(189 days)
Not Found
No
The document describes a robotic endoscope system with advanced mechanical features (articulated tip, 3D vision) but does not mention any AI or ML capabilities for image analysis, control, or other functions. The performance studies listed are standard for medical devices and do not indicate AI/ML validation.
No
The device is described as an endoscope system used for observation and surgical procedures, not for treatment or therapy. It assists in visualization and minimally invasive surgery.
No
Explanation: The device is described as an endoscope system used for "endoscopy and endoscopic surgery" within specific anatomical cavities. Its function involves providing a flexible camera system for "minimal invasive surgery application" and changing viewing direction. There is no mention of the device being used to identify, detect, or diagnose a disease, condition, or health status. The focus of the description is on visualization and surgical assistance.
No
The device description explicitly lists hardware components such as a Video Processor, Laparoscope Handle, Laparoscope Head, and Joystick. It also mentions physical characteristics like diameter, working length, and camera specifications. The performance studies include testing for biocompatibility, sterility, electrical safety, and light source safety, which are all related to hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. This involves direct visualization and manipulation of internal organs during surgical procedures.
- Device Description: The device is a robotic endoscope system designed for minimal invasive surgery. It's a camera system with a flexible tip for viewing and navigating within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The SIRIUS Endoscope System is a surgical instrument used in vivo (within the body) for visualization and assistance during surgical procedures.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
HET, GCJ, FGB
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
thoracic and abdominal cavities including female reproductive organs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained surgeons and professional clinical staff with trained use of the device.
Hospital operating theatres only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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: 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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) |
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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, New |
| Territories, 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/ Trade
| Name: | SIRIUS Endoscope System |
|---|---|
| Common Name | Endoscope system |
| Classification Name: | 876.1500 Endoscope and Accessories |
| 884.1720 Laparoscope, Gynecologic (And Accessories) | |
| Classification Panel: | General & Plastic Surgery |
| Obstetrics/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
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.
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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 3D
Deflectable Videoscope
MAJ-Y1054 3D Processor
Olympus CV-190 EVIS Extra
III Video system center | -- |
| Manufacturer | Precision Robotics (Hong
Kong) Limited | Olympus Medical System
Corp. | -- |
| Device Class | Class II | Class II | Same |
| Product Code | HET, GCJ, FGB | HET, GCJ, NWB, FGB | Similar |
| Regulation number | 876.1500
884.1720 | 876.1500
884.1720 | Same |
| Regulation Name | Endoscope and Accessories | Endoscope and Accessories | Same |
| Intended Use/
Indications for Use | It is intended for use for
endoscopy and endoscopic
surgery within the thoracic
and abdominal cavities | This instrument is
indicated for use within
the thoracic and
abdominal cavities | Same |
| | | | |
| | including female
reproductive organs. Not
suitable for use for
observation and treatment
of the heart and must not
contact the heart or its
vicinity. | including female
reproductive organs.
This instrument must not
be used for observation or
treatment of the heart and
must not contact the heart
or any area near the
heart. In addition, this
instrument must not come
into contact with any
device or therapeutic
accessory that contacts
the heart or any area near
the heart. | |
| Operating Principles | Tendon driven articulating
3D video endoscope driven
electromechanically using
motors in the handle. | Cable steered articulating
3D video endoscope driven
manually using mechanical
levers in the scope handle. | Different
The laparoscope
head movement of
subject device is
controlled
electromechanically.
It shas validated and
compliance to
IEC60601-1, IEC
62304 and ISO8600. |
| 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 | $\pm$ 90° for each up-down
joint allowing retroflexion
$\pm$ 45° for left-right joint | $\pm$ 100° | Similar
Angle of deflection
meet the
requirement of ISO
8600-1:2015. |
| Working Length | 340 mm | 370 mm | Different
Physical difference. |
| Shaft material | TPU, Stainless steel,
FLUORZ-UPF75-2 | Carbon Fiber, covered with
heat shrink sheathing | Different
Differences are
addressed through
biocompatibility
testing per
ISO10993. |
| Optics Type | Color | Color | Same |
| Resolution | 1920 x 1080 | 1080 x 601 | Subject has higher
resolution |
| Single Use | Yes | No | Different
The sterilization
validation has been
performed 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 provided
non-sterile | Different
The sterilization
validation has been
performed by ISO
11135:2014. |
|------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Biocompatibility | Patient contacting
components meet
ISO10993 standard | Patient contacting
components meet
ISO10993 standard | Same |
| Electrical Safety and
EMC | complies with IEC 60601-1,
IEC60601-2-18 standards
for safety and IEC
60601-1-2 standard for
EMC | complies with IEC 60601-1,
IEC60601-2-18 standards
for safety and IEC
60601-1-2 standard for
EMC | 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.