(686 days)
Not Found
No
The summary describes a mechanical device that delivers a hemostatic powder. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is used for hemostasis (stopping bleeding) in nonvariceal gastrointestinal bleeding, which is a therapeutic action.
No
The device is used for hemostasis (stopping bleeding), which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is composed of physical components: Absorbable Modified Polymer (AMP®) particles, a PE bellow, and an EndoClot® Applicator. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hemostasis of nonvariceal gastrointestinal bleeding". This describes a therapeutic intervention performed in vivo (within the body) to stop bleeding.
- Device Description: The device is a system for delivering particles to a bleeding site. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat a condition (bleeding) within the body.
N/A
Intended Use / Indications for Use
EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QAU
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, OECD 474:2016, ASTM F756-17, USP42_NF37 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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
1
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) | |
|---|---|
| ------------------------------------------------- | -- |
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
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.
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,
5
OECD 474:2016, ASTM F756-17, USP42_NF37 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.