(316 days)
No
The summary describes a pre-operative planning software and patient-specific guides based on imaging data, but there is no mention of AI or ML being used in the planning or guide generation process. The focus is on surgeon-validated planning and anatomical landmarks.
No
This device is an orthopedic instrument system and associated planning software designed to assist in the positioning of instrumentation for Total Ankle Replacement implantation, rather than providing direct therapeutic treatment.
No
The device, including the PSI guides and planning software, is described as an "orthopaedic instrument system to assist in the instrumentation positioning" and for "preoperative surgical planning." Its primary function is to aid in the accurate placement of implants and surgical cuts, not to diagnose a condition or disease.
No
The device description explicitly includes physical components like "QUANTUM® patient specific tibial and talar guides," "QUANTUM® reusable instruments," and "QUANTUM® patient specific tibial and talar bone models," in addition to the software.
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 surgical planning software. Their purpose is to assist surgeons in the positioning of instruments and planning for Total Ankle Replacement surgery.
- No Biological Samples: The description does not mention the device interacting with or analyzing any biological samples from the patient. Its function is based on anatomical imaging (X-rays and CT-scans) and surgical planning.
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 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.
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.
Note: The Indications for Use of the QUANTUM® Patient Specific Instrumentation (PSI) Guides and the TAR Planning Software remain unchanged compared to the primary predicate (K211883) including the QUANTUM® Patient Specific Instrumentation (PSI) and TAR Planning Software provided in the original submission.
Product codes
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
• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission).
The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software.
The QUANTUM® 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.
The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432.
The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software 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
Ankle
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. Functional cadaver testing and software validations (previously provided under K221432) 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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April 23, 2024
In2Bones SAS % Christine Scifert VP, QA & RA In2Bones USA 6600 Poplar Avenue, Suite 115 Memphis, Tennessee 38119
Re: K231699
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 Code: HSN, OYK Dated: March 20, 2024 Received: March 21, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Peter G. Allen Digitally signed by Peter Date: 2024.04.23 01:36:03 နာ -04'00
For Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices
2
OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231699
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 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.
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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K231699 page 1 of 4
Image /page/4/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval shape. The text "IN2BONES" is in white, with the "2" in orange.
510(k) SUMMARY For QUANTUM® Patient Specific Instrumentation (PSI) System December 15, 2023
| Sponsor
identification | In2Bones SAS
Stephan Epinette
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 | December15, 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
• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission). |
| | The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software. |
| | The QUANTUM® 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. |
| | The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432. |
| | The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software 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 devices:
QUANTUM® Patient Specific Instrumentation (PSI) System (K230313), In2Bones SAS |
| | QUANTUM® Total Ankle Prosthesis (K191380), In2Bones SAS |
| | 3D-Side Customize software (K221432) |
| 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
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. |
| | 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. |
| | Note: The Indications for Use of the QUANTUM® Patient Specific
Instrumentation (PSI) Guides and the TAR Planning Software remain
unchanged compared to the primary predicate (K211883) including
the QUANTUM® Patient Specific Instrumentation (PSI) and TAR
Planning Software provided in the original submission. |
| 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 addition of a manufacturer for
the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning
software related to the In2Bones QUANTUM® Patient Specific
Instrumentation (PSI) Guides for Total Ankle Replacement (TAR). |
| Performance
Data | Non-clinical performance data were included in the 510(k) submission. Functional cadaver testing and software validations
(previously provided under K221432) were conducted to demonstrate that the QUANTUM® PSI system is substantial equivalence to the predicate device. |
| CONCLUSION | Based on the comparison of indications for use and technological characteristics and the results of the testing performed, the QUANTUM® PSI System is substantially equivalent to the predicate device identified in the 510(k) submission. |
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