← Product Code [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI) · K172734 # Single Use Electrosurgical Snare SD-400 (K172734) _Olympus Medical Systems Corp. · FDI · Dec 7, 2017 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K172734 ## Device Facts - **Applicant:** Olympus Medical Systems Corp. - **Product Code:** [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI.md) - **Decision Date:** Dec 7, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. ## Device Story Single-use electrosurgical snare for endoscopic GI procedures; used by physicians in healthcare facilities. Device comprises handle, tube, and loop sections. Loop is extended/retracted via handle; inserted through endoscope to capture target tissue. Resection performed with or without high-frequency current. Enables polyp removal/cauterization; benefits patient by facilitating minimally invasive tissue excision. ## Clinical Evidence Bench testing only. Performance testing included snare operation, dimensional verification, and loop wire durability. Biocompatibility (ISO 10993), sterilization (ISO 11135), shelf-life (ASTM F1980), and electrical safety/EMC (IEC 60601 series) testing performed. No clinical data. ## Technological Characteristics Materials: ABS (handle), fluorocarbon polymer (tube), stainless steel (loop). Silicone oil coating on loop. Energy: High-frequency current. Sterilization: ETO. Standards: ISO 11135, ISO 10993-1/5/7/10/11, ASTM F1980-16, AAMI/ANSI/ISO 11607-1/2, AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, AAMI/ANSI/IEC 60601-2-2, ISO 14971. ## Regulatory Identification An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. ## Predicate Devices - CAPTIVATOR II, SINGLE-USE POLYPECTOMY SNARES ([K133987](/device/K133987.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue. December 7, 2017 Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Vallev. PA 18034-0610 Re: K172734 Trade/Device Name: Single Use Electrosurgical Snare SD-400 Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FDI, FGX Dated: November 14, 2017 Received: November 15, 2017 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 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 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); 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. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clear and easy to read. 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) K172734 #### Device Name Single Use Electrosurgical Snare SD-400 Indications for Use (Describe) These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Type of Use (Select one or both, as applicable) | Residential Use (Per 31 CFR 801.2, Select Place) | |----------------------------------------------------------------------------------------------------------------------------------| | On-The-Go Use (31 CFR 801.2, Select Place) | > 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/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Underneath the word is a thin, horizontal, yellow line. Below the line, the words "Your Vision, Our Future" are written in a smaller font. # 510(k) Summary September 8,2017 #### I. General Information - . Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 . Official Correspondent: Sheri L. Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 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: | Aomori Olympus Co., Ltd.
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan 036-0357
Establishment Registration No.: 9614641 | |---------------|---------------------------------------------------------------------------------------------------------------------------------------| |---------------|---------------------------------------------------------------------------------------------------------------------------------------| #### II. Device Identification | Device Trade Name: | Single Use Electrosurgical Snare SD-400 | |--------------------|-----------------------------------------| |--------------------|-----------------------------------------| ■ Common Name: Snares - . Regulation Number: 876.4300 876.4730 . Regulation Name: Endoscopic electrosurgical unit and accessories Manual gastroenterology-urology surgical instrument and accessories - I Regulatory Class: II - . Classification Panel: Gastroenterology and urology - . Product Code: FDI FGX - . Classification Name snare, flexible snare, non-electrical {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a gold line, and below the line is the text "Your Vision, Our Future". ### III. Predicate Device and Reference Devices Information | Single Use Electrosurgical knife | | | |------------------------------------------------|-------------------------------|---------| | Predicate Device | | | | Device name | Applicant | 510(k)# | | CAPTIVATOR II,SINGLE-USE
POLYPECTOMY SNARES | Boston Scientific Corporation | K133987 | ### IV. Device Description The subject device is designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section. The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current. #### V. Indications for Use These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. #### VI. Comparison of Technological Characteristics Compared to the predicate devices, the proposed subject device, Single Use Electrosurgical Snare SD-400 has similar technological characteristics except for the following differences. - Shape of the snare loop - - Maximum insertion portion diameter - - Lineup (Loop width) - - -Diameter of the snare loop wire Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for OLYMPUS. The word "OLYMPUS" is written in large, bold, blue letters. Underneath the word is a thin, yellow line. Below the line, the words "Your Vision, Our Future" are written in a smaller, thinner font. A side by side comparison of the subject device and the predicate device is provided below. | Item |
Single Use Electrosurgical
Snare SD-400 |
CAPTIVATOR II,
SINGLE-USE
POLYPECTOMY SNARES
(K133987) | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | These instruments have been
designed to be used with an
Olympus endoscope for the
removal and/or cauterization of
diminutive polyps, sessile
polyps, pedunculated polyps
and tissue from within the GI
tract. | The Polypectomy Snares are
used endoscopically in the
removal and /or cauterization
of diminutive polyps, sessile
polyps, pedunculated polyps
and tissue from within the GI
tract. | | Common name | Snares | Polypectomy Snare | | Regulation number | 876.4300
876.4730 | 876.4300
876.4730 | | Regulation name | Endoscopic electrosurgical unit
and accessories
Manual
gastroenterology-urology
surgical instrument and
accessories | Endoscopic electrosurgical
unit and accessories
Manual
gastroenterology-urology
surgical instrument and
accessories | | Regulatory class | II | II | | Classification panel | Gastroenterology and Urology | Gastroenterology and Urology | | Product code | FDI
FGX | FDI
FGX | | Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | | Single/repeat use | Single-Use | Single-Use | | Sterile/non-sterile | Marketed as a sterile device | Marketed as a sterile device | | Sterilization method | ETO sterile | ETO sterile | | Energy source | With or without
High-frequency current | With or without
High-frequency current | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller font. | | | Single Use Electrosurgical Snare SD-400 | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Item |
Single Use Electrosurgical
Snare SD-400 |
CAPTIVATOR II,
SINGLE-USE
POLYPECTOMY SNARES
(K133987) | | General type of
materials | Composed of ABS (handle section), fluorocarbon polymer (tube section), and stainless steel (loop section).
The materials used in the device do not conform to an FDA recognized consensus standard for medical use. | Unknown | | Patient-contact
potential (Duration
and type of contact) | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours). | Same as subject device | | Coatings/additives | Silicone oil is used as coating on the part of the loop section.
No additives are applied to patient contact materials. | Unknown | ## VII. Summary of non-clinical testing Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the Single Use Electrosurgical Snare SD-400 is at least equivalent to the predicate device. - -Snare operation with the compatible endoscopes - Dimensions of each part of the snare - - -Durability of snare loop wire The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012. The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per AAMI/ANSI/ISO 11607-1:2006/(R) 2010 and AAMI/ANSI/ISO 11607-2:2006/(R)2010 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Below the line is the text "Your Vision, Our Future". Biocompatibility testing was performed in accordance with the FDA Guidance." Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. The cytotoxicity, sensitization, intracutaneous irritation and system toxicity tests were performed to demonstrate the biocompatibility of the device. Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-1-2 Edition 3: 2007-03, and in particular we also conducted tests on high frequency surgical equipment and accessories for endoscopes per IEC 60601-2-18: Edition 3.0 2009-08 and AAMI/ANSI/IEC 60601-2-2:2009. Finally, risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971 Second edition 2007-03-01. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. | Standard # | Standard Title | Related Documents | |-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | 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 | Section14 | | ISO 10993-7 Second
edition 2008-10-15 | Biological evaluation of medical devices -
Part 7: Ethylene oxide sterilization
residuals [Including: Technical
Corrigendum 1 (2009)] | Section14 | | ASTM F1980-16 | Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical
Devices | Section14 | | AAMI/ANSI/ISO
11607-1:2006/(R)2010 | Packaging for terminally sterilized
medical devices - Part 1: Requirements
for materials, sterile barrier systems and
packaging systems [Including:
Amendment 1 (2014)] | Section14 | | Single Use Electrosurgical Snare SD-400 | | | | Standard # | Standard Title | Related
Documents | | AAMI/ANSI/ISO
11607-2:2006/(R)2010 | Packaging for terminally sterilized
medical devices - Part 2: Validation
requirements for forming, sealing and
assembly processes [Including:
Amendment 1 (2014)] | Section14 | | 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)]. (Biocompatibility) | Section15 | | ISO 10993-5 Third edition
2009-06-01 | Biological evaluation of medical devices
– Part5 Tests for in vitro cytotoxicity | Section15 | | ISO 10993-10 Third Edition
2010-08-01 | Biological evaluation of medical devices
– Part10 Tests for irritation and skin
sensitization | Section15 | | ISO 10993-11 Second
Edition 2006-08-15 | Biological evaluation of medical devices -
Part 11 Tests for systemic toxicity | Section15 | | AAMI / ANSI
ES60601-1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012 | Medical electrical equipment - part 1:
general requirements for basic safety and
essential performance (IEC 60601-1:2005,
mod). | Section17 | | IEC 60601-1-2 Edition 3:
2007-03 | Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
standard: Electromagnetic compatibility
-requirements and tests | Section17 | | AAMI / ANSI IEC
60601-2-2:2009 | Medical electrical equipment - Part 2-2:
Particular requirements for the basic
safety and essential performance of high
frequency surgery equipment and high
frequency surgical accessories. | Section17 | | 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. | Section17 | | ISO 14971 Second edition
2007-03-01 | Medical devices-Application of risk
management to medical devices | Section21 | The following standards have been applied to the Single Use Electrosurgical Snare SD-400: {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line, and below that is the text "Your Vision, Our Future". {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line, and below that is the text "Your Vision, Our Future". # VIII. Conclusion Compared to the predicate device, the proposed design modifications to the Single Use Electrosurgical Snare SD-400 were verified and validated and did not raise any new issues with safety and effectiveness. Therefore, the subject device is substantially equivalent to the cited predicate device. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K172734](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K172734) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com