(134 days)
No
The summary describes a standard interbody fusion cage and associated instruments, focusing on material properties, dimensions, and mechanical testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which falls under the definition of a therapeutic intervention.
No
Explanation: The device is an interbody fusion system (implant) used for treating degenerative disc disease, not for diagnosing conditions. Its primary function is to provide stabilization and promote fusion, not to identify or characterize a disease state.
No
The device description explicitly states it is a "Lumbar Interbody Cage System" and includes descriptions of physical implants made of Ti6Al4V and instruments made of stainless steel. This indicates it is a hardware 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 intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc.
- Device Description and Intended Use: The Renovis S141 Lumbar Interbody Fusion System is a physical implant (a cage) designed to be surgically placed in the lumbar spine to facilitate bone fusion. Its purpose is to provide structural support and promote the growth of bone between vertebrae.
- Lack of Diagnostic Activity: The device itself does not perform any diagnostic tests on biological samples. It is a therapeutic device used in a surgical procedure.
- Performance Studies: The performance studies listed are related to the mechanical properties and biocompatibility of the implant, not diagnostic accuracy or analytical performance.
Therefore, based on the provided information, the Renovis S141 Lumbar Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Renovis S141 Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Renovis S141 Lumbar Interbody Cage System is FDA cleared as K143126. This application describes a manufacturing change to the K143126 S141 Ti6Al4V cages; internal dimensional changes; additional cages geometries; and a packaging change. The new name of the system is the Renovis S141 Lumbar Interbody Fusion System (S141 System).
The S141 System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion.
The Ti6Al4V is compliant with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The system also includes instruments which are manufactured from stainless steel in compliance with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine at one or two contiguous levels from L2-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
The following performance testing was successfully conducted:
- Dynamic Compression
- Stereological, SEM and ECD evaluation
- Mechanical strength of porous structure:
- Static Tensile testing
- Static Shear testing
- Shear Fatigue testing
- Compressive Elastic Modulus testing
- Tensile Elastic Modulus testing
- Abrasion resistance testing
- Cytotoxicity and bacterial endotoxin testing
- Cytotoxicity
- Pyrogenicity testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Renovis Surgical Technologies % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland, Massachusetts 01721
August 8, 2017
Re: K170888
Trade/Device Name: Renovis S141 Lumbar 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, 2017 Received: June 26, 2017
Dear Dr. Orton:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Renovis S141 Lumbar Interbody Fusion System
Indications for Use (Describe)
The Renovis S141 Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis $141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
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)
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K170888 Page 1 of 3
ORENOVIS
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K170888
A ) Submitted by: Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571
Official Contact: Anthony DeBenedictis Vice President of Quality Assurance
Consultant: Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721
- B) Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Common Name: Intervertebral body fusion device
Proprietary Name: Renovis S141 Lumbar Interbody Fusion System
Device Class: Class II
Regulations 21 CFR 888.3080 and Product Code: MAX
Classification panel: Orthopedic
- K143125 Renovis S141 Lumbar Interbody Cage System C) Primary Predicate: Additional Predicate: K150481 K2M Cascadia
- D) Date Prepared: June 23, 2017
E) Device Description:
The Renovis S141 Lumbar Interbody Cage System is FDA cleared as K143126. This application describes a manufacturing change to the K143126 S141 Ti6Al4Vcages; internal dimensional changes; additional cages geometries; and a packaging change. The new name of the system is the Renovis S141 Lumbar Interbody Fusion System (S141 System).
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The S141 System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion.
The Ti6Al4V is compliant with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The system also includes instruments which are manufactured from stainless steel in compliance with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
E) Intended Use/Indications For Use:
The Renovis S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
F) Substantial Equivalence Comparison and Discussion
A reference device (K2M Cascadia, K150481) is included.
The modified and new cages have the same Indications for Use, same surgical procedure, a porous structure applied to the superior and inferior surface area, are manufactured from Ti6Al4V in compliance with ASTM F136, and are gamma sterilized, the same as the predicate cages. The new and modified cages are dimensionally equivalent in overall form and fit (sizes and footprint) to the predicate cages, and are within the specifications of the FDA cleared cages.
Internal dimensional specification changes, and change in porous structure were assessed for risk and tested under Design Controls. The manufacturing change was validated.
G) Performance - Bench
The following performance testing was successfully conducted:
- Dynamic Compression ●
- Stereological, SEM and ECD evaluation
- Mechanical strength of porous structure: ●
- Static Tensile testing o
- Static Shear testing o
5
- Shear Fatigue testing o
- Compressive Elastic Modulus testing o
- Tensile Elastic Modulus testing o
- Abrasion resistance testing o
- Cytotoxicity and bacterial endotoxin testing ●
- Cytotoxicity
- . Pyrogenicity testing
H) Compliance with Standards or FDA Guidance
The Renovis S141 System cages comply with the following:
- · ASTM E8/E8M-15 Standard Test Methods for Tension Testing of Metallic Materials
- · ASTM E9-09 Standard Test Methods of Compression Testing of Metallic Materials at Room Temperature
- · ASTM F1044-05 (R)2011 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
- · ASTM F1147-05 (R)2011 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
- · ASTM F1160-14 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
- · ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
- · ASTM F1978-12 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
- · ASTM F2077-14 Test methods for intervertebral body fusion devices
- · ASTM F2847-10:2010 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
- · AAMI/ANSI ST72:2011 (R)2016 Bacterial endotoxins test methods, routine monitoring, and alternatives to batch testing
- · AAMI/ANSI/ISO 10993-1:2009 (R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009(R)2014 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: . Intervertebral Body Fusion Device, June 2007
Conclusion
There are no new or different issues of safety or effectiveness associated with the changes described for the modified cages or with the new cages. Testing, where applicable, was verified under Design Controls and found to be acceptable.
The modified and new S141 System Ti6A14V cages are substantially equivalent to the predicate S141 System Ti6A14V cages.