MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE by MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH

MSI MedServ International Deutschland GmbH rigid endoscopes and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals.

Device Description

A rigid endoscope is a tubular endoscopic device with any of a group of accessory devices which attach to the endoscope and is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals. It is typically used with a Fiberoptic light source and carrier to provide illumination.

AI/ML Overview

This is not an AI/ML device and therefore the requested information is not applicable.

Summary

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

JUL 27 2015

MSI MedServ International Deutschland GmbH Ms. Christine Strobel Managing Director Escad Strasse 3 D-88630 Pfullendorf Germany

Re: K083840

Trade/Device Name: MSI MedServ International - Rigid Endoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCM Dated (Date on orig SE ltr): September 11, 2009 Received (Date on orig SE ltr): September 11, 2009

Dear Ms. Strobel,

This letter corrects our substantially equivalent letter of September 28, 2009.

We have reviewed vour 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 (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.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Indications for Use

FDA CORRENE

SEP 11 2009

510(k) Number (if known):

K 083840

OUTLINE OF
PROPOSED RESEARCH

Device Name:

MSI MedServ International - Rigid Endoscope

Indications for Use:

Rigid Endoscopes

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	for mkm
(Division Sign-Off)

Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number	K083840
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K683840

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Section 4. 510(k) Summary :

General Provisions	Submitter'sName and Adress	MSI MedServInternational GmbHEscad Str. 3D-88630 Pfullendorf
	Contact Person	Mr. Karl-Heinz Puscher49 7552-936-570khpuscher@medservinternational.de
	Classification Name	Endoscopes and accessories
	Proprietary Name	MSI MedServInternationalRigid endoscopes
Name of PredicateDevice	Predicate Device	510 (k) Reference No.Olympus America Inc.K950076
Device Description	A rigid endoscope is a tubular endoscopic device with any ofa group of accessory devices which attach to the endoscopeand is intended to provide access, illumination and allowobservation or manipulation of body cavities, hollow organs,and canals. It is typically used with a Fiberoptic light sourceand carrier to provide illumination.
Intended Use	The rigid endoscopes and accessories of MSI MedServInternational Deutschland GmbH are devices used to provideaccess, illumination, and allow observation or manipulation ofbody cavities, hollow organs and canals.
Summary ofTechnologicalCharacteristics	The rigid endoscopes of MSI are similar in construction andmaterials to the previously cleared endoscope K950076 ofOlympus, America.
Summary ofsubstantialequivalence	The rigid endoscopes of MSI are considered to besubstantially equivalent to the currently marketed Olympusrigid endoscope based on a comparison of the intendeduses, designs and results of the testing and evaluationsperformed.

Regulation Number and Section

§ 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.