(284 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of a sphincterotome, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to perform a transendoscopic sphincterotomy, which is a medical procedure to treat a condition by opening the Papilla of Vater and/or the Sphincter of Oddi. This directly addresses health issues and is not solely diagnostic or for general wellness.
No
The device is described as being used for "cannulation of the biliary ducts" and "transendoscopic sphincterotomy," which are interventional procedures, not diagnostic ones. It facilitates access and performs surgical cuts.
No
The device description clearly outlines a physical medical device consisting of a plastic tube, wire, and intended for electrosurgical procedures, indicating it is hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a surgical instrument used for a procedure (sphincterotomy) within the body. It is used to cut tissue and facilitate access to anatomical structures.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is mechanical and electrical, used directly on the tissue.
The information provided describes a device used for a therapeutic and interventional procedure, not for diagnostic testing of samples.
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 (comma separated list FDA assigned to the subject device)
KNS
Device Description
The sphincterotome described in this submission are a sterile, single use devices 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 the papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. For 50910 series, there's preloaded guide wire.
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.
Performance testing of the proposed device in comparison with the predicate:
(1)Injection performance;
(2)Compatibility with traction guide wire;
(3)Compatibility with Endoscope;
(4)X-ray detectability;
⑤Visibility under endoscopy,
⑥Electric performance,
⑦Operation flexibility,
⑧Rotation performance;
Connected firmly
Force to Bow
Orientation of Cutting Wire and Visualization of Cutting Wire testing
Ink Validation testing
Fluoroscopic Visibility testing
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
§ 876.4300 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 8, 2021
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: K201121
Trade/Device Name: Sphincterotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS
Dear Chunqi Han:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 5, 2021. Specifically, FDA is updating this SE Letter with a signature as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thelma Valdes, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-9621, Thelma.valdes@fda.hhs.gov.
Sincerely,
Date: 2021.02.08 Thelma I. Valdes -S 12:47:14 -05'00'
Thelma Valdes, Ph.D. Acting 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
1
Image /page/1/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 text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
February 5, 2021
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: K201121
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 22, 2020 Received: April 27, 2020
Dear Chungi 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
2
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-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,
Thelma Valdes, PhD Acting Assistant Director Obesity and Hepatobiliary Devices Team 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
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)
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)
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."
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Image /page/4/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue circular design with a green center, resembling a stylized medical symbol. To the right of the symbol, the text "AGS MEDTECH" is written in a simple, sans-serif font, with the Chinese characters for "Anjie Si Medical" appearing below it.
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: | Apr. 22, 2020 |
5.2 Proposed Device
| Trade Name: | Sphincterotome |
|---|---|
| Device Name: | Sphincterotome |
| Common Name: | Sphincterotome |
| 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 Predicate Device
| Trade Name: | Howell D.A.S.H.® |
|---|---|
| Device Name: | Sphincterotome with DomeTip |
| Common Name: | Sphincterotome with DomeTip |
| 510(k) Number: | K172665 |
| 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) |
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Image /page/5/Picture/1 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 the same name written in Chinese characters. The text is in a simple, sans-serif font.
| Trade Name: | Huibregtse® |
|---|---|
| Device Name: | Needle knife |
| Common Name: | Needle knife |
| 510(k) Number: | K040981 |
| 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) |
5.4 Device Description
The sphincterotome described in this submission are a sterile, single use devices 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 the papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. For 50910 series, there's preloaded guide wire.
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.
5.6 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
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Image /page/6/Picture/1 description: The image contains a logo with the text "AGS MEDTECH" and "安杰思医学". The logo consists of a circular design with three curved shapes in blue and green. The text "AGS MEDTECH" is in a smaller font size and is positioned above the Chinese characters "安杰思医学", which are in a larger font size. The overall design is clean and professional, suggesting a company in the medical technology field.
| Item | Proposed device | Predicate device | Comparison | |
|---|---|---|---|---|
| Common name | Sphincterotome | Sphincterotome with DomeTip | Similar | |
| Trade name | Sphincterotome | D.A.S.H | / | |
| Model number | 5096, 5098, 50910 | DASH-21, DASH-21-480, | ||
| DASH-1, DASH-260, | ||||
| DASH-480, DASH-ACRO- | ||||
| 25-450, DASH-35, DASH- | ||||
| ACRO-35-260, DASH-35- | ||||
| 480, DASHACRO-35-450 | / | |||
| 510(k) submitter | Hangzhou AGS | |||
| MedTech Co., Ltd. | Wilson-Cook Medical, Inc. | / | ||
| 510(k) number | / | K172665 | / | |
| 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. | Howell D.A.S.H.® | |||
| Sphincterotome with | ||||
| DomeTip® (Cook | ||||
| Reference Part Numbers | ||||
| DASH-21, DASH-21-480, | ||||
| DASH-1, DASH-260, | ||||
| DASH-480, DASH-ACRO- | ||||
| 25-450, DASH-35, DASH- | ||||
| ACRO-35-260, DASH-35- | ||||
| 480, DASHACRO-35-450): | ||||
| This device is used for | ||||
| cannulation of the ductal | ||||
| system and for | ||||
| sphincterotomy. If | ||||
| preloaded, also aids in | ||||
| bridging difficult strictures | ||||
| during ERCP. | Same | |||
| Technical Principles of | ||||
| operation | Monopolar | |||
| Sphincterotome | ||||
| manufactured is an | ||||
| applied part of | ||||
| electrosurgical | ||||
| generator, using | ||||
| monopolar high- | ||||
| frequency current | ||||
| delivered by the | 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- | Same | |||
| Item | Proposed device | Predicate device | Comparison | |
| electrosurgical | ||||
| generator for | ||||
| sphincterotomy with | ||||
| the electrode. The | ||||
| high-frequency | ||||
| electricity flows from | ||||
| the active electrode to | ||||
| the neutral electrode | ||||
| placed on patient skin. | 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 | |||
| Preloaded | ||||
| Wire Guide | ||||
| or not | Preloaded Wire Guide: | |||
| 50910 | ||||
| Not preloaded Wire | ||||
| Guide: 5096, 5098; | Preloaded Wire Guide: | |||
| DASH-21-480, DASH- | ||||
| ACRO-25-450, DASH-480, | ||||
| DASH-260, DASH-ACRO- | ||||
| 35-260, DASH-35-480, | ||||
| DASHACRO-35-450; | ||||
| Not preloaded Wire Guide: | ||||
| DASH-21, DASH-1, | ||||
| DASH-35; | / | |||
| Sheath tube | 2.4mm | Catheter Size: 5.5Fr | ||
| (≈1.8mm), 6Fr (≈2mm), | ||||
| 6.5Fr (≈2.1mm) | Similar | |||
| Wire Guide | ||||
| Diameter | 0.63mm, 0.89mm | Wire Guide Diameter inch: | ||
| 0.021 (≈0.53mm), 0.025 | ||||
| (≈0.58mm), 0.035 | ||||
| (≈0.89mm); | Similar | |||
| Minimum | ||||
| Accessory | ||||
| Channel: | 2.8mm | 2.8mm | Same | |
| Working | ||||
| length | 1800mm | 1960mm; | Similar | |
| Performance | (1)Injection | |||
| performance; | ||||
| (2)Compatibility with | ||||
| traction guide wire; | ||||
| (3)Compatibility with | ||||
| Endoscope; | ||||
| (4)X-ray detectability, | No information | Substantial | ||
| equivalence. | ||||
| We conducted all | ||||
| the performance | ||||
| testing on our | ||||
| proposed device in | ||||
| comparison with | ||||
| our chosen | ||||
| Item | Proposed device | Predicate device | Comparison | |
| ⑤Visibility under | ||||
| endoscopy, | ||||
| ⑥Electric | ||||
| performance, | ||||
| ⑦Operation | ||||
| flexibility, | ||||
| ⑧Rotation | ||||
| performance; | predicate. All the | |||
| test results show | ||||
| that the proposed | ||||
| device is | ||||
| substantial | ||||
| equivalence with | ||||
| the predicate. For | ||||
| bench tests | ||||
| reports, please | ||||
| refer to Section 18 | ||||
| of this submission. | ||||
| Connected firmly: | ||||
| ensure the device does | ||||
| not cause device | ||||
| breakage or | ||||
| detachment between | ||||
| joints. | Connected firmly: ensure | |||
| the device does not cause | ||||
| device breakage or | ||||
| detachment between joints. | Substantial | |||
| equivalence. | ||||
| We conducted | ||||
| Connected firmly | ||||
| on our proposed | ||||
| device in | ||||
| comparison with | ||||
| our chosen | ||||
| predicate. All the | ||||
| test results show | ||||
| that the proposed | ||||
| device is safer | ||||
| than our predicate | ||||
| device. For bench | ||||
| tests reports, | ||||
| please refer to | ||||
| Section 18 of this | ||||
| submission. | ||||
| Force to Bow | Force to Bow | Substantial | ||
| equivalence. | ||||
| We conducted | ||||
| Force to Bow on | ||||
| our proposed | ||||
| device in | ||||
| comparison with | ||||
| our chosen | ||||
| predicate. All the | ||||
| test results show | ||||
| that the proposed | ||||
| device is as safe | ||||
| Item | Proposed device | Predicate device | Comparison | |
| and effective as | ||||
| our predicate | ||||
| device. For bench | ||||
| tests reports, | ||||
| please refer to | ||||
| Section 18 of this | ||||
| submission. | ||||
| Orientation of Cutting | ||||
| Wire and Visualization | ||||
| of Cutting Wire | ||||
| testing: ensure for | ||||
| orientation and | ||||
| visualization of the | ||||
| cutting wire when | ||||
| endoscopically | ||||
| viewed. | Orientation of Cutting Wire | |||
| and Visualization of Cutting | ||||
| Wire: ensure for orientation | ||||
| and visualization of the | ||||
| cutting wire when | ||||
| endoscopically viewed. | Substantial | |||
| equivalence. | ||||
| We conducted | ||||
| Orientation of | ||||
| Cutting Wire and | ||||
| Visualization of | ||||
| Cutting Wire on | ||||
| our proposed | ||||
| device in | ||||
| comparison with | ||||
| our chosen | ||||
| predicate. All the | ||||
| test results show | ||||
| that the proposed | ||||
| device is as safe | ||||
| and effective as | ||||
| our predicate | ||||
| device. For bench | ||||
| tests reports, | ||||
| please refer to | ||||
| Section 18 of this | ||||
| submission. | ||||
| Ink Validation testing: | ||||
| ensure for ink marking | ||||
| visualization when | ||||
| endoscopically | ||||
| viewed. | Ink visualization: ensure for | |||
| ink marking visualization | ||||
| when endoscopically | ||||
| viewed. | Substantial | |||
| equivalence. | ||||
| We conducted Ink | ||||
| visualization on | ||||
| our proposed | ||||
| device in | ||||
| comparison with | ||||
| our chosen | ||||
| predicate. All the | ||||
| test results show | ||||
| that the proposed | ||||
| device is as safe | ||||
| Item | Proposed device | Predicate device | Comparison | |
| and effective as | ||||
| our predicate | ||||
| device. For bench | ||||
| tests reports, | ||||
| please refer to | ||||
| Section 18 of this | ||||
| submission. | ||||
| Fluoroscopic Visibility | ||||
| testing: ensure the end | ||||
| user is able to | ||||
| fluoroscopically | ||||
| visualize the location | ||||
| of the | ||||
| sphincterotome. | Fluoroscopic Visibility: | |||
| ensure the end user is able | ||||
| to fluoroscopically | ||||
| visualize the location of | ||||
| the sphincterotome. | Substantial | |||
| equivalence. | ||||
| We conducted | ||||
| Fluoroscopic | ||||
| Visibility on our | ||||
| proposed device in | ||||
| comparison with | ||||
| our chosen | ||||
| predicate. All the | ||||
| test results show | ||||
| that the proposed | ||||
| device is as safe | ||||
| and effective as | ||||
| our predicate | ||||
| device. For bench | ||||
| tests reports, | ||||
| please refer to | ||||
| Section 18 of this | ||||
| submission. | ||||
| Biolo- | ||||
| gical | Materials or | |||
| substances in | ||||
| contact with | ||||
| the same | ||||
| human tissue | ||||
| or body | ||||
| fluids | Plastic PTFE, | |||
| Stainless Steel 304, | ||||
| PET; | ||||
| Silicone oil, PTFE, | ||||
| Polyurethane, Medical | ||||
| grade hydrophilic | ||||
| coating; | No exact information. | Different. | ||
| Biocompatibility | ||||
| tests have been | ||||
| done for the | ||||
| difference. | ||||
| Biological risks | ||||
| are acceptable. | ||||
| Biocompatibility | In Vitro Cytotoxicity | |||
| Test: ISO 10993-5: | ||||
| 2009; | ||||
| Skin sensitization | ||||
| Test: ISO 10993-10: | ||||
| 2010; | ||||
| Intracutaneous | ||||
| Reactivity Test: ISO | No exact information. | |||
| Item | Proposed device | Predicate device | Comparison | |
| 10993-10: 2010; | ||||
| Acute Systemic | ||||
| Toxicity Test: ISO | ||||
| 10993-11:2017; | ||||
| Pyrogenicity: ISO | ||||
| 10993-11:2017; | ||||
| Single / | ||||
| Use | Yes | Yes | Same | |
| Shelf / | ||||
| life | ||||
| and | ||||
| sterili- | ||||
| zation | Shelf life: 3 years | |||
| Sterilization: EO | ||||
| Sterilization, SAL OF | ||||
| 10-6 | Shelf life: 3 years | |||
| Sterilization: EO | ||||
| Sterilization | Same |
7
Image /page/7/Picture/1 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 a sans-serif font, followed by Chinese characters below it.
8
K201121
Page 5 of 11
Image /page/8/Picture/1 description: The image shows the 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 Chinese characters below it. The logo appears to be for a medical technology company.
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Image /page/9/Picture/0 description: The image shows the text 'K201121' on the first line and 'Page 6 of 11' on the second line. The text is in a simple, sans-serif font and is horizontally aligned. The text likely indicates a document identifier and page number within a larger document.
Image /page/9/Picture/1 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 circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The Chinese characters are likely the Chinese translation of "AGS MEDTECH".
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Image /page/10/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue teardrop shapes arranged in a triangle, with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the Chinese characters "安杰思医学".
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Image /page/11/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue circular design with three curved shapes inside, one of which is green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it.
Table 5.6-2 Comparison of technical characteristics
| Item | Proposed device | Predicate device | Comparison | |
|---|---|---|---|---|
| Common name | Sphincterotome | Needle knife | Similar | |
| Trade name | Sphincterotome | Huibregtse® | / | |
| Model number | 5099 | G24885/HPC-3 | / | |
| 510(k) submitter | Hangzhou AGS | |||
| MedTech Co., Ltd. | Wilson-Cook Medical, Inc. | Same | ||
| 510(k) number | K201121 | K040981 | / | |
| 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 Wilson-Cook USW | |||
| Needleknife Papillotome is | ||||
| intended for accessing the | ||||
| common bile duct when | ||||
| standard cannulation methods | ||||
| have been exhausted. The | ||||
| USW Needleknife Papillotome | ||||
| is supplied sterile and intended | ||||
| for single use only. | Same | |||
| Item | Proposed device | Predicate device | Comparison | |
| 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 | |||
| Catheter Size | 2.4mm-1.8mm | 7Fr(2.33mm)-5Fr(1.67mm) | Same | |
| Wire Guide | ||||
| Diameter | 0.63mm, 0.89mm | 0.035 (~0.89mm); | Similar | |
| Minimum | ||||
| Accessory | ||||
| Channel | 2.8mm | 2.8mm | Same | |
| Working | ||||
| length | 1800mm | 2000mm | Similar | |
| Performance | (1)Injection performance; | |||
| (2)Compatibility with | ||||
| traction guide wire; | ||||
| (3)Compatibility with | ||||
| endoscope; | ||||
| (4)Visibility under | ||||
| endoscopy; | ||||
| (5)Electric performance; | ||||
| (6)Operation flexibility; | ||||
| (7)Connected firmly. | ||||
| (8)Orientation of Cutting | ||||
| Wire and Visualization of | ||||
| Cutting Wire testing; | No information | Similar. | ||
| Bench tests | ||||
| have been | ||||
| done for | ||||
| both the | ||||
| proposed | ||||
| device and | ||||
| predicate | ||||
| device. | ||||
| Please refer | ||||
| to Section | ||||
| 18 of this | ||||
| submission. | ||||
| Item | Proposed device | Predicate device | Comparison | |
| ⑨Ink Validation testing; | ||||
| Biolo- | ||||
| gical | Materials or | |||
| substances in | ||||
| contact with | ||||
| the same | ||||
| human tissue | ||||
| or body | ||||
| fluids | Plastic PTFE, Stainless | |||
| Steel 304; | No exact information. | Different. | ||
| Biocompatib | ||||
| ility tests | ||||
| have been | ||||
| done for the | ||||
| difference. | ||||
| Biological | ||||
| risks are | ||||
| acceptable. | ||||
| Biocompatibi | ||||
| lity | 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; | No information. | |||
| Single | ||||
| Use | / | Yes | Yes | Same |
| Shelf | ||||
| life | ||||
| and | ||||
| sterili | ||||
| zation | / | Shelf life: 3 years | ||
| Sterilization: EO | ||||
| Sterilization, SAL OF 106 | Shelf life: 3 years | |||
| Sterilization: EO Sterilization | Same |
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Image /page/12/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue circular design with a green triangular shape 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 below it.
K201121
Page 9 of 11
Section 5 510(k) Summary
Sphincterotome
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Image /page/13/Picture/0 description: The image shows the 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 a simple, sans-serif font. Below the English text, there is Chinese text, which is likely the company's name in Chinese.
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
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Image /page/14/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with 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.
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.