(75 days)
Not Found
No
The document describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device, the Renovis Lumbar Interbody Fusion (LIF) System, is designed for intervertebral body fusion procedures to treat degenerative disc disease, which is a medical condition. Its intended use directly involves treating a disease to restore function, meeting the definition of a therapeutic device.
No
The device is described as an implant system (lumbar interbody fusion system) used for surgical repair, not for diagnosing conditions. Its intended use is for intervertebral body fusion procedures, not for identifying diseases.
No
The device description explicitly states that the device is an implant manufactured from PEEK or Titanium, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Renovis Lumbar Interbody Fusion (LIF) System and its components (S134 ALIF System) are described as implants (cages) made of PEEK or Titanium, intended for surgical implantation into the lumbar spine.
- Intended Use: The intended use is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample outside the body.
The text clearly describes a surgically implanted medical device used for structural support and fusion, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Renovis Lumbar Interbody Fusion (LIF) 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 LIF 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.
The Renovis S134 ALIF System must be used with supplemental fixation cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The purpose of this submission is an additional offering to the Renovis lumbar interbody fusion system portfolio. The S134 Anterior Lumbar Interbody Fusion (ALIF) System implants (cages) are intervertebral body fusion devices with a screw-less design that requires supplemental fixation. The S134 ALIF cages 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 PEEK markers are manufactured from Tantalum.
The Renovis S134 ALIF System cages are to be used with supplemental fixation, and are intended to be used with autogenous bone graft.
The Renovis S134 ALIF System is used with device specific instruments including trials.
The Renovis S134 ALIF System implants comply with the following material standards:
- ASTM F2026-08 Standard Specification for PEEK Polymers for Surgical . Implant Applications
- ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant ● Applications
The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user).
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)
Comparison of technological characteristics, engineering rationale and FEA were used to determine that this design change does not introduce a new worst case.
The Renovis S134 ALIF System implants have the same footprint (ID and OD profile dimensions), materials, manufacturing methods, and sterilization offerings; and similar intended use, design and function as the Renovis S128 ALIF System implant. Therefore, the Renovis S134 ALIF System is substantially equivalent to the predicate device.
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.
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
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, layered on top of each other. The profiles are connected by a curved line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2014
Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Incorporated 200 Homer Avenue Ashland, Massachusetts 01721
Re: K142095
Trade/Device Name: Renovis S134 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, MAX Dated: September 15, 2014 Received: September 16, 2014
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
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" (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 yours.
Ronald Dalean -S for
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) K142095
Device Name
Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System
Indications for Use (Describe)
The Renovis Lumbar Interbody Fusion (LIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative 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 LIF 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.
The Renovis S134 ALIF System must be used with supplemental fixation cleared by the FDA for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K142095 Page 1 of 1
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ORENOVIS
Special 510(k) Summary as required by 21 CFR 807.92(a) K142095
| | A ) Submitted by: | | Renovis Surgical Technologies, Inc.
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 | |
| Date: | | | October 14, 2014 |
| B) | Device Name: | | Intervertebral Fusion Device With Bone Graft, Lumbar |
| | Common Name: | | Intervertebral body fusion device |
| | Proprietary Name: | | S134 Anterior Lumbar Interbody Fusion (ALIF) System |
| | Device Class: | | Class II - 888.3080 |
| | Regulation and
and product codes: | | 21 CFR 888.3080
OVD - Intervertebral Body Fusion Device with Integrated
Fixation, Lumbar
MAX - Intervertebral Body Fusion Device with Bone Graft,
Lumbar |
| | Classification panel: | | Orthopedic |
C) Predicate:
- . K140106 Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System
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D) Device Description:
The purpose of this submission is an additional offering to the Renovis lumbar interbody fusion system portfolio. The S134 Anterior Lumbar Interbody Fusion (ALIF) System implants (cages) are intervertebral body fusion devices with a screw-less design that requires supplemental fixation. The S134 ALIF cages 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 PEEK markers are manufactured from Tantalum.
The Renovis S134 ALIF System cages are to be used with supplemental fixation, and are intended to be used with autogenous bone graft.
The Renovis S134 ALIF System is used with device specific instruments including trials.
The Renovis S134 ALIF System implants comply with the following material standards:
- ASTM F2026-08 Standard Specification for PEEK Polymers for Surgical . Implant Applications
- ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant ● Applications
The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user).
E) Indications For Use:
The Renovis Lumbar Interbody Fusion (LIF) 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 LIF 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.
The Renovis S134 ALIF System must be used with supplemental fixation cleared by the FDA for use in the lumbar spine.
5
F) Substantial Equivalence Comparison and Discussion
Comparison of technological characteristics, engineering rationale and FEA were used to determine that this design change does not introduce a new worst case.
Conclusion
The Renovis S134 ALIF System implants have the same footprint (ID and OD profile dimensions), materials, manufacturing methods, and sterilization offerings; and similar intended use, design and function as the Renovis S128 ALIF System implant. Therefore, the Renovis S134 ALIF System is substantially equivalent to the predicate device.
G) Compliance with Design Controls
The results of assessment under Design Controls support that the Renovis S134 ALIF System is substantially equivalent to the predicate device. The offering of implants that are not standalone and require supplemental fixation does not raise new issues of safety or effectiveness.
H) Compliance with Consensus Standards and FDA Guidance
The Renovis S134 ALIF System complies with:
- · ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
- · ASTM F2026-12 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- · ASTM F560-08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
- · ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
- · ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- · Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, October 2007