EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Device Description

EndoClot® Submucosal Injection Agent is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a plastic bottle and a spiral plunger syringe. AMP® particles are dissolved with sterile 0.9% saline to make the agent prior to use. The syringe has a Luer lock fitting to ensure a secure connection to a standard, commercially available endoscopic injection needle. The agent can be injected by rotating the plunger.

AI/ML Overview

This document does not contain the information required to fully answer the request. The document describes a medical device, the EndoClot Submucosal Injection Agent, and its substantial equivalence to predicate devices, but it does not provide detailed acceptance criteria and the results of a specific study proving the device meets these criteria in the format requested.

However, I can extract what is available regarding performance and testing:

Key Takeaways (Missing Data for Comprehensive Answer):

No explicit "acceptance criteria" table with corresponding "reported device performance" values are provided. The document states that performance tests were conducted and that the device meets design specifications, but it doesn't quantify those specifications or the results in a comparative table.
The document describes device verification rather than a clinical study for demonstrating "AI vs. human" comparative effectiveness. The device is a physical submucosal injection agent, not an AI or imaging diagnostic tool that would typically involve such a study.
No information is provided about training sets, expert qualifications, adjudication methods, or specific sample sizes for establishing ground truth, as these are typically relevant for AI/diagnostic device studies.

Extracted Information Regarding Device Performance and Testing:

Here's an attempt to structure the available information, noting where requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments/Details from Document
Material Properties	N/A (Not explicitly stated)	The document states "the properties (pH, density, viscosity and osmolality) of the agent are close to the predicate device". Specific values or acceptance ranges are not provided.
Cushion-forming Duration	"better"	The EndoClot® Submucosal Injection Agent "has better cushion-forming duration" compared to the predicate device. Specific duration values or metrics are not provided.
Biocompatibility	"biocompatible and safe"	Met standards: ISO10993-5:2009, ISO10993-6:2016, ISO10993-10:2010, ISO 10993-11:2006, OECD 471:1997, OECD 473:2014, OECD 474:2014, ASTM F756-13, USP40 NF35<85>.
Sterility	"safe"	Met standard: ISO 11737-2: 2009/(R)2014.
Efficacy (Animal Study)	"safe and effective"	Animal studies demonstrated the device is "safe and effective" for submucosal lift during EMR/ESD procedures.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (for Animal Study): Not specified. The document states "Animal studies have also been conducted," but does not give the number of animals.
Data Provenance: "porcine model" (animal study).
Retrospective/Prospective: Not specified, but animal studies are typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This information is typically relevant for diagnostic devices that require expert review (e.g., radiologists interpreting images). The EndoClot device is a physical injection agent, and its performance (e.g., lift, duration, safety) is assessed directly through physical and biological tests, not by expert interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. As above, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this device. This type of study would compare human readers' performance with and without an AI diagnostic aid. The EndoClot device is a physical medical device (submucosal injection agent), not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This question is also focused on AI/algorithmic performance, which does not apply to a physical medical device like the EndoClot Submucosal Injection Agent.

7. The Type of Ground Truth Used

For Biocompatibility and Sterility: Established by adherence to recognized international standards and guidance documents (e.g., ISO, OECD, ASTM, USP).
For Material Properties (pH, density, viscosity, osmolality): Likely established through laboratory measurements and comparison to predicate device specifications.
For "Cushion-forming duration": Likely established through laboratory or in-vivo testing to measure duration of submucosal lift.
For Efficacy/Safety: Established through observed outcomes in the porcine model following EMR/ESD procedures, likely including visual assessment of lift and histological examination for safety.

8. The Sample Size for the Training Set

Not Applicable. This question relates to machine learning models. The EndoClot device is a physical product and does not involve a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As above, this relates to machine learning.

Summary

{0}------------------------------------------------

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 30, 2020

EndoClot Plus Co., Ltd. % Jonathan Hu Technical Manager Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai 200093 CHINA

Re: K191254

Trade/Device Name: EndoClot Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PLL Dated: December 18, 2019 Received: December 26, 2019

Dear Jonathan Hu:

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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 mediation-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}------------------------------------------------

Indications for Use

510(k) Number (if known) K191254

Device Name EndoClot

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X 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."

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

Image /page/3/Picture/2 description: The image shows the logo for EndoClot. The logo is in blue and black, with a red plus sign to the right of the word. The word "EndoClot" is written in a stylized font.

Date Prepared: Jan 30th, 2020

510(k) Summary

[As required by 21 CFR 807.92]

1. Submitter's Information

Name of Sponsor:	EndoClot Plus Co., Ltd.
Address:	101 Room, B8 Building, 218 Xinghu Street, Suzhou Industrial Park
Contact Name:	Hendry Zhang
Telephone No.:	086-512-62605550
Fax No.:	086-512-62605551
Email Address:	Hendry@endoclot.com
2. Correspondent's Information
Company Name:	Med-wheat Shanghai
Correspondent Name:	Jonathan Hu

Telephone No.:	86-021-65181421
Email Address:	Jonathan.hu@medwheat.com

3. Trade Name, Common Name, Classification

Trade Name:	EndoClot®
Common Name:	Submucosal Injection Agent
Model Name:	SIA-30 (Former Name: SIS-30)
Regulation Classification	Endoscope Accessories
Regulation Number	21 CFR 876.1500
Product Code:	PLL
Classification Panel:	Gastroenterology/Urology
Device Class:	II

4. Identification of Predicate Device(s)

The identified predicates are as follow:

The SIC 8000 Submucosal Injection Composition has been cleared by FDA through 510(k) No. K150852 (Decision Date - September 3, 2015).

The Merit Syringe has been cleared by FDA through 510(k) No. K173601 (Decision Date -October 3, 2017).

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

510(k) Submission

Image /page/4/Picture/2 description: The image shows the word "EndoClot" in a stylized font. The "E" is in a blue, italicized font, and the rest of the word is in a black, sans-serif font. There is a red plus sign to the right of the word. The plus sign is slightly larger than the letters in the word.

5. Description of the Device

6. Intended Use/Indication for Use

7. Technological Characteristics

Endoclot® Submucosal Injection Agent is composed of Absorbable Modified Polymer (AMP®) particles in a plastic bottle and a spiral plunger syringe. Prior to use, the AMP® particles are dissolved with sterile 0.9% saline to make the agent. Then the agent is injected into the submucosal layer using our accompanied spiral plunger syringe and a standard, commercially available, endoscopic injection needle.

When comparing with the SIC8000 (K150852), the Endoclot® Submucosal Injection Agent has the same intended use, same classification, and same principle of operation which is operated by advancing the plunger within the barrel to inject fluids. Yet, there are also differences, such as product composition, sterilization method, packaging and shelf life. However, substantial equivalence has been demonstrated through verification.

When comparing with the Merit Syringe (K173601), the syringe of Endoclot® Submucosal Injection Agent has a smaller scope of intended use and most of the device material is same as that of the predicate device. The differences are the plunger material, piston material, the syringe's structure and shelf life. However, substantial equivalence has been demonstrated through verification.

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

510(k) Submission

Image /page/5/Picture/2 description: The image shows the logo for EndoClot. The logo is in blue and black, with a red plus sign to the right of the word "EndoClot". The "E", "N", "D", and "O" are in blue, while the "Clot" is in black. The plus sign is red.

8. Performance Data

Performance tests, biocompatibility tests, sterility test and animal studies were conducted to demonstrate that the Endoclot® Submucosal Injection Agent and the predicate device are substantially equivalent.

According to the performance tests, the properties (pH, density, viscosity and osmolality) of the agent are close to the predicate device, and the Endoclot® Submucosal Injection Agent has better cushion-forming duration. The results demonstrated that the proposed device is substantially equivalent to the predicate device for these performance measures.

The biocompatibility tests (ISO10993-5:2009, ISO10993-6:2016, ISO10993-10:2010, ISO 10993-11:2006, OECD 471:1997, OECD 473:2014, OECD 474:2014, ASTM F756-13, USP40 NF35<85>) and sterility test (ISO 11737-2: 2009/(R)2014) in accordance to Food and Drug Administration related guidance and recognized international standards, indicated that the Endoclot® Submucosal Injection Agent is biocompatible and safe for its intended use.

Animal studies have also been conducted to support substantial equivalence claims of our product as compared to the predicate device SIC 8000 Submucosal Injection. The objective of this study was to validate the efficacy and safety of EndoClot® Submucosal Injection Agent (compared to the predicate device) for submucosal lift during EMR/ESD procedures in GI tract of a porcine model. The results demonstrated that the proposed device is safe and effective.

9. Conclusion [21 CFR 807.92(b) (3)]

The Endoclot® Submucosal Injection Agent has the same intended use, same classification, and the same principle of operation comparing with the SIC 8000 Submucosal Injection. The syringe of Endoclot® Submucosal Injection Agent has a smaller scope of intended use and almost the same material comparing with the Merit Syringe. A series of tests have been conducted to verify the safety and effectiveness of the Endoclot® Submucosal Injection Agent.

1. The performance tests demonstrated that the device meets the design specifications and is suitable for the intended use.
1. The biocompatibility tests and sterility test indicated that the Endoclot® Submucosal Injection Agent is biocompatible and safe for its intended use.
1. The animal studies demonstrated that the EndoClot® Submucosal Injection Agent is safe and effective.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. EndoClot Plus Co., Ltd. concludes that Endoclot® Submucosal Injection Agent is substantially equivalent to the predicate devices with regard to safety and effectiveness.

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.