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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Single-use Extraction Baskets." This type of document is concerned with demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing. It is not a document that details the rigorous clinical validation of an AI-powered diagnostic device, which is what your request implies by asking about acceptance criteria, ground truth, training sets, and MRMC studies.

Therefore, most of the information you requested regarding acceptance criteria and a study proving device performance (especially for an AI device) cannot be found in this document because the device in question is a mechanical medical device (extraction baskets), not an AI diagnostic tool, and the review process outlined here focuses on substantial equivalence through non-clinical and mechanical performance testing.

However, I can extract information related to what was used to demonstrate the device's performance for this specific 510(k) submission:

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

The document does not provide a formal table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of performance tests conducted and states that the "test results demonstrated that the subject device complies with the standard requirements." "Compliance with standard requirements" is the implicit acceptance criterion for these non-clinical tests.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility Testing	In accordance with ISO 10993-1, including cytotoxicity, sensitization, and irritation testing.	Complies with standard requirements; testing performed.
Sterilization Validation	In accordance with ISO 11135:2014 (Half-cycle approach).	Confirmed validation.
Shelf Life Testing	In accordance with ASTM F1980-21 (accelerated aging).	Confirmed stability (three years real-time aging test will be performed).
Mechanical Performance Testing - Dimensions Testing - Tensile Pull Testing - Simulated-Use Functionality & Durability Testing - Stone Capture Testing - Deflection Testing	Demonstrates basic performance and performs as intended.	Confirmed that the subject device performs as intended.
Comparative Testing	Performance comparable to the predicate device (K203322).	Demonstrated that the subject is as safe and effective as the predicate.

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

Sample Size for Test Set: Not specified in terms of numbers of devices or specific test runs for each mechanical test. The document states "The following performance data were provided..." without quantifying the test samples.
Data Provenance: Not explicitly stated, given that these are non-clinical bench tests rather than patient data. These tests would typically be performed in a lab setting by the manufacturer.

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 and not provided in this document. Since the device is a mechanical extraction basket, there is no "ground truth" in the diagnostic sense or expert interpretation required for these performance tests. The ground truth for mechanical performance is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for human expert review processes, typically in clinical studies or for establishing ground truth in diagnostic AI datasets. This document describes non-clinical engineering and performance tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in image-based diagnostics. This document is for a mechanical medical device, not an AI diagnostic tool.
The document explicitly states: "The clinical data is not applicable."

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

No, this is not applicable. The device is a "Single-use Extraction Basket," a physical tool, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The type of ground truth used

For mechanical performance tests: The "ground truth" is established by engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM). For example, "Dimensions Testing" would verify that the device's dimensions meet pre-defined specifications. "Stone Capture Testing" would evaluate the basket's ability to capture stones under simulated conditions, with the "truth" being whether it successfully performed the action based on defined criteria.
Not applicable for clinical or diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data, as this is not an AI diagnostic device.

8. The sample size for the training set

Not applicable. This device is a mechanical one and does not involve AI or machine learning that requires a "training set."

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

Not applicable. As a mechanical device, there is no AI training set.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{3}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/metal-expandable-biliarystents-premarket-notification-510k-submissions

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, JiangsuProv., 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)(5)

Regulation Number and Section

§ 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.