(273 days)
Not Found
No
The document describes a robotic system controlled by a hand-held device, but there is no mention of AI or ML in the device description, intended use, or performance studies. The testing focuses on electrical, environmental, and EMC standards, not on algorithmic performance metrics typically associated with AI/ML.
No
Explanation: The LapMan is a robotic system that holds and positions a laparoscope/endoscope during surgery; it is a surgical assistant device, not a therapeutic device that directly treats a condition.
No
The LapMan is a robotic system designed to hold and position a laparoscope during surgical procedures. Its function is to assist in surgery, not to diagnose medical conditions.
No
The device description explicitly states it is a "robotic computer-driven system" and mentions a "radiofrequency Hand Controlled device," indicating the presence of significant hardware components beyond just software. The performance studies also focus on electrical, EMC, and environmental testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Description: The LapMan is described as a robotic computer-driven system used to hold and position a rigid laparoscope/endoscope during surgical procedures. It is a tool used during surgery, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it is for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. This is an in vivo (within the living body) application.
The information provided focuses on the device's mechanical and electrical performance, safety standards, and its function in assisting surgical procedures. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel, such as trained surgeons, gynecologists, and similarly-trained medical personnel trained in the use of laparoscopic/endoscopic devices.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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.
2
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.
3
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 (301) 594-4659. 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 (301) 443-6597 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
4
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