(255 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML or image processing.
Yes
The device is designed to retrieve stones from the biliary tract, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as an instrument designed to retrieve stones from the biliary tract, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components like a handle, insertion portion, sheath, and basket, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retrieve stones from the biliary tract." This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description details a mechanical device with a basket designed for physical retrieval of stones. It does not involve the examination of specimens derived from the human body for the purpose of providing information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
IVD devices are used to perform tests on samples (like blood, urine, tissue) outside of the body to diagnose or monitor medical conditions. This device is a surgical tool used directly within the body.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
Product codes (comma separated list FDA assigned to the subject device)
LQR, OCZ
Device Description
The subject device is designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
This product consists of the operation portion (Handle) and insertion portion. The insertion portion consists of distal end portion and sheath portion. The distal end portion contains a basket. The Basket is connected to the Control grip of the operating portion through the insertion portion. Activating the Control grip allows the basket to open or close.
The insertion portion and the distal end portion of the subject device are inserted into the biliary tract through the endoscope. The Basket opens to retrieve the stones from the biliary tract.
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)
Risk analysis was carried out 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 is 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"" including cytotoxicity, sensitization, and irritation testing.
Performance testing including sterilization validation, shelf life, and mechanical performance/bench testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
Sterilization validation was carried out with Methods Half-cycle approach in accordance with ISO 11135:2014.
Shelf life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three years real-time aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Mechanical performance testing was conducted on the following items to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- Insertion / withdrawal
- Open/Close basket
- Dimensions of the basket
- Attachment / Detachment of hook
- Injecting fluid
- Visual inspection of package
- Peel strength of the package
- Endurance to splitting of the package
- Integrity of the package
- Maximum diameter of catheter
- Working length of the catheter
- Position of V marking
- Strength of junction
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
§ 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.
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 27, 2017
Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
Re: K170811
Trade/Device Name: Single Use Retrieval Nitinol Basket V Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary catheter and Accessories Regulatory Class: II Product Code: LQR, OCZ Dated: October 16, 2017 Received: October 17, 2017
Dear Sheri L. Musgnung:
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. 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.
1
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Single Use Retrieval Nitinol Basket V
Indications for Use (Describe)
This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
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510(k) SUMMARY Single Use Retrieval Nitinol Basket V
November 27, 2017
K170811 Page 1 of 4
5.1 General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan | |
| 192-8507 | |
| Establishment Registration No: 8010047 |
- Official Correspondent: Sheri L. Musgnung Manager, Regulatory Affairs 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. 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0357 Establishment Registration No.: 9614641
5.2 Device Identification
| ■ Device Trade Name: | Single Use Retrieval Nitinol Basket V |
|---|---|
| ■ Common Name: | Retrieval Basket |
| ■ Regulation Number: | 876.5010 |
| ■ Regulation Name: | Biliary Catheter and Accessories |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Gastroenterology and urology |
| ■ Product Code: | LQR, OCZ |
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Image /page/4/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, dark blue font.
Predicate Device Information 5.3
| Device Trade Name | Common Name | Applicant | 510(k)
number |
|-------------------------------------------------------------------------------------|---------------------------------------------|----------------------------|------------------|
| TRAPEZOID RX
LITHOTRIPTER
COMPATIBLE
BASKET,
MODELS 1086,
1087, 1088 | Retrieval Basket /
Lithotripsy
Basket | BOSTON SCIENTIFIC
CORP. | K040447 |
| Olympus Basket
Graspers | Grasping forceps | OLYMPUS AMERICA INC. | K955063 |
5.4 Device Description
The subject device is designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
This product consists of the operation portion (Handle) and insertion portion. The insertion portion consists of distal end portion and sheath portion. The distal end portion contains a basket. The Basket is connected to the Control grip of the operating portion through the insertion portion. Activating the Control grip allows the basket to open or close.
The insertion portion and the distal end portion of the subject device are inserted into the biliary tract through the endoscope. The Basket opens to retrieve the stones from the biliary tract.
ર્સ્ડ Indications for Use
This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
5
Image /page/5/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, black font.
Comparison of Technological Characteristics ર્સ્વ
Compared to the predicate devices, the proposed subject device: Single Use Retrieval Nitinol Basket V, has similar technological characteristics. There is no significant difference that affects the safety or effectiveness of the subject device.
5.7 Summary of non-clinical testing
·Risk analysis was carried out 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
Biocompatibility testing is 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"" including cytotoxicity, sensitization, and irritation testing.
•Performance testing including sterilization validation, shelf life, and mechanical performance/bench testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
Sterilization validation
Sterilization validation was carried out with Methods Half-cycle approach in accordance with ISO 11135:2014.
Shelf life testing
Shelf life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three years real-time aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Mechanical performance testing
Mechanical performance testing was conducted on the following items to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
-
- Insertion / withdrawal
- 2, Open/Close basket
- 3, Dimensions of the basket
- 4, Attachment / Detachment of hook
6
Image /page/6/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, gold line. Underneath the line is the text "Your Vision, Our Future".
- 5, Injecting fluid
- 6, Visual inspection of package
- 7, Peel strength of the package
- 8, Endurance to splitting of the package
- 9, Integrity of the package
- 10, Maximum diameter of catheter
- 11, Working length of the catheter
- 12, Position of V marking
- 13, Strength of junction
·The following standards have been applied to the Single Use Retrieval Nitinol Basket V.
| Standard number | Standard Title |
|---|---|
| ISO 10993-1 Fourth | |
| Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1: |
| Evaluation And Testing Within A Risk Management | |
| Process [Including: Technical Corrigendum 1 | |
| (2010)] | |
| AAMI ANSI ISO | |
| 10993-5:2009/(R)2014 | Biological Evaluation Of Medical Devices – Part5: |
| 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 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. | |
| ASTM F1980-16 | Standard Guide For Accelerated Aging Of Sterile |
| Barrier Systems For Medical Devices | |
| ISO 14971 Second Edition: | |
| 2007-03-01 | Medical Devices - Application Of Risk |
| Management To Medical Devices |
5.8 Conclusion
When compared to the predicate device, the Single Use Retrieval Nitinol Basket V does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.