FSC 2

K090601 · Schoelly Imaging, Inc. · NTN · May 11, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090601
• Device Name: FSC 2
• Applicant: Schoelly Imaging, Inc.
• Product Code: NTN · Gastroenterology, Urology
• Decision Date: May 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The FSC 2 is to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images. The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.

Device Story

FSC 2 is a camera hand piece with integrated LED illumination; designed for use with Schoelly endoscopes. Device attaches to proximal eyepiece of endoscope via Flexilock connector. Captures optical images; converts to electrical signals; amplifies for output to external accessories like computers. Used in hospitals, clinics, and physician offices by medical professionals. Provides illumination and video visualization of body spaces during endoscopic procedures; assists clinicians in observing internal anatomy. Benefits patient by enabling visual assessment of body cavities.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Camera hand piece with integrated LED illumination. Connects to endoscopes via Flexilock. Electrical output for external display/processing. Conforms to IEC 60601-1 for electrical safety. Non-sterile, non-patient contacting device.

Indications for Use

Indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces in any patient population where endoscopic devices are used.

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

• Schoelly FSC 50MH (K053412)

Submission Summary (Full Text)

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## FSC 2 Traditional 510(k) Premarket-Notification Submission

### 510k Summary

K090601
pg 1 of 2

A) Submitted by: Schoelly Imaging, Inc. 100 Hartwell St. West Boylston, MA 01583 Registration: 3005305991

MAY 1 1 2009

- Contact: MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 x20 508-231-8861 Fax
B) Device Name: FSC 2

Common Name: Endoscope and accessories

21 CFR 876.1500 Class II Device Class:

Product Code: XXX, LED light source FCW, Light Source, Fiberoptic

Common Name: Surgical camera and accessories

Device Class: 21 CFR 878.4160, Class I, exempt

Product Code FWF

## C) Predicates: Schoelly FSC 50MH K053412

21 CFR 876.1500, Endoscope and accessories, Class II, Product code GCT and FWC

21 CFR 878-4160, Surgical camera and accessories, Class I, 510(k) exempt, product code FWF

D) Device Description: The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.

E) Intended Use: The FSC 2 is to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images.

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F) Comparison to Predicate Device(s):

| Features | FSC 2 | Predicate: K053412<br>FSC 50 MH/ 50 MHC |
|-------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| General design | Camera with LED lamp<br>type | Camera with metal halide<br>lamp type |
| Intended Use | Use in conjunction with<br>endoscopic devices to<br>provide illumination and<br>video visualization of<br>optical images | Use in conjunction with<br>endoscopic devices to<br>provide illumination and<br>video visualization of<br>optical images |
| Target population | Any patient population | Any patient population |
| Anatomical sites | Any where endoscopic<br>devices are used | Any where endoscopic<br>devices are used |
| Where used | Hospitals, clinics, and<br>physician offices | Hospitals, clinics, and<br>physician offices |
| Biocompatibility | NA - no patient<br>contacting surfaces | NA- no patient contacting<br>surfaces |
| Sterility | NA - non-sterile | NA - non-sterile |
| Electrical safety | Conforms with IEC<br>60601-1 | Conforms with IEC<br>60601-1 |
| Mechanical safety | NA | NA |
| Performance | NA | NA |

G) Standards met:

IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety

H) Conclusion:

Schoelly Imaging, Inc. believes that the FSC 2 is substantially equivalent to the predicate device based on the same the general design and technology, indication for use, and function.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

MAY 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Schoelly Imaging, Inc. % Mr. F. David Rothkopf President MEDIcept, Inc. 200 Homer Avenue ASHLAND MA 01721

Re: K090601

Trade/Device Name: FSC 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NTN Dated: March 2, 2009 Received: March 5, 2009

Dear Mr. Rothkopf:

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 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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

(Gastroenterology/Renal/Urology) 21 CFR 876.xxx (Obstetrics/Gynecology) 21 CFR 884.xxx 21 CFR 892.xxx (Radiology) Other

[phone] [phone]. [phone] [phone]

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

> Sincerely wours. NAME

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): K 09 0 6 0 1

Device Name: FSC 2

Indications for Use: The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.

Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use_21CFR 801.109

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

Concurrence of CDRH, Office of Device InVitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign Off Office of Device InVitro Diagnostic Device Evaluation and Safety

Hela Reene

510 (K)

(Division \$ign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K09060

Schoelly Imaging, Inc. Traditional 510(k) February 20, 2009

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