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.

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. 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 is 10 mm diameter and 340 mm working length. Stereo camera with 1080 high-definition resolution. It has 120 degrees field of view, 10-100mm depth of view and bright light with 300 lumen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (if available)	Reported Device Performance
Biocompatibility	Meets ISO 10993 standards	Complies with ISO 10993-1, -5, -10, -11 requirements (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogen testing performed).
Sterility	Sterility Assurance Level 10^-6	Validated via Ethylene Oxide (EO) sterilization per ISO 11135:2014 overkill half-cycle approach. EO and chlorohydrin residuals within ISO 10993-7 limits.
Electrical Safety and EMC	Complies with IEC 60601 standards	Complies with IEC 60601-1, IEC 60601-2-18 (safety) and IEC 60601-1-2 (EMC).
Light Source Safety	Complies with IEC 62471	Lamp certified as Risk group 2 and complies with IEC 62471:2006.
Software Verification and Validation	Adherence to FDA Guidance	Software Verification and Validation Testing conducted as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern.
Usability Evaluation	Adherence to ANSI AAMI IEC 62366-1	Conducted per ANSI AAMI IEC 62366-1:2015+AMD1:2020. Usability testing and improvement actions minimized residual risk.
Performance Testing (Endoscope Standards)	Meets ISO 8600-1	Complies with ISO 8600-1:2015.
	Meets ISO 8600-3	Complies with ISO 8600-3:2019 (determination of field of view and direction of view).
	Meets ISO 8600-4	Complies with ISO 8600-4:2014 (determination of maximum width of insertion portion).
	Meets ISO 8600-7	Complies with ISO 8600-7:2012 (basic requirements for water-resistant medical endoscopes).
Tip Articulation	Meets ISO 8600-1:2015 requirements	Angle of deflection for ±90° up-down and ±45° left-right joints meet the requirement of ISO 8600-1:2015.
Shaft Material Compatibility	Biocompatible	Different materials from predicate, but both are biocompatible, and biocompatibility tests demonstrated safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and compliance to international standards. It does not specify "test sets" in the context of patient data or clinical trials with specific sample sizes. The data provenance is not mentioned beyond the manufacturer being in Hong Kong. The testing appears to be primarily laboratory-based (bench testing) rather than clinical studies using patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document focuses on technical and regulatory compliance testing rather than expert-derived ground truth from clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the studies described are not clinical studies requiring adjudication of diagnostic outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. The device described is an endoscope system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

There is no mention of an algorithm-only standalone performance study. The device is hardware (an endoscope system) with associated software, but not an AI algorithm performing diagnostic tasks independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance testing, the "ground truth" is adherence to international standards (e.g., ISO 8600 series) and published specifications. For biocompatibility, sterility, electrical safety, etc., the ground truth is defined by the requirements of the respective international standards (e.g., ISO 10993, ISO 11135, IEC 60601, IEC 62471).

8. The sample size for the training set

This information is not applicable or not provided. The device is an endoscope system, and the testing described is not related to machine learning model training.

9. How the ground truth for the training set was established

This information is not applicable or not provided for the same reasons as above.

Summary

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December 12, 2022

Precision Robotics (Hong Kong) Limited % Sharon Hsu Consultant Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China

Re: K221642

Trade/Device Name: SIRIUS Endoscope System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope And Accessories Regulatory Class: Class II Product Code: HET. GCJ. FGB Dated: November 9, 2022 Received: November 9, 2022

Dear Sharon Hsu:

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,

Jessica Carr -S

for Long Chen, PhD 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

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Indications for Use

510(k) Number (if known) K221642

Device Name Sirius Endoscope System

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image contains the logo for Precision Robotics. The logo consists of a stylized blue atom-like symbol on the left, followed by the words "PRECISION" and "ROBOTICS" stacked on top of each other in a sans-serif font, also in blue. The overall design is clean and modern.

510(k) Summary

1. SUBMITTER

Name :	Precision Robotics (Hong Kong) Limited
Address:	Suite 611-612 Lakeside 2 (10W), Hong Kong Science Park, Shatin, NewTerritories, Hong Kong
Contact Name:	Sai Yan Ng
Telephone No.:	+852 3974 6970
Fax:	+852 3974 6971
Email Address:	s.ng@precisionrobotics.com
Date Prepared:	2022-12-03

2. DEVICE

Device Name/ TradeName:	SIRIUS Endoscope System
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

Olympus LTF-190-10-3D, Endoeve Flex 3D Deflectable Videoscope, K123365: MAJ-Y1054 3D Processor, Olympus CV-190 EVIS Extra III Video system center

4. DEVICE DESCRIPTION

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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 is 10 mm diameter and 340 mm working length. Stereo camera with 1080 high-definition resolution. It has 120 degrees field of view, 10-100mm depth of view and bright light with 300 lumen.

The SIRIUS Endoscope System is to be used only under the supervision of a trained surgeons and professional clinical staff with trained use of the device.

The device is intended for use in Hospital operating theatres only.

5. INDICATION FOR USE

lt 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 (K221642)	Predicate Device(K123365)	Comments
Trade Name	SIRIUS Endoscope System	Olympus LTF-190-10-3D,Endoeye Flex 3DDeflectable VideoscopeMAJ-Y1054 3D ProcessorOlympus CV-190 EVIS ExtraIII Video system center	--
Manufacturer	Precision Robotics (HongKong) Limited	Olympus Medical SystemCorp.	--
Device Class	Class II	Class II	Same
Product Code	HET, GCJ, FGB	HET, GCJ, NWB, FGB	Similar
Regulation number	876.1500884.1720	876.1500884.1720	Same
Regulation Name	Endoscope and Accessories	Endoscope and Accessories	Same
Intended Use/Indications for Use	It is intended for use forendoscopy and endoscopicsurgery within the thoracicand abdominal cavities	This instrument isindicated for use withinthe thoracic andabdominal cavities	Same

	including femalereproductive organs. Notsuitable for use forobservation and treatmentof the heart and must notcontact the heart or itsvicinity.	including femalereproductive organs.This instrument must notbe used for observation ortreatment of the heart andmust not contact the heartor any area near theheart. In addition, thisinstrument must not comeinto contact with anydevice or therapeuticaccessory that contactsthe heart or any area nearthe heart.
Operating Principles	Tendon driven articulating3D video endoscope drivenelectromechanically usingmotors in the handle.	Cable steered articulating3D video endoscope drivenmanually using mechanicallevers in the scope handle.	DifferentThe laparoscopehead movement ofsubject device iscontrolledelectromechanically.It shas validated andcompliance toIEC60601-1, IEC62304 and ISO8600.
Anatomical Access	Thoracic and abdominalcavities including femalereproductive organs.	Thoracic and abdominalcavities including femalereproductive organs.	Same
Direction of View	0° camera angle	0° camera angle	Same
Shaft diameter (OD)	10 mm	10 mm	Same
Tip Articulation	$\pm$ 90° for each up-downjoint allowing retroflexion$\pm$ 45° for left-right joint	$\pm$ 100°	SimilarAngle of deflectionmeet therequirement of ISO8600-1:2015.
Working Length	340 mm	370 mm	DifferentPhysical difference.
Shaft material	TPU, Stainless steel,FLUORZ-UPF75-2	Carbon Fiber, covered withheat shrink sheathing	DifferentDifferences areaddressed throughbiocompatibilitytesting perISO10993.
Optics Type	Color	Color	Same
Resolution	1920 x 1080	1080 x 601	Subject has higherresolution
Single Use	Yes	No	DifferentThe sterilizationvalidation has beenperformed by ISO

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Image /page/5/Picture/0 description: The image shows the logo for Precision Robotics. The logo consists of a blue atom-like symbol on the left, followed by the words "PRECISION ROBOTICS" in a sans-serif font. The word "PRECISION" is stacked on top of the word "ROBOTICS", and both words are in blue.

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Image /page/6/Picture/0 description: The image contains the logo for Precision Robotics. The logo consists of a blue atom-like symbol on the left, followed by the words "PRECISION" and "ROBOTICS" stacked on top of each other in a sans-serif font, also in blue. The logo is simple and modern, conveying a sense of technology and precision.

Sterilization	EO sterilization	Product is providednon-sterile	DifferentThe sterilizationvalidation has beenperformed by ISO11135:2014.
Biocompatibility	Patient contactingcomponents meetISO10993 standard	Patient contactingcomponents meetISO10993 standard	Same
Electrical Safety andEMC	complies with IEC 60601-1,IEC60601-2-18 standardsfor safety and IEC60601-1-2 standard forEMC	complies with IEC 60601-1,IEC60601-2-18 standardsfor safety and IEC60601-1-2 standard forEMC	Same

Discussion:

The tip articulation of subject device is within the range of predicate device. The specification of tip articulation of subject device fulfils the requirement of ISO 8600-1:2015. The difference does not affect the effectiveness and safety of the device.

The subject device has shorter working length than predicate device, this physical different does not impact the effectiveness and safety of the device.

The shaft material of subject device and predicate device are made of different materials, but both are biocompatible materials. The biocompatibility tests conducted demonstrated the safety of subject device.

The subject device is singe use device with EO sterilization validated by ISO 11135:2014. This difference does not impact the effectiveness and safety of the device.

Therefore, the differences between the subject device and its predicate do not affect substantially equivalent 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

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Image /page/7/Picture/1 description: The image shows the logo for Precision Robotics. The logo consists of a blue atom-like symbol on the left and the words "PRECISION ROBOTICS" in blue on the right. The words are stacked on top of each other.

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.

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 for this device was considered as a "Moderate" level of concern.

Usability Evaluation

The Usability evaluation for SIRIUS endoscope system is conducted in accordance with ANSI AAMI IEC 62366-1:2015+AMD1:2020, and, therefore, by extension IEC 60601-1-6 Edition 3.2. The usability verification and validation are well defined with criteria specified in the Usability Engineering Report. Usability testing results and improvement action demonstrated that residual risk regarding usability is minimized and acceptable. It is concluded that the usability evaluation is well performed and acceptable.

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:

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Image /page/8/Picture/1 description: The image contains the logo for Precision Robotics. The logo consists of a blue atom-like symbol on the left, followed by the words "PRECISION ROBOTICS" in a stylized, sans-serif font. The word "PRECISION" is stacked on top of the word "ROBOTICS". The color of the text is the same blue as the atom symbol.

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

8. CONCLUSIONS

The SIRIUS Endoscope System is substantially equivalent to the predicate device and present no new questions of safety or effectiveness.

Regulation Number and Section

§ 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.