(268 days)
Not Found
No
The summary describes a semi-active robotic system that uses pre-operative CT imaging and surgeon-defined planning. There is no mention of AI, ML, or related terms, nor is there a description of training or test sets typically associated with AI/ML development. The system relies on haptic feedback and surgeon control, not automated decision-making based on learned patterns.
No.
The device assists surgeons with spatial boundaries and orientation during hip procedures, but it does not directly treat or diagnose a disease or condition itself.
No
This device is intended to assist a surgeon during a hip replacement procedure by providing spatial boundaries and reference information for anatomical structures, and helping with planning component size and alignment. It is an intraoperative surgical assistance system, not a device used to identify a medical condition or disease.
No
The device description explicitly states it is a "semi-active robotic system" and mentions a "robotic arm," indicating it includes hardware components beyond just software.
Based on the provided information, the RobPath® Total Hip Application 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.
- RobPath® Total Hip Application's Function: The RobPath® Total Hip Application is a surgical robotic system used during a surgical procedure (Total Hip Arthroplasty). It assists the surgeon with spatial guidance and planning based on pre-operative imaging. It does not analyze biological samples from the patient.
The device's function is to aid in the surgical process itself, not to diagnose or provide information about a patient's health status through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The RobPath® Total Hip Application is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RobPath® Total Hip Application is indicated for use in a surgical hip procedure in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
• Total Hip Arthroplasty (THA)
Product codes
OLO
Device Description
The proposed RobPath® Total Hip Application is a semi-active robotic system. Pre-operative CT imaging is used to generate a 3D model of the native hip joint. An initial plan is created using selected CT landmarks and superimposed onto the 3D reconstruction. The surgeon is then able to fine-tune this to ensure optimal templating of component size and alignment, thus allowing the desired restoration of hip biomechanics, bone coverage, component positioning and leg-length correction. The robotic arm is not fully automated but based on haptic feedback, so the surgeon retains partial control during the implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical hip procedure
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 verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications, and the risk management results. The results of these tests demonstrate that the proposed RobPath-THA-001 meet the acceptance criteria and is adequate for its intended use.
The proposed RobPath-THA-001 did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 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 name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 9, 2022
Hangzhou Lancet Robotics Co., Ltd. % Gordon Shu Director of Regulatory Affairs Shanghai Zhirui Management Consulting Co., Ltd. No. 741 Yao Zhou Road, Xin Cun, Chong Ming district Shanghai, Shanghai 202150 China
Re: K220774
Trade/Device Name: RobPath® Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 7, 2022 Received: November 7, 2022
Dear Gordon Shu:
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.
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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 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.
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K220774
Device Name RobPath® Total Hip Application
Indications for Use (Describe)
The RobPath® Total Hip Application is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RobPath® Total Hip Application is indicated for use in a surgical hip procedure in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
· Total Hip Arthroplasty (THA)
| 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 of Safety and Effectiveness
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the RobPath-THA-001 510(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.
| Date Prepared: | December 9, 2022 | |
|---|---|---|
| Sponsor: | Hangzhou Lancet Robotics Co., Ltd. | |
| 508, 5th Floor, Building 4, No. 5, Lvtai Road, Zhongtai | ||
| Street, Yuhang District, Hangzhou, Zhejiang, CHINA, | ||
| 311100 | ||
| Contact | ||
| Person: | Rennes Zhang | |
| Director of Quality & Regulatory | ||
| Phone: +86-571-86268173 | ||
| E-mail: zhangguoxin80@126.com | ||
| Submission | ||
| correspondent: | Shanghai Zhirui Management Consulting Co., Ltd. | |
| No. 741 Yao Zhou Road, Xin Cun, Chong Ming district | ||
| Gordon Shu | ||
| Director of Regulatory Affairs | ||
| Phone: +86-13656237738 | ||
| E-mail: jian_shu2002@hotmail.com | ||
| Subject Device: | ||
| Classification: | RobPath® Total Hip Application (RobPath-THA-001) | |
| Classification name: Orthopedic Stereotaxic Instrument | ||
| Classification Regulation: 21CFR 882.4560 | ||
| Review Panel: Orthopedic | ||
| Device Class: Class II | ||
| Product Code: OLO | ||
| Predicate Device | Trade name: MAKO Total Hip Application | |
| Manufacturer: Mako Surgical Corp. | ||
| 510(k) Clearance: K193128 | ||
| Classification Regulation: 21CFR 882.4560 | ||
| Classification name: Orthopedic Stereotaxic Instrument | ||
| Review Panel: Orthopedic | ||
| Device class Class II | ||
| Product Code: OLO | ||
| Device Description: | The proposed RobPath® Total Hip Application is a | |
| semi-active robotic system. Pre-operative CT imaging | ||
| is used to generate a 3D model of the native hip joint. | ||
| An initial plan is created using selected CT landmarks | ||
| and superimposed onto the 3D reconstruction. The | ||
| surgeon is then able to fine-tune this to ensure optimal | ||
| templating of component size and alignment, thus | ||
| allowing the desired restoration of hip biomechanics, | ||
| bone coverage, component positioning and leg-length | ||
| correction. The robotic arm is not fully automated but | ||
| based on haptic feedback, so the surgeon retains | ||
| partial control during the implantation. | ||
| Indications for Use: | The RobPath® Total Hip Application is intended to | |
| assist the surgeon in providing software defined spatial | ||
| boundaries for orientation and reference information to | ||
| anatomical structures during orthopedic procedures. | ||
| The RobPath® Total Hip Application is indicated for | ||
| use in a surgical hip procedure in which the use of | ||
| stereotactic surgery may be appropriate, and where | ||
| reference to rigid anatomical bony structures can be | ||
| identified relative to a CT based model of the anatomy. | ||
| These procedures include: | ||
| • Total Hip Arthroplasty (THA) | ||
| Summary of | ||
| Technological | ||
| Characteristics: | The rationale for substantial equivalence is based on | |
| consideration of the following characteristics: | ||
| • The subject and predicate devices are intended to | ||
| assist the surgeon in providing software defined spatial | ||
| boundaries for orientation | ||
| • The subject and predicate devices assist in | ||
| intraoperative navigation of the patient's anatomy and | ||
| are utilized to facilitate implant positioning. | ||
| • The subject and predicate device consists of the | ||
| same major components including Robotic Arm, | ||
| Guidance Module, Optical Tracking system, Foot | ||
| switch, Medical electric bone drill and Surgical | ||
| Instruments. | ||
| • The instrument features and functions of the subject | ||
| and predicate devices are intended to allow assembly | ||
| of the sensors, to attach the subject bones, to register | ||
| or digitize the applicable landmarks, and to adjust the | ||
| alignment of provided guides. | ||
| Summary of Non- | ||
| Clinical Performance | ||
| Data: | The proposed RobPath-THA-001 comply with the following | |
| international and FDA-recognized consensus standards: | ||
| • AAMI / ANSI ES60601-1:2005/(R)2012 and | ||
| A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 | ||
| (Consolidated Text) Medical Electrical Equipment - | ||
| Part 1: General Requirements for Basic Safety and | ||
| Essential Performance (IEC 60601-1:2005, MOD). |
• IEC 60601-1-2 Edition 4.0: 2014-02
Medical Electrical Equipment - Part 1-2: General
Requirements for Basic Safety and Essential
Performance - Collateral Standard: Electromagnetic
disturbances - Requirements and Tests |
| | | |
| ● | IEC 60601-1-6 Edition 3.1: 2013-10
Medical Electrical Equipment -- Part 1-6: General
Requirements for Basic Safety and Essential
Performance -- Collateral Standard: Usability | |
| ● | IEC 62366-1 Edition 1.0: 2015-02
Medical devices - Part 1: Application of usability
engineering to medical devices | |
| ● | IEC 80601-2-77 Edition 1.0: 2019-07
Medical electrical equipment - Part 2-77: Particular
requirements for the basic safety and essential
performance of robotically assisted surgical
equipment | |
| ● | ASTM F2554-18
Standard Practice for Measurement of Positional
Accuracy of Computer Assisted Surgical Systems | |
| ● | IEC 62304 Edition 1.1: 2015
Medical device software - Software life cycle
processes. | |
| ● | ISO14971 Edition 2: 2007-03-01
Medical devices - Application of risk management to
medical devices. | |
| ● | ISO 10993-1 Fifth edition 2018-08
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process | |
| ● | ISO 10993-4 Third edition 2017-04
Biological evaluation of medical devices--Part 4:
Selection of tests for interactions with blood | |
| ● | ISO 10993-5 Third edition 2009-06-01
Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity | |
| ● | ISO 10993-10 Third Edition 2010-08-01
Biological evaluation of medical devices - Part 10:
Tests for irritation and skin sensitization | |
| ● | ISO 10993-11 Third edition 2017-09
Biological evaluation of medical devices - Part 11:
Tests for systemic toxicity | |
| | ISO 10993-4 Third edition 2017-04
Biological evaluation of medical devices--Part 4:
Selection of tests for interactions with blood Guidance for Industry and FDA Staff — Guidance for
the Content of Premarket Submissions for Software
Contained in Medical Devices (issued May 11, 2005) Guidance for Industry and FDA Staff — Content of
Premarket Submissions for Management of
Cybersecurity in Medical Devices (issued October 2, 2014) Guidance for Industry and FDA Staff – Use of
International Standard ISO 10993-1, "Biological
evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process"
(issued June 16, 2016) Guidance for Industry and FDA Staff - Information to
Support a Claim of Electromagnetic Compatibility
(EMC) of Electrically-Powered Medical Devices
(issued July 11, 2016) Guidance for Industry and FDA Staff -Reprocessing
Medical Devices in Health Care Settings: Validation
Methods and Labeling (issued March 17, 2015) | |
| | Non-Clinical verification and validation tests have been
performed with regards to the intended use, the technical
claims, the requirement specifications, and the risk
management results.
Therefore, the proposed RobPath-THA-001 are
substantially equivalent to the currently marketed predicate
device MAKO Total Hip Application (K193128) in terms of
safety and effectiveness. | |
| Summary of Clinical
Data: | The proposed RobPath-THA-001 did not require clinical
study since substantial equivalence to the legally marketed
predicate device was proven with the verification/validation
testing. | |
| Substantial
Equivalence
Conclusion: | The proposed RobPath-THA-001 and the currently
marketed predicate device MAKO Total Hip Application
(K193128) have the same indications for use.
The proposed RobPath-THA-001 are substantially
equivalent to the currently marketed predicate device MAKO
Total Hip Application (K193128) in terms of design features,
fundamental scientific technology, indications for use, and | |
| | safety & effectiveness. Any differences do not raise new
questions of safety and effectiveness | |
| | The results of these tests demonstrate that the proposed
RobPath-THA-001 meet the acceptance criteria and is
adequate for its intended use. | |
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