LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001

K023735 · Medsys, S.A. · GCJ · Aug 7, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023735
• Device Name: LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
• Applicant: Medsys, S.A.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other surgical procedure or purpose. The LapMan should only be used by qualified medical personnel, such as trained surgeons, gynecologists, and similarly-trained medical personnel trained in the use of laparoscopic/endoscopic devices.

Device Story

LapMan is a robotic, computer-driven system designed to hold and position a rigid laparoscope during minimally invasive surgery. Surgeon controls the device via a radiofrequency (RF) hand-held controller. The system automates scope positioning, replacing manual holding by an assistant. Used in OR settings by surgeons, gynecologists, and urologists. Compared to predicate systems (AESOP 3000), LapMan uses RF communication instead of voice or wired control and features restricted motion speed and magnitude to enhance patient safety. The device provides stable visualization, potentially reducing surgeon fatigue and improving procedural efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included electrical safety (IEC 601-1), electromagnetic compatibility (EN 60601-1-2), and radio spectrum compliance (EN 300 220-3).

Technological Characteristics

Robotic laparoscope manipulator. RF-controlled. Motion parameters restricted for safety. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and EN 300 220-3 (radio spectrum).

Indications for Use

Indicated for patients undergoing laparoscopic procedures in General Surgery (cholecystectomy, Nissen Fundoplication, inguinal hernia repair, gastric banding), Gynecology (adnexal surgery, ectopic pregnancy management, endometriosis treatment, myomectomy, hysterectomy, colposuspension), and Urology (prostatectomy). For use by trained surgeons, gynecologists, and urologists.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• AESOP 3000 System and accessories (K972699)

Submission Summary (Full Text)

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# Appendix F. LapMan 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K023735

## Applicant Information:

Xavier Moreels Managing Director Medsys S.A. Rue Chainisse, 39 B-5030 Gembloux. BELGIUM.

## Date Prepared:

October 30, 2002

## Proposed Device:

LapMan Laparoscope Manipulator.

## Classification:

General and Plastic Surgery Class II 21 CFR PART 876.1500

## Predicate Device:

#### AESOP 3000 System and accessories. K972699

THE AESOP 3000 is a robotic computer-driven system whose basic function is to hold and position a rigid laparoscope/endoscope under the direct control of a surgeon in the field of endoscopy/laparoscopy surgery. Communication between surgeon and robotic system is ensured by a voice controlled or a wired system.

## Device Description:

LapMan is a robotic computer-driven system used by surgeon to hold and position a rigid laparoscope/endoscope. Surgeon orders are transmitted to the robotic system by a radiofrequency Hand Controlled device. It is indicated for use in General surgery (laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding), Gynaecology (laparoscopic adnexal surgery i.e. ovarian cystectomy, oophorectomy, salpingectomy, salpingoneostomy, tubal reanastomosis, laparoscopic management of ectopic pregnancy, laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension) and Urology (laparoscopic prostatectomy).

## Statement of intended use:

The LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other suraical procedure or purpose.

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The LapMan should only be used by qualified medical personnel, such as trained surgeons, gynecologists, and similarly-trained medical personnel trained in the use of laparoscopic/endoscopic devices.

K023735 2/2

### Comparison of Technological Characteristics:

The existing differences between the Predicate device and LapMan involve a communication system using radiofrequency instead of a voice controlled or wired svstem. Magnitude and speed of the allowed motions for LapMan are significantly lower than for predicate. This reduces the risk for the patient in cases of unexpected motions. However the volume which can be explored with LapMan remains sufficient for the intended used and indications.

The differences do not affect safety and effectiveness of the device.

## Testing:

Performance testing was performed according to the EN 60529:1991 Amendment1:2000 and IEC 601-1 Amendment 1 (1993), IEC 601-1 Amendment 2 (1995). This electrical test has been conducted by PHOENIX TEST-LAB GmbH, Königswinkel, 10 D-32825 Blomberg, Germany.

Performance testing was performed according to the EN 300 220-3 V1.1.1 (2000-09) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices (SRD); Radio equipment to be used in the 25 MHz to 1000 Mhz frequency range with power levels ranging up to 500 mW; Part 3 : Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive. This test has been conducted by PHOENIX TEST-LAB GmbH, Königswinkel, 10 D-32825 Blomberg Germany.

Environmental Testing was conducted according to the following standards:

- IEC 601 (1988), EN 60601 .
- IEC 601-1 Amendment 1 (1991) .
- IEC 601-1 Amendment 2 (1995) ●
- IEC 601-1-1 (1992) ●
- IEC 601-1-1 Amendment 1 (1995) ●
- IEC 601-1-2 (1993) ●
- IEC 601-2-18 (1996) ●

Electrical and EMC characteristics of the LapMan have been determined to be in compliance with the following standards by SNCH laboratory:

- EN 60601-1-2: 1993 Radiated disturbances (30 MHz to 1 GHz) .
- EN 60601-1-2: 1993 Immunity requirements for medical equipment ●
- EN 61000-4-2: 1995 Electrostatic discharge ●
- EN 61000-4-3: 1996 Radiofrequency electromagnetic field AM ●
- EN 61000-4-8: 1993 Power frequency magnetic field .

The LapMan Laparoscope Manipulator System and Accessories intended to be introduced complies with the CE Declaration of Conformity European Directive 93/42/EC Annex VII. Testing was performed by SNCH / SEE-Certification (Testing & Calibration), Rue de la Gare, 11A, L-8325 CAPELLEN LUXEMBOURG without deviation or adaptation to the standards listed above. No differences were found to exist between the LapMan and the applicable standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the symbol, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2003

Medsys, s.a. c/o Mr. Jeff Morgan JWM Associates 13723 Dana Lane East Puyallup, Washington 98373

Re: K023735

Trade/Device Name: The LapMan Laparoscope Manipulator System and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 12, 2003 Received: May 21, 2003

Dear Mr. Morgan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jeff Morgan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix C. Indications for Use Statement

Ko23735 510(k) Number (if known):

Device Name: The LapMan Laparoscope Manipulator System and Accessories

Indications for use:

The LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other surgical procedure or purpose.

The LapMan should only be used by qualified medical personnel, such as trained surgeons, gynecologists, urologists, and similarly-trained medical personnel trained in the use of laparoscopic/endoscopic devices.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Prescription Use
(per 21 CFR §801.109)

Over-the-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023735