(14 days)
No
The summary focuses on the mechanical structure and intended use of a variable stiffness endoscope, with no mention of AI or ML capabilities.
Yes
The device is used for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum, which are therapeutic procedures.
No
The device is described as a variable stiffness scope for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. Its intended use is to perform surgical procedures, not to diagnose conditions.
No
The device description clearly describes a physical, mechanical device (variable stiffness scope) intended for insertion into the body, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for endoscopy and endoscopic surgery within the duodenum. This involves directly visualizing and potentially performing procedures within the body.
- Device Description: The description focuses on the mechanical structure of a variable stiffness scope used for these procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis of biological samples.
This device is a medical device used for direct visualization and intervention within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.
Do not use these instruments for any purpose other than their intended uses.
Product codes
FDT, KOG
Device Description
This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
duodenum
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
When compared to the predicate device, XTJF-160AF does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
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/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus Optical Co., Ltd. % Mr. Donald J. Sherratt Medical Stream Director Intertek Testing Services NA, Inc. ETL SEMKO 70 Codman Hill Road Boxborough, MA 01719
JUL 2,7,2015
Re: K024033
Trade/Device Name: XTJF - 160AF Duodenovideoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated (Date on orig SE Itr); December 5, 2002 Received (Date on orig SE ltr): December 6, 2002
Dear Mr. Sherratt,
This letter corrects our substantially equivalent letter of December 20, 2002.
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
Page 2 -
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 (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
510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________ Device Name:_XTJF-160AF DUODENOVIDEOSCOPE
Indications for Use:
The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.
Do not use these instruments for any purpose other than their intended uses.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use_
્વર
Over-The-Counter Use_
(Per 21 CFR 801.109)
Daniel A. Lannon
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number
(Optional Format 1-2-96)
3
KO24033
DEC 2 0 2002
SMDA 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR Section 807.92.
A. Submitter's Name, Address, Phone and Fax Number
| 1. Applicant: | Olympus Opt-Electronics Co., Ltd.
(New Company Name: AIZU Olympus Co., Ltd.)
500 Aza Muranishi Ooaza Niidera, Monden-machi
Aizuwakamatsu-shi Fukushima, Japan, 965-8520
Registration No.: 9610595 | | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 2. Initial Importer | Olympus America Inc.
Two Corporate Center Drive
Melville, NY 11747-3157
Registration No.: 2429304 | | |
| 3. Contact Person | Junko Obata | | |
| 3. Contact Person | Junko Obata |
|---|---|
| Olympus Optical Co., Ltd. | |
| 2951 Ishikawa-cho | |
| Hachioji-shi, Tokyo 192-8507, Japan | |
| TEL 81-426-42-2891 | |
| FAX 81-426-42-2291 |
B. Device Name, Common Name
-
- Trade/Proprietary Name and Common Name Trade Name: XTJF-160AF DUODENOVIDEOSCOPE Common Name: DUODENOVIDEOSCOPE
-
- Class, Classification Number and Classification Name
| AER Number - -
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Classification iver
Name | · · Product Cope · |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------|
| 876.1500 | Endoscopes and accessones | R-KOG |
-
- Identification of Legally Marketed Devices Which we Claim Substantial Equivalence The following listed devices are seem to be as predicate devices in consideration of its characteristic and the following table shows regulatory history.
| Model | #510(k) | Manufacturer | Class | Product Code |
|---|---|---|---|---|
| TJF-140R | ||||
| Duodenovideoscope | #K980465 | Olympus Optical Co., | II | 78-KOG |
| JF-V10 | ||||
| Videoimage Duodenoscope | #K853585 | Olympus Optical Co., | II | 78-KOG |
| EVIS EXERA | ||||
| Colonovideoendoscopes | #K001241 | Olympus Optical Co., | II | 78-KOG |
4
C. Summary Description of the Device
-
- Summary
This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device,
- Summary
2. Design
XTJF-160AF has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-2 and IEC60601-2-18.
-
- Materials
There are no new patient contacting materials. All of patient contacting materials is cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.
- Materials
4. Intended Use of the device
The XTJF-160AF has been designed to be used with an OLYMPUS EVIS Video System Center, Light Source, Documentation Equipment, Video Monitor, Endo Therapy Accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electorosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.
5. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, XTJF-160AF does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.