The Disposable Sclerotherapy Needle device consists of: Luer connector, handle, molding metal tube, Inner sheath connection limit tube, Fixing sleeve, Outer sheath, Inner sheath, connection tube, metal cap, needle. EO Sterilization and use for single use only. The material expected to come into contact with the patient is SUS304 、SUS303、PP/PE.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the "Disposable Sclerotherapy Needle." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through extensive clinical trials as would be required for a novel device.

Therefore, the acceptance criteria and study detailed in this document are not for an AI/ML powered device, nor do they involve complex aspects like:

AI/ML model performance metrics: There are no metrics like sensitivity, specificity, AUC, etc.
Test set and training set details: No data sets, their provenance, or sample sizes related to AI are mentioned because there is no AI component.
Expert ground truth establishment: No expert consensus readings or adjudication methods are discussed because there is no AI algorithm to evaluate.
MRMC studies: No human reader studies are conducted because the device is a physical instrument, not an AI diagnostic tool.
Standalone algorithm performance: There's no algorithm to perform standalone.

Instead, the document focuses on bench testing and biocompatibility evaluations for a physical medical instrument.

Here's a breakdown of the relevant information provided, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (for a physical medical device)

The document implicitly defines "acceptance criteria" by stating compliance with relevant international standards and successful completion of bench tests. The "performance" is demonstrated by the passing results of these tests and the determination of substantial equivalence.

Acceptance Criteria Category	Specific Criteria (from standards/tests)	Reported Device Performance/Findings
Biocompatibility	Compliance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals". Ensure materials in contact with patient are safe.	"The proposed device meets the requirements of ISO 10993..." and "The results show the device is safe in the aspect of biocompatibility evaluation." The materials expected to come into contact with the patient (SUS304, SUS303, PP, or PE) were evaluated.
Sterilization	Compliance with ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices." Ensure effective sterilization and minimal residuals.	"The proposed device meets the requirements of ... ISO 11135-1..." The device is single-use, EO sterilized.
Physical Properties	Bench tests performed on "Appearance" and "Physical properties." Implicitly, these tests would cover aspects relevant to the device's function and integrity, such as needle sharpness, sheath integrity, handle functionality, Luer connector fit, and overall structural soundness. (Specific numerical criteria for these are not detailed in the summary, which is common for 510(k) summaries).	"The following bench tests were performed on Disposable Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing." This indicates that the device met all internal specifications for its physical characteristics and appearance.
Functional Equivalence	Demonstration that the proposed device is substantially equivalent to the predicate device (K171454) in terms of indications for use, configuration, sheath diameter, needle size, working length, packaging, materials, and principle of operation. Minor differences should not raise new questions of safety or effectiveness.	The document provides a detailed comparison table (Section 5.6) highlighting similarities and minor differences. It concludes: "The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness." And ultimately: "...Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Disposable Sclerotherapy Needle is substantially equivalent to Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454."

Study Details (for a physical medical device)

1. Sample Size for the Test Set and Data Provenance:

Test Set: The document states that "bench tests were performed." While "sample size" for specific physical properties is not explicitly quantified (e.g., "N=X needles tested"), it refers to the number of units tested to ensure properties like appearance and physical integrity. For medical devices, this is typically a statistically relevant sample from a production batch, not a "data set" in the computational sense.
Data Provenance: Not applicable in the context of "data provenance" for AI models. The testing was conducted by the manufacturer, Hangzhou AGS MedTech CO., Ltd, in China (as per their address). It is implied these are results from prospective testing specifically conducted for this 510(k) submission, not retrospective data.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

This question is not applicable to this submission. The "ground truth" for a physical device like a sclerotherapy needle is established by established engineering specifications, material standards, and functional performance benchmarks (e.g., a needle must be sharp enough to penetrate tissue without bending, the Luer connector must fit). There are no human "experts" establishing a "ground truth" in the way a radiologist establishes disease presence for AI training. The adherence to international standards and passing bench tests are the "truth."

3. Adjudication Method for the Test Set:

Not applicable. There is no "adjudication" in the sense of reconciling divergent expert opinions, as there are no expert readings of images or data. Bench tests yield objective, measurable results (pass/fail, within specified tolerances).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, not performed, and not applicable. This is a physical medical device, not an AI assistant. MRMC studies are designed to compare the diagnostic performance of human readers with and without AI assistance. This device does not have an AI component.

5. Standalone Performance:

Not applicable in the AI sense. There isn't an "algorithm" to perform standalone. The closest equivalent would be the "bench tests" performed on the device itself, which demonstrated its standalone physical properties and compliance with standards.

6. Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:
- Engineering Specifications and Design Requirements: The device must meet its predetermined design and functional requirements.
- International Standards: Adherence to ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7) for biocompatibility and sterilization.
- Bench Test Results: Objective measurements of physical properties (e.g., appearance, integrity, mechanical characteristics).
- Comparison to Predicate Device: The predicate device itself serves as a benchmark for substantial equivalence, implying its safe and effective performance in the past.

7. Sample Size for the Training Set:

Not applicable. This device does not have an AI/ML component, therefore there is no "training set."

8. How the Ground Truth for the Training Set Was Established:

Not applicable. Since there is no training set for an AI model, there is no ground truth to be established in this context.

Summary

{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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

February 27, 2020

Hangzhou AGS MedTech CO., Ltd Yangping Fu RA Specialist Building 5, Building 6, Kangxin Road No.597 Yuhang District 311106 Hangzhou, Zhejiang CHINA

Re: K190032

Trade/Device Name: Disposable Sclerotherapy Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: February 20, 2020 Received: February 26, 2020

Dear Yangping Fu:

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

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

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,

Shanil P. Haugen, 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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190032

Device Name

Disposable Sclerotherapy Needle

Indications for Use (Describe)

The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

Image /page/3/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle around a green center. To the right of the circular design, the text "AGS MEDTECH" is written in a simple, sans-serif font. Below that, there are Chinese characters, likely representing the company's name in Chinese.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

5.1 Submitter

Submitted by:	Hangzhou AGS MedTech CO., Ltd.Building 5, Building 6, No.597 Kangxin Road,Yuhang District, 311106 Hangzhou, Zhejiang, China
EstablishmentRegistration Number:	3010288205
Owner/Operator Number:	10052959
Contact Person:	Yanping FuPhone: +86-571--87671223Fax: +86-571--87671225Email:fuyp@bioags.com
Date Prepared:	Jan 3, 2019

5.2 Proposed Device

Trade Name:	Disposable Sclerotherapy Needle
Common Name:	Disposable Sclerotherapy Needle
Classification:	Class II
Regulation Number:	876.1500
Regulation Name:	Endoscope and accessories
Product Code:	FBK
Product Code Name:	Endoscopic Injection Needle, Gastroenterology-Urology

5.3 Predicate Device

Trade Name:	Injection Therapy Needle Catheter
Common Name:	Injection Therapy Needle Catheter
Manufacturer:	Boston Scientific Corporation
510(k) Number:	K171454
Classification:	Class II
Regulation Number:	876.1500
Regulation Name:	Endoscope and accessories
Product Code:	FBK
Product Code Name:	Endoscopic Injection Needle, Gastroenterology-Urology

5.4 Device Description

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

Image /page/4/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it.

SUS303、PP/PE.

5.5 Indication for Use:

The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.

5.6 Comparison of Technology Characteristics

The Disposable Sclerotherapy Needle has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The text is in a smaller font size compared to the logo.

Item	Proposed Device	Predicate device(K171454)	Comment
Indicationfor Use	The Disposable Sclerotherapy Needleis intended for endoscopic injectioninto the gastrointestinal mucosa.	The InterjectTM Injection Therapy NeedleCatheter is used for endoscopic injectioninto gastrointestinal mucosa and submucosato:introduce a sclerosing agent,vasoconstrictor, or other solutionsinto selected sites to control actual orpotential bleeding lesions in thedigestive system aid in Endoscopic Mucosal Resection(EMR), Endoscopic SubmucosalDissection (ESD), or polypectomyprocedures control non-variceal hemorrhage	Similar:Both canbe usedforgastrointestinalmucosalinjection.
Configuration	Luer connector, handle, molding metaltube, Inner sheath connection limittube, Fixing sleeve, Outer sheath, Innersheath, connection tube, metal cap,needle	The InterjectTM Injection Therapy NeedleCatheter is a catheter that consists of ahandlewith a hub for injection, a catheter sheath,and a needle.	Similar
Photographs	Disposable Sclerotherapy Needle:Image: Disposable Sclerotherapy Needle diagramImage: Disposable Sclerotherapy Needle close up5311 Series ( with tip forming ) :Image: Disposable Sclerotherapy Needle with tip forming	Interject Clear Single-Use InjectionTherapy Needle Catheters:Image: Interject Clear Single-Use Injection Therapy Needle CathetersInterject Contrast Single-Use InjectionTherapy Needle Catheters:Image: Interject Contrast Single-Use Injection Therapy Needle Catheters	Similar
Item	Proposed Device	Predicate device(K171454)	Comment
	5311 Series (with metal cap):Image: [5311 Series (with metal cap)]5313 Series (with metal cap):Image: [5313 Series (with metal cap)]	Image: [Predicate device(K171454)]
Sheathdiameter	2.4mm	1.8mm,2.3mm	Similar
Needlesize:	21G, 22G, 23G, 24G, 25G	23G, 25G	Similar
Outertubing	For 5311 series: PP;For 5313 series: SUS 304 covered by PE.	For clear sheath design: unknown;For contrast sheath design: unknown.	May bedifferent: Weconductedabiocompatibilityevaluationof thedevice.Theresultsshow thedevice issafe in theaspect ofbiocompatibilityevaluation
WorkingLength	1600mm, 2000mm, 2300mm	2000mm ,2400mm	Similar
Packaging	Single-use EO sterilized Tyvek pouch	Single-use EO sterilized	Similar
Item	Proposed Device	Predicate device(K171454)	Comment
	with one device per pouch.
Materials	Luer connector: PC;Handle: PC;Molding metal tube: SUS304;Inner sheath connection limit tube:PTFE;Fixing sleeve: ABS;Outer sheath: PP( 5311series); SUS304 and PE (5313 series);Inner sheath: PP;Connection tube: SUS 304;Metal cap: SUS303;Needle: SUS304.The material expected to come intocontact with the patient is SUS304,SUS303 and PP, or SUS304、SUS303and PE.	Unknown	Different:Thisdifferencedoes notalter thesuitabilityof theproposeddevice foritsintendeduse. Weconductedabiocompatibilityevaluationof thedevice.Theresultsshow thedevice issafe in theaspect ofbiocompatibilityevaluation
Principleofoperation	The outer sheath of the product isinserted into the endoscope clamp.When the front part of the outer sheathtube is placed on the lesion site, pushthe Luer connector, the needle tube isexposed to the outer sheath, and theneedle is inserted into the lesion site,	The catheter sheath of the product isinserted into the endoscope clamp. Whenthe front part of the catheter sheath isplaced on the lesion site, push the handlewith a hub for injection, the needle isexposed to the catheter sheath, and theneedle is inserted into the lesion site, then	Similar

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the 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 logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The logo appears to be for a medical technology company.

{7}------------------------------------------------

Image /page/7/Picture/0 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, forming a triangle in the center. The central triangle is filled with green color. The text "AGS MEDTECH" is written in English, while "安杰思医学" is written in Chinese.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The overall design is clean and professional, suggesting a company in the medical technology field.

5.7 Applicable Guidance Document

5.8 Performance Data

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"

The following bench tests were performed on Disposable Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.

5.9 Clinical Test

No Clinical test is included in this submission.

5.10 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Disposable Sclerotherapy Needle is substantially equivalent to Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.