(382 days)
No
The device description and performance studies focus on the mechanical and electrical functions of a biopsy forceps, with no mention of AI or ML.
Yes.
The device is intended to perform electrosurgical cauterization and hemostasis, which are therapeutic medical interventions.
No
This device is designed for therapeutic purposes (collecting tissue, cauterizing, and hemostasis) within the tracheobronchial tree, not for diagnosing conditions. While it collects tissue which might then be diagnostically evaluated, the device itself is not performing the diagnostic function.
No
The device description clearly outlines a physical medical device with a handle, insertion portion, fenestrated cups, and a plug for transmitting electrical current. The performance studies also detail testing of physical characteristics and electrical properties, not software functionality.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the tracheobronchial tree) for surgical procedures (tissue collection, cauterization, hemostasis). IVDs are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The description details a physical instrument with a handle, insertion portion, and cups designed to interact directly with tissue inside the body. This is consistent with a surgical instrument, not an IVD.
- Mechanism of Action: The device uses high-frequency electric current to heat and manipulate tissue in situ. IVDs typically involve chemical, biological, or physical tests performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples after removal), reagents, or providing diagnostic information based on laboratory testing.
Therefore, this device is a surgical instrument used for electrosurgical procedures, not an IVD.
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 tracheobronchial tree.
The product is only intended for adult populations.
Product codes
QEC
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 tracheobronchial tree.
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
tracheobronchial tree
Indicated Patient Age Range
adult populations
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
-
- Cutting performance test
-
- Compatibility with endoscope
-
- Visual inspection of package
-
- Peel strength of the package
-
- Endurance to splitting of the package
-
- Integrity of the package
-
- Joint strength test
-
- Power limit
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.
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)
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 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.
November 30, 2018
Olympus Medical Systems Corp. % Jonathan Gilbert Regulatory Affairs Consultant to OCA Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K173495
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: QEC Dated: October 30, 2018 Received: October 31, 2018
Dear Jonathan Gilbert:
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. You must comply with all the Act's
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173495
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 tracheobronchial tree.
The product is only intended for adult populations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY Single Use Hot Biopsy Forceps FD-231
November 29, 2018
5.1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,
Japan
Establishment Registration No: 8010047 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Jon Gilbert fbo Sheri Musgnung
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 |
| ■ Model Number: | FD-231C |
| ■ Common Name: | Hot Biopsy Forceps |
| ■ Regulation Number: | 876.4300 |
| ■ Regulation Name: | Endoscopic electrosurgical unit and accessories. |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Gastroenterology/Urology |
- QEC ■ Product Code:
510(k) Summary_K173495 Page 2 of 6
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| Predicate device | Reference device 1 | Reference device 2 | |
|---|---|---|---|
| Device name | Disposable Hot | ||
| Biopsy Forceps | Single Use Biopsy | ||
| Forceps FB-433D | OLYMPUS CD-6C-1 | ||
| COAGULATION | |||
| ELECTRODE | |||
| K number | K160625 | K172726 | K971328 |
| Classification | II | II | II |
5.3 Predicate Device and Reference Devices Information
Device Description 5.4
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 tracheobronchial tree.
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.
ર્સ્ટ 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 tracheobronchial tree.
The product is only intended for adult populations.
5
Image /page/5/Picture/0 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 is the text "Your Vision, Our Future".
5.6 Comparison of Technological Characteristics
Compared to the predicate device, the proposed subject device: Single Use Hot Biopsy Forceps FD-231, has similar technological characteristics except for the following differences:
-
- Compatible endoscope and accessories
-
- Electrical specification for electrosurgical biopsy
-
- Material composition and configuration of handle and 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
-
- Cutting performance test
-
- Compatibility with endoscope
-
- Visual inspection of package
-
- Peel strength of the package
-
- Endurance to splitting of the package
-
- Integrity of the package
-
- Joint strength test
-
- Power limit
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:
6
Image /page/6/Picture/0 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" in a smaller font.
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.
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.
The following standards have been applied to the Single Use Hot Biopsy Forceps FD-231:
| Standard No. | Standard Title |
|---|---|
| AAMI/ANSI/ES | |
| 60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance | |
| 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 | |
| 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 | |
| IEC 60601-2-18: Edition 3.0 2009-08 | Medical electrical equipment - Part 2-18: Particular requirements for |
| the basic safety and essential performance of endoscopic equipment | |
| ISO 10993-1 Fourth edition | |
| 2009-10-15 | Biological evaluation of medical devices - Part 1: Evaluation and |
| testing within a risk management process | |
| ISO 10993-5 Third edition | |
| 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro |
| cytotoxicity |
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Image /page/7/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, dark blue letters. Below the word is a thin, horizontal, gold line. Below the line is the text "Your Vision, Our Future" in a smaller, lighter blue font.
| Standard No. | Standard Title |
|---|---|
| ISO 10993-10 Third Edition | |
| 2010-08-01 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization | |
| ISO 10993-11 Second edition | |
| 2006-08-15 | Biological evaluation of medical devices - Part 11: Tests for |
| systemic toxicity | |
| 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 | |
| AAMI/ANSI/ISO | |
| 10993-7:2008(R)2012 | Biological evaluation of medical devices - Part 7: Ethylene oxide |
| sterilization residuals | |
| ASTM F1980-16 (2016) | Standard Guide for Accelerated Aging of Sterile Barrier Systems for |
| Medical Devices | |
| 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 | |
| AAMI/ANSI/ISO | |
| 11607-2:2006/(R)2010 | Packaging for terminally sterilized medical devices - Part 2: |
| Validation requirements for forming, sealing and assembly | |
| processes | |
| ISO 14971 Second edition | |
| 2007-03-01 | Medical devices - Application of risk management to medical |
| devices |
5.8 Conclusion
Compared to the predicate device, the Single Use Hot Biopsy Forceps FD-231 does not demonstrate any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device.