(60 days)
Not Found
No
The summary describes a system for pre-operative planning and intra-operative guiding based on radiological images, using software for planning and additive manufacturing for guides and models. There is no mention of AI or ML in the description of the device's operation, planning process, or modifications. The focus is on image-based planning and physical guides.
No
The device is described as assisting in pre-operative planning and intra-operative guiding of surgical instruments, not directly treating a disease or condition.
No
Explanation: The device is described as assisting in pre-operative planning and intra-operative guiding for surgical procedures, not for diagnosing a condition. Its function is to aid in treatment, not to identify a disease or medical 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. While there is a software component for planning, the system is not solely software.
Based on the provided information, the Signature™ ONE System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body (like blood, urine, tissue) to provide information about a person's health. The Signature™ ONE System does not analyze any biological samples.
- The intended use of the Signature™ ONE System is to assist in surgical planning and guiding instruments during shoulder replacement surgery. This is a surgical aid, not a diagnostic test performed on a biological sample.
- The system uses radiological images as input, not biological samples.
- The device description focuses on surgical planning software, patient-specific guides and bone models, and their use in the operating room.
Therefore, 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 and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.
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 preoperative 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.
Modifications have been made to include guides and bone models for the Alliance Glenoid System, to the planning application and user interface, and the inclusion of an additional glenosphere size for the Comprehensive Reverse Implant System within the Signature™ ONE planning software application. The overall planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient-specific radiological images
Anatomical Site
Shoulder
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)
Device Performance Testing includes Engineering Analysis, Performance Tests, and System Validation. System Validation involved cadaveric validation performed to validate the related user needs, intended use, safety and effectiveness of the Alliance™ Glenoid guides. Software Verification and Validation Testing was 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. The testing demonstrates that the Signature™ ONE System does not raise any new issues of safety and effectiveness as compared to 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.
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
October 12, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.
Orthosoft Inc. (d/b/a Zimmer CAS) Sankalp Dere Regulatory Affairs Specialist 75 Queen Street Suite 3300 Montreal, QC H3C 2N6 Canada
Re: K212560
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: August 12, 2021 Received: August 13, 2021
Dear Sankalp Dere:
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 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
1
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 mediation-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 Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices 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) K212560
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 and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.
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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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 September 13, 2019.
| Sponsor: | Orthosoft Inc (d/b/a. Zimmer CAS)
75 Queen St., Suite 3300
Montreal, QC, CANADA H3C 2N6
Establishment Registration Number: 9617840 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sankalp Dere
Regulatory Affairs Specialist
Telephone: +1 514-861-4074
Email: SankalpSanjay.Dere@zimmerbiomet.com |
| Date: | October 12, 2021 |
| Subject Device: | Trade Name: Signature™ ONE System
Common Name: Shoulder Arthroplasty implantation
system |
| | Classification Name:
• 21 CFR 888.3660 – Shoulder joint metal/polymer semi-
constrained cemented prosthesis |
| | Product Code:
• QHE - Shoulder Arthroplasty Implantation System |
| | Additional Product Codes:
• KWT- Shoulder joint metal/polymer non-constrained
cemented prosthesis (21 CFR 888.3650)
• KWS- Shoulder joint metal/polymer semi-constrained
cemented prosthesis (21 CFR 888.3660)
• PHX- Shoulder joint metal/polymer semi-constrained
cemented prosthesis (21 CFR 888.3660)
• MBF- Shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3670) |
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Predicate Device(s):
| K190595
(Primary) | Signature™
System | ONE | Zimmer CAS |
|------------------------|----------------------|-----|------------|
| K200615
(Secondary) | Signature™
System | ONE | Zimmer CAS |
Purpose and Device Description:
The Signature™ ONE System is developed to assist in preoperative 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.
Modifications have been made to include guides and bone models for the Alliance Glenoid System, to the planning application and user interface, and the inclusion of an additional glenosphere size for the Comprehensive Reverse Implant System within the Signature™ ONE planning software application. The overall planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.
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, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System. | |
| The Signature™ ONE Guides and bone models are intended for single use only. | |
| Differences in Indications for Use: | There is no change to indications for use. Compatibility to Alliance™ Glenoid implant system was added in predicate K200615. |
| Summary of Technological Characteristics: | The rationale for substantial equivalence is based on consideration of the following characteristics: |
| Intended Use: Same as predicate devices Indications for Use: Same as secondary predicate device Materials: Same as predicate devices Sterilization: Same as predicate devices Design Features: Modifications have been made to the planning application but the overall workflow remains unchanged from the predicate devices. The proposed device guides and bone model design features are similar to the primary predicate device. |
Summary of Performance Data (Nonclinical and/or Clinical)
The following performance data was provided in support of the substantial equivalence determination:
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Device Performance Testing:
Verification and Validation Testing for Signature™ ONE System was conducted with the following aspects:
- Engineering Analysis- Tests were documented through O Engineering Rationales to ensure the performance of the implemented features and verify related design inputs
- Performance Tests- Design verification tests were O documented to ensure the performance of the implemented features and verify related design inputs
- System Validation- Cadaveric validation performed to O validate the related user needs, intended use, safety and effectiveness of the Alliance™ Glenoid guides.
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 devices.
Substantial Equivalence Conclusion
The proposed and predicate devices 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 devices specifically the ordering of Guides and Bone Models for Alliance™ Glenoid implant system as well as some changes to planning application. In summary, any differences between the devices does not raise new questions of safety and effectiveness and the proposed device is as safe and effective as the legally marketed predicate devices.