5 STAR MEDICAL ENDOSCOPE

K963354 · Five Star Medical, Inc. · ODF · Sep 8, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963354
• Device Name: 5 STAR MEDICAL ENDOSCOPE
• Applicant: Five Star Medical, Inc.
• Product Code: ODF · Gastroenterology, Urology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Direct visualization of B.I. - B.U. system using additional accessories to perform various diagnostic and therapeutic procedures.

Device Story

5 Star Medical Endoscope is a system comprising rigid mini ureteroscopes and flexible deflecting tip scopes. Inputs consist of visual data captured via fiberoptic bundles. The device transforms these inputs into optical images viewed through an adjustable magnifying eyepiece on an optical handle. The system includes fiber optic cables, adapters, and light sources (compatible with Wolf, Olympus, Storz, ACMI, and Pentax). Used in clinical settings by physicians for visualization and diagnosis of the urethra, bladder (pediatric), ureters (adult), kidney, common bile duct, liver, and pancreatic duct. Flexible scopes can be passed through standard colonoscopes. The device enables direct visualization, aiding clinical decision-making for diagnostic and therapeutic interventions, potentially benefiting patients by allowing minimally invasive access to internal anatomical structures.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes rigid mini ureteroscopes and flexible deflecting tip scopes (lengths 30-200 cm; diameters 1.6-4.0 mm). Components: fiberoptic bundles (non-coherent glass fibers), magnifying optical handle with focusing ring, and irrigation/instrumentation channels. Connectivity: fiber optic cables with female ACMI-type connectors compatible with standard light sources (Wolf, Olympus, Storz, ACMI, Pentax). Mechanical deflection of distal tip via proximal handle manipulation. Non-electronic, purely optical/mechanical device.

Indications for Use

Indicated for direct visualization of the biliary and urinary (B.I. - B.U.) systems to facilitate diagnostic and therapeutic procedures using compatible accessories.

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

• Saratoga Modular Miniature Endoscope System

Submission Summary (Full Text)

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XIII.
510 (k) Summary for 5 Star Medical, Inc.
K 963354
P191

## DEVICE NAME

5 Star Medical Endoscope

SEP - 8 1997

## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

Saratoga Modular Miniature Endoscope System

## DESCRIPTION OF DEVICE

A description of the endoscopes' components is as follows:

### Optical Catheters

A rigid mini ureteroscope provides for examination of the lower third of the ureter. Channels are provided for irrigation and instrumentation.

The deflecting tip scopes are available in various lengths (30 to 200 cm) and outer diameters (1.6 to 4.0mm) for visualization and diagnosis of the urethra, bladder (of children), ureters (of adults) and kidney. They can also be used to directly visualize and diagnose conditions in the common bile duct, liver and pancreatic duct. The exploration of the colon can also be accomplished by passing the 5 Star Medical endoscopes through the operating channel of a standard colonoscope. They are available with a working channel, fiberoptic cable connection and device for deflection. Manipulation at the proximal end of the flexible scope activates the deflection of the distal tip.

### Optical Handle

The optical handle consists of an eye piece, a barrel and a scope connection. The handle incorporates magnifying optics which can be adjusted for focus with the focusing ring.

### Fiber Optic Cables, Adapters and Light Sources

The fiber optic cables consist of a bundle of non-coherent glass fibers. The fiber optic bundle is sheathed. The light source end of the cable is configured to fit various light sources currently available in distribution (e.g. Wolf, Olympus, Storz ACMI and Pentax). The instrument end of the cable is finished with a female ACMI type connector. Light sources which are in common use are compatible with the 5 Star Medical Endoscope. Diagnostic and photo light sources are effective and safe to use with this system. The adapters which are available for use with the fiber optic cable provide for connection to light sources built by Wolf, Olympus, Storz, ACMI and Pentax.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Beverly J. Stewart
President
5 Star Medical, Inc.
4767 Wren Court
Charlottesville, Virginia 22911

SEP - 8 1997

Re: K963354
5 Star Medical Endoscope
Dated: June 1, 1997
Received: June 13, 1997
Regulatory class: II
21 CFR §876.1500
Product codes: 78 FGB, FGC, FAJ, FDA, FTK, GCF, FBN, FGA, FAM, FDT, KOG

Dear Ms. Stewart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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AUG-29-1997 17:35
FIBERVISION TECHNOLOGY
P.02
41001
Page 4 of 4

510(k) Number (if known): K963354

Device Name: Endoscope

Indications For Use:
Direct visualization of B.I. - B.U. system using additional accessories to perform various diagnostic and therapeutic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963354

Description Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)