(378 days)
Not Found
Not Found
No
The summary describes a direct visualization endoscope system with standard optical components and does not mention any AI/ML capabilities or image processing beyond basic visualization.
Yes
The "Intended Use / Indications for Use" explicitly states that the device is used to "perform various diagnostic and therapeutic procedure."
Yes
The intended use explicitly states that the device is used to perform various diagnostic and therapeutic procedures through direct visualization.
No
The device description explicitly lists hardware components such as Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters, and Light Sources.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Direct Visualization of B.I. - B.U. System using additional accessories to perform various diagnostic and therapeutic procedure." This describes a device used for direct observation and intervention within the body, not for testing samples outside the body.
- Device Description: The components listed (Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters, and Light Sources) are typical of an endoscope, which is an instrument used for internal examination.
- Anatomical Site: The anatomical sites mentioned (Biliary and Urinary systems) are internal body systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples. IVDs are designed to provide information about a patient's health status by testing samples in vitro (outside the body).
This device is clearly an endoscope used for direct visualization and procedures within the body, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
Direct Visualization of B.I. - B.U. System using additional accessories to perform various diagnostic and therapeutic procedure.
Product codes (comma separated list FDA assigned to the subject device)
78 FGB, FGC, FAJ, FDA, FTK, GCF, FBN, FGA, FAM, FDT, KOG
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
urethra, bladder, ureters, kidney, common bile duct, liver, pancreatic duct, colon
Indicated Patient Age Range
children (bladder), adults (ureters)
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Saratoga Modular Miniature Endoscope System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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510 (k) Summary for 5 Star Medical, Inc.
Pin I
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.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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
- 8 1997 Re: K963354 5 Star Medical Endoscope Dated: June 1, 1997 Received: June 13, 1997 Regulatory class: II 21 CFR 8876.1500 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 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 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 (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 OS 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 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 yittg diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yu
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
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510(k) Number (if known): K 96 33 5 Y Device Name: dosco
Indications For Use:
ﻳ
Direct Visualization of B.I. - B.U. System
using additional accessories to perform
various diagnostic and therapeutic procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Relev 72 Aith (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number . 'rescription Use OR Per 21 CFR 801.109) Over-The-Counter Use
(Optional Formal 1-2-96)