(38 days)
Not Found
No
The description focuses on the mechanical function of a stone extraction basket and does not mention any AI/ML components or image processing for analysis.
Yes
The device is used for the removal of stones and foreign bodies from the biliary system, which directly addresses a medical condition (biliary stones) and provides a therapeutic effect.
No
This device is used for the endoscopic removal of stones and foreign bodies, which is a therapeutic rather than diagnostic function. While Type 1 uses X-ray for imaging, this is for guidance during the stone removal process, not for diagnosing the condition itself.
No
The device description clearly outlines a physical, sterile, single-use accessory with specific dimensions, connection forces, and material properties, requiring sterilization and packaging. The performance studies also focus on physical characteristics and functionality, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described device is a tool used within the body (endoscopically) to physically remove stones and foreign bodies. It does not analyze biological specimens to provide diagnostic information.
- Intended Use: The intended use is "for the endoscopic removal of stones in the biliary system and foreign bodies," which is a therapeutic/interventional procedure, not a diagnostic one.
- Device Description: The description details a physical device with a basket mechanism for capturing and removing objects. It doesn't mention any components for analyzing biological samples.
Therefore, based on the provided information, this 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
This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.
Product codes (comma separated list FDA assigned to the subject device)
LQR
Device Description
The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope.
The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (for Type 1)
Anatomical Site
Biliary system, Biliary Tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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 biocompatibility evaluation for Extraction Basket was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020.) the following tests were conducted:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. The following tests are conducted:
Type 1 :
- Dimension Testing;
- Connection Force Testing;
- Simulated-Use Testing;
- Stone Capture and Durability Testing;
- Injection Testing;
- Luer Testing;
- X-ray Detectability Testing;
Type 2 : - Dimension Testing;
- Connection Force Testing;
- Simulated-Use Testing;
- Stone Capture and Durability Testing.
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One-year accelerated aging test was performed to demonstrate the one-year stability in the shelf life.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
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.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 16, 2024
Micro-Tech (Nanjing) Co., Ltd. Sally He Regional RA Manager No.10 Gaoke Third Rd Nanjing National Hi-Tech, Industrial Development Zone Nanjing, Jiangsu 210032 China
Re: K243471
Trade/Device Name: Extraction Basket Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: LQR Dated: November 8, 2024 Received: November 8, 2024
Dear Sally He:
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 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-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,
Anthony Lee -S
Anthony Lee, Ph.D. 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)
K243471
Device Name
Extraction Basket
Indications for Use (Describe)
This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.
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/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A small registered trademark symbol is located in the upper right corner of the logo.
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number:
- Date of Preparation: 2024-11-27
Sponsor Identification 2.
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: Regional RA Manager
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: ra.micro-tech@outlook.com
3. Identification of Proposed Device
Trade Name: Extraction Basket
Regulatory Information
Classification Name: Biliary Catheter And Accessories Classification: 2 Product Code: LQR Regulation Number: 21 CFR 876.5010 Review Panel: Gastroenterology/Urology
Identification of Predicate Device 4.
510(k) Number: K171969 Product Name: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor Memory Eight Wire Baskets Fusion Wire Guided Extraction Basket Non-Lithotripsy Extraction Basket Manufacturer: Wilson-Cook Medical
5
Image /page/5/Picture/0 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected, with the "M" on the left and the "T" on the right. The logo has a registered trademark symbol, the letter R inside a circle, in the upper right corner.
ર. Indications for Use
This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.
6. Device Description
The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope.
The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.
7. Comparison of Technological Characteristics
The Extraction Basket incorporates substantially equivalent device's intended use, using environment, design, packaging fundamental technology, principles of operation, manufacturing processes including sterilization process, configuration, main material as those featured in the predicate device Memory Eight Wire Baskets cleared under K171969. Only the dimension and shelf life of proposed device are different from predicate device, which have been demonstrated not influence the safety and effectiveness of proposed device.
| Item | Proposed Device
Extraction Basket
(Type 1 ) | Proposed Device
Extraction Basket
(Type 2) | Predicate Device
(K171969) | Remark |
|---------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------|
| Product Code | LQR | LQR | LQR | SE |
| Regulation No. | 21 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 876.5010 | SE |
| Class | II | II | II | SE |
| Indications for Use | This device is used for the
endoscopic removal of
stones in the biliary
system and foreign bodies. | This device is used for the
endoscopic removal of
stones in the biliary
system and foreign
bodies. | Endoscopic removal of
stones in the biliary
system and foreign bodies. | SE |
| Single Use | Yes | Yes | Yes | SE |
6
Image /page/6/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected and appear to be made of blocks, giving them a geometric look. A circled "R" symbol, indicating a registered trademark, is positioned in the upper right corner of the logo.
| | 510(k) summary
N |
| -- | --------------------- |
|---|
| Item | Proposed Device
Extraction Basket
(Type 1 ) | Proposed Device
Extraction Basket
(Type 2) | Predicate Device
(K171969) | Remark | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------|
| Supplied in Sterile | Yes | Yes | Yes | SE | |
| Configuration | Consists of Basket
Assembly, Sheath, Handle
assembly. | Consists of Basket
Assembly, Sheath, Handle
assembly. | Consists of Basket
Assembly, Sheath, Handle
assembly. | SE | |
| Main Material | Metal wires | Metal wires | Metal wires | SE | |
| Using Environment | Hospital | Hospital | Hospital | SE | |
| Dimensions | Basket
Diameter | 10mm, 15 mm, 20 mm, 25
mm, 30 mm | 10mm, 15 mm, 20 mm,
25 mm, 30 mm | 15mm,20 mm, 25 mm, 30
mm | Similar |
| | Basket
Length | 30 mm,40 mm, 45mm,50
mm,55mm, 60 mm, 70
mm | 30 mm,40 mm, 50 mm,
60 mm, 70 mm | 35mm,40 mm, 50 mm,60
mm | Similar |
| | Outer Tube
Diameter | 7Fr | 3Fr | 5.5Fr,7Fr,8Fr,10Fr | Similar |
| | Compatible
Endoscopy
Working
Channel | 7Fr:≥3.7 mm | 3Fr:≥1.1 mm | 5.5Fr:≥2.0 mm, 7Fr:≥2.8
mm
8Fr:≥3.2 mm, 10Fr:≥4.2
mm | Similar |
| | Working
Length | 2500 mm,2000 mm | 2900 mm,2000 mm,1600
mm,1200 mm,1000
mm,800 mm,600 mm | 2000 mm | Similar |
| Principles
of
Operation | The device enters the
human
body
through
endoscope, advance the
basket to the appropriate
position, slowly open the
basket, grasp the stones
or foreign bodies by pull
the basket over them,
withdraw
the
catheter
from the bile duct to
retrieve the stones
or
foreign bodies | The device enters the
human
body through
endoscope, advance the
basket to the appropriate
position, slowly open the
basket, grasp the stones
or foreign bodies by pull
the basket over them,
withdraw
the
catheter
from the bile duct to
retrieve the stones
or
foreign bodies | The device enters the
human
body through
endoscope, advance the
basket to the appropriate
position, slowly open the
basket, grasp the stones
or foreign bodies by pull
the basket over them,
withdraw
the
catheter
from the bile duct to
retrieve the stones
or
foreign bodies | SE | |
| Applicable Body Parts | Biliary Tract | Biliary Tract | Biliary Tract | SE | |
| Packaging | Single-use EO sterilized
pouch with one device per
pouch | Single-use EO sterilized
pouch with one device per
pouch | Single-use EO sterilized
pouch with one device per
pouch | SE | |
8. Performance Data
The biocompatibility evaluation for Extraction Basket was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk
7
Image /page/7/Picture/0 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional design. The letters are blocky and connected, with the 'M' on the left and the 'T' on the right. A registered trademark symbol is located in the upper right corner of the logo. The logo has a clean and modern appearance.
510(k) summary
Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020.) the following tests were conducted:
- Cytotoxicity a)
- Sensitization b)
- Irritation c)
- Acute Systemic Toxicity d)
- Material Mediated Pyrogenicity e)
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. The following tests are conducted:
Type 1 :
-
Dimension Testing;
-
Connection Force Testing:
-
Simulated-Use Testing;
- A Stone Capture and Durability Testing;
-
Injection Testing;
-
Luer Testing;
-
X-ray Detectability Testing;
Type 2 :
- ▲ Dimension Testing;
- A Connection Force Testing;
- A Simulated-Use Testing;
- A Stone Capture and Durability Testing.
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One-year accelerated aging test was performed to demonstrate the one-year stability in the shelf life.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and
8
Image /page/8/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving them a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
K243471 Page 5 of 5
510(k) summary
Routine Control of Sterilization processes for Medical Devices".
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, Extraction Basket has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device cleared under K171969.