(106 days)
No
The description focuses on a manual instrument system and software for preoperative planning based on prescribed lengths and heights, without mentioning AI or ML algorithms for analysis or decision-making.
No
The device is an instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid for total shoulder systems; it does not directly treat or mitigate a disease or condition.
No
The device is an instrument system used for preoperative planning and intraoperative placement of a guide pin during shoulder surgery, not for diagnosing a condition.
No
The device description explicitly mentions "reusable instrument" and "SmartBase is a reusable instrument," indicating the presence of physical hardware components. While software (OrthoVis) is used for planning, the device itself includes hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin". This describes a surgical instrument used during a procedure to guide the placement of another device (a guide pin).
- Device Description: The description details a reusable instrument ("SmartBase") used to set the dimensions of another instrument ("IRI device") based on preoperative planning. This is a mechanical tool for surgical guidance.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Measuring biomarkers
The device is a surgical instrument designed to aid in the accurate placement of a guide pin during shoulder surgery, based on pre-operative planning. This falls under the category of surgical tools and not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
Product codes
KWS, PHX
Device Description
The SmartBase is a reusable instrument that allows the IRI device from the Arthrex Glenoid IRIS system (K151500) to be set according to prescribed lengths and heights for a specific patient's glenoid anatomy. The IRI leg lengths and their respective heights are determined in the OrthoVis software which is a part of the Arthrex Glenoid IRIS system. Along with the IRI leg lengths for each IRI slot and their respective heights, images of where the IRI was planned to sit on the patient's glenoid for the prescribed leg lengths and heights are given.
Loading the IRI device according to the prescribed lengths, setting the height of each IRI leg according to the prescribed SmartBase ruler heights, and then placing the IRI on the glenoid according to the preoperative plan images allows the IRI to transfer the guide pin for the surgeon-approved, preoperatively-planned glenoid implant trajectory to the patient in the OR. It provides the same function as the SmartBone (setting the IRI device), which was previously cleared in the predicate, K151500.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, OR
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)
Non-Clinical Testing:
- SmartBase vs. SmartBone End Result Comparison Study
- Sterilization/Cleaning Validation of the SmartBase device in the modified Arthrex Glenoid IRIS tray
Key results: Results of the SmartBase vs. SmartBone study found that there is no significant difference between using the SmartBase or the SmartBone-Pin Trajectory instrument in placing the glenoid guide pin. Results also found that there was no significant error in achieving the planned IRI leg heights with the SmartBase device.
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
§ 888.3660 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/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Custom Orthopaedic Solutions, Incorporated Mr. Keith Grafmever Project Manager 10000 Cedar Avenue Cleveland, Ohio 44106
February 19, 2016
Re: K153215
Trade/Device Name: SmartBase for Arthrex Glenoid IRIS Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, PHX Dated: January 29, 2016 Received: February 2, 2016
Dear Mr. Grafmeyer:
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 Parts 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" (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,
Mark N. Melkerson -S
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) K153215
Device Name SmartBase for Arthrex Glenoid IRIS
Indications for Use (Describe)
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS 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) |
|---|
| ------------------------------------------------- |
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."
3
510(k) Summary
| 510(k) SPONSOR / MANUFACTURER: Custom Orthopaedic Solutions, Inc. | |
|---|---|
| A subsidiary of Cleveland Clinic | |
| 10000 Cedar Avenue | |
| Cleveland, Ohio 44106 |
| CONTACT PERSON: | Keith Grafmeyer |
|---|---|
| Project Manager | |
| Custom Orthopaedic Solutions | |
| 10000 Cedar Avenue | |
| Cleveland, OH 44106 | |
| Tel: (216) 445-3403 | |
| Email: kgrafmeyer@customorthopaedics.com |
TRADE NAME: SmartBase for Arthrex Glenoid IRIS
COMMON NAMES:
Total shoulder replacement instruments
| Product | Product Code | Regulation and
Classification
Name | Device Class |
|-------------------------------|--------------|--------------------------------------------------------------------------------|--------------|
| SmartBase for
Glenoid IRIS | KWS, PHX | 21 CFR 888.3660
Shoulder, semi-
constrained metal /
polymer, cemented | II |
PREDICATE DEVICES:
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (K151500)
DEVICE DESCRIPTION:
The SmartBase is a reusable instrument that allows the IRI device from the Arthrex Glenoid IRIS system (K151500) to be set according to prescribed lengths and heights for a specific patient's glenoid anatomy. The IRI leg lengths and their respective heights are determined in the OrthoVis software which is a part of the Arthrex Glenoid IRIS system. Along with the IRI leg lengths for each IRI slot and their respective heights, images of where the IRI was planned to sit on the patient's glenoid for the prescribed leg lengths and heights are given.
Loading the IRI device according to the prescribed lengths, setting the height of each IRI leg according to the prescribed SmartBase ruler heights, and then placing the IRI on the glenoid according to the preoperative plan images allows the IRI to transfer the guide pin
4
for the surgeon-approved, preoperatively-planned glenoid implant trajectory to the patient in the OR. It provides the same function as the SmartBone (setting the IRI device), which was previously cleared in the predicate, K151500.
INTENDED USE AND INDICATIONS:
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II or Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component.
The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The SmartBase instrument for the Arthrex Glenoid IRIS system is substantially equivalent to the SmartBone-Pin Trajectory instrument in the Arthrex Glenoid IRIS system (K151500) in terms of intended use, function, biocompatibility, sterility, safety, and effectiveness/performance.
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the SmartBase instrument to the SmartBone-Pin Trajectory instrument of the predicate device in K151500.
- SmartBase vs. SmartBone End Result Comparison Study ●
- Sterilization/Cleaning Validation of the SmartBase device in the modified Arthrex Glenoid IRIS tray
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between the SmartBase and the SmartBone instrument (K151500).
SmartBase vs. SmartBone Comparison Study
Results of the SmartBase vs. SmartBone study found that there is no significant difference between using the SmartBase or the SmartBone-Pin Trajectory instrument in placing the glenoid guide pin. Results also found that there was no significant error in achieving the planned IRI leg heights with the SmartBase device.
Biocompatibility
5
The SmartBase device is made of an anodized aluminum base, passivated 316 stainless steel SmartBase Rulers and Central Pillar. The IRI Device only contacts the SmartBase at the rulers and central pillar. The 316 stainless steel used in the rulers and central pillar is in conformance with ISO 16061: Instrumentation for use in association with non-active surgical implants - General requirements. Brass thumb screws are used for locking the SmartBase rulers in place and do not come in contact with the IRI device.
The portions of the SmartBase device that contact the IRI and hence have a potential to indirectly contact the patient are all 316 stainless steel. According to the FDA's Guidance on the Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", the subject device (SmartBase) does not require further biocompatibility testing because the parts that may indirectly contact the patient are composed of a commonly used biocompatible alloy: 316 stainless steel. Therefore, there is no change in biocompatibility between the subject (SmartBase) and predicate (SmartBone) device.
Cleaning/Sterilization Validation
The Arthrex Glenoid IRIS Instrument Tray was modified to allow additional brackets to hold the disassembled SmartBase rulers, brass thumb screws, and central pillar. The core of the SmartBase was designed to sit in the same bracket as the SmartBone.
Cleaning and Sterilization Validation was performed on the SmartBase device in a fully loaded Arthrex Glenoid IRIS Instrument tray.