(29 days)
The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through SI in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION device.
The PROW FUSION intervertebral body fusion device must be inserted using a transforaminal approach.
The PROW FUSION Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use PROW FUSION implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the PROW FUSION Delivery System) used for its implantation. The implant is made from PEEK and titanium alloy. The implant features 4 PEEK mid segments and titanium end segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins.
The PROW FUSION intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK strip is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.
This document is a 510(k) Summary for the PROW FUSION intervertebral body fusion device. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific study design details, ground truth establishment, expert involvement, and reader studies is not typically found in this type of regulatory submission.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a formal table of acceptance criteria with specific quantitative thresholds or a direct report of the device's performance against such criteria. The "Performance Data" section broadly states that "Performance testing, including static axial compression testing per ASTM F2077, cadaver testing, and deployment force testing demonstrated that the PROW FUSION is substantially equivalent to its predicate PROW FUSION (K130254)."
The acceptance criterion, by inference, is that the device demonstrates substantial equivalence in its performance characteristics to the predicate device (K130254). The reported "performance" is that this substantial equivalence was demonstrated through the stated tests.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Static axial compression performance equivalent to predicate (per ASTM F2077). | Demonstrated substantial equivalence. |
| Cadaveric performance equivalent to predicate. | Demonstrated substantial equivalence. |
| Deployment force performance equivalent to predicate. | Demonstrated substantial equivalence. |
| No new questions of safety and effectiveness compared to the predicate regarding modifications (intermediate diameter/heights, instrumentation). | No new questions of safety and effectiveness raised. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (e.g., number of test articles, cadavers) used for the static axial compression testing, cadaver testing, or deployment force testing. It also does not state the provenance of any data (e.g., country of origin, retrospective/prospective). This level of detail is usually found in the full technical report, not the 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a mechanical device performance test, the concept of "ground truth" and "experts" as in clinical or interpretive studies (e.g., radiologists) is not applicable. The "ground truth" for mechanical testing is derived from the objective physical measurements and engineering specifications, often interpreted against established standards (like ASTM F2077).
4. Adjudication Method for the Test Set
Not applicable for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms where human readers interpret results, and the document describes an intervertebral body fusion device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm, so this question is not applicable. The performance testing conducted (static axial compression, cadaver testing, deployment force) can be considered "standalone" in the sense that it assesses the device's physical properties and function without human intervention in its operation during the test, but it is not "algorithm only" performance.
7. The Type of Ground Truth Used
For the performance testing:
- Static axial compression testing: The ground truth is established by the specified mechanical properties and failure criteria outlined in the ASTM F2077 standard, and comparison to the predicate device's performance under the same standard.
- Cadaver testing: The ground truth would be based on the observed mechanical stability, insertion characteristics, or other defined metrics within the cadaveric model, compared to the predicate.
- Deployment force testing: The ground truth would be the measured forces and comparison to predicate or specified engineering targets.
8. The Sample Size for the Training Set
This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
NLT SPINE, Limited % Mr. Jonathan S. Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K151654
Trade/Device Name: PROW FUSION Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 18, 2015 Received: June 18, 2015
Dear Mr. Kahan:
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
Page 2 - Mr. Jonathan S. Kahan
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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name PROW FUSION
Indications for Use (Describe)
The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through SI in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION device.
The PROW FUSION intervertebral body fusion device must be inserted using a transforaminal approach.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and comblete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for NLT Spine NonLinear Technologies. The logo features a stylized spine graphic on the left, composed of several blue squares stacked vertically in a curved shape. To the right of the spine graphic, the text "NLTSPine" is displayed in a sans-serif font, with "NonLinear Technologies" written in a smaller font size below it.
510(k) SUMMARY
NLT SPINE's PROW FUSION
Sponsor:
NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba Israel 44641
Contact Person:
Eti Zinger VP Regulatory Affairs NLT SPINE Ltd. Tel: +972-3-6344514 Fax: +972-3-6341599 Eti.z@nlt-spine.com
| Date Prepared: | July 17, 2015 |
|---|---|
| Name of Device: | PROW FUSION |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device21 C.F.R. § 880.3080, class II medical deviceProduct Code MAX |
Primary Predicate Device
NLT SPINE, PROW FUSION (K130254)
Intended Use / Indications for Use
The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous nonfusion spinal surgery at the involved spinal level(s).
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for NLT Spine. The logo consists of a stylized spine graphic on the left, followed by the text "NLTSPINE" in a larger, bolder font. Below "NLTSPINE" is the text "NonLinear Technologies" in a smaller, lighter font. The spine graphic is composed of several blue squares arranged in a curved line, resembling the shape of a human spine.
The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION device.
The PROW FUSION intervertebral body fusion device must be inserted using a transforaminal approach.
Purpose of the Special 510(k) notice:
The PROW FUSION is a modification to NLT's previously cleared K130254 PROW FUSION. Specifically, the submission adds intermediate diameter and heights and made some modifications to the instrumentation to improve the surgical technique.
Technological Characteristics
The PROW FUSION Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use PROW FUSION implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the PROW FUSION Delivery System) used for its implantation. The implant is made from PEEK and titanium alloy. The implant features 4 PEEK mid segments and titanium end segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins.
The PROW FUSION intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK strip is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.
Performance Data
Performance testing, including static axial compression testing per ASTM F2077, cadaver testing, and deployment force testing demonstrated that the PROW FUSION is substantially equivalent to its predicate PROW FUSION (K130254).
Substantial Equivalence
The PROW FUSION is as safe and effective as its predicate device, PROW FUSION (K130254). The PROW FUSION has substantially similar indications for use and technological characteristics as compared to the predicate device. Any minor differences between the device and predicates do not raise new questions of safety and effectiveness. Further, performance testing has established that the PROW FUSION has equivalent performance and safety as compared to the claimed predicate. Thus, the device is substantially equivalent to its predicate device.
§ 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.