FLEXIBLE ENDOSCOPIC SCISSORS

K010412 · Telemed Systems, Inc. · OCZ · Apr 2, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K010412
• Device Name: FLEXIBLE ENDOSCOPIC SCISSORS
• Applicant: Telemed Systems, Inc.
• Product Code: OCZ · Gastroenterology, Urology
• Decision Date: Apr 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use for cutting of tissue when used through the working channel of a flexible or rigid endoscope.

Device Story

The TeleMed Systems Flexible Endoscopic Scissors are reusable, metallic surgical instruments designed for use within the working channel of flexible or rigid endoscopes. Operated by a clinician during endoscopic procedures, the device is used to incise tissue. The device functions as a mechanical cutting tool; it does not involve electronic processing, software, or automated analysis. The clinician manually manipulates the scissors to perform tissue cutting, which aids in surgical or diagnostic endoscopic interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence was based solely on design characteristics and comparison to predicate devices.

Technological Characteristics

Reusable, metallic surgical scissors designed for passage through the working channel of flexible or rigid endoscopes. Mechanical device; no energy source, software, or electronic components.

Indications for Use

Indicated for cutting of tissue when used through the working channel of a flexible or rigid endoscope.

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.

Predicate Devices

• Surgical Scissors (Olympus Corp of America)
• Cuschieri Scissors (Karl Storz Endoskope)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

TeleMed Systems, Inc. Mr. Michael Carrroll President & CEO 8 Kane Industrial Drive Hudson, MA 01749

JUL 2 7 2015

K010412 Trade/Device Name: Flexible Endoscopic Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCZ Dated (Date on orig SE ltr): February 1, 2001 Received (Date on orig SE ltr): February 12, 2001

Dear Mr. Carroll,

Re:

This letter corrects our substantially equivalent letter of April 2, 2001.

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _ K_O l o 412

TeleMed Systems, Inc. Flexible Endoscopic Scissor Device Name:

Indications for Use:

The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use The Telewed Systems, Inc. I lexible Endossple Channel of a flexible or rigid endoscope.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTÍNUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the -Counter Use

David C. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 010417 510(k) Number _

000005

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# XI. 510(k) Summary

# APR - 2 2001

PG- ( DE )

K010412

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, TeleMed Systems, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." TeleMed Systems chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name: TeleMed Systems Flexible Endoscopic Scissors

Owner/Operator:

TeleMed Systems, Inc. 8 Kane Industrial Drive Hudson, MA 01749

Manufacturing Site:

TeleMed Systems, Inc. 8 Kane Industrial Drive Hudson, MA 01749

Device Generic Name:

Classification:

Flexible Endoscopic Scissors

According to Section 513 of the Federal Food. Drug, and Cosmetic Act, the device classification is Class II, Performance Standards (78KOG).

Predicate Devices:

Surgical Scissors marketed by Olympus Corp of America Cuschieri Scissors marketed by Karl Storz Endoskope

## Product Description:

The TeleMed Systems Flexible Endoscopic Scissors are reusable, metallic surgical scissors that may be passed through a gastrointestinal endoscope and used to incise tissue.

## Indications for Use:

The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use for cutting of tissue when used through the working channel of a flexible or rigid endoscope.

## Safety and Performance:

Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification. The materials. performance specifications and essential design characteristics of the TeleMed Systems device are substantially equivalent to those of the predicate devices.

## Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the TeleMed Systems, Inc. Flexible Endoscopic Scissors have been shown to be safe and effective for their intended use.

TeleMed Systems, Inc.

Flexible Endoscopic Scissors 000028