(310 days)
Not Found
No
The summary describes a passive implant made of PEEK with radiographic markers and instruments for implantation. There is no mention of software, algorithms, or any technology that would process data or make decisions, which are characteristic of AI/ML. The performance studies focus on mechanical testing of the implant itself.
Yes
The device is indicated for intervertebral body fusion to treat degenerative disc disease and is designed to provide therapeutic benefit by facilitating fusion and stabilizing the spine.
No
Explanation: The device described is a surgical implant (lumbar interbody fusion device) used for treatment (fusion), not for diagnosing conditions. Its indications for use specify that degenerated discs are "confirmed by patient history and radiographic studies" which implies that diagnosis occurs prior to the device's use.
No
The device description explicitly states the devices are made from PEEK and include titanium alloy radiographic markers, indicating they are physical implants, 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a surgical implant (Lumbar Interbody Fusion Device) used to facilitate fusion in the spine. It is implanted directly into the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is mechanical support and facilitating bone growth, not diagnostic testing of bodily fluids or tissues.
The device is a surgical implant used in a therapeutic procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Product codes
MAX
Device Description
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are made from PEEK. The PLIF Lite implants are available in lordotic and non-lordotic form, while the TLIF implants are provided with 7 degrees of lordosis only. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Three radiographic markers made of titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
Indicated Patient Age Range
skeletally mature
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)
The PLIF Lite and TLIF Lite Lumbar Interbody devices were tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear, static torsion, subsidence and expulsion. Test results demonstrate that the PLIF Lite and TLIF Lite devices are substantially equivalent to the predicate devices.
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.
P950019a, P960025, K042714, K092901
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
510(k) SUMMARY Sintea Plustek's PLIF Lite and TLIF Lite Interbody Fusion system
JUL 2 4 2014
Date: ·
September 16, 2013
Contact:
Sintea Plustek Guido Zorzoli 305-673-6226 407 Lincoln Road Suite 10/L Miami, FL 33139
PLIF Lite and TLIF Lite (PLIF Lite and TLIF Lite Interbody Fusion system) Trade Name: Common Name: Intervertebral Body Fusion Device Product Class: Class II Classification: 888.3080 Product Code: MAX Panel Code: 87
Name of Sponsor
- Sintea Plustek, LLC 407 Lincoln Road Suite 10/L Miami, FL 33139 305-673-6226
Device Description
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are made from PEEK. The PLIF Lite implants are available in lordotic and non-lordotic form, while the TLIF implants are provided with 7 degrees of lordosis only. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Three radiographic markers made of titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.
Predicate Device
The PLIF Lite and TLIF Lite Interbody Fusion system is substantially equivalent to legally marketed predicate devices. The predicate devices are the Stryker (formerly Surgical Dynamics) Ray TFC Cage (P950019a), the Depuy Spine Lumbar I/F Cage Implant System (P960025), the Zimmer (formerly Spinal Concept) Fidji PEEK Lumbar Cage (K042714) and the R Tree Innovations Epicage (K092901).
Intended Use / Indications for Use
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion
1
and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Performance Testing
The PLIF Lite and TLIF Lite Lumbar Interbody devices were tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear, static torsion, subsidence and expulsion. Test results demonstrate that the PLIF Lite and TLIF Lite devices are substantially equivalent to the predicate devices.
Summary:
The PLF Lite and TLIF Lite Interbody Fusion system is substantially equivalent to the predicate devices in regards to:
- Indications for Use .
- Materials .
- . Dimensions
- Function .
- . Mechanical testing
There are no significant differences in technological characteristics compared to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
Sintea Plustek, LLC % Rich Jansen, Pharm.D. Silver Pine Consulting. LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905
Re: K132907
Trade/Device Name: PLIF Lite and TLIF Lite Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 23, 2014 Received: June 26, 2014
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 vour device is classified (sec 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 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
3
Page 2 - Rich Jansen, Pharm.D.
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K132907
Device Name
PLIF Lite and TLIF Lite Interbody Fusion System
Indications for Use (Describe)
The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Katherine D. Kavlock, PhD
Division of Orthopedic Devices
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