(190 days)
Not Found
No
The summary explicitly states there are no differences in design, materials, or specifications compared to the predicate device, and there is no mention of AI, ML, or image processing.
No
The device is described as being "intended for observation" of the digestive tract, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is intended for "observation of the upper and lower digestive tract," which implies gathering information to aid in diagnosis, making it a diagnostic device.
No
The device description explicitly states it is a "Fiberscope," which is a hardware device used for observation. The summary focuses on the physical device and its intended use for visualization, not on software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "observation of the upper and lower digestive tract". This is a direct visualization procedure performed on a living patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The device is a "Fiberscope", which is a tool for direct visual examination.
- Lack of IVD Indicators: There is no mention of analyzing samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose diseases or conditions. This device is for direct visual inspection within the body.
N/A
Intended Use / Indications for Use
Olympus LF-DP Gastrointestinal and Sigmoid Fiberscope, accessories and ancillary equipment are inetend for observation of the upper and lower digestive tract including esophagus, stomach, and sigmoid colon.
Product codes
FDS, FCW, GCT
Device Description
The subject device, the LF-DP for use in the upper and lower digestive tract, is identical to the predicate device, the LF-DP Tracheal Intubation Fiberscope. The only difference between the subject and predicate devices is the indications for use. There are no other differences in design, materials or specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower digestive tract including esophagus, stomach, and sigmoid colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with its arms raised, or perhaps a bird in flight, represented by three curved lines that suggest movement and form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus America, Inc. Ms. Laura Storms-Tyler Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157
JUL 2 7 2015
K002231 Re: Trade/Device Name: Olympus LF-DP Gastrointestinal and Sigmoid Fiberscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, FCW, GCT Dated (Date on orig SE ltr): December 12, 2000 Received (Date on orig SE ltr): December 13, 2000
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of January 30, 2001.
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
1
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 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 Small Manufacturers, International and Consumer Assistance 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. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K00231
510(k) Number(if known): Not assigned yet Device Name:_____________________________________________________________________________________________________________________________________________________________ Indications for Use:
Olympus LF-DP Gastrointestinal and Sigmoid Fiberscope, accessories and ancillary equipment are inetend for observation of the upper and lower digestive tract including esophagus, stomach, and sigmoid colon.
(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 801.109) |
OR
| (Division Sign-Off) | Carolyn Y. Newland |
|---|---|
| for Dan Schuttz | |
| (Optoinal Format 1-2-96) |
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K002231 |
|---|---|
| --------------- | --------- |
3
JAN 3 0 2001
/500223/
510(k) SUMMARY
Pg. 1 of 2
LF-DP Gastrointestinal and Sigmoid Fiberscope, accessories and ancillary equipment
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.
A. Submitter's Name, Address, Phone and Fax Number
1. Manufacturer of the subject device
| Name & Address of Manufacturer; | Olympus Optical Co,. Ltd. | |
|---|---|---|
| 2-3-1 Shinjuku Monolis Nishi-shinjuku | ||
| Shinjuku-ku, Tokyo, 163-0914 | ||
| Japan | ||
| Registration No : | 810047 | |
| Address, Phone and Fax Number | 2951 Ishikawa-cho | |
| of R&D Department | Hachioji-shi, Tokyo 192-8507 | |
| Endoscope Division | Japan | |
| TEL 81-426-42-5177 | ||
| FAX 81-426-46-5613 | ||
| 2 Name of Contact Person | ||
| Name : | Ms.Laura Storms-Tyler | |
| Director, Regulatory Affairs | ||
| Olympus America Inc. | ||
| Address, Phone and Fax | Olympus America Inc. | |
| Two Corporate Center Drive | ||
| Melville, NY 11747-3157 | ||
| TEL (631)844-5688 | ||
| FAX (631)844-5416 | ||
B. Device Name, Common Name
| 1. Device Name : | LF-DP Gastrointestinal and Sigmoid Fiberscope accessories and ancillary equipment. |
|---|---|
| 2. Common/Usual Name : | Gastrointestinal and Sigmoid Fiberscope |
| 3. Classification Name : | 21CFR 876.1500 Class II |
| C. Predicate Devices : | # K981543 LF-DP Tracheal Intubation Fiberscopes, accessories and ancillary equipment |
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D. Summary Description of the Device
1. Summary
The subject device, the LF-DP for use in the upper and lower digestive tract, is identical to the predicate device, the LF-DP Tracheal Intubation Fiberscope. The only difference between the subject and predicate devices is the indications for use. There are no other differences in design, materials or specifications. This does not affect the safety or efficacy of the subject.
2. Design
"LE-DP Gastrointestinal and Sigmoidfiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
3. Materials
There are no new patient-contacting materials.
E. Intended Use of the device
Except for expanding the intended use to include use within the upper and lower digestive, other characteristics of the Olympus LF-DP Gastrointestinal and Sigmoidfiberscope is identical to the Predicate Olympus LF-DP Tracheal Intubation.
F. Technological Characteristics
This endoscope does not have special technological characteristics, when compared to the predicate device.
G. Reason for not requiring clinical data
When compared to the predicate devices, "T.F-DP Gastrointestinal and Sigmoidfiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Therefore clinical data is not necessary for its evaluation of safety and efficacy.