(154 days)
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.
The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application.
The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion section is 10 mm diameter and 342 mm working length. Stereo camera with 1080 high-definition resolution. It has 90 degrees field of view, 10-100 mm depth of view.
The SIRIUS Endoscope System is to be used only under the supervision of a trained surgeon and professional clinical staff with trained use of the device.
The device is intended for use in Hospital operating theatres only.
This 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a specific study design typically seen for AI/ML devices or novel technologies. The "acceptance criteria" here are implicitly linked to the performance of the predicate device and relevant international standards.
Therefore, many of the specific details you requested regarding acceptance criteria and study design (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training sets) are not present in this type of document because the submission is not presenting evidence of novel diagnostic or assistive AI performance. It's a submission for a new model of an endoscope system, demonstrating it performs as safely and effectively as a previously cleared version.
However, I can extract information related to product performance and testing where available, and explain why other details are absent based on the nature of this 510(k) submission.
Analysis of Acceptance Criteria and Device Performance for SIRIUS Endoscope System (K250939)
The SIRIUS Endoscope System (PR-SI-1230) received 510(k) clearance based on its substantial equivalence to a predicate device (K221642: SIRIUS Endoscope System). The "acceptance criteria" in this context are not defined as specific performance metrics for a novel AI algorithm, but rather as meeting the safety, effectiveness, and performance standards expected of an endoscope system, particularly in comparison to its predicate. The studies provided focus on verifying that the new model performs comparably to the predicate and adheres to relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for an updated hardware device (endoscope system) rather than a novel AI diagnostic, the acceptance criteria are primarily aligned with regulatory standards, predicate device performance, and international product standards. There are no specific AI performance metrics like sensitivity, specificity, or AUC mentioned.
| Category | Acceptance Criteria (Implied / Demonstrated by Compliance) | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility | Patient contacting components meet ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogen). | "The evaluation included the following tests: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogen", confirming compliance. |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶; EO and chlorohydrin residuals within limits per ISO 10993-7. | "Sterilization condition is validated per ISO 11135: 2014 overkill half-cycle approach. The sterility assurance level (SAL) is 10⁻⁶. The amount of ethylene oxide and chlorohydrin residual levels are within the limit and in compliance with ISO 10993-7." |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-18 standards for safety. | "The device complies with IEC 60601-1, IEC60601-2-18 standards for safety." |
| EMC | Compliance with IEC 60601-1-2 standard for EMC. | "The device complies with... the IEC 60601-1-2 standard for EMC." |
| Light Source Safety | Compliance with IEC 62471: 2006 (Risk Group 2). | "The lamp is certified as Risk group 2 and complies with IEC 62471: 2006." |
| Software V&V | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Basic Documentation Level). | "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance... The software documentation level applied for this device was considered as Basic Documentation." |
| Performance Testing | Compliance with specific ISO 8600 series standards for endoscopes (e.g., field of view, direction of view, width of insertion, water resistance). | Bench testing performed verifies compliance with: ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-7. |
| Usability | Acceptable residual risk regarding usability, benefits exceed possible risks of use-error, per ANSI/AAMI IEC 62366-1:2015+AMD1:2020. | "Formative and summative evaluations were conducted. Results and improvement action demonstrated that residual risk regarding usability is minimized and acceptable." |
| Technological Equivalence (Hardware Differences) | Performance equivalent for specified differences (e.g., working length, joystick design, locking mechanism). | Verified by electrical safety, EMC tests, and usability tests. Stated "no impact on the effectiveness and safety of the device." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of an AI/ML or diagnostic performance study. The "tests" mentioned are primarily bench tests, engineering validations, and usability evaluations, not clinical studies involving patient data or images. Therefore, details like data provenance or a specific test set sample size for diagnostic performance are not provided. The comparisons are against the predicate device's design and adherence to recognized performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is about the physical endoscope system, not an AI diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the performance section refers to engineering specifications and compliance with international standards.
4. Adjudication Method for the Test Set
Not applicable, as there's no diagnostic test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not conducted or reported. This type of study is typically done for AI algorithms that assist or augment human reading of medical images to demonstrate improvement in reader performance. The SIRIUS Endoscope System is a hardware device for visualization and surgery, not an AI-powered diagnostic tool in that sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no standalone algorithm being evaluated for performance independent of human operation for diagnostic purposes. The "software" referred to in the document relates to the device's operational software, not an AI for image analysis.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterility, IEC 60601 series for electrical safety/EMC, IEC 62471 for light source safety, ISO 8600 series for endoscope performance, and ANSI/AAMI IEC 62366-1 for usability.
- Engineering Specifications: The design and function of the device itself are validated against its own specifications and those of the predicate.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is that the new device performs "as well as the legally marketed predicate device."
8. The Sample Size for the Training Set
Not applicable. This document does not describe an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm mentioned.
Summary of Study Type:
The submission focuses on design verification and validation testing to demonstrate that the new SIRIUS Endoscope System (PR-SI-1230) is safe, effective, and performs as well as its predicate. This includes ensuring compliance with a wide array of international standards (ISO, IEC, ANSI/AAMI) for medical device manufacturing, biocompatibility, electrical safety, sterility, and basic endoscope performance. The differences from the predicate (e.g., working length, joystick design, locking mechanism) were specifically verified through engineering and usability tests to ensure they did not negatively impact safety or effectiveness.
FDA 510(k) Clearance Letter - SIRIUS Endoscope System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.00
Silver Spring, MD 20993
www.fda.gov
Precision Robotics (Hong Kong) Limited
℅ Kacia Mak
Regulatory Affairs Manager
Vee Care Asia Limited
8/F-1, No. 80, Zhouzi Street, Neihu District
Tai Pei City, 114
Taiwan
Re: K250939
Trade/Device Name: SIRIUS Endoscope System (PR-SI-1230)
Regulation Number: 21 CFR 884.1720
Regulation Name: Gynecologic Laparoscope And Accessories
Regulatory Class: Class II
Product Code: HET, GCJ, GCQ
Dated: July 31, 2025
Received: July 31, 2025
Dear Kacia Mak:
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.
August 29, 2025
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K250939 - Kacia Mak Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250939 - Kacia Mak Page 3
assistance/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,
Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2025.08.29 10:17:48 -04'00'
Colin Kejing Chen
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250939
Device Name: SIRIUS Endoscope System (PR-SI-1230)
Indications for Use (Describe)
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Sirius Endoscope System 510(k) Submission
510(k) Summary
1. SUBMITTER
| Name | Precision Robotics (Hong Kong) Limited |
|---|---|
| Address | Suite 611-612 Lakeside 2 (10W), Hong Kong Science Park, Shatin, New Territories, Hong Kong |
| Contact Name | Alan Kwok |
| Telephone No. | +852 9631 0671 |
| Fax | +852 3974 6971 |
| Email Address | a.kwok@prhk.ltd |
| Date Prepared | 2024-12-05 |
2. DEVICE
| Device Name/ Trade Name | SIRIUS Endoscope System |
|---|---|
| Model Number | PR-SI-1230 |
| Common Name | Endoscope system |
| Classification Name | 876.1500 Endoscope and Accessories884.1720 Laparoscope, Gynecologic (And Accessories) |
| Classification Panel | General & Plastic SurgeryObstetrics/Gynecology |
| Product Code | HET, GCJ, FGB |
| Device Class | II |
3. PREDICATE DEVICE
K221642: SIRIUS Endoscope System
4. DEVICE DESCRIPTION
The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application.
Page 6
The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion section is 10 mm diameter and 342 mm working length. Stereo camera with 1080 high-definition resolution. It has 90 degrees field of view, 10-100 mm depth of view.
The SIRIUS Endoscope System is to be used only under the supervision of a trained surgeon and professional clinical staff with trained use of the device.
The device is intended for use in Hospital operating theatres only.
5. INDICATIONS FOR USE
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The SIRIUS Endoscope System is substantially equivalent to the predicate device in terms of intended use and technological characteristics. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device.
The following are comparisons between subject device and the predicate device.
| Subject Device | Predicate Device (K221642) | Comments |
|---|---|---|
| Trade Name | SIRIUS Endoscope System | SIRIUS Endoscope System |
| Model No. | PR-SI-1230 | N/A |
| Manufacturer | Precision Robotics (Hong Kong) Limited | Precision Robotics (Hong Kong) Limited |
| Device Class | Class II | Class II |
| Product Code | HET, GCJ, FGB | HET, GCJ, FGB |
| Regulation number | 884.1720876.1500 | 884.1720876.1500 |
| Regulation Name | Endoscope and Accessories | Endoscope and Accessories |
Page 7
| Intended Use/ Indications for Use | It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity. | It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity. | Same |
|---|---|---|---|
| Operating Principles | Tendon driven articulating 3D video endoscope driven electromechanically using motors in the handle. | Tendon driven articulating 3D video endoscope driven electromechanically using motors in the handle. | Same |
| Anatomical Access | Thoracic and abdominal cavities including female reproductive organs. | Thoracic and abdominal cavities including female reproductive organs. | Same |
| Direction of View | 0° camera angle | 0° camera angle | Same |
| Shaft diameter (OD) | 10 mm | 10 mm | Same |
| Tip Articulation | ± 90° for each up-down joint allowing retroflexion ± 45° for left-right joint | ± 90° for each up-down joint allowing retroflexion ± 45° for left-right joint | Same |
| Working Length | 342 mm | 340 mm | DifferentPhysical difference; no difference in performance |
| Shaft material | TPU, Stainless steel, UPF75-2 | TPU, Stainless steel, UPF75-2 | Same |
| Optics Type | Color | Color | Same |
| Resolution | 1920 x 1080 | 1920 x 1080 | Same |
| Single Use | Yes | Yes | Same |
| Sterilization | EO sterilization | EO sterilization | Same |
| Biocompatibility | Patient contacting components meet ISO10993 standard | Patient contacting components meet ISO10993 standard | Same |
| Electrical Safety | Comply with EMC standards for medical electrical equipment in IEC 60601-1-2 | Comply with EMC standards for medical electrical equipment in IEC 60601-1-2 | Same |
| Joystick Design | Customized joystick | Off-the-shelf joystick | DifferentPerformance verified to be equivalent |
| Locking Mechanism | Locking mechanism was added for the laparoscope handle | No locking mechanism for the laparoscope handle | DifferentPerformance verified to be equivalent |
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Discussion:
The subject device has the same intended use and technological characteristics as the predicate device. Operating principles, anatomical access, shaft material and other technical specifications are the same for both devices. Mechanical and electronic feature differences between the subject device and its predicate were verified by electrical safety and electromagnetic compatibility tests and usability tests. These differences have no impact on the effectiveness and safety of the device, so it does not affect substantial equivalence on safety and effectiveness.
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Laparoscope Head was conducted in accordance with International Standard ISO 10993-1:2005, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2017 as recognized by FDA. The evaluation included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Pyrogen
Sterility
The sterilization of the product is achieved using ethylene oxide sterilization. Sterilization condition is validated per ISO 11135: 2014 overkill half-cycle approach. The sterility assurance level (SAL) is 10⁻⁶. The amount of ethylene oxide and chlorohydrin residual levels are within the limit and in compliance with ISO 10993-7: 2008 requirement.
Page 9
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on SIRIUS endoscope system. The device complies with IEC 60601-1, IEC60601-2-18 standards for safety and the IEC 60601-1-2 standard for EMC.
Light Source Safety
Light source safety was conducted on SIRIUS endoscope system. The lamp is certified as Risk group 2 and complies with IEC 62471: 2006.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software documentation level applied for this device was considered as Basic Documentation.
Performance Testing
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ISO 8600-1:2015, Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- ISO 8600-3:2019, Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
- ISO 8600-4:2014, Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- ISO 8600-7:2012, Endoscopes — Medical endoscopes and endotherapy devices — Part 7: Basic requirements for medical endoscopes of water-resistant type
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Usability Engineering Testing
Usability engineering tests were conducted on SIRIUS endoscope system according to ANSI AAMI IEC 62366-1:2015+AMD1:2020. Formative and summative evaluations were conducted. Results and improvement action demonstrated that residual risk regarding usability is minimized and acceptable. The benefits of the evaluated medical device SIRIUS Endoscope System significantly exceed its possible risks of use-error concerns.
8. CONCLUSIONS
Based on the information provided within the 510(k) submission, proposed SIRIUS Endoscope System substantially equivalent to the predicate device and is as safe, as effective and perform as well as the legally marketed predicate device.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.