The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description

The Schoelly Laparoscope is a rigid reusable endoscope for visualization of body cavities used in conjunction with a commercially available and approved light guide, light source, video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

Light that is created by an external light source is transmitted from the laparoscope light guide connector through the laparoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid rod lens system.

Schoelly Laparoscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).

Like other currently marketed laparoscopes, the proposed device has outer surfaces mainly made from metal (304 stainless steel) and further comprise fiber optics for light transmission and rigid rod-lenses for image transmission.

The Schoelly Laparoscope is delivered in a non-sterile condition and is already CE marked.

AI/ML Overview

This document does not contain the information required to populate the fields of the request. The document describes a 510(k) premarket notification for a medical device (Schoelly Laparoscope) and focuses on demonstrating substantial equivalence to a predicate device.

The provided text details:

The device's intended use and design.
That changes were limited to material and dimensional configurations.
That performance testing involved biocompatibility in accordance with ISO 10993-1.
A conclusion that the modified device met predetermined acceptance criteria and does not introduce new risks, therefore being substantially equivalent.

However, the document does not provide:

A table of acceptance criteria and reported device performance for clinical effectiveness studies. The "acceptance criteria" mentioned refer to engineering and biocompatibility tests, not clinical performance metrics like sensitivity, specificity, accuracy, or AUC.
Details about a study that assesses clinical performance against specific acceptance criteria. The document focuses on regulatory equivalence based on design and biocompatibility, not on a clinical performance study with human subjects or a large dataset.
Information about sample sizes for test sets, training sets, or data provenance in the context of clinical AI/ML model evaluation.
Details about ground truth establishment, expert involvement, or adjudication methods.
Information regarding multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be flowing or merging together.

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

December 5, 2014

Schoelly Fiberoptic GmbH Ms. Pamela Papineau, RAC Delphi Medical Device Consulting Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K143221

Trade/Device Name: Schoelly Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 6, 2014 Received: November 10, 2014

Dear Ms. Papineau:

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 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

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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143221

Device Name Schoelly Laparoscope

Indications for Use (Describe)

The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 - Special 510(k) Summary

General Information

Preparation date:	11/06/2014
Owner's Name:Address:	Schoelly Fiberoptic GmbH (Registration: 8043903)Robert-Bosch-Str. 1 - 379211 DenzlingenGermany
Telephone Number:	+49-7666-980-0
Fax Number:	+49-7666-908-380
Contact Person:	Dr. Sandra Baumann
Subject Device Name:	Schoelly Laparoscope
Trade Name:	Schoelly Laparoscope
Common/Usual Name:	Laparoscope
Classification Name:	GCJ - Laparoscope, General & Plastic Surgery21 CFR 876.1500; Class II
Predicate Device Name:	Schoelly Laparoscope
Trade Name:	Schoelly Rigid Endoscope
Common/Usual Name:	Laparoscope
Classification Name:	GCJ - Laparoscope, General & Plastic Surgery21 CFR 876.1500; Class II
Premarket Notification:	K992437 (Schoelly Inc. /formerly known as Fiber ImagingTechnologies, Inc.) SE date September 14, 1999

Device Description

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The Schoelly Laparoscope is delivered in a non-sterile condition and is already CE marked.

Indications for Use

The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Predicate Device

The predicate device is identical to the proposed device with the same device specifications and design, the same indications for use, and the same fundamental scientific technology. The changes described in this submission are limited to a change of device materials and the addition of new device configurations that differ with respect to geometric dimensions of the endoscope insertion tube as compared to the predicate device that was cleared for marketing by FDA in K992437. These changes do not in any way alter the device indications for use, or the fundamental scientific technology upon which the device is based.

Performance Testing

This 510(k) contains a summary of the biocompatibility testing conducted in accordance with ISO 10993-1 (cytotoxicity, irritation, sensitization and acute systemic toxicity).

Conclusion

The proposed modification to the Schoelly Laparoscope has met all predetermined acceptance criteria as specified by applicable standards, test protocols, and/or customer inputs and does not introduce new patient or user risks. The device with the changed material and additional dimensional configurations is substantially equivalent to the predicate device.

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.