ISC-1000 PENTAX CONFOCAL LASER SYSTEM

K042740 · Pentax Medical Company · GCJ · Oct 19, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042740
• Device Name: ISC-1000 PENTAX CONFOCAL LASER SYSTEM
• Applicant: Pentax Medical Company
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Device Story

The Pentax Confocal Laser System is a software-controlled accessory for video endoscopes equipped with a confocal imaging module. It utilizes a laser light source to transmit light through an optical fiber in the endoscope to the target tissue. The system receives return light signals, processes the confocal image information, and displays it on a monitor. It also functions as an image storage device for still frames. Operated by clinicians in a clinical setting, the device provides real-time visualization of internal tissue microstructure, aiding in clinical assessment and decision-making during endoscopic procedures.

Clinical Evidence

No clinical data.

Technological Characteristics

System includes laser light source, system computer, and display monitor. Utilizes optical fiber for laser light transmission and signal reception. Software-controlled. Class II device under 21 CFR 876.1500.

Indications for Use

Indicated for adult and pediatric patients requiring endoscopic visualization of internal tissue microstructure.

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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Pentax Medical Company
% Mr. Tamas Borsai
Division Manager, Medical Division, and
Program Manager, Third Party, Review Program
TÜV Rheinland of North America
12 Commerce Road
Newtown, CT 06470

JUL 27 2015

Re: K042740
Trade/Device Name: ISC-1000 Confocal Laser System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: GCJ
Dated (Date on orig SE ltr): September 30, 2004
Received (Date on orig SE ltr): October 4, 2004

Dear Mr. Borsai,

This letter corrects our substantially equivalent letter of October 19, 2004.

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

{1}

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); 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 toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D.
Director
Division of Reproductive, Gastro-Renal, and Urological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

510(k) Number (if known): K042740
Device Name: ISC-1000, Confocal Laser System
Page 1 of 1

## Intended Use Statement:

The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

*Miriam C. Provost*
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices

510(k) Number K042740

{3}

OCT 19 2004
k042740

# 510(k)Summary Pentax Confocal Laser System

## Submitter Information:

Pentax Medical Company
102 Chestnut Ridge Road
Montvale, New Jersey 07645-1856
Tel: [phone]

## Name Of Device:

| Trade Name: | Pentax Confocal Laser System |
| --- | --- |
| Classification Name: | Endoscope and Accessories (78KOG) {876.1500} [Class II] |

## Predicated Device(s) Information:

| Model, Description | Manufacturer | PMN# |
| --- | --- | --- |
| Zeiss Confocal Laser | Carl Zeiss, Inc. | K912581 |

## Device Description:

The Pentax Confocal Laser System (software controlled device) is intended for use as a required accessory with Pentax video endoscope system that are equipped with confocal imaging module. The confocal laser system includes a laser light source, system computer, and display monitor. A video endoscope equipped with a confocal imaging module is connected to a conventional video endoscope system that will present the video endoscopic image. The endoscope is connected to the confocal system laser light source. The endoscope confocal imaging module contains an optical fiber that transmits laser light to, and receives return light from, the subject tissue. The confocal laser system contains a laser light source which produces visible laser light and contains signal detection circuitry to transmit/ receive the light signals through the endoscope confocal imaging module. The detected signal is sent to the system computer. The System Computer processes the confocal image information for display on the system monitor, controls the laser light source, and acts as an image storage device for still frame images.

## Intended Use:

The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

## Comparison To Predicated Device(s):

The submission for substantial equivalence included Pentax Confocal laser system literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.

## Prepared By:


Paul Silva, Regulatory Affairs Coordinator
09-09-2004
Date

Control Number: PS-726.ConfocalSys.510KS page 1 of 1
Revision: a