k) Summary PLATEAU® Spacer System
MAY 1 5 2008
| Submitted By: | Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rebecca Brooks
Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | February 14, 2008 |
| Trade Name: | PLATEAU® Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, 21 CFR 888.3080, Class II |
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 either analonical considered one (PEEK-OPTIMA LT1) with titanium markers. The implant is hollow to I oryeneredier with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to as in the interface with the vertebral endplates to prevent rotation and/or migration.
Intended Use of the Device:
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature The Hatcad Spacer of themsee (DDD) at one or two contiguous levels (12-51). DDD is defined as back pain of discogenies origin with degeneration of the disc confirmed by history Is delined as back pun of ensorgane exgin well as 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.
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Image /page/1/Picture/0 description: The image shows the logo for Life Spine. The logo is in black and has a stylized wave design underneath the word "Spine". There is a registered trademark symbol to the right of the word "Spine".
K080411
Page 2 of 2
Performance Data:
r erormance Data.
Biomechanical testing in accordance with ASTM standards was conducted to demonstrate substantial equivalence to the predicate intervertebral body fusion 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.
The first the contraction of the contribution of the comments of the comments of
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Life Spine % Ms. Rebecca Brooks 2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169
MAY 1 5 2008
Re: K080411
Trade/Device Name: PLATEAUTM Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 14, 2008 Received: February 15, 2008
Dear Ms. Brooks:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Rebecca Brooks
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PLATEAU® Spacer System
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative 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)
Nailre Bal fis mam
Division of General, Restorative, and Neurological Devices
510(k) Number.