(183 days)
Not Found
No
The description focuses on manual instruments, CT data for preoperative planning, 3D modeling, and patient-specific instruments. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an instrument system used to facilitate the placement of a guide pin in shoulder surgery, not a device that directly treats a medical condition or disease.
No
The device is an instrument system for surgical planning and intraoperative guidance of a guide pin for glenoid implant placement, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of "two (2) manual instruments" and describes their use in a surgical procedure, indicating it includes physical hardware components. While it utilizes CT data and 3D modeling for planning, the core device is a system of physical instruments.
Based on the provided text, the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Glenoid IRIS Function: The Glenoid IRIS is a surgical instrument system used during surgery to facilitate the placement of a guide pin in the glenoid bone for total shoulder replacement. It uses pre-operative CT data for planning but its function is entirely focused on guiding a surgical procedure on the patient's body, not on analyzing specimens taken from the body.
- Intended Use: The intended use clearly states it's for "facilitate preoperative planning and intraoperative placement of the central glenoid guide pin". This is a surgical aid, not a diagnostic test.
- Device Description: The description details manual instruments used to transfer a pre-operative plan to the patient's anatomy during surgery.
Therefore, the Glenoid IRIS falls under the category of a surgical instrument or device, not an In Vitro Diagnostic.
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 Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty.
The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The Glenoid Intelligent Reusable Instrument System is composed of two (2) manual instruments intended for use to facilitate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. CT data and 3D modeling is used to provide preoperative planning of total shoulder glenoid component or reverse shoulder metaglene component orientation according to each patient's glenoid anatomy. The preoperatively planned and surgeon approved component orientation is subsequently transferred to the patient's glenoid during surgery by the use of a patient specific instrument and an adjustable instrument with patient specific settings. A patient specific Glenoid SmartBone - Pin Trajectory instrument is used to set the adjustable reusable instrument, the Glenoid Intelligent Reusable Instrument (Glenoid IRI), with the settings necessary to reflect the guide pin trajectory embedded in the Glenoid SmartBone. The Glenoid IRI is then used to guide the placement of the standard 2.5 mm pin (Steinmann pin) by the surgeon that is used in preparation of the glenoid for implantation of the glenoid component. All other steps of the surgical procedure are accomplished according to each system's standard surgical technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data
Anatomical Site
glenoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-Clinical Testing:
- Performance testing - verification and validation testing
- Performance testing - biocompatibility and toxicity (ISO 10993-10; USP Class VI)
- Performance testing - cadaver study
- Performance testing - sawbones study
- Performance testing - software validation
- Performance testing - packaging integrity testing
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Glenoid IRIS and the predicate devices.
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.
K060874, K981487, K092122, 062250
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
APR 0 5 2013
510(k) SPONSOR / MANUFACTURER:
Custom Orthopaedic Solutions, Inc. A subsidiary of Cleveland Clinic 10000 Cedar Avenue Cleveland, Ohio 44106
CONTACT PERSON:
Stephen J. Peoples, VMD, MS Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 Tele: (260) 645 - 0327 Email: SPeoplesVMD@gmail.com
TRADE NAME:
Glenoid Intelligent Reusable Instrument System (Glenoid IRIS)
COMMON NAMES:
Total shoulder replacement instruments
| Product | Product Code | Regulation and
Classification Name | Device Class |
|---------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------|--------------|
| Glenoid Reusable
Intelligent Instrument
System (Glenoid IRIS) | KWS | 21 CFR 888.3660
Shoulder, semi-
constrained metal /
polymer, cemented | II |
PREDICATE DEVICES:
DePuy Global Shoulder AP Shoulder System (K060874 DePuy Global Shoulder Glenoid (K981487) DePuy Global StepTech Anchor Peg Glenoid (K092122) DePuy Delta Xtend Reverse Shoulder System (062250)
DEVICE DESCRIPTION:
The Glenoid Intelligent Reusable Instrument System is composed of two (2) manual instruments intended for use to facilitate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. CT data and 3D modeling is used to provide preoperative planning of total shoulder glenoid component or reverse shoulder metaglene component orientation according to each patient's glenoid anatomy. The preoperatively planned and surgeon approved component orientation is subsequently transferred to the patient's glenoid during surgery by the use of a patient specific instrument and an adjustable instrument with patient specific settings. A patient specific Glenoid SmartBone - Pin Trajectory instrument is used to set the adjustable reusable instrument, the Glenoid Intelligent Reusable Instrument (Glenoid IRI), with the settings necessary to reflect the guide pin trajectory embedded in the Glenoid SmartBone. The Glenoid IRI is then used to guide the placement of the standard 2.5 mm pin (Steinmann pin) by the surgeon that is used in preparation of the glenoid for implantation of the glenoid component. All other steps of the surgical procedure are accomplished according to each system's standard surgical technique.
1
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 Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty.
The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is intended to be used as an alternative method and instrument system for placing the 2.5 mm glenoid guide pin that is used for preparing the glenoid for implantation with the DePuy Global AP Shoulder Glenoid component, the DePuy Global StepTech Anchor Peg Glenoid component, or the DePuy Delta Xtend Reverse Shoulder System metaglene component. The Glenoid IRIS replaces the standard instruments and techniques for the placement of the guide pin in these systems as described in each system's surgical technique. The Glenoid IRIS has the same intended use and indications for use and similar function, surgical technique, design." materials, and performance as the standard instruments used for placing the elenoid guide pin in these systems. All other surgical steps are completed according to the steps described in the surgical techniques for each system using the standard instruments supplied for each system. The indications for use of the DePuy shoulder systems, with which the Glenoid IRIS is intended to be used, are not changed by the Glenoid IRIS and remain the same as described in the labeling for these shoulder systems.
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the Glenoid IRIS to the predicate devices.
- . Performance testing - verification and validation testing
- . Performance testing - biocompatibility and toxicity (ISO 10993-10; USP Class VI)
- . Performance testing - cadaver study
- . Performance testing - sawbones study
- . Performance testing - software validation
- . Performance testing - packaging integrity testing
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between the Glenoid IRIS and the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Custom Orthopaedic Solutions, Inc. A subsidiary of Cleveland Clinic c/o Stephen J. Peoples, VMD, MS Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN, 46814
Letter dated: April 5, 2013
Re: K123122
Trade/Device Name: Glenoid Intelligent Reusable Instrument System (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 Dated: March 11, 2013 Received: March 14, 2013
Dear Dr. Peoples,
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 iddictions 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, Dr to 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 resustration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and in warranties. We remind you; however, that device labeling must be truthful and not misleding.
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
3
Page 2 - Mr. Stephen J. Peoples ·
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/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
4
Indications for Use Statement
510(k) Number (if known): K123122
Device Name: Glenoid Intelligent Reusable Instrument System
Intended Use and 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 glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.
The Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty.
The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
page 1 of 1
Elizabeth፣២៦Erank -S
Division of Orthopedic Devices
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