General surgery: laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding.
Gynaecology: laparoscopic adnexal surgery (ovarian cystectomy, oophorectomy, adnexectomy, salpingectomy, salpingoneostomy, tubal reanastomosis), laparoscopic management of ectopic pregnancy. laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension
Urology: laparoscopic prostatectomy.

Device Description

AI/ML Overview

The provided text describes the LapMan Laparoscope Manipulator System, a robotic computer-driven system used to hold and position a rigid laparoscope/endoscope. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (AESOP 3000 System) and compliance with various electrical and environmental standards.

However, the document does not contain information regarding acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. The testing mentioned primarily relates to electrical safety, electromagnetic compatibility, and environmental standards, which are engineering and regulatory compliance tests, not performance studies evaluating the device's functional attributes against clinical acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and comparative effectiveness studies cannot be extracted from the provided text because such studies were not conducted or reported in this 510(k) summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided based on the text. The document describes various electrical and environmental standards the device complies with, but it does not specify "acceptance criteria" related to a clinical performance study or "reported device performance" in a functional or diagnostic sense. The text primarily states that the device "complies with the CE Declaration of Conformity European Directive 93/42/EC Annex VII" and "No differences were found to exist between the LapMan and the applicable standards."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided based on the text. There is no mention of a human-based test set or any clinical data provenance. The testing described refers to laboratory-based electrical and environmental assessments (e.g., PHOENIX TEST-LAB GmbH in Germany, SNCH laboratory in Luxembourg).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided based on the text. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided based on the text. No clinical test set and thus no adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided based on the text. This device is a surgical manipulator (a robotic arm), not an AI-powered diagnostic tool for "human readers." Therefore, an MRMC study is not applicable, and no such study was reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided based on the text. As mentioned, this is a surgical manipulator, not an algorithm, and the performance described is compliance with technical standards, not standalone diagnostic performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be provided based on the text. No clinical ground truth is discussed. The "ground truth" for the tests performed was compliance with specific engineering and safety standards.

8. The sample size for the training set

Cannot be provided based on the text. There is no mention of a "training set" as this device does not appear to involve machine learning in a way that would require one in the context of diagnostic accuracy or clinical decision support.

9. How the ground truth for the training set was established

Cannot be provided based on the text. (See #8)

Summary

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o 62968

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:

Applicant Information:

JAN - 3 2007

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

Date Prepared:

September 25, 2006

Proposed Device:

Lapman Laparoscope Manipulator System and Accessories

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).

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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.

Statement of intended use:

The LapMan can be used during the laparoscopic procedures listed below and should not be used for any other surgical procedure or purpose.

1. General surgery: laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding.
1. Gynaecology: laparoscopic adnexal surgery (ovarian cystectomy, adnexectomy, salpingectomy, salpingoneostomy, tubal reanastomosis), laparoscopic management of ectopic pregnancy, laparoscopic treatment of endometriosis. laparoscopic myomectomy, laparoscopic hysterectorny, laparoscopic colposuspension
1. Urology: laparoscopic prostatectomy.

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 system. Maqnitude 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) .

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IEC 601-1-2 (1993) .
t 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/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MedSys S.A. % JWM Associates, LLC Mr. Jeff Morgan Principal Consultant 13723 Dana Lane East Puyallup, Washington 98373

JAN - 3 2007

Re: K062968

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: December 1, 2006 Received: December 8, 2006

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, Trug 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

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Page 2 - Mr. Jeff Morgan

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.

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. N elkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K062968

Device Name: The LapMan Laparoscope Manipulator System and Accessories

Indications For Use:

The LapMan can be used during the laparoscopic procedures listed below and should not be used for any other surgical procedure or purpose.

1. General surgery: laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding.
1. Gynaecology: laparoscopic adnexal surgery (ovarian cystectomy, oophorectomy, adnexectomy, salpingectomy, salpingoneostomy, tubal reanastomosis), laparoscopic management of ectopic pregnancy. laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension
1. Urology: laparoscopic prostatectomy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 1206296f

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.