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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus Disposable Grasping Forceps FG-52D/FG-54D. It outlines the device's characteristics, indications for use, comparison to a predicate device, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated format. Instead, it lists the types of tests conducted to demonstrate safety and effectiveness. The "acceptance criteria" are implied by the successful completion and positive results of these tests, leading to the conclusion of substantial equivalence.

Here's a re-formatted table based on the provided "Performance Data" section:

Performance Data Category / Acceptance Criteria (Implied)	Reported Device Performance (Implied by successful completion)
Biocompatibility	Met standards 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 <151>).
Sterilization Validation	Met standards per ISO 11135:2014.
Ethylene Oxide Residuals	Met standards per ISO 10993-7:2008.
Packaging Validation & Shelf Life	Met standards in accordance with ISO 11607-1:2019 and ASTM F1980-16.
Mechanical Testing & Comparative Testing	Verified device performance for: Insertion force/Withdrawal force, Handle Operation, Grasping Performance, Strength Testing of the Connection and Distal Tip, and Device Reliability. (Implies successful performance within acceptable limits, though specific values are not provided).
Human Factors Testing	Conducted. (Implies safe and effective usability, though specific findings are not detailed).

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test conducted. It generally states that "Performance Data" was provided. For the provenance, the data seems to be from non-clinical bench testing conducted by the manufacturer, Olympus Medical Systems Corp. The document does not mention the country of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The device is a physical medical instrument (graspers), not an AI/ML algorithm that requires expert labeling for ground truth. The "ground truth" for its performance is established through standardized engineering and biological tests, not expert consensus on data interpretation.

4. Adjudication method for the test set

This information is not applicable as the device is not an AI/ML algorithm that involves human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical grasping forceps.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized testing methodologies as referenced in the performance data section (e.g., ISO standards for biocompatibility, sterilization, packaging, and specific mechanical tests like insertion force, grasping performance, and strength testing). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML validation for this type of medical device.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML algorithm.

Summary

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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.

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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

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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

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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.

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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 ForcepsFG-52D/FG-54D	Microvasive® Zero Tip™Airway Retrieval Basket	Analysis
Manufacturer	Olympus Medical Systems Corp.	Boston Scientific Corp.	N/A
Indications forUse Statement	The Disposable Grasping ForcepsFG-52D/54D are intended to beused to retrieve foreign bodies,calculus or tissue specimens fromthe tracheobronchial tree incombination with an endoscope.	The Microvasive® Zero Tip™Airway Retrieval Basket is usedto access the airway tree via abronchoscope for the purpose ofremoving foreign bodies.	Substantiallyequivalent
Models	FG-52DFG-54D	M00513200	N/A

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	Disposable Grasping ForcepsFG-52D/FG-54D	Microvasive® Zero Tip™Airway Retrieval Basket	Analysis
MaximumInsertionPortionDiameter	FG-52D: 0.8 mmFG-54D: 1.05 mm	M00513200: 0.8 mm	Substantiallyequivalent
WorkingLength	1150 mm	1200 mm	Substantiallyequivalent
OpeningWidth	FG-52D: 8 mmFG-54D: 10 mm	M00513200: 12 mm	Substantiallyequivalent
Shape of theGraspingPortion	FG-52D: Spiral Basket TypeFG-54D: Three Nail Type	M00513200: Basket Type	Substantiallyequivalent
CompatibleEndoscopes	Model and length: working lengthless than 700 mm (BF)Channel inner diameter: Ø 1.2,2.0, 2.2, 2.6, 2.8, 3.2	Unknown	Substantiallyequivalent
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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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 <151>)
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.

Regulation Number and Section

§ 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.