(220 days)
Not Found
Not Found
No
The summary describes a standard video gastroscope system with optical visualization and image capture capabilities, but there is no mention of AI, ML, or advanced image processing beyond basic visualization.
Yes
The "Intended Use / Indications for Use" states that the system is for "visual examination and treatment of the upper digestive tract". Additionally, the "Device Description" mentions "therapeutic access" and "biopsy channels", indicating its capability beyond just diagnosis.
Yes
The device is used for visual examination of the upper digestive tract, which involves identifying abnormalities or conditions, thus aiding in diagnosis.
No
The device description explicitly details hardware components such as a flexible endoscope with a distal-CCD chip, a Camera Control Processor (CCU), image module, air/water insufflation, jet nozzle, suction, illumination light, and biopsy channels. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Karl Storz Video Gastroscope System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "visual examination and treatment of the upper digestive tract". This involves direct visualization and therapeutic access within the body, not testing samples outside the body.
- Device Description: The description details a flexible endoscope with optical visualization and channels for various procedures performed in vivo.
- Classification: The device is classified under 21CFR876.1500, Endoscope and accessories, which are devices used for internal examination and procedures, not for in vitro diagnostic testing.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Karl Storz Video Gastroscope System operates directly on the patient's internal anatomy.
N/A
Intended Use / Indications for Use
The Karl Storz Video Gastroscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the upper digestive tract including the esophagus, stomach, and duodenum. The Video Gastroscope System is intended to provide optical visualization via a video monitor and therapeutic access to the upper digestive tract.
Product codes
FDS, GCT, FWF
Device Description
The Karl Storz Video Gastroscope System is a flexible endoscope with a distal-CCD chip technology which connects to the Karl Storz Camera Control Processor (CCU) to provide clear images on the video monitor during the examination and treatment of the upper digestive tract. The flexible video gastroscope contains image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Gastroscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Optical visualization
Anatomical Site
upper digestive tract including the esophagus, stomach, and duodenum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / endoscopist
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
NOV - 9 2006 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paul S. Lee
Senior Regulatory Affairs Specialist
Telephone +1-310-410-2769
Fax +1-310-410-5519
E-mail: plee@ksea.com |
Trade Name: Karl Storz Video Gastroscope System
The Karl Storz Video Gastroscope System is intended to be used by Indication: physician / endoscopist in the visual examination and treatment of the upper digestive tract including the esophagus, stomach, and duodenum. The Video Gastroscope System is intended to provide optical visualization via a video monitor and therapeutic access to the upper digestive tract.
Device Description: The Karl Storz Video Gastroscope System is a flexible endoscope with a distal-CCD chip technology which connects to the Karl Storz Camera Control Processor (CCU) to provide clear images on the video monitor during the examination and treatment of the upper digestive tract. The flexible video gastroscope contains image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Gastroscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
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The Karl Storz Video Gastroscope System is substantially Substantial Equivalence: equivalent to predicate devices since the basic technology and design are similar. The intended usage is similar to predicate devices and raise no new issues of safety and effectiveness. The minor differences between the Karl Storz Video Gastroscope System and predicate devices have no effect on the performance, function or intended use of the devices.
Signature: __
Paul Lee Senior Regulatory Affairs Specialist
2
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Paul S. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive CULVER CITY CA 90230
NOV - 9 2006
、な
Re: K060907
Trade/Device Name: Karl Storz Video Gastroscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Codes: FDS, GCT and FWF Regulatory Class: II Dated: October 11, 2006 Received: October 12 2006
Dear Dr. Lec:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by text that is difficult to read due to the image quality.
eding and Promoting Public S
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Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/edrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
KOLO907
Device Name: Karl Storz Video Gastroscope System
Indications for Use: The Karl Storz Video Gastroscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the upper digestive tract including the esophagus, stomach, and duodenum. The Video-Gastroscope System is intended to provide optical visualization via a video monitor and therapeutic access to the upper digestive tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
(Per 21 CFR 801.Subpart D) AND/OR Over-The-Counter Use:
(21 CFR 801 Subpart C)
Nancy C Brogdon
(Division Sign-C Division of Reproductive. Abde and Radiological Devic 510(k) Number.
00022