(97 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML capabilities.
No
The device is used to retrieve stones from the biliary tract, which is a diagnostic or interventional procedure rather than a therapeutic treatment in itself.
No
The device is described as a "retrieval basket" intended "to retrieve stones from the biliary tract." Its function is interventional (retrieval), not diagnostic.
No
The device description clearly outlines physical components made of stainless steel, a handle, an insertion section, a sheath, and a basket. It also mentions compatibility with endoscopes, lithotriptors, and guidewires, all of which are hardware devices. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Single Use Retrieval Basket V is intended to be used to retrieve stones from the biliary tract in combination with an endoscope. This is a surgical or interventional procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of Diagnostic Information: The device's purpose is mechanical retrieval, not the generation of diagnostic information from a biological sample.
Therefore, the device falls under the category of a surgical or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.
Product codes
LQR, OCZ
Device Description
The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type.
Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope.
The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency.
Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract
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 performance data were provided to demonstrate substantial equivalence:
- Biocompatibility testing per ISO 10993-1:2018 including cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity.
- Sterilization validation per ISO 11135:2014.
- Packaging validation and shelf life testing in accordance with ISO 11607-1:2019 and ASTM F1980-21.
- Mechanical testing to verify device performance:
- Insertion / Withdrawal
- Open / Close Basket
- Dimensional verification
- Grasping Basket Effective Test
- Attachment / Detachment of Hook
- Injecting Fluid
- Strength of Junction
Animal study data and clinical study data were not required to demonstrate substantial equivalence.
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features an abstract design of human figures. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 18, 2025
Olympus Medical Systems Corp. % Roshana Ahmed Regulatory Affairs Consultant Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K243807
Trade/Device Name: Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: LQR, OCZ Dated: February 27, 2025 Received: February 27, 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.
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"
1
(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 OS 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 Rue"). 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.
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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,
Anthony Lee -S
Anthony C. Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
Indications for Use (Describe)
The Single Use Retrieval Basket V FG-V421PR/FG-V431P/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract 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/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a registered trademark symbol to the right of the word. The background is white.
510(k) Summary
I. Submitter
Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachiochi-shi, Tokyo 192-0032 Japan
Contact Person: Seiko Yunoki, Manager, Endotherapy Product, RA TSD Phone: +81-42-642-2111
Date Prepared: March 3, 2025
II. Device
| Device Proprietary Name | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P |
|---|---|
| Common or Usual Name | Biliary catheter and accessories |
| Classification Name | Dislodger, Stone, Biliary |
| Regulation Number | 876.5010 |
| Product Code | LQR, OCZ |
| Device Classification | 2 |
Predicate Device III.
Substantial equivalence is claimed to the following device:
-
Single Use Retrieval Nitinol Basket V, K170811, Olympus Medical Systems Corp. .
The following device is cited as a reference device: -
Memory Baskets, K171969, Wilson-Cook Medical Inc. ●
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Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, creating a solid block of text. A registered trademark symbol is located to the right of the letter "S". The background is white.
Device Description IV.
The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type.
Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope.
The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency.
Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.
V. Indications for Use
The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.
VI. Comparison of Technological Characteristics
The subject device has the same intended use as the predicate device.
A comparison of the subject and predicate device technological characteristics is provided below.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Single Use Retrieval Basket V | Single Use Retrieval Nitinol | Analysis | |
| Series | Basket | ||
| Indications for | |||
| use | The Single Use Retrieval Basket V | ||
| FG-V421PR/V422PR/V431P/V432P | |||
| are intended to be used to retrieve | |||
| stones from the biliary tract in | |||
| combination with an endoscope. | The instrument has been designed to | ||
| be used with Olympus endoscopes | |||
| to retrieve stones from the biliary | |||
| tract. | Substantially | ||
| equivalent | |||
| Models | FG-V421PR | ||
| FG-V422PR | |||
| FG-V431P | FG-V451P | - |
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Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and appear to be a sans-serif font. Below the word "OLYMPUS" is a horizontal gold bar. The registered trademark symbol is located to the right of the letter "S".
K243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
| FG-V432P | |||
|---|---|---|---|
| Working Length | 1900 mm | 1900 mm | Identical |
| Opening Width | 20 mm | ||
| 22 mm | 20 mm | Substantially | |
| equivalent | |||
| Maximum | |||
| Insertion Portion | |||
| Diameter | Ø 2.4 mm | ||
| Ø 2.9 mm | Ø 2.9 mm | Substantially | |
| equivalent | |||
| Minimum | |||
| Working Channel | |||
| Size | Ø 4.2 mm | Ø 3.7 mm | Substantially |
| equivalent | |||
| Retrieval Basket | |||
| Configuration | |||
| Type | 8 wire type | ||
| 4 wire type | 8 wire spiral type | Substantially | |
| equivalent | |||
| Basket Function | Rotatable | ||
| Distal Wire-Guided | Distal Wire-Guided | Substantially | |
| equivalent | |||
| Basket Wire | |||
| Material | Stainless steel | Nitinol | Substantially |
| equivalent | |||
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
| Sterile | Yes, Ethylene oxide | Yes, Ethylene oxide | Identical |
| Single Use | Yes | Yes | Identical |
The subject device and predicate devices are sterile, single use, retrieval baskets with a working length of 1900 mm which are used with compatible Olympus endoscopes.
The subject device models FG-V421PR and FG-V431P are identical to the predicate device with respect to opening width, retrieval basket configuration type. The subject device models FG-V431P and FG-V432P are identical to the predicate device with respect to the maximum insertion portion diameter, and basket function.
The subject and predicate devices differ as follows:
- | Models FG-V422PR and FG-V432P feature an opening width of 22 mm and a 4 wire type retrieval basket configuration
- Models FG-V421PR and FG-V422PR feature a maximum insertion portion diameter of । 2.4 mm, a minimum working channel size of 4.2 mm, and a rotatable basket,
- The shape of the retrieval basket -
- Basket wire material -
The differences in basket function (introduction of rotatable baskets), opening width (introduction of 22 mm opening width), maximum insertion diameter (introduction of 2.4 mm diameter), minimum working channel size (introduction of 4.2 mm), basket wire shape, configuration type (introduction of 4 wire type) and material of construction do not raise
7
different questions of safety or effectiveness when comparing the subject device to the predicate device. These differences are addressed through bench testing and biocompatibility testing of the subject device and predicate and reference devices. Testing on a reference device supports the difference in basket function (introduction of rotatable baskets).
VII. Performance Data
OLYMPU
The following performance data were provided to demonstrate substantial equivalence:
- Biocompatibility testing per ISO 10993-1:2018 including cytotoxicity, sensitization, . irritation, acute systemic toxicity, and material mediated pyrogenicity.
- Sterilization validation per ISO 11135:2014. ●
- Packaging validation and shelf life testing in accordance with ISO 11607-1:2019 and ● ASTM F1980-21.
- Mechanical testing to verify device performance: .
- Insertion / Withdrawal
- Open / Close Basket |
- । Dimensional verification
- Grasping Basket Effective Test —
- | Grasping Basket Effective Test
- Attachment / Detachment of Hook
- Injecting Fluid |
- Strength of Junction |
Animal study data and clinical study data were not required to demonstrate substantial equivalence.
VIII. Conclusion
The Single Use Retrieval Basket V Series models have the same intended use, and principles of operation as the predicate devices. Non-clinical testing demonstrates that the slight differences in device design do not alter the safety, efficacy, or performance of the subject devices when compared to the predicate devices.
The technological differences between the subject and predicate devices do not raise different questions of safety and effectiveness when compared to the predicate devices. The data presented within this submission supports substantial equivalence of the Single Use Retrieval Basket V Series to the identified predicate devices.