EndoClot® Applicator is a medical device composed of applicator (catheter, gas/powder mixing chamber), connecting tube and gas filter, with a tube connecting to gas source in hospital. The device has good biocompatibility. By combining with external gas source, it can deliver the powdered hemostatic agent to the treatment site in endoscopic surgical procedures.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "EndoClot® Applicator," which is intended to assist in the delivery of a powdered hemostatic agent during endoscopic surgeries.

The acceptance criteria and study proving the device meets these criteria are not described in detail in the provided text in the way a clinical study for a new AI/software medical device would be. This document is a 510(k) summary for a Class II medical device, which demonstrates substantial equivalence to a previously cleared predicate device, rather than proving novel effectiveness through rigorous clinical trials and statistical goals.

Here's a breakdown based on the provided text, and where it falls short of the requested information for an AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria in a quantitative, measurable way for performance as one would expect for an AI/software device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" for a 510(k) are typically met by demonstrating:

Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device.
Meeting Recognized Standards: Compliance with relevant international and FDA-recognized standards for medical devices (e.g., biocompatibility, sterility, performance testing).

Reported Device Performance (as inferred from the document):

Acceptance Criteria (Inferred for 510(k))	Reported Device Performance
Biocompatibility: Device materials are not harmful to the body.	Meets Standards: Testing conducted in accordance with ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and sensitization), and ISO 10993-11:2006 (systemic toxicity). The document states "Test data and report information are included in this submission," indicating the tests were performed and results were acceptable.
Sterility: Device is sterile for its intended use.	Meets Standards: EO sterilization method is used, which is the same as the predicate device. Compliance with relevant sterility standards (implied, as it's a critical safety aspect for medical devices).
Performance (Functional Equivalence): Delivers powdered agent effectively and safely.	Demonstrated through Equivalence to Predicate: "The working situation and environment of EndoClot® Applicator is the same as that of the MEDAFOR DIRECT Gas-Assisted Application System, the technological characteristics of this product is designed to make same as that of the equivalence product." Specific performance metrics (e.g., flow rate, dispersion pattern, delivery accuracy) are not detailed beyond stating functional similarity and "performance testing" was conducted. ASTM F756-13 (Standard Practice for Assessment of Biomaterials for Surgical Implants) and ISO 11607-1:2006 (Packaging for terminally sterilized medical devices) are mentioned, which relate to material and packaging integrity, important for performance and safety.
Shelf Life: Device maintains integrity over time.	3 Years: Same as the predicate device.
Packaging: Maintains sterility and integrity until use.	Tyvek and PETG: Same as the predicate device. Compliance with ISO 11607-1:2006 for packaging.

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

Sample Size: Not specified in terms of clinical cases or patient data. The "tests" mentioned are non-clinical, involving materials, sterilization, and basic functional characteristics.
Data Provenance: The tests were "conducted related non-clinical tests" by the submitter (EndoClot Plus Co., Ltd.). The location of the company is China (Suzhou Industrial Park). No human data or patient samples are referenced for these non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable in this context. This device is a mechanical applicator, not an AI/software device requiring expert interpretation of diagnostic images or patient outcomes for ground truth establishment. The "ground truth" for this submission revolves around physical and chemical properties and functional equivalence to a predicate device, assessed through laboratory testing and engineering analysis, not expert clinical consensus.

4. Adjudication Method for the Test Set:

Not applicable. There's no test set in the sense of clinical cases requiring adjudication by multiple readers or experts. Device testing (biocompatibility, sterility, etc.) typically involves passing pre-defined criteria in laboratory settings.

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

Not performed/applicable. This type of study is specifically designed for AI/software devices where human readers' performance with and without AI assistance is evaluated. This 510(k) is for a mechanical medical device, not an AI.

6. Standalone (Algorithm Only) Performance:

Not applicable. As this is a mechanical applicator, there is no "algorithm" or standalone software component to evaluate.

7. Type of Ground Truth Used:

The "ground truth" for this device's substantial equivalence determination is based on engineering specifications, material properties, predicate device characteristics, and compliance with recognized international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, ISO 11607 for packaging). It is not based on expert consensus, pathology, or outcomes data from a clinical trial.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. As there is no training set, there is no ground truth establishment process for it relevant to AI/ML.

In summary: The provided document describes a 510(k) submission for a physical medical device (EndoClot® Applicator). The "proof" that it meets acceptance criteria (substantial equivalence) is primarily through non-clinical bench testing, material characterization, and direct comparison of design and intended use to a legally marketed predicate device (MEDAFOR DIRECT Gas-Assisted Application System in K123325). The document does not involve or require the types of studies (clinical trials, expert consensus, MRMC studies) typically associated with establishing performance and ground truth for AI/software medical devices.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 18, 2017

EndoClot Plus Co., Ltd. % Mr. Jonathan Hu Technical Manager Med-wheat (Shanghai) Medical Technology Co., Ltd. Yangpu District, Liaoyuan East Road, Shuangyang First Suite No.33 Room 303 Shanghai, China 200093 CN

Re: K162197

Trade/Device Name: EndoClot Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 15, 2016 Received: December 22, 2016

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162197

Device Name disposable applicator

Indications for Use (Describe)

The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the in endoscopic surgeries.

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)

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Date Prepared: Dec 15th, 2016

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, SuzhouIndustrial 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:	EndoClot® Applicator
Mode Name:	EA230
Regulation Classification	Endoscope Accessories
Product Code:	GCJ
Classification Panel:	Gastroenterology/Urology
Device Class:	II

4. Identification of Predicate Device(s)

The identified predicates within this submission are as follows:

The MEDAFOR DIRECT Gas-Assisted Application System have been cleared by FDA through 510(k) No. K123325 (Decision Date - Jan 24, 2013).

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5. Description of the Device

6. Intended Use/Indication for Use

The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.

7. Technological Characteristics

The working situation and environment of EndoClot® Applicator is the same as that of the MEDAFOR DIRECT Gas-Assisted Application System, the technological characteristics of this product is designed to make same as that of the equivalence product. It applies EO sterilization method, which is also same as that of SE product.

TechnologicalCharacteristics	Endoclot Applicator	MEDAFOR DIRECT Gas-Assisted Application System inK123325
Product Code	GCJ	GCJ
Intended Use	The EndoClot® Applicator isintended to assist the delivery of apowdered hemostatic agent to thetreatment site in endoscopicsurgeries.	The device is intended to assist thedelivery of a powdered hemostaticagent to the treatment site insurgical procedures includingendoscopic surgeries, using a 5 mmor larger trocar.
Product Structure	Applicator(Catheter, gas/powdermixing chamber), connectingtube, gas filter	applicator, tubing set
Applicator	PTFE, PP	PTFE, PP
Connecting Tube	PVC	PVC
Gas Filter	styrene-butadienecopolymer
Shelf Life	3 years	3 years
Sterilization Method	EO sterilization	EO sterilization
Packaging	Tyvek and PETG	Tyvek and PETG

A comparison of technological characteristics is provided in the following table:

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8. Discussion of Non-clinical Testing

The EndoClot® Applicator has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which contains the standards including ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2006, ASTM F756-13, ISO11607-1:2006.

9. Substantial Equivalence

The EndoClot® Applicator has taken the biocompatibility, sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission.

10. Conclusion

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 disposable applicator is substantially equivalent to 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.