FLEXISCOPE, MODELS 50MH AND 50 MHC

K053412 · Schoelly Imaging, Inc. · FWF · Feb 23, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053412
• Device Name: FLEXISCOPE, MODELS 50MH AND 50 MHC
• Applicant: Schoelly Imaging, Inc.
• Product Code: FWF · General, Plastic Surgery
• Decision Date: Feb 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4160
• Device Class: Class 1

Intended Use

The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.

Device Story

FlexiScope 50MH/50MHC system consists of camera handpiece and combination light source/video processor. Device attaches to proximal eyepiece of user-supplied flexible or rigid endoscopes. Light source provides visible illumination for endoscopic examination. Camera CCD sensor captures optical images from endoscope objective lens, converts to electrical signal, and amplifies for output to external monitors or printers. Used in clinical settings by healthcare professionals. System facilitates visualization of internal anatomy during endoscopic procedures, aiding clinical decision-making through real-time video display.

Clinical Evidence

Bench testing only. Compliance with international standards for electrical safety and electromagnetic compatibility (IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18) was used to demonstrate safety and performance.

Technological Characteristics

System includes camera handpiece and combination light source/video processor. Utilizes CCD sensor for image capture. Energy source: visible light for illumination. Connectivity: output to external monitors/printers. Standards: IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18.

Indications for Use

Indicated for use with endoscopic devices to provide illumination and video visualization of optical images in patients undergoing endoscopic procedures.

Regulatory Classification

Identification

A surgical camera and accessories is a device intended to be used to record operative procedures.

Predicate Devices

• AngioLaz Video Endoscopic System (K933868)
• AMD Telemedicine AMD-300s Illumination & Imaging System (K940270)

Submission Summary (Full Text)

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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<br>Video camera and light source for endoscopic use (510(k)-exempt) |
| Classification: | Light Source, Endoscope, Xenon Arc / GCT<br>Camera, Television, Endoscopic, without Audio / FWF (510(k)-exempt) |
| Predicate Devices | AngioLaz Video Endoscopic System (K933868)<br>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.

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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.

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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 [phone] or [phone] 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

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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