(67 days)
Not Found
No
The document describes a standard endoscopic camera system for visualization and illumination, with no mention of AI/ML processing or analysis of the images.
No.
The device is intended for visualization and observation of body spaces, not for treatment or therapy.
No
The description states the device provides illumination and video visualization of optical images for observation, but it does not mention any medical determination, diagnosis, or screening function. Its purpose is to facilitate viewing, not to make a diagnosis.
No
The device description explicitly states it is a "camera hand piece with built-in LED illumination," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Schoelly FSC 2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide illumination and video visualization of optical images within the body using endoscopic devices. This is for direct observation and visualization of anatomical spaces.
- Device Description: The device is a camera handpiece with built-in LED illumination that attaches to an endoscope. It captures optical images and converts them to electrical signals for display.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The FSC 2 does not perform any analysis on bodily specimens. It is a tool for visualizing the inside of the body directly.
The FSC 2 is a medical device used for endoscopic visualization, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NTN, XXX, FCW, FWF
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.
Mentions image processing
Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Any where endoscopic devices are used
Indicated Patient Age Range
Any patient population
Intended User / Care Setting
Hospitals, clinics, and physician offices
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)
NA
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
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
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