(124 days)
No
The summary describes a manual instrument system for surgical planning and guide pin placement, focusing on material and design modifications from a predicate device. There is no mention of AI or ML in the intended use, device description, or performance studies. The term "Intelligent" in the device name appears to refer to its function in guiding the surgeon, not the use of AI/ML.
No
Explanation: The device is an instrument system intended to facilitate preoperative planning and intraoperative placement of a guide pin for preparing the glenoid for implant reception. It does not treat or prevent a disease, but rather aids in a surgical procedure.
No
The Glenoid IRIS is an instrument system intended for surgical planning and placement of a central glenoid guide pin during total shoulder replacement surgery. It is a surgical tool, not a device used to render a medical diagnosis.
No
The device description explicitly details physical components made of stainless steel and photopolymer, including instruments, legs, mounts, and a case/tray carrier. These are hardware components, not software.
Based on the provided text, the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Glenoid IRIS is a surgical instrument system used during surgery to assist in the placement of a guide pin for glenoid implants. It interacts directly with the patient's anatomy during a surgical procedure, not with a specimen in vitro (outside the body).
- The intended use and device description clearly describe a surgical instrument system. The text focuses on facilitating preoperative planning and intraoperative placement of a guide pin, and the components are described as reusable surgical instruments and a tray/carrier.
- There is no mention of analyzing biological specimens. The device description and performance studies relate to the accuracy of guide pin placement in a simulated surgical setting.
Therefore, the Glenoid IRIS falls under the category of a surgical instrument or system, not an In Vitro Diagnostic device.
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 indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemi-shoulder replacement. The Indications for Use of these DePuy shoulder systems are:
DePuy Global AP™ Shoulder System and Global StepTech™ Anchor Peg Glenoid
The DePuy Global AP™ Shoulder System and Global StepTech™ Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from:
- A severely painful and/or disabled joint resulting from osteoarthritis, ● traumatic arthritis or rheumatoid arthritis.
- . Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience dictates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder surgery arthrodesis or . resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Global AP™ Glenoid and StepTech™ glenoid components are indicated only for use with bone cement.
DePuy Delta Xtend™ Reverse Shoulder System
- . The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.
- The Delta Xtend™ Reverse Shoulder prosthesis is indicated for use in a grossly ● efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
- . The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
Product codes
KWS, PHX
Device Description
The Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K123122, except for the following modifications:
-
In K123122, the IRI legs were plastic, single use, and were shipped sterile in quantities of 2 of each recommended leg length. In this submission, the IRI legs are stainless steel, reusable, and are shipped non-sterile in the Glenoid IRIS instrument tray/carrier/kit for steam sterilization prior to use at the hospital where the procedure will be taking place. Each Glenoid IRIS kit contains a full set of reusable IRI legs.
-
The SmartBone instruments (SmartBone-Pin Trajectory, SmartBone-Reamed, SmartBone-Fixation Feature Prep, and SmartBone-Implant) are made of a different photopolymer from K123122.
-The SmartBone instruments are shipped non-sterile and are sterilized on-site where the procedure will be taking place.
-The IRI wrench was removed from the Glenoid IRIS system and the IRI cap was modified to facilitate tightening and loosening the IRI instrument by hand. The Glenoid IRIS instrument tray was made to include a slot that could be used to replace the disassembly feature of the nubs on the IRI wrench.
-The SmartBone—Pin Trajectory instrument is pre-marked where the recommended IRI legs contact the SmartBone instrument. The marker is a non-toxic marker that is compatible with steam, EO & Sterrad Sterilization. We performed testing to determine how great the risk of the marking from the marker bleeding and or transferring when wiped with a polar and non-polar solvent. The study indicated that the marker was compatible with steam sterilization and did not undergo bleeding. Likewise, the marker did not transfer to a white rag when rubbed with a polar or non-polar solvent.
-The SmartBone mount is made of stainless-steel, is reusable, and is shipped nonsterile as part of the Glenoid IRIS system in a kit/carrier. When the SmartBone is placed on the SmartBone mount, the glenoid is positioned such that vertical is the plane of the scapula. When the SmartBone is set on its base without the SmartBone Mount, the guide pin hole is vertical for ease in setting the IRI.
-The Glenoid IRIS system includes a case/tray carrier for ease in shipping, storing, carrying, and organizing the Glenoid IRI device, the Glenoid IRI legs, the SmartBone instrument (or a place to put the SmartBone instrument, when it arrives after having been shipped separately), and the SmartBone Mount.
-Minor dimensional and aesthetic marking changes to the IRI components
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder/Glenoid
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)
Non-Clinical Testing:
- Drawings comparison (see list of changes in Device Description above)
- Biocompatibility testing of new photopolymer printed SmartBones
- Shipping/Distribution Testing of new photopolymer printed/packaged SmartBones
- Artificial Cadaver Surgeon Evaluation (Validation)
Biocompatibility: Testing was performed on steam sterilized samples of the SmartBones in the new photopolymer for cytotoxicity and intracutaneous irritation and sensitization. All tests passed, indicating that the new photopolymer is biocompatible and the modification to the SmartBone material is still substantially equivalent to the original Glenoid IRIS (K123122). The change in IRI leg material from acetal copolymer to stainless steel is in conformance with ISO 16061 and does not alter biocompatibility.
Shipping Distribution Testing of New Photopolymer Printed/Packaged SmartBones: The new SmartBone material with packaged SmartBones was tested in temperature extremes of 140°F and -112°F for 120 hours. The material successfully passed the shipping/distribution temperature tests and drop testing, remaining substantially equivalent to the original Glenoid IRIS submission (K123122).
Artificial Cadaver Surgeon Evaluation: A simulated use, artificial cadaver comparison test was performed between the original and modified Glenoid IRIS. Both versions were used five times on an artificial training cadaver of a patient with severe glenoid retroversion. The mean version and inclination of both systems were compared to each other and to the deviation from the planned guide pin location. The modified Glenoid IRIS was shown to be substantially equivalent in performance to the original Glenoid IRIS (K123122).
Clinical Testing: Not necessary to determine substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Glenoid Intelligent Reusable Instrument System (Glenoid IRIS)(K123122)
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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three human profiles in silhouette.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2014
Custom Orthopaedic Solutions, Incorporated Justin Baker, Ph.D. Regulatory and Quality Manager 10000 Cedar Avenue Cleveland, Ohio 44106
Re: K142072
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. PHX Dated: October 21, 2014 Received: October 27, 2014
Dear Dr. Baker:
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 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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142072
Device Name
Glenoid Intelligent Reusable Instrument System (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 Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Global AP Shoulder glenoid component, Global Shoulder StepTech Anchor Peg glenoid component, or Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems.
The indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemishoulder replacement. The Indications for Use of these DePuy shoulder systems are:
DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid
The DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from:
· A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis.
· Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience dictates that alternative methods of treatment are unsatisfactory.
· Other difficult clinical problems where shoulder surgery arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Global AP Glenoid and StepTech glenoid components are indicated only for use with bone cement.
DePuy Delta Xtend Reverse Shoulder System
· The Delta Xtend Reverse Shoulder prosthesis is intended for use as total shoulder replacement.
· The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
· In cases of bone defects in the proximal humerus, the monoblock implant should be used and then only in cases where the residual bone permits firm fixation of this implant.
· Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.
· The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.
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)
3
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4
510(k) Summary
| 510(k) SPONSOR / MANUFACTURER: | Custom Orthopaedic Solutions, Inc.
A subsidiary of Cleveland Clinic
10000 Cedar Avenue
Cleveland, Ohio 44106 |
| -------------------------------- | ----------------------------------------------------------------------------------------------------------------------- |
|---|
| CONTACT PERSON: | Justin J. Baker, PhD, RAC
Regulatory & Quality Manager
Custom Orthopaedic Solutions
10000 Cedar Avenue
Cleveland, OH 44106
Tel: (216) 445-2164
Email: jbaker@customorthopaedics.com |
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
DATE PREPARED: November 22, 2014
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 Intelligent
Reusable
Instrument System
(Glenoid IRIS) | KWS, PHX | 21 CFR 888.3660
Shoulder, semi-
constrained metal /
polymer, cemented | II |
PREDICATE DEVICES:
Glenoid Intelligent Reusable Instrument System (Glenoid IRIS)(K123122)
DEVICE DESCRIPTION:
The Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoid IRIS cleared in K123122, except for the following modifications:
- In K123122, the IRI legs were plastic, single use, and were shipped sterile in quantities of 2 of each recommended leg length. In this submission, the IRI legs are stainless steel, reusable, and are shipped non-sterile in the Glenoid IRIS instrument
5
tray/carrier/kit for steam sterilization prior to use at the hospital where the procedure will be taking place. Each Glenoid IRIS kit contains a full set of reusable IRI legs.
- The SmartBone instruments (SmartBone-Pin Trajectory, SmartBone-Reamed, SmartBone-Fixation Feature Prep, and SmartBone-Implant) are made of a different photopolymer from K123122.
-The SmartBone instruments are shipped non-sterile and are sterilized on-site where the procedure will be taking place.
-The IRI wrench was removed from the Glenoid IRIS system and the IRI cap was modified to facilitate tightening and loosening the IRI instrument by hand. The Glenoid IRIS instrument tray was made to include a slot that could be used to replace the disassembly feature of the nubs on the IRI wrench.
-The SmartBone—Pin Trajectory instrument is pre-marked where the recommended IRI legs contact the SmartBone instrument. The marker is a non-toxic marker that is compatible with steam, EO & Sterrad Sterilization. We performed testing to determine how great the risk of the marking from the marker bleeding and or transferring when wiped with a polar and non-polar solvent. The study indicated that the marker was compatible with steam sterilization and did not undergo bleeding. Likewise, the marker did not transfer to a white rag when rubbed with a polar or non-polar solvent.
-The SmartBone mount is made of stainless-steel, is reusable, and is shipped nonsterile as part of the Glenoid IRIS system in a kit/carrier. When the SmartBone is placed on the SmartBone mount, the glenoid is positioned such that vertical is the plane of the scapula. When the SmartBone is set on its base without the SmartBone Mount, the guide pin hole is vertical for ease in setting the IRI.
-The Glenoid IRIS system includes a case/tray carrier for ease in shipping, storing, carrying, and organizing the Glenoid IRI device, the Glenoid IRI legs, the SmartBone instrument (or a place to put the SmartBone instrument, when it arrives after having been shipped separately), and the SmartBone Mount.
-Minor dimensional and aesthetic marking changes to the IRI components
INTENDED USE AND INDICATIONS:
The intended use and indications for use of the modified Glenoid Intelligent Reusable Instrument System remain unchanged from that cleared in K123122.
6
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 indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemi-shoulder replacement. The Indications for Use of these DePuy shoulder systems are:
DePuy Global APTM Shoulder System and Global StepTech™ Anchor Peg Glenoid
The DePuy Global AP™ Shoulder System and Global StepTech™ Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from:
- A severely painful and/or disabled joint resulting from osteoarthritis, ● traumatic arthritis or rheumatoid arthritis.
- . Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience dictates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder surgery arthrodesis or . resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
The Global AP™ Glenoid and StepTech™ glenoid components are indicated only for use with bone cement.
DePuy Delta Xtend™ Reverse Shoulder System
- . The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.
- The Delta Xtend™ Reverse Shoulder prosthesis is indicated for use in a grossly ● efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
- . The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
7
- In cases of bone defects in the proximal humerus, the monoblock implant should be used and then only in cases where the residual bone permits firm fixation of this implant.
- Delta Xtend™ hemi-shoulder replacement is also indicated for hemi-arthroplasty . if the glenoid is fractured intraoperatively.
- The metaglene component is HA coated and is intended for cementless use with . the addition of screws for fixation. All other components are for cemented use only.
| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | Over-The-Counter Use | |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (21 CFR 801 Subpart C) |
BASIS OF SUBSTANTIAL EQUIVALENCE:
The modified Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is substantially equivalent to the Glenoid Intelligent Reusable Instrument System described in K123122 as it is the same system with minor dimensional modifications, modifications to whether the product is reusable and shipped sterile, and modifications to the material from which the instruments are manufactured. The convenience of a system carrier/kit/tray has been included as a part of the Glenoid IRIS system in this submission. The IRI wrench has been removed from the modified system. The modified Glenoid Intelligent Reusable Instrument System functions in the same way as the original Glenoid IRIS. The indications for use for the Glenoid Intelligent Reusable System with these modifications have not changed from K123122.
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the Glenoid IRIS to the predicate device in K123122.
- Drawings comparison (see list of changes in Device Description above) ●
- Biocompatibility testing of new photopolymer printed SmartBones ●
- Shipping/Distribution Testing of new photopolymer printed/packaged . SmartBones
- Artificial Cadaver Surgeon Evaluation (Validation)
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between the modified Glenoid IRIS and the predicate Glenoid IRIS (K123122).
Drawings Comparison
Changes in the IRI drawings were minor and are listed in the Device Description above.
Biocompatibility
As the SmartBone models are considered an external communicating device that contacts
8
bone/tissue/dentin for a limited duration, cytotoxicity and intracutaneous irritation and sensitization testing was performed. Testing was performed on steam sterilized samples of the SmartBones in the new photopolymer. All tests passed, indicating that the new photopolymer is biocompatible. The original Glenoid IRIS submission likewise used biocompatible materials, and so this modification in the SmartBone material is still substantially equivalent to the original Glenoid IRIS (K123122).
The modified Glenoid IRIS changes the IRI legs from a biocompatible acetal copolymer to a stainless steel that is in conformance with ISO 16061: Instrumentation for use in association with non-active surgical implants - General requirements. In this regard, the change in IRI leg material does not alter the biocompatibility of the modified Glenoid IRIS and the original and modified Glenoid IRIS systems remain substantially equivalent.
Shipping Distribution Testing of New Photopolymer Printed/Packaged SmartBones
The original Glenoid IRIS (K123122) tested packaged SmartBones at temperature extremes of 140°F and -20°F for 48 hours. The modified Glenoid IRIS tested the new SmartBone material with packaged SmartBones in temperature extremes of 140°F and -112°F for 120 hours. The new SmartBone material successfully passed the shipping/distribution temperature tests and drop testing, and in this regard despite the SmartBone material change, remains substantially equivalent to the original Glenoid IRIS submission (K123122).
Artificial Cadaver Surgeon Evaluation
A simulated use, artificial cadaver comparison test between the original and modified Glenoid IRIS was performed. The original Glenoid IRIS was used on an artificial training cadaver of a patient with severe glenoid retroversion five times. The modified Glenoid IRIS was also used on this same patient five times. The mean version and inclination of the original and modified Glenoid IRIS was compared between each other and to the amount of deviation from the planned guide pin location. The modified Glenoid IRIS was shown to be substantially equivalent in performance to the original Glenoid IRIS (K123122).