(78 days)
Not Found
No
The description focuses on standard optical imaging and signal processing, with no mention of AI, ML, or related concepts.
No
The device provides illumination and visualization of optical images, which are diagnostic functions, not therapeutic. It does not exert any direct therapeutic effect on the patient.
No
The device provides illumination and visualization of optical images, transferring them to a monitor or printer. It does not analyze or interpret these images to diagnose a condition.
No
The device description explicitly states the system is comprised of a camera handpiece and a combination light source/video processor, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide illumination and video visualization of optical images in conjunction with endoscopic devices. This is a function related to imaging and visualization within the body, not the analysis of samples outside the body.
- Device Description: The description details a camera system and light source used with endoscopes to capture images. This aligns with an imaging device used for direct observation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely related to providing visual access and recording images during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
Product codes (comma separated list FDA assigned to the subject device)
GCT, FWF
Device Description
The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate devices, as well as on the results of testing to establish compliance with international standards for electrical safety and electromagnetic compatibility (IEC 60601-1-1; IEC 60601-1-1; IEC 60601-1-2 & IEC 60601-2-18).
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
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
FlexiScone 50MH / 50M
510(k) Premarket Notifica
Schoelly Imaging, Inc. December 5, 2005
FEB 2 3 2006
510(k) Summary
General Company Information
Schoelly Imaging, Inc.
173 Grove Street Worcester, MA 01605 James Bonneville, Operations Manager 508-425-6989
General Device Information
| Product Name: | FlexiScope 50MH / 50MHC |
|---|---|
| Common Name: | Light source for endoscope |
| Video camera and light source for endoscopic use (510(k)-exempt) | |
| Classification: | Light Source, Endoscope, Xenon Arc / GCT |
| Camera, Television, Endoscopic, without Audio / FWF (510(k)-exempt) | |
| Predicate Devices | AngioLaz Video Endoscopic System (K933868) |
| AMD Telemedicine AMD-300s Illumination & Imaging System (K940270) |
Indications for Use:
The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
Product Description:
The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.
Safety and Performance:
Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate devices, as well as on the results of testing to establish compliance with international standards for electrical safety and electromagnetic compatibility (IEC 60601-1-1; IEC 60601-1-1; IEC 60601-1-2 & IEC 60601-2-18).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Schoelly FlexiScope 50MH / 50MHC has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "Department of Health & Human Services" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2006
Mr. David A. McNally President Schoelly Imaging, Inc. 173 Grove Street WORCESTER MA 01605
Re: K053412
Trade/Device Name: FlexiScope 50MH / 50MHC Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT and FCW Regulation Number: 21 CFR §878.4160 Regulation Name: Surgical camera and accessories Regulatory Class: Exempt Product Code: FWF Dated: January 30, 2006 Received: January 31, 2006
Dear Mr. McNally:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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, 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); 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgn manxemig your avoice of your device to a legally premarket notification. The FDA inding of sausantial equice 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), pleased on the regulation murposition murposition murposition murposition murposit If you desire specific advice for your device on our laboring mg
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation childing on your responsibilities under the Act from the 807.97). You may obtain other general intornation on your 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,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Schoelly Imaging, Inc. December 5, 2005
510(k) Premarket Notification (Traditional) FlexiScope 50MH / 50MHC
Page
510(k) Number (if known): Ko53412
FlexiScope 50MH / 50 MHC Device Name:
Indications for Use:
The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (CDE)
Nancy Roagdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
000008