(20 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a spinal implant, with no mention of AI or ML technology.
Yes
The device is described as an "intervertebral body fusion device" intended for spinal fusion procedures, which are therapeutic interventions to address degenerative disc disease.
No
This device is an intervertebral body fusion device, used for spinal fusion procedures, and its description clearly states it is an implant and not for diagnosis.
No
The device description clearly states the device is an implant fabricated from PEEK with radiographic markers and teeth, indicating it is a physical hardware device, not software.
No, 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. They are used outside of the body.
- Device Description: The Small PLATEAU Spacer System is an implantable medical device designed to be surgically placed inside the body (specifically, in the spine) to facilitate spinal fusion.
- Intended Use: Its purpose is to provide structural support and promote bone growth in vivo (within the living organism), not to analyze biological samples in vitro.
The description clearly indicates a surgical implant for spinal fusion, which falls under the category of medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
Product codes
ODP
Device Description
The Small 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 radiographic 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 Small PLATEAU Spacer System components with components from any other system or manufacturer. The Small 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
C2-T1
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)
Data was presented show that a new worst case is not being presented and to demonstrate the substantial equivalence of the Small PLATEAU Spacer System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Plateau Spacer System (K093043), DePuy Bengal System (K081917)
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.
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JUL 1 9 2011
510(k) Summary Small 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 27th, 2011 |
| Trade Name: | Life Spine Small PLATEAU Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | ODP, 21 CFR 888.3080, Class II |
| Predicate Device: | Plateau Spacer System (K093043), DePuy Bengal System (K081917) |
Device Description:
The Small 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 radiographic 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 Small PLATEAU Spacer System components with components from any other system or manufacturer. The Small PLATEAU Spacer System components should never be reused under any circumstances.
1
Intended Use of the Device:
The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
Material:
The Small 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 Small 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.
Test Data:
Data was presented show that a new worst case is not being presented and to demonstrate the substantial equivalence of the Small PLATEAU Spacer System.
Substantial Equivalence:
The Small Plateau Spacer System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Life Spine, Inc. % Mr. Randy Lewis 2401 W. Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169
JUL 1 9 2011
Re: K111835
Trade/Device Name: Small PLATEAU® Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 27, 2011 Received: June 29, 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 or any Federal statutes and regulations administered by other Federal agencies. You must
3
Page 2 - Mr. Randy Lewis
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 yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K川11435 510(k) number (if known):
Device Name: Small PLATEAU® Spacer System
The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-TI). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
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)
(Diysion Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
KIJ1835 510(k) Number_