(59 days)
QUANTUM® Total Ankle Prosthesis (K191380)
No
The summary describes pre-operative planning software and patient-specific instrumentation based on imaging data, but there is no mention of AI or ML algorithms being used in the planning or guide design process. The focus is on surgeon validation of the plan.
No
The device is described as an "orthopaedic instrument system to assist in the instrumentation positioning" during Total Ankle Replacement implantation. It is a surgical guide and planning software, not an implant or something that directly treats a condition.
No
The device, In2Bones PSI, is described as an orthopaedic instrument system consisting of patient-specific instrumentation guides and planning software used to assist in the positioning of instruments for total ankle replacement implantation. Its function is to guide bone marking and preview implant components, not to diagnose a medical condition or disease.
No
The device description explicitly states that the system consists of both software (TAR Planning Software) and hardware components (patient specific instrumentation (PSI) guides and reusable instruments).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and the associated TAR Planning Software are described as orthopaedic instruments and preoperative surgical planning software. Their purpose is to assist the surgeon in the positioning and implantation of a total ankle replacement prosthesis.
- No Biological Samples: The device does not interact with or analyze biological samples from the patient. It uses imaging data (X-rays and CT-scans) to create physical guides and a surgical plan.
Therefore, the device falls under the category of surgical instruments and planning software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants.
PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.
TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
HSN, OYK
Device Description
The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:
- QUANTUM® patient specific tibial and talar guides;
- QUANTUM® reusable instruments;
- QUANTUM® patient specific tibial and talar bone models (not medical devices);
• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software.
The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.
The scope of this submission is an addition of a manufacturer, slight update to dimensions and raw material for the cut guides related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays and CT-scan
Anatomical Site
distal tibia and proximal talus
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 performance data were included in the 510(k) submission. Validations equipment, biocompatibility (ISO 10993) and sterilization (ISO 17665) were conducted to demonstrate that the QUANTUM PSI system is substantial equivalence to the predicate device.
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.
QUANTUM® Patient Specific Instrumentation (PSI) System (K211883)
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.
QUANTUM® Total Ankle Prosthesis (K191380)
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
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.
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April 6, 2023
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In2Bones SAS % Christine Scifert VP QA & RA In2Bones USA 6600 Poplar Ave, Suite 115 Memphis, Tennessee 38119
Re: K230313
Trade/Device Name: QUANTUM Patient Specific Instrumentation (PSI) System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Codes: HSN, OYK Dated: February 3, 2023 Received: February 6, 2023
Dear Christine Scifert:
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
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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 (OS) 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,
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For:
[Vacant] 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
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Indications for Use
510(k) Number (if known)
Device Name
QUANTUM® Patient Specific Instrumentation (PSI) System
Indications for Use (Describe)
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants.
PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.
TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
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510(k) SUMMARY For QUANTUM® Patient Specific Instrumentation (PSI) System February 3, 2023
| Sponsor identification | In2Bones SAS
Sabina Ahaddad
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | January 9, 2023 |
| Contact person | Christine Scifert
In2BonesUSA
6000 Poplar Avenue, Suite 115
Memphis, TN 38119
Cell: 901-831-8053
Email: cscifert@i2b-usa.com |
| Proprietary Name | QUANTUM® Patient Specific Instrumentation (PSI) System |
| Common name | Ankle Arthroplasty Implantation System |
| Device classification regulation | 21 CFR 888.3110
Class II |
| Device Product Code and Panel | Orthopedic
HSN: Prosthesis, Ankle, Semi-Constrained, Cemented,
Metal/Polymer
OYK: Ankle Arthroplasty Implantation System |
| Device
Description | The previously cleared single use QUANTUM® Patient Specific
Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable
instruments:
- QUANTUM® patient specific tibial and talar guides;
- QUANTUM® reusable instruments;
- QUANTUM® patient specific tibial and talar bone models
(not medical devices);
• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning
software. |
| | The QUANTUM® PSI system is to be used with the given
QUANTUM® Total Ankle Prosthesis (K191380) and their cleared
indication for use, provided that anatomic landmarks necessary for
alignment and positioning of the implant are identifiable on patient
imaging scans. |
| | QUANTUM® PSI guides are single use instruments designed using
the dedicated ORTHO-PLANIFY TAR planning software, in
correlation with a pre-operative surgical plan validated by the
surgeon. They fit the anatomy of the specific patient's distal tibia and
proximal talus. |
| | The scope of this submission is an addition of a manufacturer, slight
update to dimensions and raw material for the cut guides related to
the In2Bones QUANTUM® Patient Specific Instrumentation (PSI)
Guides for Total Ankle Replacement (TAR) previously cleared in
K211883. |
| Predicate
Devices | Primary predicate:
QUANTUM® Patient Specific Instrumentation (PSI) System
(K211883), In2Bones SAS |
| | Reference predicate:
QUANTUM® Total Ankle Prosthesis (K191380), In2Bones SAS. |
| Indications for
use: | In2Bones PSI: In2Bones QUANTUM® Patient Specific
Instrumentation (PSI) Guides for Total Ankle Replacement (TAR)
is indicated as an orthopaedic instrument system to assist in the
instrumentation positioning dedicated to In2Bones QUANTUM®
Total Ankle Replacement implantation. In2Bones QUANTUM®
PSI guides are compatible with QUANTUM® tibial tray,
QUANTUM® tibial inlay, as well as standard and Flat-Cut
QUANTUM® talar implants. |
| CONCLUSION | Based on the comparison of indications for use and technological
characteristics and the results of the testing performed, the
OUANTUM® PSI System is substantially equivalent to the
predicate device identified in the 510(k) submission. |
| Performance
Data | Non-clinical performance data were included in the 510(k)
Validations
submission.
equipment,
biocompatibility (ISO 10993) and sterilization (ISO 17665) were
conducted to demonstrate that the QUANTUM PSI system is
substantial equivalence to the predicate device. |
| Technological
characteristics: | The provided detailed comparison demonstrates the subject cut
guides for the QUANTUM PSI system are substantially equivalent in
intended use, design, operating principles, materials and performance
characteristics to the predicate device cleared in K211883. The
primary difference is an additional manufacturer for the cut guides. |
| | TAR Planning software: The TAR Planning Software is a
preoperative surgical planning software intended to be used with
In2Bones QUANTUM® Patient Specific Instrumentation (PSI)
Guides and QUANTUM® Total Ankle Replacement. TAR Planning
Software allows the surgeon to use advanced display and positioning
tools to guide the marking of bone before cutting and preview the
total ankle replacement components intraoperatively, provided that
anatomic landmarks necessary for alignment and positioning of the
implant are identifiable on patient X-rays and imaging scans. X-rays
and CT-scan are the accepted imaging modalities for these
procedures. |
| | PSI Guides are intended for single use only. PSI Guides are
manufactured in correlation with a pre-operative planning validated
by the surgeon on the TAR Planning Software and assist in the
positioning of the dedicated QUANTUM® instrumentation with
which drillings or bone cuts will be performed. In2Bones
QUANTUM® PSI guides are indicated for patient population
fulfilling the QUANTUM® Total Ankle Replacement indications
and for which X-rays and CT-scan images are available and
compliant with imaging protocol provided by In2Bones. |
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