(66 days)
Not Found
No
The device description and performance studies focus on the mechanical function and biocompatibility of a physical biopsy forceps, with no mention of software, algorithms, or data processing related to AI/ML.
No
The device is described as biopsy forceps designed to collect tissue for examination, which is a diagnostic purpose, not a therapeutic one.
No
The device is a biopsy forceps, designed to collect tissue samples. It is an instrument used to obtain samples for examination, rather than performing the examination or diagnosis itself.
No
The device description clearly details a physical, single-use biopsy forceps with mechanical components (handle, slider, cups, wires, sheath). The performance studies focus on physical characteristics, biocompatibility, sterilization, and mechanical function, not software validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect tissue endoscopically for examination". This describes a device used to obtain a biological sample from the body.
- Device Description: The description details a mechanical device (forceps) used to physically "collect tissue by biting the surface of lesions".
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing the collected tissue in vitro (outside the body). IVDs are typically used to examine samples like blood, urine, or tissue after they have been collected, to provide information about a patient's health.
This device is a surgical instrument used for biopsy, which is a procedure to collect a sample for subsequent diagnostic testing (which would involve IVD devices and procedures). The forceps itself is the tool for collection, not the diagnostic device.
N/A
Intended Use / Indications for Use
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope.
The subject device is single-use biopsy forceps sterilized by Ethylene Oxide.
The subject device is inserted into the channel of a bronchoscope to collect tissue by biting the surface of lesions with the pair of cups affixed to the distal end of the subject device. Users withdraw the subject device from the bronchoscope channel to collect the biopsy sample.
The subject device consists of the Handle and the Insertion portion. The Handle consists of the Body and the Slider. The Insertion portion is divided into the Distal end including the Cups as well as other connection parts, and the Sheath portion including the Operation wire, the Coil sheath and other joint pipes. The Handle Slider is designed to connect to the Operation wire in the Insertion and the Cups, actuating the Cups to open/close by advancing and retracting the Slider.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device.
Risk analysis was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Biocompatibility testing for Single Use Biopsy Forceps FB-456D were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Sterilization and shelf-life testing for the Single Use Biopsy Forceps FB-456D was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Sterile". Sterilization validation was carried out with the method of Half-cycle approach in accordance with ISO 11135:2014. The shelf-life for three years has been validated by accelerated testing according to ASTM F1980-16. Three-year aging analyses will be performed to support the results of the accelerated aging test.
The requirements on packaging for terminally sterilized medical device per AAMI/ ANSI/ISO 11607-1/2 have also been validated. Performance testing as below was carried out to demonstrate the safety and the effectiveness of the subject device.
-
- Compatibility with the endoscope
-
- Open and close of the cups
-
- Performance after repeated operation
-
- Maximum insertion portion diameter
-
- Visual inspection of the insertion portion
-
- Strength of the junction and cups
-
- Strength when opening/closing the cups
-
- Package inspection
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
April 24, 2020
Image /page/0/Picture/1 description: The image shows 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.
Olympus Medical Systems Corp. % Jonathan Gilbert Regulatory Affairs Consultant to OCA Olympus Corporation of the Americas 3500 Corporation Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K200397
Trade/Device Name: Single Use Biopsy Forceps FB-456D Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: February 15, 2020 Received: February 18, 2020
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 may, 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 aware 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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Single Use Biopsy Forceps FB-456D
Indications for Use (Describe)
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible Olympus bronchoscope.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A thin, light-yellow line is visible beneath the word, adding a subtle highlight.
K200397 510(k) Summary Single Use Biopsy Forceps FB-456D
April 23, 2020
1. General Information
| ■ 510(k) submitter: | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, | |
| Japan | |
| Establishment Registration No: 8010047 | |
| ■ Contact Person: | Jon Gilbert fbo Sheri L. Musgnung |
| Olympus Corporation of the Americas | |
| 3500 Corporate Parkway PO Box 610 | |
| Center Valley, PA 18034-0610, USA | |
| Phone: 484-896-5691 | |
| FAX: 484-896-7128 | |
| Email: sheri.musgnung@olympus.com | |
| ■ Manufacturing site: | Aomori Olympus Co., Ltd. |
| 2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357 | |
| Japan | |
| Establishment Registration No.: 9614691 | |
| 2. Device Identification | |
| ■ Device Trade Name: | Single Use Biopsy Forceps FB-456D |
| ■ Common Name: | Single Use Biopsy Forceps |
| ■ Regulation Number: | 874.4680 |
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced. A registered trademark symbol is present to the right of the word.
- Bronchoscope (flexible or rigid) and accessories ■ Regulation Name:
- Regulatory Class: II
- Ear Nose & Throat ■ Classification Panel:
- Product Code: EOQ
3. Predicate Device Information
Predicate device
- Device Name: Single Use Biopsy Forceps FB-433D ■ Common Name: Biopsy Forceps ■ Applicant OLYMPUS MEDICAL SYSTEMS CORP. ■ 510(k) No. K172726
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4. Device Description
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope.
The subject device is single-use biopsy forceps sterilized by Ethylene Oxide.
The subject device is inserted into the channel of a bronchoscope to collect tissue by biting the surface of lesions with the pair of cups affixed to the distal end of the subject device. Users withdraw the subject device from the bronchoscope channel to collect the biopsy sample.
The subject device consists of the Handle and the Insertion portion. The Handle consists of the Body and the Slider. The Insertion portion is divided into the Distal end including the Cups as well as other connection parts, and the Sheath portion including the Operation wire, the Coil sheath and other joint pipes. The Handle Slider is designed to connect to the Operation wire in the Insertion and the Cups, actuating the Cups to open/close by advancing and retracting the Slider.
5. Indications for Use
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible Olympus bronchoscope.
6. Comparison of Technological Characteristics
In comparison to the predicate device, the subject device, Single Use Biopsy Forceps FB-456D, has similar technological characteristics except for the following differences.
- Cup shape -
- Maximum insertion portion diameter -
- -Bronchoscope compatibility
- Configuration of handle -
- Patient-contact material -
The differences above have been validated and demonstrate that these technological features do not raise new issues in terms of the claims of substantial equivalence to the subject device.
6
7. Summary of non-clinical testing
The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device.
Risk analysis was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Biocompatibility testing for Single Use Biopsy Forceps FB-456D were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Sterilization and shelf-life testing for the Single Use Biopsy Forceps FB-456D was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Sterile". Sterilization validation was carried out with the method of Half-cycle approach in accordance with ISO 11135:2014. The shelf-life for three years has been validated by accelerated testing according to ASTM F1980-16. Three-year aging analyses will be performed to support the results of the accelerated aging test.
The requirements on packaging for terminally sterilized medical device per AAMI/ ANSI/ISO 11607-1/2 have also been validated. Performance testing as below was carried out to demonstrate the safety and the effectiveness of the subject device.
-
- Compatibility with the endoscope
-
- Open and close of the cups
-
- Performance after repeated operation
-
- Maximum insertion portion diameter
-
- Visual inspection of the insertion portion
-
- Strength of the junction and cups
-
- Strength when opening/closing the cups
-
- Package inspection
7
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly blurred, and there is a registered trademark symbol to the right of the letter "S". There is a blurred yellow line underneath the word.
The following standards have been applied to the subject device.
| Standard No. | Standard Title |
|---|---|
| ISO11135 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 | |
| ISO 10993-7 Second | |
| edition 2008-10-15 | Biological evaluation of medical devices - part 7: ethylene |
| oxide sterilization residuals | |
| ISO 11607-1 First edition | |
| 2006-04-15 | Packaging for terminally sterilized medical devices - part |
| 1: requirements for materials, sterile barrier systems and | |
| packaging systems | |
| ISO 11607-2 First edition | |
| 2006-04-15 | Packaging for terminally sterilized medical devices - part |
| 2: validation requirements for forming, sealing and | |
| assembly processes | |
| ASTM F1980-16 | Standard Guide For Accelerated Aging Of Sterile Barrier |
| Systems For Medical Devices | |
| 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 | |
| ISO 10993-10 Third | |
| Edition 2010-08-01 | Biological evaluation of medical devices - part 10: tests |
| for irritation and skin sensitization | |
| ISO 10993-11 Third | |
| edition 2017-09 | Biological evaluation of medical devices - part 11: tests |
| for systemic toxicity | |
| ISO 14971 Second edition | |
| 2007-03-01 | Medical devices - application of risk management to |
| medical devices |
8. Conclusion
In comparison to the predicate device, the subject Single Use Biopsy Forceps FB-456D device does not raise different questions of safety and effectiveness and is substantially equivalent to the predicate device.