The DirectVision" Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

Device Description

The DirectVision™ Guide System is comprised of two (2) distinct components: a flexible semirigid microendoscope, and a handheld camera with integral LED illumination and camera control unit (CCU). The microendoscope is designed to work with the Schoelly Imaging Inc. FSC2 light source and CCU (K090601). The DirectVision TM Guide System is indicated for use in the endoscopic examination of the urethra and bladder, when placing the PercuCath™ Urologic Catheter (K090262). The catheter provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use. The microendoscope coupler is connected to the cleared camera and integral light source such that the light source is collinear with the light fiber optic bundle and the camera is collinear with the image fiber optic bundle. The image transmitted through the image fiber optic bundle to the camera is then displayed on a monitor accessory for the clinician to view.

AI/ML Overview

The provided 510k summary for the DirectVision™ Guide System does not contain information related to specific acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like diagnostic accuracy, sensitivity, or specificity. This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general characteristics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Device Performance

No specific quantitative or qualitative performance acceptance criteria (e.g., minimum visual acuity, field of view, illumination levels) and no reported device performance against such criteria are detailed in this 510k summary. The summary relies on comparison to a predicate device and adherence to general standards.

Study Information (Missing for Performance)

The document does not describe a performance study in the analytical or clinical sense that would involve a test set, ground truth, or expert review for the DirectVision™ Guide System.

Information Not Applicable / Not Provided in the Document:

A table of acceptance criteria and the reported device performance: Not provided. The summary focuses on design and safety compliance rather than performance metrics.
Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an endoscope, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not use an algorithm for standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information Available & Relevant to the Submission:

While not a "performance study" in the requested sense, the submission details compliance with general performance standards relative to endoscopes.

Predicate Device Comparison (Indirect 'Performance' Justification):

The submission establishes substantial equivalence to the Davlite Microendoscope (K020310) based on:

Intended Use: Both are for visual examination within the body. The DirectVision™ Guide System specifies use in the urethra and bladder when placing the PercuCath™ Urologic Catheter, while the Davlite Microendoscope has a broader indication for viewing "an interior cavity of the human body."
Design: Both are flexible microendoscopes with glass fiber optic bundles for light and image, an objective lens at the tip, and a camera adapter.
Body Contact Material: Both use biocompatible materials (Polyimide and glass for DirectVision™, Polymer and glass for Davlite).
Performance Standard: Both adhere to ISO 8600.
Biocompatibility: Both are declared biocompatible.
Sterility: Both are supplied non-sterile.
Re-Use: Both are multi-use devices.

Recognized Consensus Standards Met (Acceptance Criteria for Safety & Design):

The DirectVision™ Guide System meets requirements of the following recognized consensus standards, which can be seen as "acceptance criteria" for the safety, design, and processing of the device:

ISO 8600-1:2005 (Optics and Photonics -- Medical Endoscopes Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices)
AAMI TIR12: 2004 (Designing, Testing, and Labeling Reusable Medical Devices for Preprocessing in Health Care Facilities)
AAMI / ANSI ST81:2004 (Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Devices)
AAMI / ANSI ST35:2003 (Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings)
IEC 60601-2-18 (Particular Requirements for the Safety of Endoscopic Equipment)
ISO10993-1:2003 (Biological Evaluation of Medical Devices)

The submission implies that by meeting these standards and demonstrating substantial equivalence to a legally marketed predicate, the device is considered safe and effective for its intended use, without requiring a specific performance study in the document provided.

Summary

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Ko9/600

510k Summary

Submitted by:

Percuvision LLC 765 North Hamilton Road, Suite 260A Gahanna, Ohio 43230 Telephone: 614-337-8700 Facsimile: 614-337-2274 Establishment Registration Number: To be assigned

'AUG 2 5 2009

Contact

F. David Rothkopf MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01721 Telephone: (508) 231-8842 Facsimile: (508) 231-8861

Device Name

Common Name:	Microendoscope Video System
Proprietary Name:	DirectVisionTM Guide System

Classification

Device:	DirectVision TM Guide System
Medical Specialty:	Urologic

Device Class:	21 CFR 876.1500, Endoscope and Accessories, Class II
Product Codes:	FGC (Endoscope)

Predicate Devices

510(K):	K020310
Trade Names:	Davlite Microendoscope
Manufacturer:	Davlite Technologies.
	37 Kris Allen Dr
	Holden, MA 01520
Device Class:	21 CFR 876.1500, Endoscope and Accessories, Class II
Product Code:	GCJ
Regulation #:	876.1500

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General Description

091600

2013

Intended Use:

The DirectVision™ Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter,

		DirectVision™ GuideSystem	Davlite Microendoscope
Intended Use		It is intended to be usedin the visualexamination of theurethra and bladderwhen placing thePercuCath™ UrinaryCatheter.	This device is to be usedby physicians for viewingan interior cavity of thehuman body througheither a natural opening oran incision
Design	Stiffness	Flexible	Flexible
	Light Carrier	Glass Fiber Opticbundle	Glass Fiber Optic bundle
	ImageCarrier	Glass Fiber Opticbundle	Glass Fiber Optic bundle
	Lens	Objective lens at tip	Objective lens at tip
	CameraAdapter	Yes	Yes
	BodyContactMaterial	BiocompatiblePolyimide and glass	Biocompatible Polymerand glass
	Performance Standard	ISO 8600	ISO 8600
Biocompatiblity		Yes	Yes
Sterility		Supplied non sterile	Supplied non sterile
Re-Use		Multi use	Multi use

Comparison to Predicate Device(s):

Percuvision LLC

Proprietary and Confidential

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Performance Standards

091600

No applicable mandatory performance standards or special controls exist for this device. Form 3654 may be found in Attachment H

The DirectVision™ Guide System meets the requirements of the following recognized consensus standards, where applicable:

ISO 8600-1:2005 Optics and Photonics -- Medical Endoscopes Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
AAMI TIR12: 2004 Designing, Testing, and Labeling Reusable Medical Devices for Preprocessing in Health Care Facilities
AAMI / ANSI ST81:2004, Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Devices
AAMI / ANSI ST35:2003 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
IEC 60601-2-18 Particular Requirements for the Safety of Endoscopic Equipment
ISO10993-1:2003 Biological Evluation of Medical Devices

Substantial Equivalence

The DirectVision™ Guide System microendoscope is substantially equivalent to the Davlite Microendoscope manufactured by Davlite Technologies in materials, intended use, and basic design concept.

Percuvision LLC

Proprietary and Confidential

DirectVision™ Guide System

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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes a stylized human figure on the left. To the right of the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a sans-serif font. A horizontal line is placed beneath the text.

Public Health Service

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

Errol O. Singh, M.D. President & CEO Percuvision , LLC 765 North Hamilton Road, Suite 260A GAHANNA OH 43230

AUG 2 6 2009

Re: K091600

Trade/Device Name: DirectVision" Guide System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGC Dated: June 3, 2009 Received: June 3, 2009

Dear Dr. Singh:

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 (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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Landry M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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- Indications for Use Statement - - - - - -

510(k) Number (if known): Ko 9 16 00

Device Name: DirectVision™ Guide System

Indications for Use:

The DirectVision" Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

Prescription Use X = =

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Horace Whang

Division Sign-Off

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

Percuvision LLC

Proprietary and Confidential

DirectVision™ Guide System

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.