(109 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality for tissue collection, cauterization, and hemostasis, with no mention of AI/ML terms or capabilities.
Yes
The device is designed to electrosurgically collect tissue, cauterize, or perform hemostasis, all of which are therapeutic interventions.
No
The device is designed for therapeutic purposes, specifically for electrosurgical collection of tissue, cauterization, and hemostasis within the urinary organs, rather than for diagnosing conditions.
No
The device description clearly outlines a physical medical device with a handle, insertion portion, and fenestrated cups, designed to be inserted into an endoscope and utilize high-frequency electric current for tissue collection, cauterization, and hemostasis. The performance studies also focus on physical and electrical characteristics, biocompatibility, and packaging, indicating a hardware-based device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs." This describes a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a physical instrument used to grasp and apply electrical current to tissue within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), reagents, or diagnostic testing.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. This device is used to obtain and treat tissue directly within the body.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
Product codes
KGE
Device Description
Single Use Hot Biopsy Forceps FD-231 has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
The Single Use Hot Biopsy Forceps FD-231consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.
During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.
By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests on key features of performance specification were conducted to demonstrate the safety and effectiveness of the subject device as identical as predicate devices.
-
- Insertion into /Withdrawal from endoscope of Hot Biopsy Forceps
-
- Advance/ retraction of Hot Biopsy Forceps
-
- Grasp of specimens
-
- Electrical characteristic
-
- Ablation of specimens
-
- Compatibility with endoscope
-
- Visual inspection of package
-
- Peel strength of the package
-
- Endurance to splitting of the package
-
- Integrity of the package
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 13, 2017
Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K171916
Trade/Device Name: Single Use Hot Biopsy Forceps FD-231 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: September 26, 2017 Received: September 27, 2017
Dear Sheri 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. 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
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -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)
K171916
Device Name Single Use Hot Biopsy Forceps FD-231
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CER 801 Subnart 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 features the word "OLYMPUS" in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Underneath the line, the text "Your Vision, Our Future" is written in a smaller, sans-serif font.
510(k) SUMMARY Single Use Hot Biopsy Forceps FD-231
September 26, 2017
5.1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,
Japan
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.
2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357,
Japan
Establishment Registration No.: 9614691 |
5.2 Device Identification
| ■ Device Trade Name: | Single Use Hot Biopsy Forceps FD-231 |
|---|---|
| ■ Common Name: | Hot Biopsy Forceps |
| ■ Regulation Number: | 876.4300 |
| ■ Regulation Name: | Endoscopic electrosurgical unit and accessories |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Gastroenterology/Urology |
| ■ Product Code: | KGE |
510(k) Summary Page 2 of 6
4
Image /page/4/Picture/0 description: The image displays the logo for OLYMPUS. The word "OLYMPUS" is written in large, bold, dark blue letters. A thin, gold line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller, lighter blue font.
5.3 Predicate Devices Information
| | Predicate
device 1(primary predicate device) | Predicate
device 2 |
|----------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Device name | FD-7C-1 Hot Biopsy Forceps | Olympus Unipolar
Optical Biopsy Forceps |
| K number | K993041*
(OLYMPUS XCYF-1T3 OES
CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND
ANCILLARY EQUIPMENT) | K983811 |
| Classification | II | II |
*Predicate device was cleared as one of accessories in original 510(K) applications.
5.4 Device Description
Single Use Hot Biopsy Forceps FD-231 has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
The Single Use Hot Biopsy Forceps FD-231consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.
During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.
By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.
5
Image /page/5/Picture/0 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.
ર્સ રાજ્યના સાથે જિલ્લાના એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે ખાતે ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત Indications for Use
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
5.6 Comparison of Technological Characteristics
Compared to the predicate devices, the proposed subject device: Single Use Hot Biopsy Forceps FD-231, has similar technological characteristics except for the following differences.
- Sterilization status and packaging (including forceps cap to protect distal end cups)
- Compatible endoscope and accessories -
- Material composition and configuration of handle -
- -Material composition of the outer sheath, marking in insertion portion
Validation from non-clinical testing demonstrated that these technological features do not raise further problems on safety or effectiveness of the subject device.
5.7 Summary of non-clinical testing
The following tests on key features of performance specification were conducted to demonstrate the safety and effectiveness of the subject device as identical as predicate devices.
-
- Insertion into /Withdrawal from endoscope of Hot Biopsy Forceps
-
- Advance/ retraction of Hot Biopsy Forceps
-
- Grasp of specimens
-
- Electrical characteristic
-
- Ablation of specimens
-
- Compatibility with endoscope
-
- Visual inspection of package
-
- Peel strength of the package
-
- Endurance to splitting of the package
-
- Integrity of the package
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.
510(k) Summary Page 4 of 6
6
Image /page/6/Picture/0 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. Underneath the line is the text "Your Vision, Our Future".
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.
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 No. | Standard Title | Related
Documents |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| AAMI/ANSI/ES
60601-1:2005/(R)2012 and
A1:2012 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance | Section 17 |
| 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 | Section 17 |
| 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 surgical equipment
and high frequency surgical accessories | Section 17 |
| Standard No. | Standard Title | Related
Documents |
| 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 | Section 17 |
| ISO 10993-1 Fourth edition
2009-10-15 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process | Section 15 |
| ISO 10993-5 Third edition
2009-06-01 | Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity | Section 15 |
| ISO 10993-10 Third Edition
2010-08-01 | Biological evaluation of medical devices - Part 10:
Tests for irritation and skin sensitization | Section 15 |
| ISO 10993-11 Second edition
2006-08-15 | Biological evaluation of medical devices - Part 11:
Tests for systemic toxicity | Section 15 |
| 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 | Section 14 |
| AAMI/ ANSI/ISO
10993-7 :2008(R)2012 | Biological evaluation of medical devices - Part 7:
Ethylene oxide sterilization residuals | Section 14 |
| ASTM F1980-16 (2016) | Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices | Section 14 |
| 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 | Section 14 |
| AAMI/ANSI/ISO
11607-2:2006/(R)2010 | Packaging for terminally sterilized medical devices -
Part 2: Validation requirements for forming, sealing
and assembly processes | Section 14 |
| ISO 14971 Second edition
2007-03-01 | Medical devices - Application of risk management to
medical devices | Section 21 |
The following standards have been applied to the Single Use Hot Biopsy Forceps FD-231:
510(k) Summary Page 5 of 6
7
Image /page/7/Picture/0 description: The image features the logo of OLYMPUS in bold, dark blue letters. A thin, golden line is placed beneath the logo, adding a touch of elegance. Below the line, the tagline "Your Vision, Our Future" is written in a smaller, lighter font, completing the corporate branding.
OLYMPUS MEDICAL SYSTEMS CORP.
510(k) Premarket Notification Single Use Hot Biopsy Forceps FD-231
5.8 Conclusion
Comparing with the predicate devices, the Single Use Hot Biopsy Forceps FD-231 does not cause any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device.