(269 days)
No
The 510(k) summary describes a mechanical interbody fusion device and its materials. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are mechanical tests, not software validation.
Yes
The device is intended for spinal fusion procedures to treat degenerative disc disease, which falls under therapeutic intervention.
No
Explanation: This device is described as an interbody fusion device intended for spinal fusion procedures, providing structural stability. It is used in treatment and not for diagnosing diseases or conditions.
No
The device description explicitly states it is manufactured from titanium alloy and Polyetheretherketone, and contains an expandable mechanism, indicating it is a physical implantable device, 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 for diagnosis, monitoring, or screening.
- PROW FUSION-L Function: The PROW FUSION-L is a physical implantable device used in spinal fusion surgery. It provides structural support and stability between vertebrae.
- Lack of Specimen Analysis: The description of the PROW FUSION-L does not involve the analysis of any biological specimens. Its function is purely mechanical and structural within the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. 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 non-fusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).
Product codes
MAX
Device Description
PROW FUSION-L is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-L is provided in different sizes to fit the anatomical needs of a wide variety of patients. PROW FUSION-L is manufactured from titanium alloy per ASTM F136 and Polyetheretherketone per ASTM F 2026. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. PROW FUSION-L is to be filled with autogenous bone graft material.
Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae. The devices require the use of commercially available supplemental spinal fixation systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L2 through 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 testing consisting of static and dynamic axial compression, static and dynamic compression-shear according to ASTM F2077 and subsidence according to ASTM F2267 was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 to demonstrate substantial equivalence to the predicate. In addition, expulsion and wear particle assessment testing was also performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133717, K112359, K130254, K151654, K153786, K143297, K132897, K143163, K123231, K100210
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
NLT SPINE Ltd. % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K153665
Trade/Device Name: PROW FUSION-L Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 16, 2016 Received: August 16, 2016
Dear Dr. Smith:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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 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,
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
510(k) Number (if known) K153665
K153665 Page 1 of 1
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page
Device Name
PROW FUSION-L
Indications for Use (Describe)
The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. 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 non-fusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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Image /page/3/Picture/0 description: The image shows the logo for NLT Spine NonLinear Technologies. The logo features a stylized spine graphic in blue on the left, followed by the text "NLTSPINE" in a bold, sans-serif font. Below "NLTSPINE" is the text "NonLinear Technologies" in a smaller, lighter font. The overall design is clean and modern, suggesting a focus on spinal health and advanced technology.
510(k) SUMMARY
K153665 Page 1 of 3
NLT SPINE's PROW FUSION-L
As required by 21 C.F.R. § 807.92
Sponsor:
NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba Israel 4464103
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: September 13, 2016
Name of Device: PROW FUSION-L
Common or Usual Name: Intervertebral body fusion device Classification Name: Intervertebral body fusion device 21 CFR §880.3080 Product Code MAX
Predicate Device
Primary predicate: Life Spine, Longbow Spacer System (K133717)
Additional predicates: NLT SPINE, PROW FUSION (K112359, K130254, K151654), PROW FUSION-V (K153786); Zimmer, BAK-L (K143297); Medtronic, CLYDESDALE® Spinal System (K132897); Stryker, ARIATM Spinal System (K143163); Globus, Caliber (K123231);TranS1 Lateral Intervertebral Fusion Device (K100210)
Intended Use / Indications for Use
The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and
4
Image /page/4/Picture/0 description: The image contains the logo for NLT Spine NonLinear Technologies. The logo features a stylized spine graphic in light blue on the left. To the right of the spine graphic, the text "NLTSPINe" is displayed in a bold, dark gray font. Below "NLTSPINe", the words "NonLinear Technologies" are written in a smaller, lighter gray font.
K153665 Page 2 of 3
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). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device. The device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).
Device Description
PROW FUSION-L is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-L is provided in different sizes to fit the anatomical needs of a wide variety of patients. PROW FUSION-L is manufactured from titanium alloy per ASTM F136 and Polyetheretherketone per ASTM F 2026. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. PROW FUSION-L is to be filled with autogenous bone graft material.
Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae. The devices require the use of commercially available supplemental spinal fixation systems.
Summary of Technological Characteristics
The PROW FUSION-L is an intervertebral body fusion device designed for placement into a prepared disc space following discectomy, maintain the height of the disc space and promote interbody fusion, all in a manner substantially similar to the predicate device. The placement technique of the PROW FUSION-L and the predicate is identical. Both the PROW FUSION-L and the predicate are manufactured from titanium alloy and PEEK. Both devices create a closed volume for bone graft between their members after expansion.
Performance Data
Mechanical testing consisting of static and dynamic axial compression, static and dynamic compression-shear according to ASTM F2077 and subsidence according to ASTM F2267 was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 to demonstrate substantial equivalence to the predicate. In addition, expulsion and wear particle assessment testing was also performed.
5
Image /page/5/Picture/0 description: The image shows the logo for NLT Spine, a company specializing in nonlinear technologies. The logo features a stylized spine graphic on the left, composed of blue squares arranged vertically. To the right of the spine graphic, the text "NLTSPINE" is displayed in a bold, sans-serif font, with "NonLinear Technologies" written below in a smaller font size. The overall design is clean and modern, conveying a sense of innovation and expertise in the field of spinal technology.
Conclusions
K153665 Page 3 of 3
PROW FUSION-L is similar to the predicate with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject PROW FUSION-L to the predicate device.