(449 days)
No
The device description focuses on robotic control via joystick or manual input, calculating movements based on a defined trocar point and desired view. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "software of the device calculates the required individual movements" based on explicit inputs, which is standard algorithmic control, not AI/ML.
No
Explanation: The SOLOASSIST II is a robotic system designed to hold and position a rigid laparoscope/endoscope during minimally invasive surgical interventions. It does not directly provide therapy or treatment to the patient; its function is to assist the surgeon by providing stable visualization.
No
The SOLOASSIST II is a robotic computer-driven system designed to hold and position a rigid laparoscope/endoscope during minimally invasive procedures. Its function is to provide physical support and controlled movement for the endoscope, not to interpret or analyze medical images or data for diagnostic purposes.
No
The device description clearly outlines physical components such as a robotic arm, motors, a joystick, a control panel with buttons and indicators, a tension sleeve, an endoscope clamp, and a universal joint. It also mentions mechanical movements and a quick fastener for mounting/removal, indicating it is a hardware device with integrated software for control.
Based on the provided information, the SOLOASSIST II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- SOLOASSIST II Function: The SOLOASSIST II is a robotic system designed to hold and position a rigid laparoscope/endoscope during surgical procedures. Its function is to assist the surgeon with visualization by controlling the movement of the endoscope.
- No Specimen Analysis: The SOLOASSIST II does not analyze any biological specimens. It is a tool used during a surgical procedure to facilitate visualization, not to perform diagnostic tests on samples.
Therefore, the SOLOASSIST II falls under the category of a surgical instrument or robotic surgical system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.
Product codes
NAY
Device Description
The SOLOASSIST II is a robotic computer driven system designed to hold and position a rigid laparoscope/endoscope. The device includes a key unit, a mains adapter, an endoscope clamp, a tension sleeve, a sterilization tray, and a joystick. Patient-contacting components include a universal joint (tracer pin). Accessories include a transport trolley and a sterile cover.
The device weighs 11.5 kg and has dimensions of 1153 x 401 x 270mm. It has a safe working load of 1 kg and features 3 motorized axes with software-based movement control. It is controlled by a joystick and has a quick-fastener for mounting/removal. Components like the universal joint, joystick, endoscope clamp, and tension sleeve can be steam pressure sterilized.
The SOLOASSIST II allows the user to control endoscope movements via a wired joystick mounted on the surgical instrument, or manually by pushing a release button on the Control Panel. The Control Panel has two buttons (one for setting the TROCAR POINT, one for manual movement) and five indications. The device calculates required individual axis movements based on the saved TROCAR POINT and desired view to achieve the total movement. For example, pushing the joystick's left button moves the image left, and the device adjusts accordingly. It also allows for zoom in/out. The Tension Sleeve and Endoscope clamp are screwed together, slid over the endoscope, and tightened. The correct tension sleeve for the endoscope diameter must be used. Endoscope, camera, and monitor are not part of the SOLOASSIST II. The Universal Joint, mounted on the SOLOASSIST II, has a tracer pin used to define the TROCAR POINT near the body opening; this point is saved by pushing a button on the control panel. The Endoscope Clamp is then mounted on the Universal Joint. The system can be manually repositioned by holding the control panel and pushing the unlocking button while moving the arm. The quick-fastener allows for complete mounting or removal for emergency open surgery conversion.
Key performance specifications include stable endoscope fixation (even with power loss), enabling endoscope repositioning via joystick or alternative input (functionality may be lost with power loss), and manual repositioning of the system arm via button (functionality may be lost with power loss).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
minimally invasive abdominal surgery, thoracic surgery, urology surgery or gynecology surgery.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Users: general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.
Care Setting: healthcare facility/hospital, Operating room / operation table.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Biocompatibility testing: Conducted according to Directive 93/42/EEC, 90/385/EEC, DIN EN ISO/IEC 17025: 2005, and GLP. Tests included Cytotoxicity (L 929-Proliferation EN ISO 10993-5, -12, LM P 4-06, LM SOP 4-06-01) and Chemical analysis (characterization of organic leachables/extractables) (EN ISO 10993-1, -12, -18, LM P8-01, LM SOP 8-01-01).
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4, IEC 60601-1-6, and IEC 60601-2-18 standards.
- Software Verification and Validation Testing: Conducted according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern. Complies with IEC 62366 and IEC 62304 standards.
- Mechanical, acoustic and bench testing:
- Quick release connector and angle joint: Tested tilting mounted on rails (0°, 45°, 90°) and angle joint engagement.
- Temperature test: Tested use and storage temperature ranges.
- Force test: Tested forces needed to move arm system in release status.
- Lifetime test: 35,000 movements in x-direction, 55,000 movements in y-direction, 35,000 movements in z-direction (movement length 30cm). Motor lifetime for at least 1000h (500h with cycle movement with radius 15cm and 28cm).
- Testing moving after fixation: Shifting after manual positioning with 1kg load (3 turns, averaged measurement 2.93mm); Falling speed after 2 hours (max. 0.0024mm/min).
- Tensile stress: Examination weight 8.1kg (8x normal load) according to EN 60601-1:2016; Chapter 9.8.2.
- Sound test: 64.0 dBA (pushing release button); 60.2 dBA (during active operation and 1kg load) according to EN 60601-1:2006, Chapter 9.6.2.1.
- Shock resistance: Continuous force of 240N for 5s (contact with surfaces by a 30mm diameter circular area) according to EN 60601-1:2006, Chapter 15.3.2.
- Impact resistance: Steel ball, weight 500g, height 1.3m according to EN 60601-1:2006; Chapter 15.3.3.
- Drop resistance: Dropped 3 times from 3cm height over a wooden plate (d=50mm +/- 5mm) from each intended use start situation according to EN 60601-1:2006, Chapter 15.3.4.2.
- Tightening test: Turning star knob clock and anti-clockwise till stop and held for 2s with 4Nm force, repeated 10 times according to EN 60601-1:2006, Chapter 15.4.6.1.
- Animal Study: No animal study was conducted.
- Cybersecurity risk assessment: Conducted based on FDA guideline "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- Sterilization: Tests conducted according to Directive 93/42/EEC, 90/385/EEC, DIN EN ISO/IEC 17025: 2005, and GLP. Included Microbiological efficiency control of steam sterilization (EN ISO 17664, EN ISO 17665-1, ANSI/AAMI ST79, ANSI/AAMI ST81, ANSI/AAMI TIR12, ASTM E 1766 mod., EN 556-1, ANSI/AAMI ST67, KRINKO/RKI/BfArM guideline, LM P 2-11-04, LM SOP 2-11-04), Microbiological efficiency control of automated cleaning and disinfection (EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR12 mod., AAMI TIR 30 mod., ASTM E 2314 mod., ASTM E 1837 mod., KRINKO/RKI/BfArM guideline, LM SOP 2-11-01), Efficiency control for cleaning (optimized protein test) during automated cleaning/disinfection (EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR 12 mod., AAMI TIR 30, ASTM E 2314 mod. , KRINKI/RKI/BfArM guideline, FDA guidance, LM SOP 2-11-01), Microbiological efficiency control of manual cleaning and disinfection (EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR12 mod., AAMI TIR 30 mod., ASTM E 2314 mod., ASTM E 1837 mod., KRINKO/RKI/BfArM guideline, LM SOP 2-11-02), Efficiency control for manual cleaning (optimized protein test) (EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR 12 mod., AAMI TIR 30, ASTM E 2314 mod. , KRINKI/RKI/BfArM guideline, FDA guidance, LM SOP 2-11-01), and Efficiency control of the cleaning (TOC method) during automated cleaning/disinfection (EN ISO 17664, ANSI/AAMI/ISO 17664, ANSI/AAMI TIR12 mod., AAMI TIR 30, ASTM E 2314 mod, KRINKO/RKI/BfArM guideline, RDS 007, FDA guidance, LM SOP 2-11-01).
- Human Factor Testing: Conducted according to FDA guideline "Applying Human Factors and Usability Engineering to Medical Devices" (issued on February 3, 2016). 15 operations were conducted successfully with no unexpected device or patient-related adverse events.
- Packaging: Package drop test conducted for the SOLOASSIST II and its trolley according to ISTA 1A. Drop height for mass 45 to 68kg was 200mm. All surfaces, relevant edges, and a corner were tested. No damage occurred.
Clinical Performance Data:
- No clinical evaluation was conducted for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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September 21, 2018
AKTORmed GmbH % Mr. Martin Dumberger Managing Director Micro-Epsilon America 8120 Browneigh Road Raleigh, North Carolina 93092
Re: K171947
Trade/Device Name: SOLOASSIST II Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: August 20, 2018 Received: August 22, 2018
Dear Mr. Dumberger:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known) | K171947 |
|---|---|
| Device Name | SOLOASSIST II |
| Indications for Use (Describe) |
The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.
| 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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្រុក
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Image /page/3/Picture/1 description: The image contains the logo for AKTORmed Robotic Surgery. The logo features the letters 'am' in a blue circle on the left. To the right of the circle is the word 'AKTORmed' in a larger, bold font, with the letters 'TM' in a smaller font in the upper right corner. Below 'AKTORmed' are the words 'ROBOTIC SURGERY' in a smaller font.
510(k) Summary for SOLOASSIST II
The 510(k) summary information is being submitted in accordance with the requirements of the Code of Federal Regulations Title 21 section 807.92.
1. Prepared by
| Name and date
510(k) Summary was prepared | Author name: Andreas Mohr
Date created: 2018-JUL-19 |
| ---------------------------------------------- | -------------------------------------------------------- |
|---|
2. 510 (k) Submitter
| Manufacturer / 510(k) Submitter
(Company Name, Address, Web) | AKTORmed GmbH
Borsigstraße 13
D-93092 Barbing
Germany
http://aktormed.info/en/homepage |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person for 510 (k)
(Name, Title, Address, Phone & Fax Number, Email) | Andreas Mohr
M.Sc.
Borsigstraße 13
D-93092 Barbing
Germany
Tel: +49 9401 9320 150
Fax: +49 9401 9320 115
andreas.mohr@aktormed.com |
3. New Device
| Device Trade Name & Model Number(s)
(The trade name is the name under which the device will be
| marketed) | SOLOASSIST II |
|---|---|
| Device Common or Usual Name | |
| (is the name of the device as it is commonly known e.g., syringe, hip | |
| implant.) | Active endoscope holder |
| Device Medical specialty panels and Regulation | |
| Part Number | |
| (such as Anesthesiology 21CFR868, Cardiovascular Part | |
| 21CFR870, Chemistry 21CFR862, Dental 21CFR872 ) | Gastroenterology-Urology 21 CFR 876 |
| Device Regulation Number | |
| (such as 21CFR 868.1075 ) | 21 CFR 876.1500 |
| Device Regulation Name | |
| (such as Argon gas analyzer ) | Endoscope and accessories |
| Device Classification Product Code | |
| (3 character unique product identifier) | NAY |
| Device Class | |
| (i.e., whether it is unclassified or a class I, II, or III device) | Class II |
4
4. Predicate Device
| Manufacturer / 510(k)Submitter
| (Company Name) | COMPUTER MOTION, INC. |
|---|---|
| Device Trade Name & Model Number(s) | |
| (The trade name is the name under which the device will be | |
| marketed) | AESOP 3000 System |
| Device Regulation Number | |
| (such as 21 CFR 868.1075..) | 21 CFR 876.1500 |
| Device Classification Product Code | |
| (3 character unique product identifier) | GCJ |
| Device Class | |
| (i.e., whether it is unclassified or a class I, II, or III device) | Class II |
| Predicate Device 510(k) Number | K972699 |
5. Description of the Device
Device Identification:
- Key device: .
- Soloassist II ।
- Device components
- Mains adapter with connector and connecting cable -
- Endoscope clamp l
- -Tension sleeve Ø4 - 12,7mm
- -Sterilisation Tray
- Joystick -
- . Patient contacting components
- Universal joint (tracer pin) -
- Device accessories ●
- Transport trolley -
- -Sterile Cover
Device Characteristics
- Weight: 11,5kg ●
- Dimensions: 1153 x 401 x 270mm ●
- Safe working load: ● 1kg
- 3 motorized axes of the arm system ●
- Software based movement control of the arm system .
- Controlled by joystick ●
- Quick-fastener
- Sterilization method: steam pressure sterilization (Universal joint, joystick, endoscope ● clamp, tension sleeve)
Environment of Use
- healthcare facility/hospital: .
- Operating room / operation table ।
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Image /page/5/Picture/1 description: The image is a logo for AKTORmed Robotic Surgery. The logo features the letters "am" in a blue circle on the left. To the right of the circle is the word "AKTORmed" in gray, with the letters in a bold sans-serif font. Below the word "AKTORmed" is the phrase "ROBOTIC SURGERY" in a smaller, sans-serif font.
Brief Written Description of the Device:
The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a joystick or manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II.
The joystick is linked to related connection of the SOLOASSIST II by a wire. The joystick is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm.
The Tension Sleeve and the Endoscope clamp are loosely screwed together. The combination of Tension Sleeve and Endoscope clamp are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right tension sleeve for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II.
The starting point of the movement for an operation will be saved as the TROCAR POINT. The Universal Joint has to be mounted on the SOLOASSIST II. A mounted Universal Joint can be removed by using the release slider. To define the Trocar point the Universal Joint has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of SOLOASSIST
The Endoscope Clamp (together with Tension Sleeve and Endoscope) is mounted on the Universal Joint, so the SOLOASSIST II is ready for operation.
Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the joystick the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the joystick it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out.
Additionally it is possible to move the arm of the SOLOASSIST II without the use of the iovstick. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system.
To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.
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Image /page/6/Picture/1 description: The image shows the logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters 'am' inside, followed by the word 'AKTORmed' in a larger, bolder font. Below 'AKTORmed' are the words 'ROBOTIC SURGERY' in a smaller font.
Key Performance Specifications/Characteristics of the Device
Stable fixation of an endoscope: The system holds an endoscope in a fixed position, which was adjusted by the user. This must also be assured when power is lost.
Enabling the repositioning of an endoscope: The system enables the user (surgeon) to reposition the endoscope by use of a joystick or alternative input device. In case of power loss or other failures it is acceptable that this function is not available.
Manual repositioning of the system arm: The system enables the user (surgeon) to reposition the endoscope by pushing a button. In case of power loss or other failures it is acceptable that this function is not available.
6. Intended Use and Indication for Use
6.1. Intended Use
The SOLOASSIST II allows the user (surgeon) to control movements of a rigid endoscope directly by using the joystick. The SOLOASSIST II is intended for use in minimally invasive abdominal surgery, thoracic surgery, urology surgery or gynecology surgery where a rigid endoscope is intended for use. The SOLOASSIST II gives the advantage of an image without jerking.
6.2. Indication for Use
The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.
6.3. Comparison to Predicate Device
The AKTORmed SOLOASSIST II is substantially equivalent in intended use and technology to the predicate device, COMPUTER MOTION, INC. AESOP 3000 System (K972699).
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Image /page/7/Picture/1 description: The image is a logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters "am" in white on the left side. To the right of the circle is the word "AKTORmed" in gray, with the letters in a bold, sans-serif font. Below "AKTORmed" is the phrase "ROBOTIC SURGERY" in a smaller, lighter gray font.
7. Comparison of Technological Characteristics with the Predicate Device
Holding and controlling the movement of a rigid endoscope by motorized axes is the technological principle for both, the SOLOASSIST II and the predicate devices AESOP 3000. Both devices are used for minimally invasive interventions with a software based assistance system.
At a high level, SOLOASSIST II and the predicate devices AESOP 3000 are based on the following same technological elements:
- Used for minimally invasive surgery ●
- Software based control of moving and holding of a rigid endoscope .
- Joystick to control the device ●
- Electricity as energy source
- . Compatible with most of the common endoscopes
- Similar accessory
- . Invariant trocar point to position the arm system
The following technological differences exist between SOLOASSIST II and the predicate devices:
- Different assembly of the motorized axes ●
- Joystick of SOLOASSIST II can be mounted on the MIT instrument of the surgeon, so ● the surgeon can move the system while operating.
- Additional input devices for the AESOP 3000: Voice control and foot pedals ● → Not implementing these input devices in the SOLOASSIST do not affect the safety and efficiency
- Number of motorized axes .
- Different dimensions: SOLOASSIST II is smaller than AESOP 3000 ●
- Safe working load: SOLOASSIST II can carry a load of 1kg, AESOP 3000 only 500g ●
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
8.1. Summary Non-Clinical Performance Data
8.1.1.Biocompatibility testing
The biocompatibility evaluation for the SOLOASSIST II device was conducted according to Directive 93/42/EEC, 90/385/EEC, DIN EN ISO/IEC 17025: 2005 (DAkkS D-PL-13392-01-00 accredited, ZLG-AP-311.10.26 recognized), and Good Laboratory Practices (GLP).
Following tests were conducted:
Cytotoxicity, L 929-Proliferation EN ISO 10993-5, -12, LM P 4-06, LM SOP 4-06-01 Chemical analysis (characterization of organic leachables/extractables) EN ISO 10993-1, -12, -18, LM P8-01, LM SOP 8-01-01
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Image /page/8/Picture/1 description: The image is a logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters "am" inside, followed by the word "AKTORmed" in gray. Below the word "AKTORmed" is the phrase "ROBOTIC SURGERY" in a smaller, gray font. The logo is clean and modern, and it conveys a sense of precision and technology.
8.1.2.Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted for the SOLOASSIST II device. The system complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. They system also complies with IEC 60601-1-4 standard, IEC 60601-1-6 and IEC 60601-2-18.
8.1.3.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, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.
The SOLOASSIST II complies with the IEC 62366 standard and the IEC 62304.
8.1.4.Mechanical, acoustic and bench testing
Mechanical, acoustic and bench testing were conducted for the SOLOASSIST II.
Following tests were conducted:
Quick release connector and angle joint: -
In this test the tilting of the SOLOASSIST II mounted on rails was tested (0°, 45°, 90°); also the engage of the angle joint of the SOLOASSIST II was tested according to functionality
-Temperature test:
Testing the use of the device for its temperature range for use and testing the status of the device for its storage temperature range
-Force test:
Testing the forces that are needed to move the arm system while in release status
-Lifetime test:
35.000 movements in x-direction, 55.000 movements in y-direction, 35.000 movements in z-direction (movement length 30cm)
Motor lifetime for at least 1000h (500h with cycle movement with radius 15cm and 28cm)
-Testing moving after fixation:
- Shifting after manual positioning with 1kg load; 3 turns; averaged । measurement 2,93mm
- Falling speed after 2 hours: max. 0,0024mm / min -
Tensile stress: -
(Mechanic according to EN 60601-1:2016; Chapter 9.8.2): Examination weight 8,1kg (8x normal load)
-Sound test:
(Mechanic according to EN 60601-1:2006, Chapter 9.6.2.1): 64.0 dBA (pushing release button); 60,2 dBA (during active operation and 1kg load)
-Shock resistance:
(Mechanic according to EN 60601-1:2006, Chapter 15.3.2): continuous force of 240N for 5s (contact with surfaces by a 30mm diameter circular area)
-Impact resistance:
(Mechanic according to EN 60601-1:2006; Chapter 15.3.3): Steel ball, weight 500q: Height of steel ball: 1,3m
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Image /page/9/Picture/1 description: The image is a logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters "am" inside, followed by the word "AKTORmed" in a bold, sans-serif font. Below the word "AKTORmed" is the phrase "ROBOTIC SURGERY" in a smaller, sans-serif font. The TM symbol is located to the right of the word "AKTORmed".
-Drop resistance:
(Mechanic according to EN 60601-1:2006, Chapter 15.3.4.2): SOLOASSIST II is hold over a wooden plate (d = 50mm +/- 5mm) in a height of 3cm. Dropped down 3 times out of each start situation that the SOLOASSIST II can be during the intended use.
-Tightening test:
(Mechanic according to EN 60601-1:2006, Chapter 15.4.6.1): Turning star know clock and anti-clockwise till stop and hold the position for 2s with a force of 4Nm. Repeated 10 times.
8.1.5.Animal Study
No animal study was conducted for this device
8.1.6.Cybersecurity risk assessment
Cybersecurity risk assessment was conducted based on FDA quideline "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
8.1.7.Sterilization
The Sterilization tests for the SOLOASSIST II device was conducted according to Directive 93/42/EEC. 90/385/EEC. DIN EN ISO/IEC 17025: 2005 (DAkkS D-PL-13392-01-00 accredited, ZLG-AP-311.10.26 recognized), and Good Laboratory Practices (GLP).
Following tests were conducted:
- Microbiological efficiency control of steam sterilization, fractionated vacuum cycle l / dynamic-air-removal cycle, product group sterilizable arm components EN ISO 17664, EN ISO 17665-1 (overkill method, partial cycle), ANSI/AAMI ST79, ANSI/AAMI ST81, ANSI/AAMI TIR12, ASTM E 1766 mod., EN 556-1, ANSI/AAMI ST67, KRINKO/RKI/BfArM guideline, LM P 2-11-04, LM SOP 2-11-04
- -Microbiological efficiency control of the automated cleaning and disinfection. product group sterilizable arm components EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR12 mod., AAMI TIR 30 mod., ASTM E 2314 mod., ASTM E 1837 mod., KRINKO/RKI/BfArM quideline, LM SOP 2-11-01
- Efficiency control for cleaning (optimized protein test) during automated cleaning/Disinfection, product group sterilizable arm components EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR 12 mod., AAMI TIR 30, ASTM E 2314 mod. , KRINKI/RKI/BfArM guideline, FDA guidance, LM SOP 2-11-01
- -Microbiological efficiency control of the manual cleaning and disinfection, product group sterilizable arm components EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR12 mod., AAMI TIR 30 mod., ASTM E 2314 mod., ASTM E 1837 mod., KRINKO/RKI/BfArM guideline, LM SOP 2-11-02
- -Efficiency control for manual cleaning (optimized protein test), product group sterilizable arm components
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Image /page/10/Picture/1 description: The image contains the logo for AKTORmed Robotic Surgery. The logo features a blue circle with the letters "am" inside, followed by the word "AKTORmed" in a larger, bold font. Below the word "AKTORmed" are the words "ROBOTIC SURGERY" in a smaller font.
EN ISO 17664, ANSI/AAMI ST81, ANSI/AAMI TIR 12 mod., AAMI TIR 30, ASTM E 2314 mod. , KRINKI/RKI/BfArM guideline, FDA guidance, LM SOP 2-11-01
- Efficiency control of the cleaning (TOC method) during automated cleaning / disinfection, product group sterilizable arm components EN ISO 17664, ANSI/AAMI/ISO 17664, ANSI/AAMI TIR12 mod., AAMI TIR 30, ASTM E 2314 mod, KRINKO/RKI/BfArM guideline, RDS 007, FDA guidance, LM SOP 2-11-01
8.1.8.Human Factor Testing
Human Factor Testing for the SOLOASSIST II was conducted according to FDA quideline "Applying Human Factors and Usability Engineering to Medical Devices" (issued on February 3, 2016)
Human factor test has been conducted for the SOLOASSIST II. There has been 15 operations conducted. The test was performed successfully. No unexpected device related events or patient related adverse events occurred during the Human Factor Testing.
8.1.9.Packaging
Package drop test was conducted for the SOLOASSIST II and its trollev according to ISTA 1A. SOLOASSIST II and trolley have been packages in wooden box with filling materials. Drop height for mass 45 to 68kg was set to 200mm. All surfaces and relevant edges as well as a corner was tested. No damage of the SOLOASSIST II occurred.
8.2. Summary Clinical Performance Data
No clinical evaluation was conducted for this device.
8.3. Conclusion Performance Data
Based on the nonclinical performance data, we conclude that the SOLOASSIST II is substantially equivalent to the predicated device under the Federal Food, Drug and Cosmetic Act.