The AutoLap System is indicated for General laparoscopic, Gynecologic and Urologic procedures for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope within surgical cavities during minimally invasive laparoscopic surgery.

Device Description

The AutoLap System is designed to hold and control the movement of a laparoscope or rigid endoscope during laparoscopic procedures. The AutoLap System includes both software and hardware. Hardware components include a Processing Unit, which includes the system's electronics and software algorithms, a Base Unit and a Laparoscopic Unit that include motors and sensors. The Base Unit is mounted on the operating bed. An accessory cart that is used for placing the system's components during the procedure and their storage afterwards is also provided. To maneuver the laparoscope to the desired position, the surgeon presses a single button, referred to as Command Unit, which is affixed to his/her hand or to the surgical instrument and transmits RF signals to the system. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system. Movements can be performed in the left/right, up/down and zoom in/ zoom out directions.

AI/ML Overview

This submission (K131375) describes the MST AutoLap System, a device designed to hold and control the movement of a laparoscope or rigid endoscope during minimally invasive laparoscopic surgery. The performance evaluation for this device primarily focuses on demonstrating its safety and meeting functional specifications, rather than clinical efficacy studies often seen with diagnostic AI.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety & Electrical	Electrical safety in accordance with ANSI/AAMI 60601-1:2005.	"Electrical safety was tested in accordance with ANSI/AAMI 60601-1:2005 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance."
Electromagnetic Compatibility	EMC in accordance with IEC 60601-1-2:2007.	"Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests."
Sterilization	Sterilization validation in accordance with ISO 11135-1 and 10993-7.	"Sterilization validation was conducted in accordance with the ISO 11135-1 and 10993-7 standards."
Packaging & Shelf Life	Packaging integrity and shelf life validation in accordance with ISO 11607-2 and ASTM D1649-09.	"Packaging integrity and shelf life validation in accordance with ISO 11607-2 and ASTM D1649-09."
Bench Testing (Functional)	Movement velocities in all DOF (degrees of freedom).	"Performance in terms of movement velocities in all DOF... have all been demonstrated." (Implies meeting predefined limits, though specific numerical criteria for velocities are not provided.)
	Movement range in all DOF.	"Performance in terms of... movement range in all DOF... have all been demonstrated." (Implies meeting predefined limits, though specific numerical criteria for ranges are not provided.)
	Directional movement control.	"Performance in terms of... directional movement control... have all been demonstrated." (Implies accurate response to commands.)
	Image stability.	"Performance in terms of... image stability, have all been demonstrated." (Implies the laparoscope movement does not introduce unacceptable image shake or blur.)
Bench Testing (Safety)	Emergency Stop Button functionality.	"Safety features such as Emergency Stop Button functionality... have all been demonstrated to meet their respective acceptance criteria." (Functionality, meaning it successfully stops the device when activated.)
	Warning messages.	"Safety features such as... warning messages have all been demonstrated to meet their respective acceptance criteria." (Correct display and function of warning messages.)
Animal Study	No operative complications related to the use of the AutoLap System.	"No operative complications related to the use of the AutoLap were observed."
	System's performance and safety during procedures.	"The results demonstrated the system's performance and safety. The system's performance in terms of the movement control was validated." (Implies that the device functioned as intended and safely during the animal procedures).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The primary "test set" that involves a direct assessment of device functionality in a surgical context is described as an "animal study."
Sample Size: Not explicitly stated as a number of animals (e.g., "5 pigs"), but refers to "domestic pigs" for "laparoscopic cholecystectomy and Nissen fundoplication."
Data Provenance: Not specified, but implied to be prospective data collected specifically for this study during the animal procedures. Country of origin not stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: "Several surgeons" performed the procedures in the animal study.
Qualifications of Experts: Not specified. It can be presumed they are experienced surgeons performing these types of laparoscopic procedures. However, no details on their specific qualifications (e.g., years of experience, board certification) are provided.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies where multiple readers or experts independently assess cases and their agreement or disagreement needs to be resolved to establish ground truth outcomes.

In this context, for the animal study:

Adjudication Method: Not applicable/not described in the traditional sense. The "ground truth" for complications and performance appears to be established directly by the "several surgeons" performing the procedures, likely based on their real-time observation and expert judgment during the surgeries. There's no mention of independent review or formal adjudication of findings after the fact by a separate panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The animal study focused on observing the device's performance and safety during procedures, not on comparing surgeon performance with and without the AI (or automated assistance in this case) on multiple cases with multiple readers. There's no mention of an effect size for human reader improvement with AI assistance. This device is not primarily an "AI diagnostic assistance" tool but rather a robotic/automated surgical assistant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Standalone Performance: Not explicitly described as a standalone study for the entire system's clinical performance. The "bench testing" represents a form of standalone testing for the device's functional parameters (movement velocities, range, control, image stability, safety features) without a human-in-the-loop during that specific test. However, this isn't assessing the device's diagnostic or surgical outcome capability as a standalone AI, but rather its electromechanical adherence to specifications. The system is designed to be a human-in-the-loop assistant, so a true "algorithm only" clinical performance assessment wouldn't be directly applicable to its intended use.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for bench testing (e.g., movement velocities, range, safety features) would be the device's engineering specifications and physical measurements obtained from sensors or external measurement tools.
Animal Study: The ground truth for the animal study was based on direct observation and expert judgment by the surgeons performing the procedures regarding the device's performance (movement control) and the occurrence (or absence) of operative complications related to its use. This is a form of expert consensus/clinical observation.

8. The Sample Size for the Training Set

The provided text does not contain any information about a specific "training set" or "sample size for training." This device is more of a robotic system with embedded software algorithms than a machine learning or AI algorithm that requires a separate, large training dataset to learn patterns from data. Its software likely relies on predefined control algorithms rather than adaptive learning from a dataset.

9. How the Ground Truth for the Training Set was Established

Since no training set is described in the provided information, there is no information on how ground truth for a training set was established.

Summary

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K131375

510(k) SUMMARY MST AutoLap System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

MST - Medical Surgery Technologies Ltd. Kochav Yokneam Building, POB 685, Yokneam Ilit 20692, Israel

Phone: +972-73-796-5570 Facsimile: +972-73-796-5571 Contact Person: Tami Harel Date Prepared: August 21, 2013

Name of Device and Name/Address of Sponsor

AutoLap System MST - Medical Surgery Technologies Ltd. Kochav Yokneam Building, POB 685, Yokneam Ilit 20692, Israel

Common or Usual Name

SEP 19 2013

Laparoscope Holder

Classification Name

Laparoscope, General and Plastic Surgery 21 C.F.R. 876.1500, Product Code GCJ

Predicate Devices

LapMan Laparoscope Manipulator System and Accessories, Manufactured by MEDSYS, S.A. (K062968)

Intended Use / Indications for Use

Technological Characteristics

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accessory cart that is used for placing the system's components during the procedure and their storage afterwards is also provided.

To maneuver the laparoscope to the desired position, the surgeon presses a single button, referred to as Command Unit, which is affixed to his/her hand or to the surgical instrument and transmits RF signals to the system. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system. Movements can be performed in the left/right, up/down and zoom in/ zoom out directions.

Performance Data

The following testing was conducted to evaluate the device:

Electrical safety was tested in accordance with ANSI/AAMI 60601-1:2005 -. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Sterilization validation was conducted in accordance with the ISO 11135-1 and . 10993-7 standards.
Packaging integrity and shelf life validation in accordance with ISO 11607-2 and . ASTM D1649-09.
. Bench testing was conducted in order to demonstrate that the AutoLap system performs according to its requirements and specifications. Performance in terms of movement velocities in all DOF, movement range in all DOF, directional movement control and image stability, have all been demonstrated. Safety features such as Emergency Stop Button functionality and warning messages have all been demonstrated to meet their respective acceptance criteria.
. The company performed an animal study evaluating the use of the AutoLap system in laparoscopic cholecystectomy and Nissen fundoplication on domestic pias. Procedures were performed by several surgeons. No operative complications related to the use of the AutoLap were observed and the device met all predefined acceptance criteria. The results demonstrated the system's performance and safety. The system's performance in terms of the movement control was validated.

All performance testing demonstrates that the AutoLap System performs according to specifications and functions as intended.

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Substantial Equivalence

The AutoLap System is substantially equivalent to the LapMan Laparoscope Manipulator System and Accessories. The AutoLap System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the AutoLap System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the AutoLap System is as safe and effective as the LapMan Laparoscope Manipulator System and Accessories. Thus, the AutoLap System is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 19, 2013

Medical Surgery Technologies, Ltd. c/o John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington DC 20004

Re: K131375

Trade/Device Name: AUTOLAP Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 21, 2013 Received: August 21, 2013

Dear Dr. Smith:

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. 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

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Page 2 - Dr. John Smith

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K131375 510(k) Number (if known):

Device Name: AUTOLAP

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Digitally signed by Long H. Chen -ADN: c=US, o=U.S. Government, ou=HHS,	for MXM
Long H. Chen -A ou=FDA, ou=People, cn=Long H. Chen - A,0.9.2342.19200300.100.1.1=1300369056Date: 2013.09.18 07:04:48 -04:00

(Division Siqn-Off) Division of Surgical Devices 510(k) Number: K131375

Regulation Number and Section

§ 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.