(90 days)
No
The summary describes a system for pre-operative planning and intra-operative guidance based on radiological images, but there is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on patient-specific images and manufactured guides, which is consistent with traditional image-guided surgery systems.
No.
The device is described as assisting in pre-operative planning and intra-operative guiding of surgical instruments, rather than directly treating a disease or condition. It is a surgical planning and guiding system, not a therapeutic intervention itself.
No
The Signature ONE System is indicated to assist in pre-operative planning and/or intra-operative guiding of surgical instruments, rather than to diagnose a condition. Its purpose is to aid surgical procedures, not to identify the presence or nature of a disease or condition.
No
The device description explicitly states that the system includes "Signature ONE Guides and Bone Model" which are physical components manufactured using additive manufacturing and used intraoperatively. This indicates the system is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Signature™ ONE System Function: The Signature™ ONE System is used for pre-operative planning and intra-operative guiding of surgical instruments for shoulder replacement surgery. It uses patient-specific radiological images to create physical guides and models that assist the surgeon during the procedure.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on surgical planning and execution based on imaging data.
Therefore, based on the provided information, the Signature™ ONE System falls under the category of a surgical planning and guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Signature™ ONE System 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 precluded from being radiologically scanned.
The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.
The Signature™ ONE Guides and bone models are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
QHE, KWT, KWS, PHX, MBF
Device Description
The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.
The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.
The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient-specific radiological images
Anatomical Site
Shoulder, glenoid component
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Hospital
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)
The following performance data was provided in support of the substantial equivalence determination:
Biocompatibility Testing: The biocompatibility evaluation for Signature™ ONE System was conducted in accordance with ISO 10993. The evaluation reveals that the Signature™ ONE System device meets biocompatibility requirements.
Sterilization and Shelf-Life: This analysis was conducted to ensure that the cleaning and sterilization instructions for the Signature™ ONE System parts respect the acceptable residual levels that should be achieved by the cleaning and sterilization method, as required by the applicable standards. Testing was also conducted to ensure the acceptance criteria was met of the guides keeping their dimensional integrity throughout their shelf life of 6 months.
Device Performance Testing: Verification and Validation Testing for Signature™ ONE System was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with the Signature™ ONE System
- Validation Lab- performed to validate that using the Signature™ ONE System is safe and effective and that the performances of the Signature™ ONE System are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing: Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor injury. The testing demonstrates that the Signature™ ONE System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
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.
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.
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
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
June 05, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthosoft, Inc (d/b/a Zimmer CAS) Paul Hardy Regulatory Affairs Senior Specialist 75 Queen Street Suite 3300 Montreal, QC, CANADA H3C 2N6
Re: K190595
Trade/Device Name: Signature™ ONE System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWT, KWS, PHX, MBF Dated: March 6, 2019 Received: March 7, 2019
Dear Paul Hardy:
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
1
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) 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 (QS) 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 medical devices and radiation-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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K190595
Device Name Signature™ ONE System
Indications for Use (Describe)
The Signature™ ONE System 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 precluded from being radiologically scanned.
The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.
The Signature™ ONE Guides and bone models are intended for single 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)
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3
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Signature™ ONE System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Orthosoft, Inc (d/b/a Zimmer CAS)
75 Queen St., Suite 3300
Montreal, QC, CANADA H3C 2N6
Establishment Registration Number: 9617840 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Hardy
Regulatory Affairs Sr. Specialist
Telephone: 574-372-6799 |
| Date: | June 5, 2019 |
| Subject Device: | Trade Name: Signature™ ONE System
Common Name: Shoulder Arthroplasty implantation
system |
| | Classification Name:
• QHE-Shoulder Arthroplasty implantation system (21
CFR 888.3660) |
| | Additional Product Codes |
| | • KWT- Shoulder joint metal/polymer non-constrained
cemented prosthesis
• KWS- Shoulder joint metal/polymer semi-constrained
cemented prosthesis
• PHX- Shoulder joint metal/polymer non-constrained
cemented prosthesis
• MBF- Shoulder joint metal/polymer/metal non-
constrained or semi-constrained porous coated
uncemented prosthesis |
4
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Zimmer CAS | ||
| *Primary | Zimmer PSI | |
| Shoulder | K150730 | |
| Biomet | Signature | |
| Personalized Patient | ||
| Care System- | ||
| Glenoid Guide | ||
| System | K130126 | |
| Zimmer CAS | ||
| *Reference Device | CAS PSI Knee | |
| System | K131409 |
Predicate Device(s):
Purpose and Device Description:
The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.
The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.
The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.
5
| Indications for Use: | The Signature™ ONE System 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 precluded from being radiologically
scanned. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Signature™ ONE System is to be used with the
glenoid components of the following shoulder implant
systems in accordance with their indications and
contraindications: Zimmer® Trabecular Metal™ Reverse
Plus Shoulder, Comprehensive® Total Shoulder System,
Comprehensive® Reverse Shoulder System and
Comprehensive® Reverse Augmented Baseplates. |
| | The Signature™ ONE Guides and Bone Models are
intended for single use only. |
| Differences in Indications for Use | The proposed device offers options specific to the
compatible implant components that are not present in the
primary predicate device |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on
consideration of the following characteristics:
The proposed and predicate device are intended to assist in
pre-operative planning and/or intraoperative guiding of
surgical instruments for shoulder replacement surgical procedures The proposed and predicate device both utilize preoperative
images, intraoperative guidance of instruments, and
assistance of glenoid component placement The proposed and predicate device utilize 3D printing (SLS) |
| | to manufacture the guides, the guides are non-sterile single-
use, and have a shelf life of 6 months
The proposed and predicate device utilize internal
manufacturing software applications and a planning
application that the surgeon interacts with to review, modify and approve the plan |
6
Summary of Performance Data (Nonclinical and/or Clinical)
The following performance data was provided in support of the substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation for Signature™ ONE System was conducted in accordance with ISO 10993. The evaluation reveals that the Signature™ ONE System device meets biocompatibility requirements.
Sterilization and Shelf-Life
This analysis was conducted to ensure that the cleaning and sterilization instructions for the Signature™ ONE System parts respect the acceptable residual levels that should be achieved by the cleaning and sterilization method, as required by the applicable standards. Testing was also conducted to ensure the acceptance criteria was met of the guides keeping their dimensional integrity throughout their shelf life of 6 months.
Device Performance Testing
Verification and Validation Testing for Signature™ ONE System was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of o the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the o implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with the O Signature™ ONE System
- Validation Lab- performed to validate that using the O Signature™ ONE System is safe and effective and that the performances of the Signature™ ONE System are acceptable under full simulated use on cadaveric specimens
7
Software Verification and Validation Testing
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor injury. The testing demonstrates that the Signature™ ONE System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
Substantial Equivalence Conclusion
The proposed and predicate device(s) have the same intended use and similar technological characteristics and the same principles of operation. The proposed device offers options specific to the compatible implant components that are not present in the predicate device as well as the option for the user to end the preoperative workflow after planning without ordering guides. In addition, the proposed device pin guide provides a larger contact surface than found on the predicate device. In sum, any differences between the devices do not raise new questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate device(s).