(81 days)
Not Found
No
The summary describes a physical medical device (interbody fusion system) and its materials, dimensions, and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for intervertebral body fusion procedures to treat degenerative disc disease, which involves addressing a medical condition.
No
This device is an intervertebral body fusion device (cage) used for surgical treatment of degenerative disc disease, not for diagnosing it. The text describes it as an "additional offering to the Renovis system of interbody fusion devices" and details its physical characteristics and materials for implantation.
No
The device description explicitly states it includes cages manufactured from Ti6A14V and instruments manufactured from Stainless steel and Ti-6Al-4V, which are hardware components.
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, or tissue) to provide information about a person's health.
- Device Description: The Renovis S180 Lateral Lumbar Interbody Fusion System is a surgical implant designed to be placed within the lumbar spine to facilitate bone fusion. It is a physical device used in the body, not a test performed on samples from the body.
- Intended Use: The intended use is for intervertebral body fusion procedures, which is a surgical intervention, not a diagnostic test.
The information provided clearly describes a surgical implant and its intended use in a surgical procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Renovis S180 Lateral 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 at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment with the devices.
The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Renovis S180 Lateral Lumbar Interbody System is an additional offering to the Renovis system of interbody fusion devices. This application describes changes in lengths, widths, heights and lordosis configurations; material standard; packaging; and additive manufacturing device. The S180 LLIF 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 a lateral surgical approach for insertion. The S180 LLIF System cages are manufactured from Ti6A14V compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion. The system also includes instruments which are manufactured from: Stainless steel in compliance with: ASTM F564/A564M 13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes Ti-6Al-4V in compliance with: ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications ASTM F1472-14 Standard Specification for Wrought Titanium-6Aluminumo 4 Vanadium Alloy for Surgical Implant Applications
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lumbar spine at one or two contiguous 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)
Successful mechanical/functional testing of the new worst-case S180 LLIF cages was conducted as follows:
- Dynamic axial compression testing in accordance with ASTM F2077 .
- . Expulsion, static push-out, testing
- Mechanical Tensile Testing per ASTM E8/E8M-15a methods ●
Sterilization validation was conducted.
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.
K170888 Renovis S141 Lumbar Interbody Fusion System, K131122 Renovis S128 Anterior Lumbar Interbody Fusion System, K140106 Renovis S128 Anterior Lumbar Interbody Fusion System
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).
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§ 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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September 11, 2018
Renovis Surgical Technologies % Ms. Sharyn Orton Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland. Massachusetts 01721
Re: K181655
Trade/Device Name: Renovis S180 Lateral Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 9, 2018 Received: July 10, 2018
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181655
Device Name
Renovis S180 Lateral Lumbar Interbody Fusion System
Indications for Use (Describe)
The Renovis S180 Lateral 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 at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment with the devices.
The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft.
| 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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Image /page/3/Picture/0 description: The image shows the word "RENOVIS" in red font. To the left of the word is a gray symbol that looks like three curved ribbons intertwined. The ribbons are shaded to give them a three-dimensional appearance. The word "RENOVIS" is in all capital letters.
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K181655
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 S180 Lateral Lumbar Interbody Fusion System
Device Class: Class II
Regulations 21 CFR 888.3080 and Product Code: MAX
Classification panel: Orthopedic
- C) Predicates:
D) Date Prepared: September 10, 2018
E) Device Description:
The Renovis S180 Lateral Lumbar Interbody System is an additional offering to the Renovis system of interbody fusion devices.
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This application describes changes in lengths, widths, heights and lordosis configurations; material standard; packaging; and additive manufacturing device.
The S180 LLIF 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 a lateral surgical approach for insertion.
The S180 LLIF System cages are manufactured from Ti6A14V compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion.
The system also includes instruments which are manufactured from:
- Stainless steel in compliance with: ●
- 0 ASTM F564/A564M 13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
- Ti-6Al-4V in compliance with: ●
- O ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F1472-14 Standard Specification for Wrought Titanium-6Aluminumo 4 Vanadium Alloy for Surgical Implant Applications
F) Intended Use/Indications For Use:
The Renovis S180 Lateral 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). Patients should be skeletally mature and have at least six months of non-operative treatment prior to treatment with the devices.
The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft.
G) Substantial Equivalence Comparison and Discussion
The S180 cages have the same clinical Indications for Use, are functionally the same, have a porous structure applied to the superior and inferior surface area, are additively manufactured from Ti-6Al-4V, and are gamma sterilized like the predicate devices.
The S180 cages include different heights, widths, lengths and lordosis; and a change to the additive manufacturing machine. The manufacturing change was validated.
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The S180 LLIF System cages are substantially equivalent to the predicate devices.
H) Performance Testing - Bench
Successful mechanical/functional testing of the new worst-case S180 LLIF cages was conducted as follows:
- Dynamic axial compression testing in accordance with ASTM F2077 .
- . Expulsion, static push-out, testing
- Mechanical Tensile Testing per ASTM E8/E8M-15a methods ●
Sterilization validation was conducted.
I) Compliance with Standards or FDA Guidance
The Renovis S180 LLIF System cages comply with the following:
- · ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices Part 2: Validation requirements for forming, sealing and assembly processes
- · ISTA 2A:2011 Packaged-products weighing 150 lbs. (68kg) or less
- · ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and Systems
- · ASTM E8/E8M-15a Standard Test Methods for Tension Testing of Metallic Materials
- · ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
- ASTM F1044-05 (R)2017e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
- ASTM F1147-05 (R)2017e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
- · ASTM F1160-14 (R)2017e1 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 F1978-17 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
- · ASTM F2077-17 Test methods for intervertebral body fusion devices
- · AAMI/ANSI ST72:2011 Bacterial endotoxins test methods, routine monitoring, and alternatives to batch testing
o Same as AAMI/ANSI ST72:2011(R)2016
- · AAMI/ANSI/ISO 10993-1:2009(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- AAMI/ANSI/ISO 10993-5:2009(R)2014 Biologic Evaluation Of Medical Devices Part 5: Tests For In Vitro Cytotoxicity
- · AAMI/ANSI/ISO 11137-2:2013 Sterilization of health care products radiation part 2: establishing the sterilization dose
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- · AAMI/ANSI/ISO 11737-1:2006 R(2011)Sterilization of health care products microbiological methods - part 1: determination of the population of microorganisms on product
- · ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
- · Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007
- · Guidance for Industry and FDA Staff Technical Considerations for Additive Manufactured Medical Devices, December 2017
- · Guidance for Industry and FDA Staff Reporting of Computational Modeling Studies in Medical Device Submissions, September 2016
Conclusion
There are no different issues of safety or effectiveness associated with the S180 LLIF System cages. Testing, where applicable, was conducted found to be acceptable. The S180 LLIF System cages are substantially equivalent to the predicate devices and are expected to perform per their intended use.