(87 days)
Not Found
No
The summary describes a mechanical device for polyp removal and cauterization, with no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on mechanical, electrical, and biocompatibility aspects.
Yes
Explanation: The device is used for the removal and/or cauterization of polyps and tissue within the GI tract, and resection of target tissue, which are therapeutic interventions.
No
The device is described as an instrument for removal and/or cauterization of polyps and tissue within the GI tract, and its description focuses on its mechanical and electrical function for tissue resection. There is no mention of it being used for diagnosis or generating diagnostic information.
No
The device description clearly outlines physical components (handle, tube, loop) and mentions insertion into the GI tract through an endoscope, indicating a hardware-based medical device. The performance studies also focus on physical characteristics and testing (dimensions, durability, sterilization, biocompatibility, electrical safety), further confirming it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and/or cauterization of tissue from within the GI tract. This is a direct intervention on the patient's body for therapeutic or diagnostic tissue collection purposes.
- Device Description: The device is a physical tool (snare) used to resect tissue. It operates mechanically and/or with high-frequency current.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological or pathological state. IVDs typically involve analyzing samples like blood, urine, or tissue in a laboratory setting.
- Performance Studies: The performance studies focus on the physical and electrical characteristics of the device, its biocompatibility, sterilization, and shelf-life – all typical for a surgical instrument, not an IVD.
In summary, this device is a surgical instrument used for tissue resection within the body, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FDI, FGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract (Gastrointestinal tract)
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 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.
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.
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
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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)
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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
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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.
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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 |
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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.
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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:
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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".
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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.