(265 days)
Not Found
No
The device description focuses on the mechanical and electrical components of a standard sphincterotome and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is used to perform a transendoscopic sphincterotomy, which is a therapeutic intervention to treat conditions related to the Papilla of Vater and/or the Sphincter of Oddi.
No
Explanation: The device description states its purpose is for "cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi," which are interventional/therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines physical components such as a plastic tube, wire, and mentions compatibility with endoscopes, 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 for a surgical procedure (cannulation and sphincterotomy) performed directly on the patient's anatomy (biliary ducts, Papilla of Vater, Spincter of Oddi).
- Device Description: The device is a tool used to cut tissue using high-frequency current. This is a therapeutic/surgical function, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for treatment.
N/A
Intended Use / Indications for Use
The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.
Product codes
KNS
Device Description
The Sphincterotome described in this submission is a sterile, single use device compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.
For non-exchangeable models, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 2.8mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For normal exchangeable models, there is a small hole on the sheath which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For C-type exchangeable models, there is an open channel on the sheath to rapid exchange the guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For 50910, 50913, 50916 and 50917 series, there's preloaded guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the OD of preloaded guide wire is detailed in the device's label.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts, Papilla of Vater, Spincter of Oddi
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 Sphincterotome meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) 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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
May 3, 2023
Hangzhou AGS MedTech Co., Ltd. Jiayuan Zhang RA Specialist Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA
Re: K222421
Trade/Device Name: Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: April 4, 2023 Received: April 4, 2023
Dear Jiayuan Zhang:
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
1
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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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-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-devices/device-advicecomprehensive-regulatory-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,
Glenn B. Bell -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222421
Device Name Sphincterotome
Indications for Use (Describe)
The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.
Type of Use (Select one or both, as applicable)
IZ] Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
| Hangzhou AGS MedTech Co., Ltd. | |
|---|---|
| Submitted by/Owner: | Building 5, Building 6, No.597 Kangxin Road Yuhang |
| District, 311106 Hangzhou, Zhejiang, China | |
| Establishment | |
| Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Jiayuan Zhang |
| Phone: 0086-18668235131 | |
| Fax: 0086-0571-87671225 | |
| Email: zhangjy@bioags.com | |
| Date Prepared: | May 2, 2023 |
5.2 Device Identification
| Trade Name: | Sphincterotome |
|---|---|
| Device Name: | Sphincterotome |
| Common Name: | Sphincterotome |
| Regulation Class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
5.3.1 Primary Predicate Device
| Trade Name: | Autotome™ RX |
|---|---|
| Device Name: | Autotome RX Cannulating Sphincterotome |
| Common Name: | Sphincterotome |
| 510(k) Number: | K013153 |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
4
| Trade Name: | Sphincterotome |
|---|---|
| Device Name: | Sphincterotome |
| Common Name: | Sphincterotome |
| 510(k) Number: | K201121 |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
5.3.2 Secondary Predicate Device
5.4 Device Description
The Sphincterotome described in this submission is a sterile, single use device compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.
For non-exchangeable models, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 2.8mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For normal exchangeable models, there is a small hole on the sheath which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For C-type exchangeable models, there is an open channel on the sheath to rapid exchange the guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For 50910, 50913, 50916 and 50917 series, there's preloaded guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the OD of preloaded guide wire is detailed in the device's label.
5.5 Indication for use statement
The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.
5
5.6 Comparison of Technology Characteristics
Our proposed device Sphincterotome is substantially equivalent to the predicate devices. The differences between the Sphincterotome and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:
6
| Item | | Proposed device
Sphincterotome | Predicate device
(K013153) | Comparison |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | | Sphincterotome | Sphincterotome | / |
| Trade name | | Sphincterotome | Autotome™ RX | / |
| Model number | | 50912, 50913, 50917 series | M00545150, M00545160, M00545170, M00545180, M00545190, M00545200 | / |
| 510(k) submitter | | Hangzhou AGS MedTech Co., Ltd. | Boston Scientific Corporation | / |
| 510(k) number | | / | K013153 | / |
| Clinical | Intended use | The Sphincterotome is indicated for use in the
cannulation of the biliary ducts and the transendoscopic
sphincterotomy of the Papilla of Vater and/or the Spincter
of Oddi. The device is supplied sterile and intended for
single use only. | The Sphincterotome is indicated for use in the
selective cannulation of the Common Bile Ducts
(CBD) and the transendoscopic sphincterotomy of the
Papilla of Vater and/or the Sphincter of Oddi. The
Sphincterotome can also be used to inject contrast
medium. | Similar.
The equivalent device has a wider
range of intended use than the
proposed device. |
| | Technical | Principles of
operation | Monopolar Sphincterotome manufactured is an applied
part of electrosurgical generator, using monopolar
high-frequency current delivered by the electrosurgical
generator for sphincterotomy with the electrode. The
high-frequency electricity flows from the active electrode
to the neutral electrode placed on patient skin. | Sphincterotome is an applied part of electrosurgical
generator, using monopolar high-frequency current
delivered by the electrosurgical generator for
sphincterotomy with the electrode. The
high-frequency electricity flows from the active
electrode to the neutral electrode placed on patient
skin. |
| Energy Use | | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same |
| | Sheath tube | 2.4mm | 2.4mm | Same |
| Item | Proposed device
Sphincterotome | Predicate device
(K013153) | Comparison | |
| Wire Guide Diameter | 0.63mm, 0.89mm | 0.63mm, 0.89mm | Same | |
| Insulation protected | With/without | Without | Similar.
This difference wouldn't influence
the safety or performance if the
device. | |
| Preloaded Wire Guide
or not | Preloaded Wire Guide: 50913, 50917;
Not preloaded Wire Guide: 50912; | No | Similar.
Bench test has been conducted to
demonstrate substantial equivalence,
please refer to Section 18 bench
performance testing. | |
| Compatible Minimum
Accessory Channel | 3.7mm | 3.7mm | Same | |
| Working length | 1800mm | 2000mm | Different.
Bench test has been conducted to
demonstrate substantial equivalence,
please refer to Section 18 bench
performance testing. | |
| Performance | Injection performance,
Compatibility with traction guide wire,
Compatibility with endoscope,
Ray detectability,
Visibility under endoscopy,
Electric performance, | Unknown | Same.
Bench test has been conducted to
demonstrate substantial equivalence,
please refer to Section 18 bench
performance testing. | |
| Item | | Proposed device
Sphincterotome | Predicate device
(K013153) | Comparison |
| | | Operation flexibility,
Connected firmly,
Rotation performance,
Force to Bow,
Orientation of Cutting Wire and Visualization of Cutting
Wire,
Ink Validation;
Cutting rate;
Energy dose analyses; | | |
| Biological | Materials or
substances in contact
with the same human
tissue or body fluids | Plastic PTFE, Stainless Steel 304, PTFE;
Silicone oil, PTFE, Polyurethane, Medical grade
hydrophilic coating; | Unknown | Different.
Biocompatibility tests have been
done. Biological risks are
acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;
Skin sensitization Test: ISO 10993-10: 2010;
Intracutaneous Reactivity Test: ISO 10993-10: 2010;
Acute Systemic Toxicity Test: ISO 10993-11:2017;
Pyrogenicity: ISO 10993-11:2017; | Unknown | |
| Single Use | | Yes | Yes | Same |
| Shelf life and sterilization | | Shelf life: 18 months;
Sterilization: EO Sterilization, SAL of 10-6; | Shelf life: 3 years;
Sterilization: EO Sterilization; | Different.
Accelerated aging tests have been
done. The proposed device can
support the claimed shelf life. |
| Item | Proposed device
Sphincterotome | Predicate device
(K201121) | Comparison | |
| Common name | Sphincterotome | Sphincterotome | / | |
| Trade name | Sphincterotome | Sphincterotome | / | |
| Model number | 5091, 5093, 5094, 5096, 5098, 5099, 50910, 50912,
50913, 50916, 50917 series | 5096, 5098, 5099, 50910 series | / | |
| 510(k) submitter | Hangzhou AGS MedTech Co., Ltd. | Hangzhou AGS MedTech Co., Ltd. | / | |
| 510(k) number | / | K201121 | / | |
| Clinical
| Intended use | The Sphincterotome is indicated for use in the
cannulation of the biliary ducts and the transendoscopic
sphincterotomy of the Papilla of Vater and/or the Spincter
of Oddi. The device is supplied sterile and intended for
single use only. | The Sphincterotome is indicated for use in the
cannulation of the biliary ducts and the transendoscopic
sphincterotomy of the Papilla of Vater and/or the
Spincter of Oddi. The device is supplied sterile and
intended for single use only. | Same |
| Technical | Principles of
operation | Monopolar Sphincterotome manufactured is an applied
part of electrosurgical generator, using monopolar
high-frequency current delivered by the electrosurgical
generator for sphincterotomy with the electrode. The
high-frequency electricity flows from the active electrode
to the neutral electrode placed on patient skin. | Monopolar Sphincterotome manufactured is an applied
part of electrosurgical generator, using monopolar
high-frequency current delivered by the electrosurgical
generator for sphincterotomy with the electrode. The
high-frequency electricity flows from the active
electrode to the neutral electrode placed on patient skin. | Same |
| | Energy Use | Monopolar Radio Frequency Current | Monopolar Radio Frequency Current | Same |
| | Preloaded Wire
Guide or Not | Preloaded Wire Guide: 50910, 50913, 50916, 50917;
Not preloaded Wire Guide: 5091, 5093, 5094, 5096, | Preloaded Wire Guide: 50910
Not preloaded Wire Guide: 5096, 5098, 5099; | Same |
| Item | Proposed device
Sphincterotome | Predicate device
(K201121) | Comparison | |
| | 5098, 5099, 50912; | | | |
| Sheath tube | 2.4mm | 2.4mm | Same | |
| Wire Guide
Diameter | 0.63mm, 0.89mm | 0.63mm, 0.89mm | Same | |
| Compatible
Minimum
Accessory Channel | 5091, 5094, 5096, 5099: 2.8mm;
5093, 5098, 50910, 50912, 50913, 50916, 50917: 3.7mm; | 5096, 5099: 2.8mm;
5098, 50910: 3.7mm; | Same | |
| Working Length | 1800mm | 1800mm | Same | |
| Performance | Injection performance,
Compatibility with traction guide wire,
Compatibility with endoscope,
Ray detectability,
Visibility under endoscopy,
Electric performance,
Operation flexibility,
Connected firmly,
Rotation performance,
Force to Bow,
Orientation of Cutting Wire and Visualization of Cutting
Wire,
Ink Validation;
Cutting rate;
Energy dose analyses; | Injection performance,
Compatibility with traction guide wire,
Compatibility with Endoscope,
Ray detectability,
Visibility under endoscopy,
Electric performance,
Operation flexibility,
Connected firmly,
Rotation performance;
Force to Bow,
Orientation of Cutting Wire and Visualization of
Cutting Wire,
Ink Validation; | Same.
Bench test has been conducted to
demonstrate substantial
equivalence, please refer to
Section 18 bench performance
testing. | |
| Item | Proposed device
Sphincterotome | Predicate device
(K201121) | Comparison | |
| Biological | Materials or
substances in
contact with the
same human tissue
or body fluids | Plastic PTFE, Stainless Steel 304, PTFE;
Silicone oil, PTFE, Polyurethane, Medical grade
hydrophilic coating; | Plastic PTFE, Stainless Steel 304, PET;
Silicone oil, PTFE, Polyurethane, Medical grade
hydrophilic coating; | Same.
Biocompatibility tests have been
done. Biological risks are
acceptable. |
| | Biocompatibility | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;
Skin sensitization Test: ISO 10993-10: 2010;
Intracutaneous Reactivity Test: ISO 10993-10: 2010;
Acute Systemic Toxicity Test: ISO 10993-11:2017;
Pyrogenicity: ISO 10993-11:2017; | In Vitro Cytotoxicity Test: ISO 10993-5: 2009;
Skin sensitization Test: ISO 10993-10: 2010;
Intracutaneous Reactivity Test: ISO 10993-10: 2010;
Acute Systemic Toxicity Test: ISO 10993-11:2017;
Pyrogenicity: ISO 10993-11:2017; | |
| Single Use | | Yes | Yes | Same |
| Shelf life and sterilization | | Shelf life: 18 months;
Sterilization: EO Sterilization, SAL of 10-6; | Shelf life: 3 years;
Sterilization: EO Sterilization, SAL of 10-6; | Different.
Accelerated aging tests have been
done. The proposed device can
support the claimed shelf life. |
Table 5.6-1 Comparison of technical characteristics
7
8
9
Table 5.6-2 Comparison of technical characteristics
10
11
12
5.7 Applicable Guidance Document
NA
5.8 Performance Data
The Sphincterotome meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) 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 Sphincterotome is substantially equivalent to the predicate devices.