K Number
K131375
Device Name
AUTOLAP SYSTEM
Date Cleared
2013-09-19

(129 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a robotic arm controlled by a surgeon via a button or manual activation, with no mention of AI/ML algorithms for decision-making or image processing.

No

The device is designed to hold and control the movement of a laparoscope during surgical procedures, not to directly treat a medical condition. It's an assistive device for surgery, not a therapeutic one.

No

Explanation: The AutoLap System is described as a device that holds and controls the movement of a laparoscope or rigid endoscope during surgery. Its function is to assist in surgical procedures by manipulating the viewing instrument, not to diagnose medical conditions.

No

The device description explicitly states that the AutoLap System includes both software and hardware components, listing specific hardware like a Processing Unit, Base Unit, Laparoscopic Unit, and accessory cart.

Based on the provided information, the AutoLap System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • AutoLap System Function: The AutoLap System is a robotic arm designed to hold and control a laparoscope within the surgical cavity during minimally invasive surgery. It directly interacts with the patient's body during a procedure.
  • Intended Use: The intended use clearly states it's for "holding and controlling the movement of a standard laparoscope or rigid endoscope within surgical cavities during minimally invasive laparoscopic surgery." This is an in vivo (within the living body) application.

The AutoLap System is a surgical assist device, not a diagnostic tool that analyzes biological samples.

N/A

Intended Use / Indications for Use

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.

Product codes

GCJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

within surgical cavities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062968

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.

0

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

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.

Technological Characteristics

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

1

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.

2

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.

3

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

4

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

5

Indications for Use Statement

K131375 510(k) Number (if known):

Device Name: AUTOLAP

Indications for Use:

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.

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)

Page 1 of 1

| Digitally signed by Long H. Chen -A

DN: 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=1300369056
Date: 2013.09.18 07:04:48 -04:00

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