(194 days)
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or image processing.
No.
The device is an extraction tool used to remove objects from the body, which is a procedural/interventional function, not a therapeutic one.
No.
The device description indicates it is used for the "endoscopic removal of biliary stones and foreign bodies," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a basket, sheath, and handle, indicating it is a hardware device, not software-only.
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 biliary stones and foreign bodies." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical tool (basket and sheath) used for mechanical extraction. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely interventional and therapeutic.
N/A
Intended Use / Indications for Use
The device is used for the endoscopic removal of biliary stones and foreign bodies.
Product codes
LQR
Device Description
The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary
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 Disposable Stone Extraction Basket meets all device standards for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
December 16, 2020
Hangzhou AGS MedTech Co., Ltd. Chunqi Han R&D Director Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou. Zhejiang 311106 China
Re: K201509
Trade/Device Name: Disposable Stone Extraction basket Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: Class II Product Code: LQR Dated: November 18, 2020 Received: November 20, 2020
Dear Chunqi Han:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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/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,
Glenn B. Bell, Ph.D. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K201509
Device Name
Disposable Stone Extraction Basket
Indications for Use (Describe)
The device is used for the endoscopic removal of biliary stones 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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FORM FDA 3881 (7/17)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue, surrounding a green triangle in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The text is in a dark color, contrasting with the white background.
K201509 510(k) Summary
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Image /page/4/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle in the center, with a green triangle in the middle. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters.
510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
5.1 Submitter
| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, NO.597 Kangxin Road Yuhang
District, Hangzhou, Zhejiang 311106 China |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu
Phone: 0086-15958493282
Fax: 0086-0571-87671225
Email: fuyp@bioags.com |
| Date Prepared: | July 18, 2019 |
5.2 Proposed Device
| Trade Name: | / |
|---|---|
| Device Name: | Disposable Stone Extraction Basket |
| Common Name: | Disposable Stone Extraction Basket |
| Regulation class: | Class II |
| Regulation Number: | 876.5010 |
| Regulation Description: | Biliary Catheter and Accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | LQR |
| Product Code Name: | Dislodger, Stone, Biliary |
5.3 Predicate Device
| Trade Name: | MEMORY BASKET 5F SOFT WIRE |
|---|---|
| Device Name: | MEMORY BASKET 5F SOFT WIRE |
| Common Name: | Non-Lithotripsy Extraction Basket |
| 510(k) Number: | K171969 |
| Regulation class: | Class II |
| Regulation Number: | 876.5010 |
| Regulation Description: | Biliary Catheter and Accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | LQR |
| Product Code Name: | Dislodger, Stone, Biliary |
5.4 Device Description
The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol
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Image /page/5/Picture/0 description: The image shows a logo with a circular design on the left and text on the right. The circular design is composed of three curved shapes, two in blue and one in green, arranged in a triangular pattern. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The text is in a dark color, contrasting with the white background.
basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.
5.5 Indication for use statement
The device is used for the endoscopic removal of biliary stones and foreign bodies.
5.6 Comparison of Technology Characteristics
Our proposed device Disposable Stone Extraction Basket is substantially equivalent to the predicate devices. The differences between the Disposable Stone Extraction Basket and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:
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Image /page/6/Picture/0 description: The image shows a logo with a blue and green circular design on the left and the text "AGS MEDTECH" and "安杰思医学" on the right. The circular design consists of three blue curved shapes that form a triangle, with a green triangle in the center. The text "AGS MEDTECH" is in a smaller font size than the Chinese characters "安杰思医学".
| Item | Proposed device | Predicate device | Comparison | |
|---|---|---|---|---|
| Common name | Disposable Stone Extraction Basket | Non-Lithotripsy Extraction Basket | / | |
| Trade name | / | MEMORY BASKET 5F SOFT WIRE | / | |
| Model number | 5061 series, 5062 series, 50631 series, 5064 series, | |||
| 5065 series, 50610 series, 50611 series, 50613 series, | ||||
| 50614 series. | MSB5-2X4 | / | ||
| 510(k) submitter | Hangzhou AGS MedTech Co., Ltd. | Wilson-Cook Medical, Inc. | / | |
| 510(k) number | / | K171969 | / | |
| Technical | Sheath | |||
| Max outer | ||||
| diameter | 5061/5062/50610/50611:1.8/2.4/3.2mm; | |||
| 5063:2.4mm; | ||||
| 5064/5065/50613/50614:1.8mm; | 5Fr ( $\approx$ 1.67mm ) | Similar. | ||
| For different size of endoscope channel, we design | ||||
| different sheath max. outer diameter, operator can | ||||
| choose different sheath max. outer diameter according | ||||
| to different clinical use situation. The difference does | ||||
| not raise different questions regarding its safety and | ||||
| effectiveness. | ||||
| Minimum | ||||
| Accessory | ||||
| Channel | 2.0mm/2.8mm/3.7mm | 2mm | Similar. | |
| Difference size of sheath max outer diameter suit for | ||||
| different endoscope channel. The difference does not | ||||
| raise different questions regarding its safety and | ||||
| effectiveness. | ||||
| Open | ||||
| width | 10,15,20,25,30mm | 20mm | Similar. | |
| We design different open width of basket for different | ||||
| size stone or foreign bodies. The difference does not | ||||
| Item | Proposed device | Predicate device | Comparison | |
| raise different questions regarding its safety and | ||||
| effectiveness. | ||||
| Working | ||||
| length | 5061/2/3/10/11: 1950mm; | |||
| 5064/5/13/14:700mm; | 2000mm | Similar. | ||
| Handle | ||||
| type | Two handle type: | |||
| One handle type: | Rotatable pin vise, two handle type. | Similar. | ||
| We design one handle type for simple operation. | ||||
| The difference does not raise different questions | ||||
| regarding its safety and effectiveness. | ||||
| Performan | ||||
| ce | Tensile strength; | |||
| Operation smoothly; | ||||
| Rotate smoothly (for rotatable models) ; | Tensile Testing; | |||
| Flexibility Testing; | ||||
| Rotate smoothly; | Different. | |||
| We conduct bench performance for our proposed | ||||
| device and the predicate device, please refer to | ||||
| Section 18 of this submission, the test results show | ||||
| that our proposed device is substantial equivalence | ||||
| with the predicate device. | ||||
| Biological | Materials | |||
| or | ||||
| substances | ||||
| in contact | ||||
| with the | ||||
| same | ||||
| human | ||||
| tissue or | ||||
| body | ||||
| fluids | 5063: SUS 303, SUS 304, PTFE; | |||
| 5061-5062, 5064-5065, 50610, 50611, 50613, 50614: | ||||
| SUS 303, Nitinol, PTFE; | Basket: metal wire; | |||
| Catheter sheath: polytetrafluoroethylene | ||||
| (PTFE); | Different. | |||
| Biocompatibility tests have been done for the | ||||
| difference. Biological risks are acceptable, please | ||||
| refer to Section 15 of this submission. | ||||
| Item | Proposed device | Predicate device | Comparison | |
| Biocompatibility | In Vitro Cytotoxicity Test | |||
| ISO 10993.5-2009; | ||||
| Skin sensitization Test, | ||||
| Intracutaneous Reactivity Test | ||||
| ISO 10993.10-2010; | Unknown |
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Image /page/7/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same text in Chinese characters. The logo appears to be for a medical technology company.
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Image /page/8/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The overall design is clean and professional, suggesting a company in the medical technology field.
5.7 Applicable Guidance Document
NA
5.8 Performance Data
The Disposable Stone Extraction Basket meets all device standards for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
5.9 Clinical Test
No Clinical test is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Disposable is substantially equivalent to the predicate devices.