(284 days)
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 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.
The provided document is a 510(k) summary for a medical device called "Sphincterotome" by Hangzhou AGS MedTech Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study. As such, information regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, multi-reader multi-case studies, and detailed ground truth establishment is not explicitly present in the format typically seen for a de novo or PMA submission.
However, based on the provided text, the acceptance criteria are implicitly derived from the comparison of the proposed device's performance against its predicate devices, as well as adherence to relevant international standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are generally considered to be demonstrating substantial equivalence to the predicate devices through similar technological characteristics and comparable performance. The document states that the proposed device "meets all design specifications and medical device standards" and its "non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."
Specific performance aspects evaluated are implicitly the "acceptance criteria" based on comparison to the predicate.
| Acceptance Criteria (Implicitly based on Predicate Comparison & Standards) | Reported Device Performance (Summary) |
|---|---|
| Common Name, Intended Use, Technical Principles, Energy Use, Single Use, Shelf Life & Sterilization | All are stated as "Same" or "Similar" to the predicate devices, indicating equivalence. For sterilization, SAL of 10-6 is specified. |
| Device Dimensions (Sheath tube, Wire Guide Diameter, Minimum Accessory Channel, Working Length) | Reported as "Similar" to predicate devices. For example, sheath tube 2.4mm vs. 1.8-2.1mm; wire guide diameter 0.63mm, 0.89mm vs. 0.53mm, 0.58mm, 0.89mm; minimum accessory channel 2.8mm (same); working length 1800mm vs. 1960mm. The document indicates these differences do not raise safety/effectiveness questions. |
| Performance (Bench Testing categories listed) | Proposed device performance: (1) Injection performance; (2) Compatibility with traction guide wire; (3) Compatibility with Endoscope; (4) X-ray detectability; (5) Visibility under endoscopy; (6) Electric performance; (7) Operation flexibility; (8) Rotation performance; (9) Connected firmly; (10) Force to Bow; (11) Orientation of Cutting Wire and Visualization of Cutting Wire testing; (12) Ink Validation testing; (13) Fluoroscopic Visibility testing. The document states: "We conducted all the performance testing on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is substantial equivalence with the predicate." It also notes improved safety in some aspects (e.g., "proposed device is safer than our predicate device" for "Connected firmly" and "as safe and effective as our predicate device" for "Force to Bow," "Orientation of Cutting Wire," "Ink Validation," and "Fluoroscopic Visibility"). Predicate device performance: "No information" on detailed performance specifications is provided for the predicate regarding these bench tests, but the comparison indicates equivalence was demonstrated. |
| Biocompatibility | The proposed device uses different materials (Plastic PTFE, Stainless Steel 304) than the listed predicate materials (Plastic PTFE, Stainless Steel 304, PET; Silicone oil, PTFE, Polyurethane, Medical grade hydrophilic coating). Biocompatibility tests (In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity) were performed according to ISO 10993 standards: ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017. The conclusion is "Biological risks are acceptable." |
| Adherence to Standards | The device meets IEC 60601 (electrosurgical safety), ISO 10993 (biocompatibility), and ISO 11135 (sterility). |
Study that proves the device meets the acceptance criteria:
The primary study mentioned to demonstrate that the device meets the acceptance criteria is a series of non-clinical performance bench tests comparing the proposed device to its predicate devices, as well as adherence to international standards.
- Non-clinical Performance Tests: The submission explicitly states: "We conducted all the performance testing on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is substantial equivalence with the predicate." Specific tests mentioned include:
- Injection performance
- Compatibility with traction guide wire
- Compatibility with Endoscope
- X-ray detectability
- Visibility under endoscopy
- Electric performance
- Operation flexibility
- Rotation performance
- Connected firmly
- Force to Bow
- Orientation of Cutting Wire and Visualization of Cutting Wire testing
- Ink Validation testing
- Fluoroscopic Visibility testing
- Biocompatibility Tests: A separate set of tests were conducted due to differences in materials. These include In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity, all performed according to ISO 10993 standards.
- Adherence to Standards: The device's compliance with IEC 60601, ISO 10993, and ISO 11135 is cited.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text for any of the individual bench tests. The term "bench tests" typically implies a limited number of samples to demonstrate adherence to specifications.
- Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd. in China. The nature of these tests (bench tests) is prospective in the sense that they were designed and performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth is generally not required in the way it would be for a diagnostic AI device. The "ground truth" for these tests is adherence to engineering and performance specifications, and comparison to the predicate device's characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation and clinical outcomes, not for the type of non-clinical bench testing described here.
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
Not applicable. The device is a physical medical instrument (Sphincterotome), not an AI software/device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is adherence to established technical specifications, engineering measurements, and comparison to the characteristics and performance of the legally marketed predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set
Not applicable. This device is not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not a machine learning model.
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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
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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
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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
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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.
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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 YuhangDistrict, Hangzhou, Zhejiang 311106 China |
|---|---|
| EstablishmentRegistration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping FuPhone: 0086-15958493282Fax: 0086-0571-87671225Email: 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 AGSMedTech Co., Ltd. | Wilson-Cook Medical, Inc. | / | |
| 510(k) number | / | K172665 | / | |
| Clinical Intended use | The Sphincterotome isindicated for use in thecannulation of thebiliary ducts and thetransendoscopicsphincterotomy of thePapilla of Vater and/orthe Spincter of Oddi.The device is suppliedsterile and intended forsingle use only. | Howell D.A.S.H.®Sphincterotome withDomeTip® (CookReference Part NumbersDASH-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 forcannulation of the ductalsystem and forsphincterotomy. Ifpreloaded, also aids inbridging difficult stricturesduring ERCP. | Same | |
| Technical Principles ofoperation | MonopolarSphincterotomemanufactured is anapplied part ofelectrosurgicalgenerator, usingmonopolar high-frequency currentdelivered by the | Monopolar Sphincterotomemanufactured is an appliedpart of electrosurgicalgenerator, using monopolarhigh-frequency currentdelivered by theelectrosurgical generator forsphincterotomy with theelectrode. The high- | Same | |
| Item | Proposed device | Predicate device | Comparison | |
| electrosurgicalgenerator forsphincterotomy withthe electrode. Thehigh-frequencyelectricity flows fromthe active electrode tothe neutral electrodeplaced on patient skin. | frequency electricity flowsfrom the active electrode tothe neutral electrode placedon patient skin. | |||
| Energy Use | Monopolar RadioFrequency Current | Monopolar RadioFrequency Current | Same | |
| PreloadedWire Guideor not | Preloaded Wire Guide:50910Not preloaded WireGuide: 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 GuideDiameter | 0.63mm, 0.89mm | Wire Guide Diameter inch:0.021 (≈0.53mm), 0.025(≈0.58mm), 0.035(≈0.89mm); | Similar | |
| MinimumAccessoryChannel: | 2.8mm | 2.8mm | Same | |
| Workinglength | 1800mm | 1960mm; | Similar | |
| Performance | (1)Injectionperformance;(2)Compatibility withtraction guide wire;(3)Compatibility withEndoscope;(4)X-ray detectability, | No information | Substantialequivalence.We conducted allthe performancetesting on ourproposed device incomparison withour chosen | |
| Item | Proposed device | Predicate device | Comparison | |
| ⑤Visibility underendoscopy,⑥Electricperformance,⑦Operationflexibility,⑧Rotationperformance; | predicate. All thetest results showthat the proposeddevice issubstantialequivalence withthe predicate. Forbench testsreports, pleaserefer to Section 18of this submission. | |||
| Connected firmly:ensure the device doesnot cause devicebreakage ordetachment betweenjoints. | Connected firmly: ensurethe device does not causedevice breakage ordetachment between joints. | Substantialequivalence.We conductedConnected firmlyon our proposeddevice incomparison withour chosenpredicate. All thetest results showthat the proposeddevice is saferthan our predicatedevice. For benchtests reports,please refer toSection 18 of thissubmission. | ||
| Force to Bow | Force to Bow | Substantialequivalence.We conductedForce to Bow onour proposeddevice incomparison withour chosenpredicate. All thetest results showthat the proposeddevice is as safe | ||
| Item | Proposed device | Predicate device | Comparison | |
| and effective asour predicatedevice. For benchtests reports,please refer toSection 18 of thissubmission. | ||||
| Orientation of CuttingWire and Visualizationof Cutting Wiretesting: ensure fororientation andvisualization of thecutting wire whenendoscopicallyviewed. | Orientation of Cutting Wireand Visualization of CuttingWire: ensure for orientationand visualization of thecutting wire whenendoscopically viewed. | Substantialequivalence.We conductedOrientation ofCutting Wire andVisualization ofCutting Wire onour proposeddevice incomparison withour chosenpredicate. All thetest results showthat the proposeddevice is as safeand effective asour predicatedevice. For benchtests reports,please refer toSection 18 of thissubmission. | ||
| Ink Validation testing:ensure for ink markingvisualization whenendoscopicallyviewed. | Ink visualization: ensure forink marking visualizationwhen endoscopicallyviewed. | Substantialequivalence.We conducted Inkvisualization onour proposeddevice incomparison withour chosenpredicate. All thetest results showthat the proposeddevice is as safe | ||
| Item | Proposed device | Predicate device | Comparison | |
| and effective asour predicatedevice. For benchtests reports,please refer toSection 18 of thissubmission. | ||||
| Fluoroscopic Visibilitytesting: ensure the enduser is able tofluoroscopicallyvisualize the locationof thesphincterotome. | Fluoroscopic Visibility:ensure the end user is ableto fluoroscopicallyvisualize the location ofthe sphincterotome. | Substantialequivalence.We conductedFluoroscopicVisibility on ourproposed device incomparison withour chosenpredicate. All thetest results showthat the proposeddevice is as safeand effective asour predicatedevice. For benchtests reports,please refer toSection 18 of thissubmission. | ||
| Biolo-gical | Materials orsubstances incontact withthe samehuman tissueor bodyfluids | Plastic PTFE,Stainless Steel 304,PET;Silicone oil, PTFE,Polyurethane, Medicalgrade hydrophiliccoating; | No exact information. | Different.Biocompatibilitytests have beendone for thedifference.Biological risksare acceptable. |
| Biocompatibility | In Vitro CytotoxicityTest: ISO 10993-5:2009;Skin sensitizationTest: ISO 10993-10:2010;IntracutaneousReactivity Test: ISO | No exact information. | ||
| Item | Proposed device | Predicate device | Comparison | |
| 10993-10: 2010;Acute SystemicToxicity Test: ISO10993-11:2017;Pyrogenicity: ISO10993-11:2017; | ||||
| Single /Use | Yes | Yes | Same | |
| Shelf /lifeandsterili-zation | Shelf life: 3 yearsSterilization: EOSterilization, SAL OF10-6 | Shelf life: 3 yearsSterilization: EOSterilization | Same |
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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.
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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 AGSMedTech Co., Ltd. | Wilson-Cook Medical, Inc. | Same | |
| 510(k) number | K201121 | K040981 | / | |
| Clinical Intended use | The Sphincterotome isindicated for use in thecannulation of the biliaryducts and thetransendoscopicsphincterotomy of thePapilla of Vater and/orthe Spincter of Oddi. Thedevice is supplied sterileand intended for singleuse only. | The Wilson-Cook USWNeedleknife Papillotome isintended for accessing thecommon bile duct whenstandard cannulation methodshave been exhausted. TheUSW Needleknife Papillotomeis supplied sterile and intendedfor single use only. | Same | |
| Item | Proposed device | Predicate device | Comparison | |
| Technical | Principles ofoperation | MonopolarSphincterotomemanufactured is anapplied part ofelectrosurgical generator,using monopolar high-frequency currentdelivered by theelectrosurgical generatorfor sphincterotomy withthe electrode. The high-frequency electricityflows from the activeelectrode to the neutralelectrode placed onpatient skin. | Monopolar Sphincterotomemanufactured is an applied partof electrosurgical generator,using monopolar high-frequency current delivered bythe electrosurgical generatorfor sphincterotomy with theelectrode. The high-frequencyelectricity flows from theactive electrode to the neutralelectrode placed on patientskin. | Same |
| Energy Use | Monopolar RadioFrequency Current | Monopolar Radio FrequencyCurrent | Same | |
| Catheter Size | 2.4mm-1.8mm | 7Fr(2.33mm)-5Fr(1.67mm) | Same | |
| Wire GuideDiameter | 0.63mm, 0.89mm | 0.035 (~0.89mm); | Similar | |
| MinimumAccessoryChannel | 2.8mm | 2.8mm | Same | |
| Workinglength | 1800mm | 2000mm | Similar | |
| Performance | (1)Injection performance;(2)Compatibility withtraction guide wire;(3)Compatibility withendoscope;(4)Visibility underendoscopy;(5)Electric performance;(6)Operation flexibility;(7)Connected firmly.(8)Orientation of CuttingWire and Visualization ofCutting Wire testing; | No information | Similar.Bench testshave beendone forboth theproposeddevice andpredicatedevice.Please referto Section18 of thissubmission. | |
| Item | Proposed device | Predicate device | Comparison | |
| ⑨Ink Validation testing; | ||||
| Biolo-gical | Materials orsubstances incontact withthe samehuman tissueor bodyfluids | Plastic PTFE, StainlessSteel 304; | No exact information. | Different.Biocompatibility testshave beendone for thedifference.Biologicalrisks areacceptable. |
| Biocompatibility | In Vitro CytotoxicityTest : ISO 10993-5:2009;Skin sensitizationTest :ISO 10993-10:2010;Intracutaneous ReactivityTest: ISO 10993-10:2010;Acute Systemic ToxicityTest: ISO 10993-11:2017;Pyrogenicity: ISO10993-11:2017; | No information. | ||
| SingleUse | / | Yes | Yes | Same |
| Shelflifeandsterilization | / | Shelf life: 3 yearsSterilization: EOSterilization, SAL OF 106 | Shelf life: 3 yearsSterilization: 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.
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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.
§ 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).