(229 days)
Not Found
No
The summary describes standard endoscopic devices and their components, with no mention of AI, ML, image processing, or any features indicative of intelligent algorithms.
Yes
The device is described as being used for "endoscopic diagnosis and treatment," indicating it has a therapeutic function in addition to diagnostic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is "designed ... for endoscopic diagnosis and treatment."
No
The device description explicitly details physical components like flexible insertion tubes, control sections, light guide connectors, video connectors, CCDs, and light fiber bundles, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that the Olympus URF-V3/V3R and URF-P7/P7R are endoscopes designed for endoscopic diagnosis and treatment within the ureter, kidney, and biliary tract. This involves inserting the device into the body for direct visualization and potential therapeutic procedures.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its primary function is visualization and access for treatment within the body.
Therefore, these devices fall under the category of medical devices used for internal examination and treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
-OLYMPUS URF-V3/V3R
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
-OLYMPUS URF-P7/P7R
This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
Product codes (comma separated list FDA assigned to the subject device)
FGB, NWB, FBN
Device Description
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R
URF-V3 and URF-V3R have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
This endoscope is a videoscope, composed of flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system. The difference between URF-V3 and URF-V3R is angle overation direction. The bending section of the URF-V3R moves towards the direction oppositely to that of the URF-V3.
URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
URF-P7 and URF-P7R have been designed to be used with an Olympus light source, documentation equipment. Monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
This endoscope is a fiberscope, composed of flexible insertion tube, control section and eyepiece section, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for directly visual observation or video camera connection.
The difference between URF-P7 and URF-P7R is angle operation direction. The bending section of the URF-P7R moves towards the direction oppositely to that of the URF-P7.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter, kidney, biliary tract (common bile duct and hepatic duct)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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)
Performance testing was carried out to verify the safety and the effectiveness of the subject device. The results of the above performance testing demonstrated that the subject devices have no concerns on safety and effectiveness.
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.
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2019
Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Surgical Technologies America 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
Re: K181451
Trade/Device Name: OLYMPUS URF-V3/V3R, OLYMPUS URF-P7/P7R Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB, NWB Dated: December 5, 2018 Received: December 6, 2018
Dear Sheri L. Musgnung:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for 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
Indications for Use
510(k) Number (if known) K181451
Device Name OLYMPUS URF-V3/V3R, OLYMPUS URF-P7/P7R
Indications for Use (Describe) -OLYMPUS URF-V3/V3R
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
-OLYMPUS URF-P7/P7R
This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A small registration mark is located to the right of the letter "S".
May 31, 2018
Section 5
510(k) Summary
5.1 GENERAL INFORMATION
- Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- Official Sheri L. Musgnung Correspondent: Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
- . Manufacturer Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan Establishment Registration No .: 9610595
5.2 DEVICE IDENTIFICATION
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R
- Device Name OLYMPUS URF-V3/V3R
- URETERO-RENO VIDEOSCOPE ■ Common Name
- Regulation Number 876.1500
- Regulation Name Endoscope and Accessories
- Regulatory Class II
- Product Code FGB (Ureteroscope And Accessories, Flexible/Rigid) NWB (Endoscope, accessories, narrow band spectrum) ■ Classification Panel Gastroenterology and urology
Section 5 510(k) Summary Page 1 of 9
4
Image /page/4/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the letter "S". A gradient of yellow is located below the word.
URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
- OLYMPUS URF-P7/P7R Device Name
- Common Name URETERO-RENO FIBERSCOPE
- Regulation Number 876.1500
- Regulation Name Endoscope and Accessories
- Regulatory Class II
- Product Code FGB (Ureteroscope And Accessories, Flexible/Rigid) FBN (Choledochoscope And Accessories, Flexible/Rigid) ■ Classification Panel Gastroenterology and urology
5.3 PREDICATE DEVICE
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R
Table 5-1 Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| OLYMPUS URF-V2/V2R | OLYMPUS MEDICAL SYSTEMS CORP. | K172246 |
URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Table 5-2 Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| OLYMPUS URF-P6/P6R | OLYMPUS MEDICAL SYSTEMS CORP. | K172298 |
5.4 DEVICE DESCRIPTION
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R
URF-V3 and URF-V3R have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
This endoscope is a videoscope, composed of flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system. The difference between URF-V3 and URF-V3R is angle overation direction. The bending section of the URF-V3R moves towards the direction oppositely to that of the URF-V3.
5
Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is present to the right of the word. The background is white.
URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
URF-P7 and URF-P7R have been designed to be used with an Olympus light source, documentation equipment. Monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
This endoscope is a fiberscope, composed of flexible insertion tube, control section and eyepiece section, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for directly visual observation or video camera connection.
The difference between URF-P7 and URF-P7R is angle operation direction. The bending section of the URF-P7R moves towards the direction oppositely to that of the URF-P7.
5.5 INDICATIONS FOR USE
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The URF-V3/V3R and URF-P7/P7R have the same technological characteristics and design as their predicate devices except for the following main features:
- Improvement of passive bending section in the insertion section.
- Addition of compatible sterilization methods.
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
All other technological characteristics of both the subject and predicate devices are identical.
6
Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a registered trademark symbol to the right of the word. The background is white, with a gradient of yellow at the bottom.
A side by side comparison of the subject devices and the predicate devices is provided below.
| Item |
OLYMPUS URF-V3/V3R |
OLYMPUS URF-V2/V2R
(K172246) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument has been
designed to be used with an
Olympus video system center,
light source, documentation
equipment, monitor,
EndoTherapy accessories, and
other ancillary equipment for
endoscopic diagnosis and
treatment within the ureter and
kidney. | This instrument has been
designed to be used with an
Olympus video system center,
light source, documentation
equipment, monitor,
EndoTherapy accessories, and
other ancillary equipment for
endoscopic diagnosis and
treatment within the ureter and
kidney. |
| Common name | URETERO-RENO
VIDEOSCOPE | URETERO-RENO
VIDEOSCOPE |
| Regulation number | 876.1500 | 876.1500 |
| Regulation name | Endoscope and Accessories | Endoscope and Accessories |
| Regulatory class | II | II |
| Classification panel | Gastroenterology and urology | Gastroenterology and urology |
| Product code | FGB, NWB | FGB, NWB |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Single/repeat use | Repeat use | Repeat use |
| Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile |
| Sterilization method | Ethylene oxide;
Hydrogen peroxide including
V-PRO maX and STERRAD
NX/100NX (with or without
ALLClear Technology). | Ethylene oxide;
Hydrogen peroxide including
STERRAD NX/100NX. |
| Energy source | Electricity | Electricity |
Table 5-3 Comparison of URF-V3/V3R and their predicate devices.
7
Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The registered trademark symbol is located to the right of the word. There is a yellow line underneath the word.
Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
| Item |
OLYMPUS URF-V3/V3R |
OLYMPUS URF-V2/V2R
(K172246) |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Material
composition of
main
patient-contact parts | Material composition of main
patient-contact parts | Material composition of main
patient-contact parts |
| main
patient-contact parts
and duration and
type of contact | Distal end: Stainless steel
Insertion tube: Fluoro resin
Bending section rubber: Fluoro
rubber
Lens: Glass
Glue: Epoxy glue | Distal end: Stainless steel
Insertion tube: Fluoro resin
Bending section rubber: Fluoro
rubber
Lens: Glass
Glue: Epoxy glue |
| | Surface-contacting device in
contact with mucosal
membranes. The contact
duration is limited exposure
(i.e. contact is up to 24 hours). | Surface-contacting device in
contact with mucosal
membranes. The contact
duration is limited exposure (i.e.
contact is up to 24 hours). |
| Table 5-4 Comparison of URF-P7/P7R and their predicate devices | |||
|---|---|---|---|
| Item |
OLYMPUS URF-P7/P7R |
OLYMPUS URF-P6/P6R
(K172298) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument has been
designed to be used with an
Olympus light source,
documentation equipment,
monitor, EndoTherapy
accessories, and other ancillary
equipment for endoscopic
diagnosis and treatment within
the ureter, kidney and biliary
tract (common bile duct and
hepatic duct). | This instrument has been
designed to be used with an
Olympus light source,
documentation equipment,
monitor, EndoTherapy
accessories, and other ancillary
equipment for endoscopic
diagnosis and treatment within
the ureter, kidney and biliary
tract (common bile duct and
hepatic duct). |
| Common name | URETERO-RENO
FIBERSCOPE | URETERO-RENO
FIBERSCOPE |
| Regulation number | 876.1500 | 876.1500 |
| Regulation name | Endoscope and Accessories | Endoscope and Accessories |
| Regulatory class | II | II |
| Classification panel | Gastroenterology and urology | Gastroenterology and urology |
| Product code | FGB, FBN | FBN, FGB |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
8
Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly stylized, with a rounded, sans-serif font. A small registration mark is visible to the upper right of the last letter, "S". The background is plain white.
Traditional 510(k) Notification ETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R RETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
| Item |
OLYMPUS URF-P7/P7R |
OLYMPUS URF-P6/P6R
(K172298) |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single/repeat use | Repeat use | Repeat use |
| Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile |
| Sterilization method | Ethylene oxide; Hydrogen
peroxide including V-PRO
maX and STERRAD
NX/100NX. | Ethylene oxide; Hydrogen
peroxide including STERRAD
NX/100NX. |
| Energy source | Electricity | Electricity |
| Material composition
of main
patient-contact parts
and duration and type
of contact | Material composition of main
patient-contact parts
Distal end: Polysulfone
Insertion tube: Fluoro resin
Bending section rubber: Fluoro
rubber
Lens: Glass
Glue: Epoxy glue
Surface-contacting device in
contact with mucosal
membranes. The contact
duration is limited exposure
(i.e. contact is up to 24 hours). | Material composition of main
patient-contact parts
Distal end: Polysulfone
Insertion tube: Fluoro resin
Bending section rubber: Fluoro
rubber
Lens: Glass
Glue: Epoxy glue
Surface-contacting device in
contact with mucosal
membranes. The contact
duration is limited exposure
(i.e. contact is up to 24 hours). |
5.7 Summary of non-clinical testing
The technological characteristic differences between the predicate devices and the subject devices have been confirmed that they are substantially equivalent through the following tests and standards.
- ·Reprocessing instruction and reprocessing method validation testing for the URF-V3/V3R and, URF-P7/P7R were assessed and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- · Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16 2016.
9
Image /page/9/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and appear to be a sans-serif font. A registered trademark symbol is located to the upper right of the word.
standards for electrical safety.
K181451 Page 7 of 9
-
•Software verification and validation testing including the requirement of cybersecurity for the URF-V3/V3R were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
· Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC were assessed for the URF-V3/V3R. The system complies with the ANSI/AAMI ES 60601-1:2005/A2:2010/(R) 2012 and IEC 60601-2-18:2009 standards for electrical safety and the IEC 60601-1-2:2014 standards for EMC. Electrical safety was assessed for the URF-P7/P7R The system complies with the ANSI/AAMI ES 60601-1:2005/A2:2010/(R) 2012 and IEC 60601-2-18:2009 -
·Performance testing was carried out to verify the safety and the effectiveness of the subject device.
-
·Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The results of the above performance testing demonstrated that the subject devices have no concerns on safety and effectiveness.
· The following standards have been applied to the URETERO-RENO VIDEOSCOPES
| Standard number | Standard Title |
|---|---|
| ISO 10993-1 Fourth | |
| Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1: |
| Evaluation And Testing Within A Risk Management | |
| Process [Including: Technical Corrigendum 1 (2010)] | |
| ISO 10993-5 Third | |
| Edition:2009-06-01 | |
| ISO 10993-7 Second | |
| Edition:2008-10-15 | |
| ISO 10993-10 Third Edition: | |
| 2010-08-01 |
Table 5.3 Standards for URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R
10
Image /page/10/Picture/1 description: The image contains the word "OLYMPUS" in large, bold, blue letters. The word is positioned at the top of the image. There is a thin, horizontal, yellow bar located underneath the word.
Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
| ISO 14971 Second
Edition:2007-03-01 | Medical Device-Application Of Risk Management To
Medical Device |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI ANSI ES60601-1:
2005/
(R)2012 and A1:2012, | C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated
Text) Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential
Performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 Edition 4:
2014-02 | Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements And Tests |
| IEC 60601-2-18 Edition 3.0:
2009-08 | Medical Electrical Equipment - Part 2-18: Particular
Requirements For The Basic Safety And Essential
Performance Of Endoscopic Equipment |
| ISO 11135 Second
Edition:2014 | Sterilization Of Health-Care Products Ethylene
Oxide-Requirements For The Development, Validation
And Routine Control Of A Sterilization Process For
Medical Devices |
·The following standards have been applied to the URETERO-RENO VIDEOSCOPE
| Standard number | Standard Title |
|---|---|
| ISO 10993-1 Fourth | |
| Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1: |
| Evaluation And Testing Within A Risk Management | |
| Process [Including: Technical Corrigendum 1 (2010)] | |
| ISO 10993-5 Third | |
| Edition:2009-06-01 | Biological Evaluation Of Medical Devices – Part5: Tests |
| For In Vitro Cytotoxicity | |
| ISO 10993-7 Second | |
| Edition:2008-10-15 | Biological Evaluation Of Medical Devices - Part 7: |
| Ethylene Oxide Sterilization | |
| ISO 10993-10 Third Edition: | |
| 2010-08-01 | Biological Evaluation Of Medical Devices - Part |
| 10: Tests For Irritation And Skin Sensitization | |
| ISO 14971 Second | |
| Edition:2007-03-01 | Medical Device-Application Of Risk Management To |
| Medical Device | |
| AAMI ANSI ES60601-1: | C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated |
Table 5.4 Standards for URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
11
Image /page/11/Picture/1 description: The image contains the word "OLYMPUS" in large, bold, blue letters. The word is positioned at the top of the image. Below the word, there is a yellow bar that spans the width of the word above it.
Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
| 2005/
(R)2012 and A1:2012, | Text) Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential
Performance (IEC 60601-1:2005, MOD) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-18 Edition 3.0:
2009-08 | Medical Electrical Equipment - Part 2-18: Particular
Requirements For The Basic Safety And Essential
Performance Of Endoscopic Equipment |
| ISO 11135 Second
Edition:2014 | Sterilization Of Health-Care Products Ethylene
Oxide-Requirements For The Development, Validation
And Routine Control Of A Sterilization Process For
Medical Devices |
5.8 CONCLUSIONS
Based on the intended use and technological comparison to the predicate devices, the subject devices OLYMPUS URF-V3/V3R and OLYMPUS URF-P7/P7R are demonstrated to raise no new issue of safety and effectiveness and are substantially equivalent to their predicate devices in terms of safety and effectiveness.