(149 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is an intervertebral body fusion system intended to treat degenerative disc disease, which involves mitigating a medical condition.
No
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is described as an implantable device used for intervertebral body fusion procedures, not for diagnosing medical conditions.
No
The device description clearly details physical implants (cages, screws, cover plates) made of PEEK and Titanium, along with manual instruments. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, a procedure performed in vivo (within the living body). IVDs are used to examine specimens taken from the body (like blood, urine, or tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an implantable system made of materials like PEEK and Titanium, designed to be placed between vertebrae. This is consistent with a surgical device, not a diagnostic tool that analyzes biological samples.
- Performance Studies: The performance studies listed are related to the mechanical properties and stability of the implant (compression, shear, expulsion, subsidence), which are relevant for a surgical device. IVD performance studies would focus on analytical and clinical performance related to detecting or measuring substances in biological samples.
In summary, the Renovis S128 ALIF System is a surgical implant used for spinal fusion, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) 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 S128 ALIF 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 S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.
Product codes
OVD
Device Description
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The Renovis S128 ALIF System contains both fixed and variable angle screw options. The fixed angle screw option provides a tight fit with the cage. The variable angle screw option provides a slight clearance between the cage and the screw which allows for a small amount of variable screw angulations.
The Renovis S128 ALIF System cages are intended to be used with autogenous bone graft. The accompanying cover plate is designed to prevent screw back-out and must be used when the screws are implanted. NOTE: The cover plate assembly and screw are part of the implant construct.
The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and coverplate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. The Renovis Si28 ALIF System is used with trials and implant specific manual instruments, and includes other class I manual orthopedic instruments.
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 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)
The Renovis S128 ALIF System implants (worse case constructs) have successfully undergone the following testing:
- Static Compression per ASTM F2077
- Dynamic Compression per ASTM F2077
- Static Shear-Compression per ASTM F2077
- Dynamic Shear-Compression per ASTM F2077
- Expulsion Testing w/screws per ASTM Draft Standard F04.25.02.02
- Expulsion Testing w/o screws per ASTM Draft Standard F04.25.02.02
- Subsidence testing per ASTM F2267
Sample coupons of the Titanium porous structure have successfully undergone the following testing:
- Shear testing of metallic coatings per ASTM F1044
- Tensile testing of metallic coatings per ASTM F1147
- Abrasion per ASTM F1978
- Porosity-and microstructure per ASTM F1854
Conclusion: Performance data results support that the Renovis S128 ALIF System is substantially equivalent to the predicate devices and that there are no new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081177, K092211, K123767, K102738, K083815, K073144, K082260
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.
0
K131122 Page 1 of 5
Abbreviated 510(k) Summary as required by 21 CFR 807.92(a) K131122
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. 200 200 Homer Ave Ashland, MA 01721
SEP 18 2013
Date Prepared: September 16, 2013
B) Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Common Name: Intervertebral body fusion device
Proprietary Name: S128 Anterior Lumbar Interbody Fusion (ALIF) System
Device Class: Class II - 888.3080
Regulation and 888.3080, OVD - Intervertebral body fusion device Product code:
Classification panel: Orthopedic
- C) Predicates:
1
D) Device Description:
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The Renovis S128 ALIF System contains both fixed and variable angle screw options. The fixed angle screw option provides a tight fit with the cage. The variable angle screw option provides a slight clearance between the cage and the screw which allows for a small amount of variable screw angulations.
The Renovis S128 ALIF System cages are intended to be used with autogenous bone graft. The accompanying cover plate is designed to prevent screw back-out and must be used when the screws are implanted. NOTE: The cover plate assembly and screw are part of the implant construct.
The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and coverplate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. The Renovis Si28 ALIF System is used with trials and implant specific manual instruments, and includes other class I manual orthopedic instruments.
E) Indications For Use:
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) 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 S128 ALIF 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 S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.
2
K131122
Page 3 of 5
ORENOVIS
F) Substantial Equivalence Comparison and Discussio
| | Renovis
S128 ALIF
System | Blackstone
(Orthofix) Pillar
K081177 | K2M
Chesapeake
K092211 | Lanx
Lateral SA
System K123767
Fusions System
K102738
Fusion System
K083815
Intervertebral
body Fusion
Device K073144 | Calvary Spine
Petra PLIF Cage
System
K082260 |
|---------------------|--------------------------------|--------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Implant Material | PEEK
Titanium | PEEK | PEEK | PEEK
Titanium alloy | PEEK |
| Dimensions in mm | | | | | |
| A/P | 26, 28, 30 | 28, 32 | 24, 28, 30 | 16, 18, 22, 26 | Crescent 13x 27 |
| M/L | 30, 34, 38 | 37, 40, 43 | 30, 36, 40 | 25 to 60 | Straight 11 x 30 |
| H | 11-21 | 12.5 - 20 | 11-19 | 6-16 | 7-15 |
| Lordosis | 7°, 12° | 7°, 12° | 10°, 15° | 0°, 8° | |
| Screw material | Titanium | Titanium | Titanium | Titanium when
applicable | Requires
supplemental
fixation |
| Number of screws | 4 | 4 | 3 | Unk | 80 |
| Screw Diameter (mm) | 4.5, 5.0 | 5.0, 5.5 | 5.5 | Unk | |
| Screw Length (mm) | 20, 25, 30, 35 | 20, 25, 30, 35 | 20, 25, 30 | Unk | |
| Cover plate | Titanium | Titanium | Titanium | Unk | Tantalum |
| Marker material | Tantalum | Tantalum | Tantalum | Tantalum | Tantalum |
3
Conclusion
Based upon the same or similar intended use, design, function, technology, and materials, the Renovis S128 ALIF System is substantially equivalent to the predicate devices and does not raise new issues of safety or effectiveness.
G) Performance Testing
The Renovis S128 ALIF System implants (worse case constructs) have successfully undergone the following testing:
-
- Static Compression per ASTM F2077
-
- Dynamic Compression per ASTM F2077
-
- Static Shear-Compression per ASTM F2077
-
- Dynamic Shear-Compression per ASTM F2077
-
- Expulsion Testing w/screws per ASTM Draft Standard F04.25.02.02
-
- Expulsion Testing w/o screws per ASTM Draft Standard F04.25.02.02
-
- Subsidence testing per ASTM F2267
Sample coupons of the Titanium porous structure have successfully undergone the following testing:
-
- Shear testing of metallic coatings per ASTM F1044
-
- Tensile testing of metallic coatings per ASTM F1147
-
- Abrasion per ASTM F1978
-
- Porosity-and microstructure per ASTM F1854
Conclusion
Performance data results support that the Renovis $128 ALIF System is substantially equivalent to the predicate devices and that there are no new issues of safety or effectiveness.
H) Compliance with FDA Guidance and Consensus Standards
The Renovis S128 ALIF System complies with the following:
FDA Guidance:
- · Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007.
- · Guidance for Industry and FDA Staff: Spinal System 510(k)s", May 2004 for labeling including labels, Instructions for Use and Surgical Manual
21 CFR 888.3080 Intervertebral body fusion device:
- · ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
4
- ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of -. Orthopedic Implants and Instruments
- . ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM F2077-3 Test Methods for Intervertebral Body Fusion Devices .
Other
- . ASTM F2026 Standard Specification for PEEK Polymers for Surgical Implant Applications
- ASTM F-136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI . (Extra Low Interstitial) Alloy for Surgical Implant Applications, and
- ASTM F 560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant . Applications
- ASTM draft standard F.04.25.02.02 Static Expulsion ●
- ASTM F1044-05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate . Coatings and Metallic Coatings
- ASTM F1147- 05(2011) Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
- ASTM F1978 12 Standard Test Method for Measuring Abrasion Resistance of Metallic . Thermal Spray Coatings by Using the Taber Abraser
- . ASTM F1854 - Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
- ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening . Stainless Steel Bars and Shapes
- . ASTM F138 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2013
Renovis Surgical Technologies, LLC % Sharyn Orton, Ph.D. MEDIcept, Incoporated 200 Homer Avenue Ashland, Massachusetts 01721
Re: K131122
Trade/Device Name: Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: August 16, 2013 Received: August 19, 2013
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 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
6
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K131122
Device Name: Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System
Indications for Use:
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) 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 S128 ALIF 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 S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.
X_____________________________________________________________________________________________________________________________________________________________________________ Over-the-Counter Use Prescription Use (21 CFR 801, Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH. Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Renovis S128 ALIF System
Abbreviated 510(k) Premarket Notification