(76 days)
The HSA system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HSA system facilitates the accurate positioning of implants, relative to these alignment axes.
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Arthroplasty
- · Unicompartmental Knee Arthroplasty: Tibial transverse resection.
The OrthAlign Harvey® Surgical Assistant System is a non-invasive computer assisted surgical navigation system for use in total knee and Unicompartmental knee arthroplasty procedures. The Harvey® Surgical Assistant System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The Harvey® Surgical Assistant System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthropolasty procedures, the device assists the surgeon in:
- . Establishing the mechanical axis of the femur. determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia. determining the varus/valgus andle and . the posterior slope angle of the cutting block relative to the tibia.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- . Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The Harvey® Surgical Assistant System comprises a single use computer module and reusable instrumentation.
Here's a breakdown of the acceptance criteria and study information for the Harvey® Surgical Assistant System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state specific numerical acceptance criteria for the Harvey® Surgical Assistant System's performance. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (OrthAlign Plus® System K162962). The performance testing aims to confirm that the modified device performs "as well as" the existing device.
The reported device performance is described in terms of functional verification and validation, ensuring the device meets its intended use.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Device can be used according to its intended use. | "Device performance testing confirms that the Harvey® Surgical Assistant system can be used according to its intended use." |
| Integrity of code, functionality, and reliability of software. | "Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences." |
| Biocompatibility of revised materials is acceptable. | "Biocompatibility testing of revised materials." |
| Device is as safe and effective as the predicate device. | "This testing regime demonstrates that the modified device is as safe, as effective, and performs as well as the existing device. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify numerical sample sizes for the test set. It mentions "various use sequences" for software testing.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the evaluation is a premarket notification for a medical device in the United States, so the testing would likely be performed to U.S. regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or establish ground truth through expert consensus for the performance testing. The testing appears to be functional and software-oriented verification and validation, rather than a clinical study requiring expert interpretation of outcomes.
4. Adjudication Method for the Test Set
As there's no mention of expert involvement or ground truth established by experts, there's no adjudication method described for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not described in the provided document. This submission is for a modification to an existing stereotaxic instrument, and the testing focuses on the functional performance of the modified device, not a comparative clinical effectiveness study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described, particularly "Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences," would largely be a standalone (algorithm only) evaluation of the software's ability to process inputs and generate correct outputs. The device itself is a "computer-controlled system intended to assist the surgeon," indicating it provides outputs (angular and positional measurements) that the surgeon then uses. Therefore, the core functional tests of the software would be standalone.
7. The Type of Ground Truth Used
The ground truth for the performance testing appears to be based on:
- Engineering specifications and expected outputs: For software verification and validation, the "ground truth" would be the pre-defined correct functionality, calculations, and expected visual displays based on engineering requirements.
- Predicate device performance: The ultimate "ground truth" for substantial equivalence is the performance of the legally marketed predicate device (OrthAlign Plus® System K162962). The testing aims to show the modified device performs comparably.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI model training in the conventional sense. The device is described as a "computer-controlled system" that utilizes algorithms to convert sensor outputs into spatial coordinates. This implies deterministic programming rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for a machine learning model, the concept of establishing ground truth for a training set does not apply here. The algorithms in this device are likely based on established biomechanical and mathematical principles, validated through traditional software and system engineering methods.
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June 18, 2020
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: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OrthAlign Inc Karyl Haskell Vice President, Regulatory Affairs and Quality Assurance 120 Columbia Suite 500 Aliso Viejo, California 92656
Re: K200892
Trade/Device Name: Harvey(R) Surgical Assistant Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 22, 2020 Received: May 22, 2020
Dear Karyl Haskell:
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
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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 medical devices and radiation-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, 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) K200892
Device Name Harvey(R) Surgical Assistant System
Indications for Use (Describe)
The HSA system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HSA system facilitates the accurate positioning of implants, relative to these alignment axes.
Example orthopedic surgical procedures include but are not limited to:
- · Total Knee Arthroplasty
- · Unicompartmental Knee Arthroplasty: Tibial transverse resection.
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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This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92(c).
DATE:
APPLICANT
21 May 2020
OrthAlign, Inc. 120 Columbia, Suite 500 Aliso Viejo CA 92656 Tel: Fax: 949.831.9500
OFFICIAL CORRESONDENT
Karyl Haskell Vice President of Regulatory Affairs and Quality Assurance 120 Columbia Suite 500 Aliso Viejo CA 92646 Tel: (949) 715-2424
DEVICE CLASSIFICATION PRODUCT CODES COMMON NAME TRADE NAME PRIMARY PREDICATE DEVICE Reference Device
Fax: (949) 831-9500 Class II, 21 CFR 882.4560 OLO: Orthopedic Stereotaxic Instrument Orthopedic Stereotaxic Instrument OrthAlign Harvey® Surgical Assistant (HAS) System OrthAlign Plus System (K162962) OrthAlign Plus System (K130387)
SUBMISSION TYPE Special 510(k) Device Modification. The subject device is a modification to the previously cleared OrthAlign Plus System (K162962)
SUBSTANTIALLY EQUIVALENT TO
The OrthAlign Harvey® Surqical Assistant System is substantially equivalent to the previously cleared OrthAlign Plus® System (K162962).
DEVICE DESCRIPTION
The OrthAlign Harvey® Surgical Assistant System is a non-invasive computer assisted surgical navigation system for use in total knee and Unicompartmental knee arthroplasty procedures. The Harvey® Surgical Assistant System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The Harvey® Surgical Assistant System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthropolasty procedures, the device assists the surgeon in:
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- . Establishing the mechanical axis of the femur. determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia. determining the varus/valgus andle and . the posterior slope angle of the cutting block relative to the tibia.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- . Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The Harvey® Surgical Assistant System comprises a single use computer module and reusable instrumentation.
INDICATIONS FOR USE
The Harvey Surgical Assistant has the same indications for total knee and unicompartmental knee arthroplasty as the previously cleared OrthAlign Plus® System (K162962). The Harvey Surqical Assistant is not indicated for total hip arthroplasty.
The Indications for Use are as follows:
Harvey Surgical Assistant System:
The Harvey Surgical Assistant System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The Harvey Surgical Assistant System facilitates the accurate positioning of implants, relative to these alignment axes.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty .
- . Unicompartmental Knee Arthroplasty: Tibial transverse resection
TECHNICAL CHARACTERISTICS COMPARED TO LEGALLY MARKETED DEVICE
The OrthAlign Plus® System was cleared to market under K162962. The OrthAlign Plus® System comprises a single use computer module, a reusable reference sensor and various surgical instruments. The devices uses algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen.
The Harvey® Surgical Assistant System update the OrthAlign Plus® System:
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- Operating System updated to a customized Android 7 operating system o
- Single use computer module and reusable reference sensor housing material are O revised
PERFORMANCE DATA
Device performance testing confirms that the Harvey® Surgical Assistant system can be used according to its intended use. The Harvey® Surgical Assistant system has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the functionality and surgical procedure steps.
Performance testing included:
- . Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
- Biocompatibility testing of revised materials ●
This testing regime demonstrates that the modified device is as safe, as effective, and performs as well as the existing device. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use.
The information provided by OrthAlign in this 510(k) premarket notification confirms that the modified OrthAlign Harvey® Surgical Assistant system is substantially equivalent to the legally marked predicate device, the OrthAlign Plus® System (K162962).
BASIS FOR DETERMINING SUBSTANTIAL EQUIVALENCE
A technological comparison and bench testing demonstrate the substantial equivalence of the Harvey® Surgical Assistant System to the legally marketed OrthAlign Plus® System.
The modified device is identical to the predicate OrthAlign Plus® System (K162962), with the following exceptions:
- . The subject device software is modified to operate on an Android 7 operating system.
- The housing material for the Harvey unit and the Harvey reference sensor have been ● modified.
§ 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).