(21 days)
Not Found
No
The device description and performance studies focus on electromechanical control and safety testing, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
This device is a scope controller system that holds and controls the movement of laparoscopes or rigid endoscopes for visualization during minimally invasive surgery. It does not provide any treatment or therapeutic effect itself.
No.
The device description indicates that the system is used to control the movement of a conventional endoscope to allow visualization of a surgical cavity, but it does not perform any diagnostic function itself. It is a tool for surgical assistance, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components, including an electromechanical arm, disposable zoom assembly, foot control, hand control, and power supply. This indicates it is a hardware-based medical device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold and control the movement of laparoscopes/endoscopes during surgical procedures for visualization. This is a surgical assist device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details an electromechanical arm and control system for manipulating an endoscope. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
The device is clearly intended for use during surgery to facilitate visualization, which is a procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Laparocision™ Scope Controller System is an electromechanical arm whose intended use is to allow a surgeon to hold and control a laparoscope's movement and position during laparoscopic surgical procedures by means of either a foot controller or a hand controller.
The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.
Product codes
GCJ
Device Description
The GMP|Surgical Solutions Laparocision™ Scope Controller System allows for surgeons to control the movement and position of conventional laparoscopes or endoscopes during thoracic, gynecologic, orthopedic, and abdominal laparoscopic procedures by means of an electromechanical arm which is controlled by either a hand controller or a foot controller. The purpose of an endoscope is to allow visualization of a surgical cavity during minimally invasive laparoscopic procedures.
The device is comprised of the following five main components:
-
The Laparocision™ Reusable Arm Assembly is the device's main component. It is attached via a clamp to an operating table and it serves to hold and control the position and movement of a laparoscope.
-
The Disposable Zoom Assembly (DZA) is attached to the distal end of the Reusable Arm Assembly, and its purpose is to hold 5mm and 10 mm diameter laparoscopes between its pinch rollers. The pinch rollers turn and act to move a laparoscope in three axes (i.e. in and out, towards the head or foot of the patient, and medially/laterally). The pinch rollers in the DZA are under the direct control of an operator via the Foot Control and the Hand Control.
-
The Foot Control and the Hand Control plug into the Reusable Arm, and by pressing control buttons on the Foot and Hand Controls, the operator can move the laparoscope in three axes.
-
The Steri-Sleeves are sterile polvethylene material bags which act to provide for protection and a sterile barrier between the reusable components (i.e. the Reusable Arm Assembly, and the Foot and Hand Controls) and the sterile field.
-
The Power Supply converts 110 alternating current voltage (VAC) to 9 volts of direct current (9VDC) required to operate the Reusable Arm Assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic, gynecologic, orthopedic, and abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, minimally invasive laparoscopic surgery.
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)
In-vitro electrical safety testing was conducted and met all the requirements in accordance with the standards, "UL 60601-1-UL Standard for Safety of Medical Device Equipment, Part 1: General Requirements for Safety First Edition", CSA C22.2 NO 601.1-M90 -Medical Electrical Equipment - Part 1: General Requirements for Safety General Instructions No 1; Supplement 1; 1994 R(1997)", IEC 60601-2-18 (1996-08) - Medical Electrical Equipment -- Part 2: Particular Requirements for the Safety of Endoscopic Equipment Second Edition; Amendment 1, 07-2000".
In-vitro Electromagnetic Compatibility (EMC) testing was performed and met all the requirements as per "IEC 60601-1-2 (2001-09) - Medical Electrical Equipment Part 1-2; General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests Second Edition". In-vitro mechanical and functional testing was also performed and demonstrated that the device's design and performance requirements were met. This functional testing also demonstrates and supports a determination of substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K050027 1/3
510(k) Summary
GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System
Classification Name: Endoscope and Accessories 21 CFR 876.1500 Device Class: II Product Code: GCJ
GMP Companies, Inc. One East Broward Boulevard Suite 1701 Fort Lauderdale, FL 33301
Phone: (954) 745-3510 Fax: (954) 745-3511
Contact: Ralph Jugo, Prepared: October 25, 2004
LEGALLY MARKETED PREDICATE DEVICE A.
The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is substantially equivalent to the Computer Motion Inc. AESOP System and Accessories that was cleared by FDA under K931783 on November 22, 1993.
B. DEVICE DESCRIPTION
The GMP|Surgical Solutions Laparocision™ Scope Controller System allows for surgeons to control the movement and position of conventional laparoscopes or endoscopes during thoracic, gynecologic, orthopedic, and abdominal laparoscopic procedures by means of an electromechanical arm which is controlled by either a hand controller or a foot controller. The purpose of an endoscope is to allow visualization of a surgical cavity during minimally invasive laparoscopic procedures.
The device is comprised of the following five main components:
-
The Laparocision™ Reusable Arm Assembly is the device's main component. It is attached via a clamp to an operating table and it serves to hold and control the position and movement of a laparoscope.
-
The Disposable Zoom Assembly (DZA) is attached to the distal end of the Reusable Arm Assembly, and its purpose is to hold 5mm and 10 mm diameter laparoscopes between its pinch rollers. The pinch rollers turn and act to move a laparoscope in three axes (i.e. in and out, towards the head or foot of the patient, and medially/laterally). The pinch rollers in the DZA are under the direct control of an operator via the Foot Control and the Hand Control.
1
-
The Foot Control and the Hand Control plug into the Reusable Arm, and by pressing control buttons on the Foot and Hand Controls, the operator can move the laparoscope in three axes.
-
The Steri-Sleeves are sterile polvethylene material bags which act to provide for protection and a sterile barrier between the reusable components (i.e. the Reusable Arm Assembly, and the Foot and Hand Controls) and the sterile field.
-
The Power Supply converts 110 alternating current voltage (VAC) to 9 volts of direct current (9VDC) required to operate the Reusable Arm Assembly.
C. INDICATIONS FOR USE
The Laparocision™ Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.
D. INTENDED USE
The Laparocision™ Scope Controller System is an electromechanical arm whose intended use is to allow a surgeon to hold and control a laparoscope's movement and position during laparoscopic surgical procedures by means of either a foot controller or a hand controller.
The trade name or proprietary name of the device which is the subject of the 510(k) premarket notification is the "GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System". The common or usual name for the device is an "Endoscope Accessory".
E. SUBSTANTIAL EQUIVALENCE SUMMARY
The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is an electromechanical medical device that has essentially the same indications for use as the predicate device. Both devices are indicated for laparoscopic surgical procedures. The only main differences between the two devices is that the AESOP device uses a computer and software to control the devices operations, while the GMP Laparocision device does not use a computer or software to control the device's operations. The differences do not alter the intended diagnostic effect. Both devices have essentially the same intended use. A comparison of the descriptive characteristics of the GMP Laparocision device and the AESOP predicate device is sufficiently precise to assure equivalence. In-vitro performance data are provided in the form of electrical safety testing and electromagnetic compatibility (EMC) testing that was performed on both devices. The results of the performance testing demonstrate compliance with the applicable electrical safety and the data also support a determination of substantial equivalence.
2
As recommended by the 3-17-95 (Draft) Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and Urology, electrical safety and Electromagnetic Compatibility (EMC) testing as per the applicable standards should be conducted and provided in a 510(k) submission.
F. TECHNOLOGICAL CHARACTERISTICS
Both devices use electronic components to control the position and movement of laparoscopes during minimally invasive laparoscopic surgical procedures. While the details differ regarding how the control of the movement of laparoscopes is achieved, given that the AESOP device uses a computer and software while the GMP device does not, the basic technology is very similar. The differences in technology do not raise any significant questions or issues regarding the safety and effectiveness of the devices,
G. TESTING
In-vitro electrical safety testing was conducted and met all the requirements in accordance with the standards, "UL 60601-1-UL Standard for Safety of Medical Device Equipment, Part 1: General Requirements for Safety First Edition", CSA C22.2 NO 601.1-M90 -Medical Electrical Equipment - Part 1: General Requirements for Safety General Instructions No 1; Supplement 1; 1994 R(1997)", IEC 60601-2-18 (1996-08) - Medical Electrical Equipment -- Part 2: Particular Requirements for the Safety of Endoscopic Equipment Second Edition; Amendment 1, 07-2000".
In-vitro Electromagnetic Compatibility (EMC) testing was performed and met all the requirements as per "IEC 60601-1-2 (2001-09) - Medical Electrical Equipment Part 1-2; General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests Second Edition". In-vitro mechanical and functional testing was also performed and demonstrated that the device's design and performance requirements were met. This functional testing also demonstrates and supports a determination of substantial equivalence to the predicate device.
H. CONCLUSIONS
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2005
GMP/Companies, Inc. c/o Mr. Daniel W. Lehtonen Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K050027
Trade/Device Name: Laparocision Scope Controller System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 21, 2005 Received: January 24, 2005
Dear Mr. Lehtonen:
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 for asso mated in the 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, FIJA 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 nust 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 (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.
4
Page 2 -- Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and with your finding of substantial equivalence of your device to a legally premated predicated 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 rr you desire specific arrestiance 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriam 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
5
Indications for Use
510(k) Number (if known):
Device Name:
GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System
Indications for Use:
The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE JS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_405 0037
Posted 13 Nov 2003
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