(134 days)
Not Found
No
The document describes a mechanical hip replacement system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical and material properties and sterilization.
Yes.
The device is a component of a hip replacement system, indicated for various joint diseases and fractures, which are conditions that impair normal function and require medical intervention for restoration of health.
No
The device is a surgical implant (hip replacement system), used for treatment rather than diagnosis.
No
The device description clearly states it is a titanium, hemispherical cup and mentions instrumentation, indicating it is a physical implant and associated tools, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint in patients with various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a titanium, hemispherical cup designed to be surgically implanted. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Performance Studies: The performance studies focus on mechanical testing, sterilization, packaging, and shipping validation, which are relevant to the safety and efficacy of a surgical implant, not the analytical or clinical performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
In summary, the Renovis Surgical Hip Replacement System is a surgical implant used for treatment, not a device used to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Renovis Surgical Hip Replacement System is indicated for patients suffering from:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
-
Correction of functional deformity;
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques; and
-
Revision procedures where other treatment or devices have failed.
Product codes
LPH
Device Description
The Renovis Porous Acetabular Cup System ("Porous shell") are titanium, hemispherical cups consisting of varying sizes (outer diameter of 44 - 66 mm) and screw hole options (no hole shell and cluster hole shells) to accommodate patient anatomy and/or surgical technique. Instrumentation is provided with the system.
The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.
The Renovis Surgical Porous Cup System complies with the following material standards:
- o ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or
- ASTM F620-11 Standard Specification for Titanium Alloy Forgings for Surgical ● Implants in the Alpha Plus Beta Condition
- ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant ● Applications (UNS R50250, UNS R50400, UNS R50550 and UNS R50700)
- 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
Hip joint, proximal femur
Indicated Patient Age Range
Not Found
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)
Performance testing was successfully completed.
The Renovis Surgical Porous Acetabular Cup System complies with:
- 21 CFR 888.3358 ●
- 0 FDA "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", April 8, 1994
- ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings ● on Medical Implants
- o ASTM F1472-08e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
- ASTM F1044-05 (2011) Standard Test Method for Shear Testing of Calcium Phosphate o Coatings and Metallic Coatings
- ASTM F1147-05 (2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1820-97:2009 Standard Test Method for Determining the Forces for ● Disassembly of Modular Acetabular Devices
Sterilization, shelf life, packaging and shipping validation studies have been conducted. The Renovis Surgical Porous Acetabular Cup System complies with:
- o ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- ASTM F1980-07 (reapproved 2011) Standard Guide for Accelerated Aging of Sterile ● Barrier Systems for Medical Devices
- ISO 11607-2:2009: Packaging for terminally sterilized medical devices Part 2: ● Validation requirements for forming, sealing and assembly processes
- ISTA 2A Partial Simulation Performance Tests; Packaged-Products weighing 150 lb (68 kg) or Less
- ASTM D4169-09: Standard Practice for Performance Testing of Shipping Containers and Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure, possibly representing the department's focus on health and human well-being. The figure is composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2014
Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Incorporated 200 Homer Avenue Ashland, Massachusetts 01721
Re: K141676
Trade/Device Name: Renovis Surgical Porous Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: September 30, 2014 Received: October 3, 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
1
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 forth in the quality systems (OS) 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/Resourcesfor You/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 yours,
Lori A. Wiggins -S
for 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) K141676
Device Name
Renovis Surgical Porous Acetabular Cup System
Indications for Use (Describe)
The Renovis Surgical Hip Replacement System is indicated for patients suffering from:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
-
Correction of functional deformity;
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques; and
-
Revision procedures where other treatment or devices have failed.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K141676
- 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 prepared: September 25, 2014
- B) Device Name: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
- Common Name: Total Hip Arthroplasty - Acetabular Components
- Proprietary Name: Renovis Surgical Porous Acetabular Cup System
- Device Class: Class II
- Regulation number: 21 CFR 888.3358
- Regulation name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
- Product code: LPH
- Classification panel: Orthopedic
- C) Predicates:
| K112897 | Renovis A400 Surgical Hip Joint Replacement System (acetabular shells) |
|---|---|
| K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System |
| K974093 | Encore Orthopedics Foundation Porous Coated Hemispherical |
| Acetabular Cup |
4
D) Device Description:
The Renovis Porous Acetabular Cup System ("Porous shell") are titanium, hemispherical cups consisting of varying sizes (outer diameter of 44 - 66 mm) and screw hole options (no hole shell and cluster hole shells) to accommodate patient anatomy and/or surgical technique. Instrumentation is provided with the system.
The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.
The Renovis Surgical Porous Cup System complies with the following material standards:
- o ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or
- ASTM F620-11 Standard Specification for Titanium Alloy Forgings for Surgical ● Implants in the Alpha Plus Beta Condition
- ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant ● Applications (UNS R50250, UNS R50400, UNS R50550 and UNS R50700)
- ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-● Hardening Stainless Steel Bars and Shapes
- E) Indications For Use:
The Renovis Surgical Hip Replacement System is indicated for patients suffering from:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- Rheumatoid arthritis;
-
- Correction of functional deformity;
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
-
- Revision procedures where other treatment or devices have failed.
- F) Substantial Equivalence Comparison and Discussion
The Renovis Surgical Porous Acetabular Cup System has similar Indications for Use, operating principle and basic design, sizes and geometries, biocompatible materials, and is offered gamma sterilized, like the predicate devices. The manufacturing processes used for the outer coating differ between the Renovis Surgical Porous Acetabular Cup System and two of the predicate devices. The Renovis Surgical Porous Acetabular Cup System meets the coating characterization criteria in 21 CFR 888.3358, and expected performance testing. The Renovis Surgical Porous Acetabular Cup System is substantially equivalent to the predicate devices.
5
- G) Performance Testing Bench
Performance testing was successfully completed.
The Renovis Surgical Porous Acetabular Cup System complies with:
- 21 CFR 888.3358 ●
- 0 FDA "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", April 8, 1994
- ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings ● on Medical Implants
- o ASTM F1472-08e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
- ASTM F1044-05 (2011) Standard Test Method for Shear Testing of Calcium Phosphate o Coatings and Metallic Coatings
- ASTM F1147-05 (2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1820-97:2009 Standard Test Method for Determining the Forces for ● Disassembly of Modular Acetabular Devices
Sterilization, shelf life, packaging and shipping validation studies have been conducted. The Renovis Surgical Porous Acetabular Cup System complies with:
- o ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- ASTM F1980-07 (reapproved 2011) Standard Guide for Accelerated Aging of Sterile ● Barrier Systems for Medical Devices
- ISO 11607-2:2009: Packaging for terminally sterilized medical devices Part 2: ● Validation requirements for forming, sealing and assembly processes
- ISTA 2A Partial Simulation Performance Tests; Packaged-Products weighing 150 lb (68 kg) or Less
- ASTM D4169-09: Standard Practice for Performance Testing of Shipping Containers and Systems
Conclusion
Renovis Surgical Porous Acetabular Cup System is substantially equivalent to the predicate devices, and does not raise new issues of safety or effectiveness.
- H) Other Standards
- o 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