(120 days)
No
The summary describes software for pre-operative planning and hardware for transferring the plan, but there is no mention of AI or ML algorithms being used in the planning or guidance process. The focus is on using radiological images and anatomical landmarks for planning and physical jigs/models for transfer.
No.
The device is a surgical instrument used for pre-operative planning and intra-operative guiding of surgical instruments, not for directly treating a disease or condition.
No
The device is intended for surgical planning and guiding, not for diagnosing a condition or disease.
No
The device description explicitly states that the CAS PSI Shoulder consists of both software and hardware components. The hardware components (jigs and bone model) are described as being made from biocompatible polyamide and stainless steel, and their function in transferring the pre-operative plan is detailed.
Based on the provided information, the CAS PSI Shoulder 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CAS PSI Shoulder's Intended Use: The CAS PSI Shoulder is intended to be used as a surgical instrument to assist in pre-operative planning and intra-operative guiding of surgical instruments for shoulder replacement procedures. It uses patient-specific radiological images, which are in vivo (within the living body) data, not in vitro specimens.
- Device Description: The device consists of software and hardware (jigs and bone model) designed to aid in surgical procedures and implant placement. This aligns with surgical planning and guidance tools, not diagnostic testing of biological samples.
Therefore, the CAS PSI Shoulder falls under the category of surgical planning and guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CAS PSI Shoulder is intended to be used as a surgical instrument to construct and transfer a pre-surgical plan to orthopaedic surgical procedures. The CAS PSI Shoulder is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned. The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications. The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.
Product codes
KWS, PBF
Device Description
The CAS PSI Shoulder consists of both software and hardware components and requires the patient to be radiologically scanned.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiological images
Anatomical Site
Shoulder
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
Non-Clinical Performance Studies Conducted:
-
- Simulated Use Testing
-
- Cadaveric Testing
-
- Biocompatibility Rationale
-
- Sterilization Rationale
-
- Dimensional Stability Testing
-
- Drop Testing
-
- Software Verification and Validation
Non-clinical testing demonstrated that the CAS PSI Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy. In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.
- Software Verification and Validation
Key Metrics
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/0 description: The image shows a logo with the letter 'Z' inside of a circle. The letter 'Z' is bold and black, and the circle is a thin black line. Below the circle is the word 'zimmer' in a lowercase, sans-serif font. The word 'zimmer' is also black.
Applicant:
Contact Person:
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
AUG 2 0 2013
510(k) Summary
Christopher McLean Zimmer CAS 75 Queen Street, Suite 3300 Montreal, Canada, Quebec H3C 2N6
Jason Heckaman Zimmer, Inc. 1800 West Center Street Warsaw, IN 46580 Telephone: (574) 371-8675 Fax: (574) 372-4605
Patient Specific Instruments
20 August 2013
CAS PSI Shoulder
Date:
Trade Name:
Common Name:
Product Code / Device:
Classification Name:
Predicate Devices:
KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PBF - Orthopaedic Surgical Planning and Instrument Guides
21 CFR § 888.3660 - Shoulder joint metal/polymer semiconstrained cemented prosthesis
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, manufactured by Materialise N.V. and cleared under K112389 on 20 July 2012. Zimmer Patient Specific Instruments System 5.0, manufactured by Materialise N.V. and cleared under K121640 on 5 Dec 2012. Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), manufactured by Custom Orthopaedic Solutions, Inc. and cleared under K123122 on 5 April 2013.
.
1
The CAS PSI Shoulder consists of both software and Device Description: hardware components and requires the patient to be radiologically scanned. Device Function, Scientific Concepts, Design Features and Physical Properties that form the Basis for the Device: The CAS PSI Shoulder has been developed with the fundamental goals to assist in pre-operative planning (using the CAS PSI Shoulder Software) and to accurately construct and transfer a pre-operative plan to orthopedic surgical procedures (using the CAS PSI Shoulder Hardware). The hardware (jigs and bone model) have features designed to mate with legally marketed instruments to aid in the implantation of legally marketed Class II implant devices. Significant Physical Characteristics: Device Design: The hardware components are designed to mate with legally marketed instruments and thus indirectly aid in the placement of legally marketed implants. Materials Used: The software is developed in C++ programming language for a windows operating system. The hardware (jigs and bone guide) are made from biocompatible polyamide (Duraform) with press-fit 304 and 17-4 Stainless Steel components. Comparison to the Predicate: The subject and predicate devices have similar indications for use and are all intended to aid (either directly or indirectly ) in the placement of Class II orthopedic devices. The subject and predicate devices have the same intended use, functioning, patient-specific template design, and use a selective laser sintering manufacturing process for hardware components. Intended Use: The CAS PSI Shoulder is intended to be used as a surgical instrument to construct and transfer a pre-surgical plan to orthopaedic surgical procedures. The CAS PSI Shoulder is indicated, based on patient-Indications for Use: specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned.
2
The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.
The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.
Performance Data:
Non-Clinical Performance Studies Conducted:
-
- Simulated Use Testing
-
- Cadaveric Testing
-
- Biocompatibility Rationale
-
- Sterilization Rationale
-
- Dimensional Stability Testing
-
- Drop Testing
-
- Software Verification and Validation
Non-Clinical Performance Testing Conclusions: Non-clinical testing demonstrated that the CAS PSI Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.
In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
Zimmer CAS % Mr. Jason Heckaman Manager, Regulatory Affairs Zimmer, Incorporated 1800 West Center Street Warsaw, Indiana 46580
Re: K131129
Trade/Device Name: CAS PSI Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, PBF Dated: July 19, 2013 Received: July 22, 2013
Dear Mr. Heckaman:
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. Drue, 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 (reporting of medical
4
Page 2 - Mr. Jason Heckaman
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Laurence D. Coyne -S
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
CAS PSI Shoulder
Indications for Use:
The CAS PSI Shoulder is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intraoperative guiding of surgical instruments for shoulder replacement surgical procedures on patients not otherwise precluded from being radiologically scanned.
The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.
The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/14 description: The image shows the text "Casey L. Hanley, Ph.D" on the top line and "Division of Orthopedic Devices" on the second line. There is a horizontal line separating the two lines of text. The text is black and the background is white.
(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K131129
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