← Product Code [NTN](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NTN) · K090601 # FSC 2 (K090601) _Schoelly Imaging, Inc. · NTN · May 11, 2009 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NTN/K090601 ## Device Facts - **Applicant:** Schoelly Imaging, Inc. - **Product Code:** [NTN](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NTN.md) - **Decision Date:** May 11, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## Regulatory 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. ## Predicate Devices - Schoelly FSC 50MH ([K053412](/device/K053412.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 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. {1}------------------------------------------------ F) Comparison to Predicate Device(s): | Features | FSC 2 | Predicate: K053412
FSC 50 MH/ 50 MHC | |-------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | General design | Camera with LED lamp
type | Camera with metal halide
lamp type | | Intended Use | Use in conjunction with
endoscopic devices to
provide illumination and
video visualization of
optical images | Use in conjunction with
endoscopic devices to
provide illumination and
video visualization of
optical images | | Target population | Any patient population | Any patient population | | Anatomical sites | Any where endoscopic
devices are used | Any where endoscopic
devices are used | | Where used | Hospitals, clinics, and
physician offices | Hospitals, clinics, and
physician offices | | Biocompatibility | NA - no patient
contacting surfaces | NA- no patient contacting
surfaces | | Sterility | NA - non-sterile | NA - non-sterile | | Electrical safety | Conforms with IEC
60601-1 | Conforms with IEC
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. {2}------------------------------------------------ ### 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. {3}------------------------------------------------ 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 (240) 276-0115 (240) 276-0115. (240) 276-0120 (240) 276-0100 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 (800) 638-2041 or (240) 276-3150 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 {4}------------------------------------------------ # 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 FSC 2 8 of 127 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NTN/K090601](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NTN/K090601) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com