(268 days)
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)
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.
The provided text does not contain specific acceptance criteria or details of a study directly proving the RobPath® Total Hip Application meets such criteria. Instead, it states that "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," and that "The results of these tests demonstrate that the proposed RobPath-THA-001 meet the acceptance criteria and is adequate for its intended use."
The document focuses on establishing substantial equivalence to a predicate device (MAKO Total Hip Application, K193128) based on technological characteristics and adherence to various international and FDA-recognized consensus standards. It explicitly states that no clinical study was required because substantial equivalence was proven through verification/validation testing.
Therefore, I cannot provide the requested information for an acceptance criteria table, sample size, expert qualifications, adjudication methods, MRMC study results, standalone performance, or details on ground truth for training or test sets, as this information is not present in the provided text.
The closest information related to performance is the mention of adherence to standards like ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This implies that the device's positional accuracy would be a key acceptance criterion, and testing defined by this standard would have been performed, but the specific numerical acceptance criteria and reported performance are not detailed.
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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, ZhongtaiStreet, Yuhang District, Hangzhou, Zhejiang, CHINA,311100 | |
| ContactPerson: | Rennes ZhangDirector of Quality & RegulatoryPhone: +86-571-86268173E-mail: zhangguoxin80@126.com | |
| Submissioncorrespondent: | Shanghai Zhirui Management Consulting Co., Ltd.No. 741 Yao Zhou Road, Xin Cun, Chong Ming districtGordon ShuDirector of Regulatory AffairsPhone: +86-13656237738E-mail: jian_shu2002@hotmail.com | |
| Subject Device:Classification: | RobPath® Total Hip Application (RobPath-THA-001)Classification name: Orthopedic Stereotaxic InstrumentClassification Regulation: 21CFR 882.4560Review Panel: OrthopedicDevice Class: Class IIProduct Code: OLO | |
| Predicate Device | Trade name: MAKO Total Hip ApplicationManufacturer: Mako Surgical Corp.510(k) Clearance: K193128Classification Regulation: 21CFR 882.4560Classification name: Orthopedic Stereotaxic InstrumentReview Panel: OrthopedicDevice class Class IIProduct Code: OLO | |
| Device Description: | The proposed RobPath® Total Hip Application is asemi-active robotic system. Pre-operative CT imagingis used to generate a 3D model of the native hip joint.An initial plan is created using selected CT landmarksand superimposed onto the 3D reconstruction. Thesurgeon is then able to fine-tune this to ensure optimaltemplating of component size and alignment, thusallowing 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 toassist the surgeon in providing software defined spatialboundaries for orientation and reference information toanatomical structures during orthopedic procedures.The RobPath® Total Hip Application is indicated foruse in a surgical hip procedure in which the use ofstereotactic surgery may be appropriate, and wherereference to rigid anatomical bony structures can beidentified relative to a CT based model of the anatomy.These procedures include:• Total Hip Arthroplasty (THA) | |
| Summary ofTechnologicalCharacteristics: | The rationale for substantial equivalence is based onconsideration of the following characteristics:• The subject and predicate devices are intended toassist the surgeon in providing software defined spatialboundaries for orientation• The subject and predicate devices assist inintraoperative navigation of the patient's anatomy andare utilized to facilitate implant positioning.• The subject and predicate device consists of thesame major components including Robotic Arm,Guidance Module, Optical Tracking system, Footswitch, Medical electric bone drill and SurgicalInstruments.• The instrument features and functions of the subjectand predicate devices are intended to allow assemblyof the sensors, to attach the subject bones, to registeror digitize the applicable landmarks, and to adjust thealignment of provided guides. | |
| Summary of Non-Clinical PerformanceData: | The proposed RobPath-THA-001 comply with the followinginternational and FDA-recognized consensus standards:• AAMI / ANSI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012(Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety andEssential Performance (IEC 60601-1:2005, MOD).• IEC 60601-1-2 Edition 4.0: 2014-02Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: Electromagneticdisturbances - Requirements and Tests | |
| ● | IEC 60601-1-6 Edition 3.1: 2013-10Medical Electrical Equipment -- Part 1-6: GeneralRequirements for Basic Safety and EssentialPerformance -- Collateral Standard: Usability | |
| ● | IEC 62366-1 Edition 1.0: 2015-02Medical devices - Part 1: Application of usabilityengineering to medical devices | |
| ● | IEC 80601-2-77 Edition 1.0: 2019-07Medical electrical equipment - Part 2-77: Particularrequirements for the basic safety and essentialperformance of robotically assisted surgicalequipment | |
| ● | ASTM F2554-18Standard Practice for Measurement of PositionalAccuracy of Computer Assisted Surgical Systems | |
| ● | IEC 62304 Edition 1.1: 2015Medical device software - Software life cycleprocesses. | |
| ● | ISO14971 Edition 2: 2007-03-01Medical devices - Application of risk management tomedical devices. | |
| ● | ISO 10993-1 Fifth edition 2018-08Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess | |
| ● | ISO 10993-4 Third edition 2017-04Biological evaluation of medical devices--Part 4:Selection of tests for interactions with blood | |
| ● | ISO 10993-5 Third edition 2009-06-01Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity | |
| ● | ISO 10993-10 Third Edition 2010-08-01Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization | |
| ● | ISO 10993-11 Third edition 2017-09Biological evaluation of medical devices - Part 11:Tests for systemic toxicity | |
| ISO 10993-4 Third edition 2017-04Biological evaluation of medical devices--Part 4:Selection of tests for interactions with blood Guidance for Industry and FDA Staff — Guidance forthe Content of Premarket Submissions for SoftwareContained in Medical Devices (issued May 11, 2005) Guidance for Industry and FDA Staff — Content ofPremarket Submissions for Management ofCybersecurity in Medical Devices (issued October 2, 2014) Guidance for Industry and FDA Staff – Use ofInternational Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluationand testing within a risk management process"(issued June 16, 2016) Guidance for Industry and FDA Staff - Information toSupport a Claim of Electromagnetic Compatibility(EMC) of Electrically-Powered Medical Devices(issued July 11, 2016) Guidance for Industry and FDA Staff -ReprocessingMedical Devices in Health Care Settings: ValidationMethods and Labeling (issued March 17, 2015) | ||
| Non-Clinical verification and validation tests have beenperformed with regards to the intended use, the technicalclaims, the requirement specifications, and the riskmanagement results.Therefore, the proposed RobPath-THA-001 aresubstantially equivalent to the currently marketed predicatedevice MAKO Total Hip Application (K193128) in terms ofsafety and effectiveness. | ||
| Summary of ClinicalData: | The proposed RobPath-THA-001 did not require clinicalstudy since substantial equivalence to the legally marketedpredicate device was proven with the verification/validationtesting. | |
| SubstantialEquivalenceConclusion: | The proposed RobPath-THA-001 and the currentlymarketed predicate device MAKO Total Hip Application(K193128) have the same indications for use.The proposed RobPath-THA-001 are substantiallyequivalent to the currently marketed predicate device MAKOTotal Hip Application (K193128) in terms of design features,fundamental scientific technology, indications for use, and | |
| safety & effectiveness. Any differences do not raise newquestions of safety and effectiveness | ||
| The results of these tests demonstrate that the proposedRobPath-THA-001 meet the acceptance criteria and isadequate for its intended use. |
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§ 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).