(61 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing or data analysis.
No.
The device is used for retrieving foreign bodies, calculus, or tissue specimens, which are diagnostic or procedural assistance rather than treating a disease or condition.
No
The intended use of the device is to retrieve foreign bodies, calculus or tissue specimens. It is a tool for extraction, not for diagnosis.
No
The device description clearly outlines physical components made of stainless steel and a handle with a ring mechanism, indicating it is a hardware 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 "retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The device is a physical tool (forceps) designed for grasping and retrieving objects within the body. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, calibrators, controls, or methods for analyzing biological markers.
Therefore, the Disposable Grasping Forceps FG-52D/54D is a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope. Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.
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
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)
Performance data:
- Biocompatibility testing per ISO 10993-1:2018 including cytotoxicity (ISO 10993-. 5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), acute systemic toxicity (ISO 10993-11:2017), and material mediated pyrogenicity (USP )
- Sterilization validation per ISO 11135:2014 .
- . Ethylene oxide residuals per ISO 10993-7:2008
- . Packaging validation and shelf life testing in accordance with ISO 11607-1:2019 and ASTM F1980-16
- . Mechanical testing and comparative testing to verify device performance:
- o Insertion force/ Withdrawal force
- Handle Operation o
- Grasping Performance о
- Strength Testing of the Connection and Distal Tip O
- Device Reliability O
- Human Factors Testing o
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2025
Olympus Medical Systems Corp. % Roshana Ahmed Regulatory Affairs Consultant Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K250263
Trade/Device Name: Disposable Grasping Forceps FG-52D/FG-54D Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: January 28, 2025 Received: January 29, 2025
Dear Roshana Ahmed:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K250263
Device Name Disposable Grasping Forceps FG-52D/54D
Indications for Use (Describe)
The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.
| 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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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a thin, blurred, yellow line underneath the word. There is a registered trademark symbol to the right of the letter "S".
510(k) Summary
I. Submitter
Olympus Medical Systems Corporation 2951 Ishikawa-cho Hachioji-shi Tokyo 192-8507 Japan
Contact Person: Seiko Yunoki Phone: +81 42-642-2111
Date Prepared: March 28, 2025
II. Device
| Device Proprietary Name | Disposable Grasping Forceps FG-52D/FG-54D |
|---|---|
| Common or Usual Name | Grasping Forceps |
| Classification Name | Bronchoscope (flexible or rigid) and accessories |
| Regulation Number | 874.4680 |
| Product Code | KTI |
| Device Classification | Class II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and ● M00513210, K020765, Boston Scientific Corp.
Device Description IV.
The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope.
5
Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.
V. Indications for Use
The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.
VI. Comparison of Technological Characteristics
There are slight differences between the subject device and predicate device indications for use statements; however, these differences do not create a new intended use with respect to the subject device. The subject and predicate devices are both used in conjunction with scopes to remove materials from the tracheobronchial tree.
The subject device and predicate devices are sterile (via EtO), single use devices which are used with compatible endoscopes. A comparison of the subject and predicate device technological characteristics is provided below.
| | Disposable Grasping Forceps
FG-52D/FG-54D | Microvasive® Zero Tip™
Airway Retrieval Basket | Analysis |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer | Olympus Medical Systems Corp. | Boston Scientific Corp. | N/A |
| Indications for
Use Statement | The Disposable Grasping Forceps
FG-52D/54D are intended to be
used to retrieve foreign bodies,
calculus or tissue specimens from
the tracheobronchial tree in
combination with an endoscope. | The Microvasive® Zero Tip™
Airway Retrieval Basket is used
to access the airway tree via a
bronchoscope for the purpose of
removing foreign bodies. | Substantially
equivalent |
| Models | FG-52D
FG-54D | M00513200 | N/A |
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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly stylized, with a modern and clean font. There is a thin, horizontal, yellow line underneath the word, adding a subtle accent to the logo. The registered trademark symbol is present to the right of the word.
| | Disposable Grasping Forceps
FG-52D/FG-54D | Microvasive® Zero Tip™
Airway Retrieval Basket | Analysis |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------|
| Maximum
Insertion
Portion
Diameter | FG-52D: 0.8 mm
FG-54D: 1.05 mm | M00513200: 0.8 mm | Substantially
equivalent |
| Working
Length | 1150 mm | 1200 mm | Substantially
equivalent |
| Opening
Width | FG-52D: 8 mm
FG-54D: 10 mm | M00513200: 12 mm | Substantially
equivalent |
| Shape of the
Grasping
Portion | FG-52D: Spiral Basket Type
FG-54D: Three Nail Type | M00513200: Basket Type | Substantially
equivalent |
| Compatible
Endoscopes | Model and length: working length
less than 700 mm (BF)
Channel inner diameter: Ø 1.2,
2.0, 2.2, 2.6, 2.8, 3.2 | Unknown | Substantially
equivalent |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Identical |
| Single-Use/
Reusable | Single Use | Single Use | Identical |
The subject and predicate devices differ as follows:
- . The subject device (model FG-54D) has a larger maximum insertion portion diameter than the predicate device.
- The working length of the subject device is slightly shorter than the working length . of the predicate device.
- . The opening width of the subject device is smaller than the opening width of the predicate device.
- . The shape of the grasping portion of the subject device (model FG-54D) is different than the grasping portion of the predicate device.
- . The subject devices are compatible with endoscopes featuring a working length of 700 mm (BF) and a channel inner diameter ranging from 1.2 - 3.2.
The differences in insertion portion diameter, working length, opening width, shape of the grasping portion, and compatible endoscopes do not raise different questions of safety or effectiveness when comparing the subject device to the predicate device. These differences are addressed through bench testing of the subject and predicate device.
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Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional effect. A thin, horizontal gold line is underneath the word. The registered trademark symbol is to the right of the S.
Performance Data VII.
The following performance data were provided to demonstrate substantial equivalence:
- Biocompatibility testing per ISO 10993-1:2018 including cytotoxicity (ISO 10993-. 5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), acute systemic toxicity (ISO 10993-11:2017), and material mediated pyrogenicity (USP )
- Sterilization validation per ISO 11135:2014 .
- . Ethylene oxide residuals per ISO 10993-7:2008
- . Packaging validation and shelf life testing in accordance with ISO 11607-1:2019 and ASTM F1980-16
- . Mechanical testing and comparative testing to verify device performance:
- o Insertion force/ Withdrawal force
- Handle Operation o
- Grasping Performance о
- Strength Testing of the Connection and Distal Tip O
- Device Reliability O
- Human Factors Testing o
Clinical data is not required to demonstrate substantial equivalence.
VIII. Conclusion
The non-clinical data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the identified predicate device. Therefore, it is concluded that the Disposable Grasping Forceps FG-52D/FG-54D are substantially equivalent to the identified predicate device.