(244 days)
No
The document describes manual instruments, reamers, and software for preoperative planning and image transfer. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation follows standard guidance for medical device software, not specific AI/ML validation protocols.
No
The device is a manual instrument system (VIP Glenoid Targeter, VIP Glenoid Reamer) and associated software (OrthoVis preoperative plan, VIP Web portal) intended to facilitate preoperative planning and intraoperative placement of glenoid components in total shoulder replacement. It is a surgical tool, not a device that provides therapy or treatment itself.
No
The device, described as the VIP Glenoid Targeter, VIP Glenoid Reamer, OrthoVis preoperative plan, and VIP Web portal, is intended for facilitating preoperative planning and intraoperative placement of instruments and implants in total shoulder systems. While it uses imaging information (from CT) and assists in planning, its primary function is to guide surgical procedures and prepare the anatomical site, not to diagnose a medical condition or disease.
No
The device description explicitly states that the subject VIP glenoid reamers are made of stainless-steel, indicating a hardware component. While software (OrthoVis and VIP Web portal) is mentioned for planning and data transfer, the overall system includes physical instruments.
Based on the provided text, the device described is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states the device is a manual instrument system (VIP Glenoid Targeter and Reamer) and software (OrthoVis preoperative plan, VIP Web portal) used for preoperative planning and intraoperative placement of a surgical guide pin and reaming the glenoid bone during total shoulder replacement surgery.
- The device interacts directly with the patient's anatomy (glenoid bone) during surgery. IVDs are used to test samples outside of the body.
- The intended use is to facilitate a surgical procedure. The purpose is to aid in the accurate placement of implants, not to diagnose a condition or monitor a patient's health status through analysis of biological samples.
The device is a surgical instrument system and associated software used in orthopedic surgery.
N/A
Intended Use / Indications for Use
The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems.
The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
The VIP Web portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians.
The VIP Web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following glenoid implant lines: Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
Product codes
QHE, KWS, PHX, LLZ
Device Description
The subject VIP glenoid reamers are made of stainless-steel. The subject device is designed for use with the Univers VaultLock glenoid and Univers Revers MGS baseplates. These glenoid components are within the indications cleared for Arthrex VIP System under K162697 and K193523. The subject VIP glenoid reamers consist of a primary reamer (pilot) and a secondary reamer (glenoid-implant specific: Univers VaultLock [with/without augment] or Univers Revers MGS [with/without augment]). The reaming depth settings for the subject devices is provided with the surgeon approved plan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
Glenoid (shoulder)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Arthrex technicians, surgeon
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)
Design verification (compression testing and side-by-side testing) and cadaver validation were performed. Compression testing was conducted to assess the function of the depth control features of the VIP glenoid reamers. Side-by-side testing with the standard reaming method was conducted to assess the primary reaming depth control accuracy of the VIP Reaming Instrumentation System.
Cadaveric validation was performed to validate the related user needs, intended use, safety and effectiveness of the subject VIP glenoid instrumentation.
Software verification and validation testing of the Arthrex VIP Web Portal software and Arthrex OrthoVis Desktop software were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered as a "major" level of concern. Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2023
Arthrex Inc. Ivette Galmez Regulatory Affairs Prinicipal Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K222007
Trade/Device Name: Arthrex Virtual Implant Positioning (VIP) System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWS, PHX, LLZ Dated: February 9, 2023 Received: February 10, 2023
Dear Ivette Galmez:
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. Although this letter refers to your product as a device, please be aware 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2023.03.08
12:24:11-05'00'
For Jiping Chen, MD, Ph.D., M.P.H. Division Director DHT6A:Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Arthrex Virtual Implant Positioning (VIP) System - VIP Glenoid Instrumentation
Indications for Use (Describe)
The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaulfLock® glenoid component. as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems.
| 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
Indications for Use
510(k) Number (if known)
K22007
Device Name
Arthrex Virtual Implant Positioning (VIP) System - OrthoVis Preoperative Plan
Indications for Use (Describe)
The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
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."
4
Indications for Use
510(k) Number (if known)
K22007
Device Name
Arthrex Virtual Implant Positioning (VIP) System - VIP Web Portal
Indications for Use (Describe)
The VIP Web portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians.
The VIP Web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following glenoid implant lines: Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
| 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)
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."
5
510(k) Summary
| Date Prepared | March 7, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Regulatory Affairs Principal Specialist | |
| 1-239-643-5553, ext. 71263 | |
| ivette.galmez@arthrex.com | |
| Name of Device | Arthrex Virtual Implant Positioning (VIP) System |
| Common Name | Total shoulder replacement system/instruments, Preoperative planning software/plan, Preoperative |
| Planning Web software | |
| Product Code | QHE, KWS, PHX, LLZ |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | II |
| Primary Predicate | K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, |
| SmartBase for Arthrex Glenoid Iris, Arthrex VIP Web Portal | |
| Secondary Predicate | K212560: Signature™ ONE System |
| Reference Device | K193523: Arthrex VIP Web Portal |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the VIP glenoid |
| reamers as a line extension to the Arthrex VIP System cleared under K162697. This submission includes | |
| modifications to the VIP glenoid targeter (formerly glenoid IRI) which were previously documented via | |
| letter to file, and VIP software updates. | |
| Device Description | The subject VIP glenoid reamers are made of stainless-steel. The subject device is designed for use with |
| the Univers VaultLock glenoid and Univers Revers MGS baseplates. These glenoid components are | |
| within the indications cleared for Arthrex VIP System under K162697 and K193523. The subject VIP | |
| glenoid reamers consist of a primary reamer (pilot) and a secondary reamer (glenoid-implant specific: | |
| Univers VaultLock [with/without augment] or Univers Revers MGS [with/without augment]). The | |
| reaming depth settings for the subject devices is provided with the surgeon approved plan. | |
| Indications for Use | The VIP Glenoid Targeter is a manual instrument system intended to facilitate preoperative planning |
| and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in | |
| total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid | |
| implant. The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total | |
| shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, | |
| as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular | |
| glenoid system (MGS) baseplates. | |
| The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems | |
| that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid | |
| Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ | |
| modular glenoid system (MGS) baseplates. | |
| The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is | |
| intended to be used are the same as those described in the labeling for these shoulder systems. | |
| The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates | |
| accurate preoperative planning and intraoperative placement of the glenoid component in total | |
| shoulder replacement. | |
| The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder | |
| systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as | |
| the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid | |
| system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® | |
| glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates. | |
| The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is | |
| intended to be used are the same as those described in the labeling for these shoulder systems. | |
| Indications for Use | |
| (continue) | The VIP Web portal is intended for use as a software interface and for the transfer of imaging |
| information from a medical scanner such as a CT scanner. It is also intended as software for | |
| displaying/editing implant placement and surgical treatment options that were generated in the | |
| OrthoVis desktop software by trained Arthrex technicians. | |
| The VIP Web portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis | |
| preoperative plan. It is indicated for use with the following glenoid implant lines: Univers™ II and | |
| Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® | |
| glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and | |
| Univers Revers™ modular glenoid system (MGS) baseplates. | |
| Summary of | |
| Technological | |
| Characteristics | The subject VIP glenoid reamers, except for the secondary reamers for the augmented MGS, are |
| reusable instruments. All VIP glenoid reamers are made of stainless steel. The subject VIP reamers are | |
| used in conjunction with the VIP glenoid targeter instrument. The subject VIP reamers are used in place | |
| of the standard glenoid reaming instrumentation. The subject reamers are designed with depth control | |
| features having similar function to the disposable reaming guide instrumentation in Zimmer-Biomet | |
| Signature One system (K212560). The settings for the reaming depth are reviewed during preoperative | |
| planning and approved by the surgeon. The reaming depth settings for the subject devices is provided | |
| with the surgeon approved plan. | |
| The subject VIP glenoid instrumentation has the same fundamental scientific technology (transfer a pre- | |
| operative plan to the orthopedic surgical procedure) as the primary predicate (K162697) and secondary | |
| predicate (K212560). | |
| Performance Data | Design verification (compression testing and side-by-side testing) and cadaver validation were |
| performed. Compression testing was conducted to assess the function of the depth control features of | |
| the VIP glenoid reamers. Side-by-side testing with the standard reaming method was conducted to | |
| assess the primary reaming depth control accuracy of the VIP Reaming Instrumentation System. | |
| Cadaveric validation was performed to validate the related user needs, intended use, safety and | |
| effectiveness of the subject VIP glenoid instrumentation. | |
| Software verification and validation testing of the Arthrex VIP Web Portal software and Arthrex | |
| OrthoVis Desktop software were conducted and documentation was provided as recommended by | |
| FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for | |
| Software Contained in Medical Devices." The software was considered as a "major" level of concern. | |
| Activities included software validation/verification, regression testing, unit testing, code reviews and | |
| checks and integration testing. | |
| Conclusion | The subject devices are substantially equivalent to the predicates in which the basic design features, |
| technological characteristics, principles of operation and intended use and indications are similar or the | |
| same as the predicates. The verification and validation activities conducted for the subject VIP glenoid | |
| reamers demonstrates that it performs as intended for the desired indications. The subject VIP glenoid | |
| reamers, when used in conjunction with the Arthrex VIP System is substantially equivalent to the | |
| predicate. The addition of the subject VIP glenoid reamer, as well as the modifications to the VIP | |
| glenoid targeter and software updates do not raise new questions of safety or effectiveness. The | |
| overall planning process, materials, sterilization methods, principles of operation, have not changed | |
| from the predicates. Any differences with the predicate are considered minor and do not raise | |
| questions regarding safety or effectiveness. |
Based on the intended use and indications, technological characteristics, principle of operation and the
summary of data submitted, Arthrex Inc. has determined that the subject device is substantially
equivalent to the currently marketed predicate device. |
6