(125 days)
No
The summary describes standard image processing and biomechanical calculations, with no mention of AI or ML algorithms.
No.
The device is a preoperative surgical planning software that aids in component selection, sizing, and placement, but it does not directly treat or prevent a disease or condition.
No
Explanation: The device is described as preoperative surgical planning software for total hip arthroplasty, aiding in component selection, sizing, and placement, and performing biomechanical and functional analysis. It does not diagnose a disease or condition but rather assists in the planning of a surgical procedure.
Yes
The device description explicitly states that ONE Planner™ Hip is an "interactive software application" and consists of an "automated templating system and a web-based templating user interface." There is no mention of accompanying hardware components that are part of the medical device itself. The software processes existing X-ray images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for preoperative surgical planning to aid orthopedic surgeons in component selection, sizing, and placement for total hip arthroplasty. This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Device Description: The device is software that uses X-ray images to perform measurements and analysis related to the patient's anatomy and biomechanics. It does not analyze biological samples like blood, urine, or tissue.
- Input: The input is X-ray images, which are medical images, not biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LZO, PBI, LPH
Device Description
ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on the patient's pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations. The software application consists of an automated templating system and a web-based templating user interface.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeons
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)
Software Verification & Validation Testing: 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, a malfunction in the device could lead to a minor injury. The testing demonstrates that the ONE Planner™ Hip does not introduce new questions of safety and effectiveness as compared to the predicate device.
Non-Clinical Testing: Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended.
Clinical Testing: Clinical testing was not necessary for the determination of substantial equivalence.
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.
K121874, K142746, K142882, K140669, K150522, K190660, K190656, K101086, K103755, K110400, K120030, K200196, K070274, K143009, K150503, K182048, K192189, K123392, K131884, K193030
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
July 7, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Orthosoft d/b/a Zimmer CAS % Mr. Paul Hardy Regulatory Affairs Associate Director 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 CANADA
Re: K210653
Trade/Device Name: ONE Planner™ Hip Regulation Number: 21 CFR 892.2050 Regulation Name: Medical imaging management and processing system Regulatory Class: Class II Product Code: LLZ, LZO, PBI, LPH Dated: May 25, 2021 Received: June 1, 2021
Dear Mr. 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 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K210653
Device Name ONE Planner™ Hip
Indications for Use (Describe)
ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
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 ONE Planner TM Hip 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(s): Paul Hardy Regulatory Affairs Associate Director Telephone: 574-453-6739 Paul.Hardy@zimmerbiomet.com Dave Bierhuizen Quality Assurance and Regulatory Affairs Manager Dave.Bierhuizen@zimmerbiomet.com Date: June 29, 2021 Trade Name: ONE Planner™ Hip Subject Device: Common Name: Image Processing System Product Code(s) / Classification Name (s): LLZ - Picture Archiving and Communications System to ● Medical imaging management and processing system (21 CFR 892.2050). . LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353) . PBI - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310) LPH- Hip joint metal/polymer/metal semi-constrained porous-. coated uncemented prosthesis (21 CFR 888.3358
Predicate Device(s):
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Corin | Corin Optimized Positioning System Insight | K192656 |
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| Purpose and Device
Description: | ONE Planner™ Hip (OPH) is an interactive software application
intended to be used as a preoperative tool for Total Hip
Arthroplasty. It enables 2D sizing and positioning of implants in
the patient's anatomy, calculates biomechanical measurements and
performs functional analysis based on the patient's pelvic
kinematics. The biomechanical measurements include
measurements related to leg length and femoral offset. The
functional analysis includes determination of pelvic parameters
(e.g. pelvic tilt), and cup orientation calculations.
The software application consists of an automated templating
system and a web-based templating user interface. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | ONE Planner™ Hip is intended for use as preoperative surgical
planning software to aid orthopedic surgeons in component
selection, sizing and placement for primary total hip arthroplasty |
| Summary of
Technological
Characteristics: | The rationale for substantial equivalence is based on consideration
of the following characteristics:
• Indications for Use: ONE Planner™ Hip and the predicate
device have the same Indications for Use.
• Design Features: Both devices have the following features:
Ο ONE Planner™ Hip and the predicate device use input files
consisting of X-ray images.
Ο ONE Planner™ Hip and the predicate device provide image
processing tools.
Ο ONE Planner™ Hip and the predicate device provide
preoperative sizing values.
Ο ONE Planner™ Hip and the predicate device provide
functional analysis of pelvic parameters
Ο ONE Planner™ Hip and the predicate device provide
interactive adjustment of the preoperative surgical plan
Ο ONE Planner™ Hip and the predicate device provide tools
for visualization and to perform measurements, and to
choose size and position implants.
Ο ONE Planner™ Hip and the predicate device export a
preoperative surgical plan. |
| Compatible Devices: | ONE Planner™ Hip can be used with the following implant
systems:
G7 Acetabular Systems (K121874, K142746, K142882, K140669,
K150522, K190660, K190656)
Taperloc Complete Stems (K101086, K103755, K110400,
K120030, K200196) |
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Echo Bi-Metric Stems (K070274, K143009, K150503) Avenir Complete (K182048, K192189) Avenir Muller and Cemented Hip Stems (K123392, K131884, K193030)
ONE Planner™ Hip has been evaluated through the following nonclinical testing:
· Software Verification & Validation Testing
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, a malfunction in the device could lead to a minor iniurv. The testing demonstrates that the ONE Planner™ Hip does not introduce new questions of safety and effectiveness as compared to the predicate device.
• Non-Clinical Testing
Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended.
· Clinical Testing
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence Conclusion:
The subject device has the same intended use, same indications for use, similar technological characteristics and principles of operation as the predicate device. The differences between the subject device and the predicate device does not introduce new types of safety and effectiveness questions. Therefore, the subject device is at least as safe and effective as the legally marketed predicate device.
Summary of Performance Data (Nonclinical and/or Clinical):