URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

K181451 · Olympus Medical Systems Corp. · FGB · Jan 16, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K181451
• Device Name: URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
• Applicant: Olympus Medical Systems Corp.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Jan 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

The Olympus URF-V3/V3R (videoscope) and URF-P7/P7R (fiberscope) are flexible endoscopes used for diagnostic and therapeutic procedures in the urinary and biliary tracts. The URF-V3/V3R uses an integrated CCD for image transfer to an Olympus video system center and monitor; the URF-P7/P7R uses a fiber bundle for image transfer, allowing for direct visual observation or connection to a video camera. Both devices feature a flexible insertion tube and a control section for steering the bending section. They are used in hospital/healthcare settings by trained clinicians. The devices facilitate visualization of internal anatomy, enabling the physician to perform endoscopic interventions using ancillary EndoTherapy accessories. Benefits include minimally invasive access to the ureter, kidney, and biliary tract for diagnosis and treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes reprocessing validation, biocompatibility testing (ISO 10993), electrical safety and EMC testing (ANSI/AAMI ES 60601-1, IEC 60601-2-18, IEC 60601-1-2), and risk analysis (ISO 14971).

Technological Characteristics

Flexible endoscopes. Materials: Stainless steel (distal end), fluoro resin (insertion tube), fluoro rubber (bending section), glass (lens), epoxy glue. Energy: Electricity. Connectivity: Compatible with Olympus video systems/light sources. Sterilization: Ethylene oxide, hydrogen peroxide (V-PRO maX, STERRAD NX/100NX). Standards: ISO 10993, ISO 14971, IEC 60601 series.

Indications for Use

Indicated for endoscopic diagnosis and treatment within the ureter and kidney (URF-V3/V3R) or ureter, kidney, and biliary tract (URF-P7/P7R).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OLYMPUS URF-V2/V2R (K172246)
• OLYMPUS URF-P6/P6R (K172298)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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#### 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)

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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: [phone] Fax: [phone] Email: [e-mail]
- . 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

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#### 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.

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## 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.

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A side by side comparison of the subject devices and the predicate devices is provided below.

| Item | <Subject Device><br>OLYMPUS URF-V3/V3R | <Predicate Device><br>OLYMPUS URF-V2/V2R<br>(K172246) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument has been<br>designed to be used with an<br>Olympus video system center,<br>light source, documentation<br>equipment, monitor,<br>EndoTherapy accessories, and<br>other ancillary equipment for<br>endoscopic diagnosis and<br>treatment within the ureter and<br>kidney. | This instrument has been<br>designed to be used with an<br>Olympus video system center,<br>light source, documentation<br>equipment, monitor,<br>EndoTherapy accessories, and<br>other ancillary equipment for<br>endoscopic diagnosis and<br>treatment within the ureter and<br>kidney. |
| Common name | URETERO-RENO<br>VIDEOSCOPE | URETERO-RENO<br>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;<br>Hydrogen peroxide including<br>V-PRO maX and STERRAD<br>NX/100NX (with or without<br>ALLClear Technology). | Ethylene oxide;<br>Hydrogen peroxide including<br>STERRAD NX/100NX. |
| Energy source | Electricity | Electricity |

Table 5-3 Comparison of URF-V3/V3R and their predicate devices.

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#### Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

| Item | <Subject Device><br>OLYMPUS URF-V3/V3R | <Predicate Device><br>OLYMPUS URF-V2/V2R<br>(K172246) |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Material<br>composition of<br>main<br>patient-contact parts | Material composition of main<br>patient-contact parts | Material composition of main<br>patient-contact parts |
| main<br>patient-contact parts<br>and duration and<br>type of contact | Distal end: Stainless steel<br>Insertion tube: Fluoro resin<br>Bending section rubber: Fluoro<br>rubber<br>Lens: Glass<br>Glue: Epoxy glue | Distal end: Stainless steel<br>Insertion tube: Fluoro resin<br>Bending section rubber: Fluoro<br>rubber<br>Lens: Glass<br>Glue: Epoxy glue |
| | Surface-contacting device in<br>contact with mucosal<br>membranes. The contact<br>duration is limited exposure<br>(i.e. contact is up to 24 hours). | Surface-contacting device in<br>contact with mucosal<br>membranes. The contact<br>duration is limited exposure (i.e.<br>contact is up to 24 hours). |

| Table 5-4 Comparison of URF-P7/P7R and their predicate devices | | | |
|----------------------------------------------------------------|--|--|--|
| | | | |

| Item | <Subject Device><br>OLYMPUS URF-P7/P7R | <Predicate Device><br>OLYMPUS URF-P6/P6R<br>(K172298) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument has been<br>designed to be used with an<br>Olympus light source,<br>documentation equipment,<br>monitor, EndoTherapy<br>accessories, and other ancillary<br>equipment for endoscopic<br>diagnosis and treatment within<br>the ureter, kidney and biliary<br>tract (common bile duct and<br>hepatic duct). | This instrument has been<br>designed to be used with an<br>Olympus light source,<br>documentation equipment,<br>monitor, EndoTherapy<br>accessories, and other ancillary<br>equipment for endoscopic<br>diagnosis and treatment within<br>the ureter, kidney and biliary<br>tract (common bile duct and<br>hepatic duct). |
| Common name | URETERO-RENO<br>FIBERSCOPE | URETERO-RENO<br>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 |

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#### Traditional 510(k) Notification ETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R RETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

| Item | <Subject Device><br>OLYMPUS URF-P7/P7R | <Predicate Device><br>OLYMPUS URF-P6/P6R<br>(K172298) |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single/repeat use | Repeat use | Repeat use |
| Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile |
| Sterilization method | Ethylene oxide; Hydrogen<br>peroxide including V-PRO<br>maX and STERRAD<br>NX/100NX. | Ethylene oxide; Hydrogen<br>peroxide including STERRAD<br>NX/100NX. |
| Energy source | Electricity | Electricity |
| Material composition<br>of main<br>patient-contact parts<br>and duration and type<br>of contact | Material composition of main<br>patient-contact parts<br>Distal end: Polysulfone<br>Insertion tube: Fluoro resin<br>Bending section rubber: Fluoro<br>rubber<br>Lens: Glass<br>Glue: Epoxy glue<br>Surface-contacting device in<br>contact with mucosal<br>membranes. The contact<br>duration is limited exposure<br>(i.e. contact is up to 24 hours). | Material composition of main<br>patient-contact parts<br>Distal end: Polysulfone<br>Insertion tube: Fluoro resin<br>Bending section rubber: Fluoro<br>rubber<br>Lens: Glass<br>Glue: Epoxy glue<br>Surface-contacting device in<br>contact with mucosal<br>membranes. The contact<br>duration is limited exposure<br>(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.

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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<br>Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1:<br>Evaluation And Testing Within A Risk Management<br>Process [Including: Technical Corrigendum 1 (2010)] |
| | ISO 10993-5 Third<br>Edition:2009-06-01 |
| ISO 10993-7 Second<br>Edition:2008-10-15 | |
| | ISO 10993-10 Third Edition:<br>2010-08-01 |

Table 5.3 Standards for URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R

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#### Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

| ISO 14971 Second<br>Edition:2007-03-01 | Medical Device-Application Of Risk Management To<br>Medical Device |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI ANSI ES60601-1:<br>2005/<br>(R)2012 and A1:2012, | C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated<br>Text) Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 Edition 4:<br>2014-02 | Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Electromagnetic<br>Compatibility - Requirements And Tests |
| IEC 60601-2-18 Edition 3.0:<br>2009-08 | Medical Electrical Equipment - Part 2-18: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of Endoscopic Equipment |
| ISO 11135 Second<br>Edition:2014 | Sterilization Of Health-Care Products Ethylene<br>Oxide-Requirements For The Development, Validation<br>And Routine Control Of A Sterilization Process For<br>Medical Devices |

·The following standards have been applied to the URETERO-RENO VIDEOSCOPE

| Standard number | Standard Title |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 Fourth<br>Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1:<br>Evaluation And Testing Within A Risk Management<br>Process [Including: Technical Corrigendum 1 (2010)] |
| ISO 10993-5 Third<br>Edition:2009-06-01 | Biological Evaluation Of Medical Devices – Part5: Tests<br>For In Vitro Cytotoxicity |
| ISO 10993-7 Second<br>Edition:2008-10-15 | Biological Evaluation Of Medical Devices - Part 7:<br>Ethylene Oxide Sterilization |
| ISO 10993-10 Third Edition:<br>2010-08-01 | Biological Evaluation Of Medical Devices - Part<br>10: Tests For Irritation And Skin Sensitization |
| ISO 14971 Second<br>Edition:2007-03-01 | Medical Device-Application Of Risk Management To<br>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

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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/<br>(R)2012 and A1:2012, | Text) Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601-1:2005, MOD) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-18 Edition 3.0:<br>2009-08 | Medical Electrical Equipment - Part 2-18: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of Endoscopic Equipment |
| ISO 11135 Second<br>Edition:2014 | Sterilization Of Health-Care Products Ethylene<br>Oxide-Requirements For The Development, Validation<br>And Routine Control Of A Sterilization Process For<br>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.