(265 days)
Not Found
No
The device description and performance studies focus on mechanical functionality and biocompatibility, with no mention of AI/ML, image processing, or data-driven performance metrics.
No.
The device is used for removal of stones, which is a physical intervention, not a therapeutic treatment.
No
The device is described as an "Extraction Basket" intended for the endoscopic removal of stones and stone fragments in the biliary system. Its function is to physically remove rather than to diagnose.
No
The device description explicitly states it consists of physical components (basket, sheath, handle) made of materials like stainless steel/nitinol wires, 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 the "endoscopic removal of stones and stone fragments in the biliary system." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device (basket, sheath, handle) used for mechanical extraction. It does not involve analyzing samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be characteristic of an in vitro diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically remove obstructions from the biliary system, which is a treatment rather than a diagnostic process.
N/A
Intended Use / Indications for Use
The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.
Product codes (comma separated list FDA assigned to the subject device)
LOR
Device Description
The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
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)
Biocompatibility testing: performed in accordance with "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.
Sterilization validation: carried out with Methods Half-cycle approach in accordance with ISO 11135:2014.
Shelf life testing: conducted based on an accelerated aging test in accordance with ASTM F1980-21. 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: conducted on the following items: Dimensions Testing, Tensile Pull Testing, Simulated-Use Functionality & Durability Testing, Stone Capture Testing, Deflection Testing.
Comparative testing: conducted on the Single-use Extraction Baskets and the predicate SpyGlass Discover Retrieval Basket (K203322).
Key results: The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate.
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). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".
October 15, 2024
Scivita Medical Technology Co., Ltd. Dan Jiang Senior Regulatory Affairs Specialist No. 2, Qingqiu Street, Suzhou Industrial Park Suzhou, Jiangsu 215000 China
Re: K240192/A001
Trade/Device Name: Single-use Extraction Baskets (EBF-1529S, EBF-1529C, EBF-1511C, EBF-1511S, EBF-1506S, EBF-1506C, EBF-1507S, EBF-1507C, EBF-1508S, EBF-1508C, EBF-2029S, EBF-2029C, EBF-2006S, EBF-2006C, EBF-2007S, EBF-2007C, EBF-2008S, EBF-2008C) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: LOR Dated: October 11, 2024 Received: October 11, 2024
Dear Dan Jiang:
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.
U.S Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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" (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 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.
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/medical
2
devices/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 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
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Indications for Use
Submission Number (if known)
K240192
Device Name
Single-use Extraction Baskets (EBF-1529S, EBF-1529C, EBF-1511C, EBF-1511S, EBF-1506S, EBF-1506C, EBF-1507S, EBF-1507C, EBF-1508S, EBF-1508C, EBF-2029S, EBF-2029C, EBF-2006S, EBF-2006C, EBF-2007S, EBF-2007C, EBF-2008S, EBF-2008C)
Indications for Use (Describe)
The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.
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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Classification
Add a primary product code and any associated product codes below. You may type in the primary product code directly (only the product code field is required) or you may filter down by choosing first a medical specialty, regulation, then product code. If a device specific quidance is available for the ? product code, the guidance name and web link will be displayed. Use the Product Classification Website resource in the help text to obtain information about your product code and check the regulation text for any special controls that need to be considered (e.g, PAE and 21 CFR 890.3450).
| Medical Specialty | Gastroenterology & Urology |
|---|---|
| Regulation | 876.5010 - Biliary catheter and accessories |
| Product Code | LQR (Class 2) - Dislodger, Stone, Biliary |
The primary product code of your device indicates a device specific guidance document is available to aid you in preparing a comprehensive submission. The document entitled "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents: Final" is available at the link below. If you have any questions about applicability of this guidance, please contact the CDRH review Office.
Associated Product Code(s)
?
5
..
| 510(k) #: | K240192 | K240192 - Page 1 of 2 | |
|---|---|---|---|
| 510(k) Summary | Prepared on: 2024-10-11 | ||
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Scivita Medical Technology Co., Ltd. | ||
| Applicant Address | No. 2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu | ||
| Prov., P.R. CHINA Suzhou 215000 China | |||
| Applicant Contact Telephone | +86-512-8187778 | ||
| Applicant Contact | Mrs. Wu Ruqin | ||
| Applicant Contact Email | wuruqin@scivitamedical.com | ||
| Correspondent Name | Scivita Medical Technology Co., Ltd. | ||
| Correspondent Address | No. 2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, | ||
| Jiangsu Prov., P.R. CHINA Suzhou 215000 China | |||
| Correspondent Contact Telephone | 86-512-81877788 | ||
| Correspondent Contact | Dan Jiang | ||
| Correspondent Contact Email | ra@scivitamedical.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Single-use Extraction Baskets (EBF-1529S, EBF-1529C, EBF-1511C,
EBF-1511S, EBF-1506S, EBF-1506C, EBF-1507S, EBF-1507C,
EBF-1508S, EBF-1508C, EBF-2029S, EBF-2029C, EBF-2006S,
EBF-2006C, EBF-2007S, EBF-2007C, EBF-2008S, EBF-2008C) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Biliary catheter and accessories |
| Classification Name | Dislodger, Stone, Biliary |
| Regulation Number | 876.5010 |
| Product Code(s) | LQR |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K203322 | SpyGlass™ Discover Retrieval Basket | LQR |
Device Description Summary
21 CFR 807.92(a)(4)
The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone
fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of
stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating
the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.## Intended Use/Indications for Use
21 CFR 807.92(a)(5)
6
The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the billary system.
Indications for Use Comparison
The Single-use Extraction Baskets has the same intended use as the predicate device. Both the Single-use Extraction Baskets and predicate device are intended for the endoscopic removal of stone fragments in the biliary system.
Technological Comparison
The subject Single-use Extraction Baskets and predicate device (K203322, SpyGlass™ Discover Retrieval Basket) share the similar technological characteristics. The differences in technological characteristics do not raise different questions of safety and/or effectiveness when compared to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance data were provided in support of the substantial equivalence determination. The test results demonstrated that the subject device complies with the standard requirements.
Biocompatibility testing
Biocompatibility testing is performed in accordance, "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 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 F1980-21, 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.
- · Dimensions Testing
- · Tensile Pull Testing
- · Simulated-Use Functionality & Durability Testing
- · Stone Capture Testing
- · Deflection Testing
Comparative testing was conducted on the Single-use Extraction Baskets and the predicate SpyGlass Discover Retrieval Basket (K203322).
The clinical data is not applicable.
The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)