(147 days)
Not Found
No
The summary describes a physical implant made of PEEK with radiographic markers and raised contours. 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 are mechanical tests, not studies of algorithmic performance.
No
The device is an intervertebral body fusion device system, used to facilitate spinal fusion in patients with degenerative disc disease, which is a structural intervention rather than a therapeutic treatment in the sense of curing a disease or alleviating symptoms through non-invasive or pharmacological means. Its purpose is to physically stabilize a segment of the spine.
No
The device is an intervertebral body fusion device, which is a therapeutic implant used for fusion in patients with degenerative disc disease. It is not used for diagnosing conditions.
No
The device description clearly states the device is comprised of implants made of PEEK and contains radiographic markers, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is an implantable device made of PEEK and intended for surgical insertion into the lumbar spine.
- Intended Use: Its purpose is to facilitate fusion between vertebrae in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant used in vivo (within the body) to treat a condition, not a device used to diagnose a condition by testing samples in vitro.
N/A
Intended Use / Indications for Use
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The in biololially maters patte treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The BoneBac™ T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral body fusion device system comprised of implants with a variety of lengths, widths, and heights to accommodate patient anatomy. The implants are made of Solvay Zeniva ZA-500 PEEK (ASTM F2026). The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant. The devices contain radiographic markers to enable fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, one or two contiguous spinal levels from 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)
Mechanical test comparisons were conducted per the following standard test methods:
- ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04, Subsidence Under Static Axial Compression
- ASTM Draft Standard F-04.25.02.02, Static Expulsion
- ASTM F1877 Wear Debris Characterization
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.
K100042, K071724, K072791, K071795, K080537
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
OCT 2 6 2011
Submitted By
Thompson MIS 45 Stiles Rd, Suite 210 Salem, NH 03079
| Contact: | Frank Sullivan | |
|---|---|---|
| Telephone: | 603-912-5306 | |
| Date Prepared: | October 4, 2011 |
Device Name and Classification:
Common Name: Intervertebral Fusion Device with Bone Graft, Lumbar
Proprietary Name: BoneBac™ T-PLIF Intervertebral Body Fusion Device System
Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar
Requlation and Classification: 21 CFR 888.3080, Class II
Product Code: MAX
Predicate Devices
K100042 - DiFusion Technologies XIPHOS IBF System K071724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K080537 - Kiscomedica L-Varlock
Device Description
The BoneBac™ T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral body fusion device system comprised of implants with a variety of lengths, widths, and heights to accommodate patient anatomy. The implants are made of Solvay Zeniva ZA-500 PEEK (ASTM F2026). The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant. The devices contain radiographic markers to enable fluoroscopic visualization.
1
Intended Use
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The in biololially maters patte treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
Technological Characteristics
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System was shown to share the same technological characteristics with predicate devices through comparison of indications for use, function, operating principles, and materials.
Basis for Substantial Equivalence
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System was evaluated in accordance with FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007, and has been found to meet criteria defined in the guidance document. The system shares the same intended use, technological characteristics, operating principles, and materials with predicate devices. Mechanical testing demonstrates substantially equivalent performance. Clinical data was not required for this device. Mechanical test comparisons were conducted per the following standard test methods:
- ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04, Subsidence Under Static Axial Compression ﺘ
- ASTM Draft Standard F-04.25.02.02, Static Expulsion -
- ASTM F1877 Wear Debris Characterization -
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three flowing lines representing the department's services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2011
Thompson MIS, Inc. % Mr. Frank Sullivan 45 Stiles Road, Suite 210 Salem, New Hampshire 03079
Re: K111512
Trade/Device Name: BoneBac" T-PLIF Intervertebral Body Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 04, 2011 Received: October 05, 2011
Dear Mr. Sullivan:
な
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. Frank Sullivan
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/Reportal?roblem/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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
000014
| 4.0 | Indications for Use Statement |
|---|---|
| ------------ | -------------------------------------- |
510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Indications For Use:
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative tor doo in othershy maxine ended for the treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
K 111512 510(k) Number_