EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS) is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a PE bellow and an EndoClot® Applicator (K162197). The device contains no human or animal components. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS), seeking substantial equivalence to predicate devices, primarily Hemospray®. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. The performance data presented are for the medical device itself, demonstrating its physical and biological equivalence to the predicate, rather than the performance of an algorithm or human readers.

Therefore, many of the requested criteria related to AI/ML device performance, expert ground truth establishment, adjudication methods, and MRMC studies, cannot be extracted from this document.

However, I can provide information based on the device's performance tests and studies, framed as acceptance criteria and proof of meeting them:

Acceptance Criteria and Device Performance for EndoClot® PHS

The EndoClot® PHS is a medical device intended for hemostasis of nonvariceal gastrointestinal bleeding. The studies presented aim to demonstrate that the proposed device is substantially equivalent to its predicate devices (Hemospray® and EndoClot® Applicator) by meeting specific performance, biocompatibility, and safety criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the properties of EndoClot® PHS were evaluated and compared to the predicate device Hemospray®. The acceptance criteria were implicitly set as being "similar to or better than" the predicate device.

Acceptance Criteria Category	Specific Metric/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Performance	Pressure of Gas Source	Similar to or better than predicate (Hemospray®)	Similar to or better than predicate
	Spray Pattern	Similar to or better than predicate (Hemospray®)	Similar to or better than predicate
	Delay Time	Similar to or better than predicate (Hemospray®)	Similar to or better than predicate
	Powder Feeding Rate	Similar to or better than predicate (Hemospray®)	Similar to or better than predicate
	Water Absorbency	Similar to or better than predicate (Hemospray®)	Similar to or better than predicate
	pH	Similar to or better than predicate (Hemospray®)	Similar to or better than predicate
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Systemic Toxicity, Genotoxicity, Hemocompatibility, Endotoxins	In accordance with FDA guidance and recognized international standards (e.g., ISO10993) to demonstrate safety	All tests indicated substantial equivalence to the predicate
Chemical Characterization	(Specific parameters not detailed)	In accordance with FDA guidance and recognized international standards (e.g., ISO10993) to demonstrate safety	Met standards, indicating substantial equivalence to the predicate
Sterility	(Specific parameters not detailed)	In accordance with recognized international standards (e.g., ISO11737-2)	Met standards, indicating substantial equivalence to the predicate
In Vivo Animal Study	Efficacy and Safety in Swine Model for GI Bleeding Control	Demonstrate efficacy and safety comparable to predicate (Hemospray®) in a swine model	Results demonstrated substantial equivalence to the predicate

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

The document does not explicitly state the sample sizes for the performance tests (e.g., number of units tested for spray pattern, pressure). For the in vivo animal study, it specifies a "swine model" but does not give the number of animals used. The provenance of the data is from testing conducted by the manufacturer (EndoClot Plus Co., Ltd. and their correspondent Med-wheat Shanghai) to support their 510(k) submission. The type of study is prospective testing of the device's physical, chemical, biological, and functional properties. The country of origin for the submitter is China (Shanghai).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to the type of device and studies described. The "ground truth" here is objective physical, chemical, and biological measurements, and observed hemostatic performance in an animal model, rather than expert interpretation of medical images or patient outcomes for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are device performance tests and animal studies, not interpretative studies requiring human expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This type of study is relevant for AI/ML diagnostic or interpretative devices where human performance with and without AI assistance is evaluated. The EndoClot® PHS is a medical device for direct therapeutic intervention, not an AI/ML algorithm.

6. Standalone (Algorithm Only) Performance

This is not applicable as the device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this device evaluation consisted of:

Objective physical measurements: For parameters like gas source pressure, spray pattern, delay time, powder feeding rate, water absorbency, and pH.
Adherence to standardized biological safety tests: Biocompatibility, sterility, and chemical characterization tests following ISO and FDA guidelines.
Observed physiological outcomes: In the in vivo swine model, the ability of the device to achieve hemostasis when applied to gastrointestinal bleeding. This can be considered a form of "outcomes data" in an animal model.
Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is the demonstration that the proposed device performs "similar to or better than" the legally marketed predicate device.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable as it refers to an AI/ML context that is not relevant to this device.

Summary

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January 29, 2021

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 Cn

Re: K190677

Trade/Device Name: EndoClot Regulation Number: 21 CFR 878.4456 Regulation Name: Hemostatic Device For Intraluminal Gastrointestinal Use Regulatory Class: Class II Product Code: QAU Dated: January 29, 2019 Received: March 15, 2019

Dear Mr. 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.

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

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190677

Device Name

EndoClot® Polysaccharide Hemostatic System

Indications for Use (Describe)

EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for EndoClot, with a red plus sign to the right of the word "Clot". Above the logo is the text "K190677 Page 1 of 3". The logo is in blue and black.

Date Prepared: Jan 28th, 2021

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:	Huihui Xie
Telephone No.:	086-512-62605550
Fax No.:	086-512-62605551
Email Address:	Hui@endoclot.com

2. Correspondent's Information

Company Name:	Med-wheat Shanghai
---------------	--------------------

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/Device Name:	Polysaccharide Hemostatic System
Mode Name:	EPK2302, EPK2303, EPK2305
Regulation Classification	878.4456
Product Code:	QAU
Classification Panel:	General & Plastic Surgery
Device Class:	II

4. Identification of Predicate Device(s)

The identified predicates within this submission are as follows:

The Hemospray® Endoscopic Hemospray®) has been cleared by FDA through De Novo No. DEN170015 (Date: May 7, 2018).

The EndoClot® Applicator has been cleared by FDA through 510(k) No. K162197 (Date: January 18, 2017).

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K190677 Page 2 of 3

5. Description of the Device

6. Intended Use/Indication for Use

EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest la classification of bleeding.

7. Technological Characteristics

EndoClot® PHS is composed of Absorbable Modified Polymer (AMP®) particles in a PE bellow and an EndoClot® Applicator (K162197). AMP® particles are delivered through a catheter inserted through the working channel of an endoscope which provides access to the bleeding site.

When compared with Hemospray® (DEN170015), EndoClot® PHS has the same intended use but with reduced indications for use. They are with the same classification and same application technique that the particles are delivered by gas source and through a catheter inserted through the working channel of an endoscope which provides access to the bleeding site. Yet, there are also multiple dimensions are different, which are hemostatic particles and packaging. However, these different parts have been verified to be substantial equivalent.

When compared with EndoClot® Applicator (K162197), the applicator of EndoClot® PHS is identical with EndoClot® Applicator (K162197).

8. Performance Data

Performance tests, biocompatibility tests, chemical characterization, sterility test and in vivo animal studies were conducted to demonstrate that Endoclot® PHS and the predicate devices are substantially equivalent.

According to the performance tests, the properties (Pressure of Gas Source, Spray Pattern, Delay Time and Powder Feeding Rate, Water Absorbency and pH) of EndoClot® PHS are similar to or better than the predicate device Hemospray®. The results demonstrated that the proposed device is substantially equivalent to the predicate device for these performance measures.

The biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Systemic Toxicity, Genotoxicity, Hemocompatibility and Endotoxins), chemical characterization and sterility test in accordance to Food and Drug Administration related guidance and recognized international standards (ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2017, ISO10993-18:2020, OECD 471:1997, OECD 473:2016,

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OECD 474:2016, ASTM F756-17, USP42_NF37<85> and ISO11737-2:2009/(R)2014), indicated that Endoclot® PHS is substantially equivalent to the predicate.

In vivo animal studies have also been conducted to support the substantial equivalence claims of our product as compared to the predicate device Hemospray®. The objective of the study was to validate the efficacy and safety of EndoClot® PHS (compared to the predicate device) in a swine model for gastrointestinal bleeding control. The results demonstrated that the proposed device is substantially equivalent to the predicate.

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

EndoClot® PHS has a reduced scope of intended use, with the same classification and application technique compared with Hemospray® (DEN170015). The applicator of EndoClot® PHS is identical with EndoClot® Applicator (K162197).

A series of tests were conducted to verify the safety and efficacy of Endoclot® PHS:

The performance tests demonstrated that the proposed device meets the design specifications and is suitable for the intended use.
The biocompatibility tests, chemical characterization and sterility test indicated that the proposed device is substantially equivalent to the predicate.
The in vivo animal studies demonstrated that the proposed device is substantially equivalent to the predicate.

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® PHS is substantially equivalent to predicate devices.

Regulation Number and Section

§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.

(a)
Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance data must support the sterility and pyrogenicity of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
(i) The ability to deliver the hemostatic material to the bleeding site;
(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
(6) Labeling must include:
(i) Information identifying and explaining how to use the device and its components; and
(ii) A shelf life.