(717 days)
No
The device description and performance studies focus on the physical and chemical properties of the powder and the mechanical delivery system. There is no mention of AI/ML in the text, and the "Mentions AI, DNN, or ML" field is marked as "Not Found".
Yes
The Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding, which is a therapeutic function.
No
The Nexpowder™ is described as being used for "hemostasis of non-variceal, upper gastrointestinal bleeding," meaning its purpose is to stop bleeding, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components including a powder, vial, delivery system (spray body, connector, catheter), and a battery-powered air pump. This indicates it is a hardware device, not software-only.
Based on the provided information, the Nexpowder™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "hemostasis of non-variceal, upper gastrointestinal bleeding." This describes a therapeutic intervention performed directly on the patient's tissue to stop bleeding.
- Device Description: The description details a system for delivering a hemostatic powder directly to the bleeding site within the gastrointestinal tract. This is a physical intervention, not a test performed on a sample taken from the body.
- Mechanism of Action: The device works by physically applying a powder to control bleeding. This is a mechanical or chemical action on the tissue, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Nexpowder™ device does not fit this definition. It is a therapeutic device used to treat a condition (bleeding) directly within the body.
N/A
Intended Use / Indications for Use
Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
Product codes
QAU
Device Description
The Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding. The Nexpowder™ is a prescription only, single-use device provided with a pre-packaged powder, a vial, and a Delivery System, which consists of a Spray body, a Connector and a Delivery Catheter. The powder vials are provided in a sterile condition with gamma radiation sterilization and the non-sterile external Spray Body delivery system with its sterile Connector and sterile Delivery Catheter.
The hemostatic powder agents of the Nexpowder™ are primarily composed of succinic anhydride ({-poly-L-lysine) and oxidized dextran and are endoscopically applied through a catheter channel of the delivery system to control qastrointestinal bleeding in the upper qastrointestinal tract. Utilizing the installed battery power, air pressures are generated from the air pump placed in the spray body of Nexpowder™ delivery system to provide effective physical force to move the hemostatic powder agent into the delivery catheter. The hemostatic agents of the Nexpowder™ ultimately get sprayed onto the hemostasis target site in the gastrointestinal tract. Nexpowder is excreted from the patient's gastrointestinal or digestive system primarily by peristalsis of the human digestive system within the three days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper gastrointestinal tract
gastrointestinal tract
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)
Design Validation Testing:
- Animal Study:
- Porcine Study I:
- Study Type: Endoscopic submucosal dissection (ESD) based bleeding models.
- Sample Size: 6 Nexpowder™ treated, 6 Hemospray® treated, 3 sham controls.
- Key Results: Initial hemostasis was achieved in all animals (6/6). None of the animals in the treatment group showed re-bleeding up to the 30-day follow-up time point. There was no gastrointestinal perforation, obstruction, or gas embolism caused by the device. Histopathological evaluation of the device application site did not reveal any important histological differences between treatment group and control group animals.
- Porcine Study II:
- Study Type: Gastroepiploic Artery (Forrest 1a) Bleeding Model.
- Sample Size: 6 Nexpowder™ treated, 3 Hemospray® treated.
- Key Results: The rate of achieving initial hemostasis was 67% (4/6) in the treatment group. None of the animals in the treatment group showed re-bleeding up to the 30-day follow-up time point. There were no gastrointestinal perforation, obstruction, and gas embolism which caused by device. Histopathological evaluation of the device application site did not reveal any important histological findings.
- Porcine Study I:
- Clinical data: Real-world evidence of device safety in nonvariceal upper gastrointestinal bleeding in the OUS market was provided, including data from 315 patients with an additional 50 patients from a Retrospective Aggregated Data Collection survey.
- A. Prospective, Multicenter, Single-blind (subject) Controlled Clinical Trial to Confirm the Efficacy and Safety of the Wound Dressing 'UI-EWD':
- Sample Size: 76 patients (37 in Test Group with Nexpowder).
- Hemostasis: 100% (37 out of 37) in Test Group.
- Adverse Events/Complication Rates: 2.7% (1 Adverse event) out of 37 Subjects (Fever).
- Re-Bleeding rate: 8.11% within 3 days.
- B. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding:
- Sample Size: 56 patients.
- Hemostasis: 96.4% (54 out of 56 cases with use of Nexpowder).
- Adverse Events/Complication Rates: Zero adverse events.
- Re-Bleeding rate: 3.7% Within 30 days.
- C. Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study:
- Sample Size: 17 patients.
- Hemostasis: 94% (16 out of 17 cases with use of Nexpowder).
- Adverse Events/Complication Rates: Zero adverse events.
- Re-Bleeding rate: 19% Within 30 days.
- D. Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding:
- Sample Size: 41 patients.
- Hemostasis: 97.5% (40 out of 41 cases with use of Nexpowder).
- Adverse Events/Complication Rates: Zero adverse events.
- Re-Bleeding rate: 4.3% within 7 days, 22.5% within 28 days.
- E. Post Market Clinical Aggregated Data Collection Survey on Nexpowder™ for Safety and Performance Evaluation:
- Sample Size: 50 patients.
- Hemostasis: 100% (50 out of 50 cases with use of Nexpowder).
- Adverse Events/Complication Rates: Zero adverse events.
- Re-Bleeding rate: 2.0% within 3 days, 4.0% within 30 days.
- A. Prospective, Multicenter, Single-blind (subject) Controlled Clinical Trial to Confirm the Efficacy and Safety of the Wound Dressing 'UI-EWD':
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Hemostasis Rate
- Adverse Events/Complication Rates
- Re-Bleeding rate
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2022
Nextbiomedical Co., Ltd. % Kyungyoon Kang CEO K-Bio Solutions 201 South 4th St, Suite 727 San Jose, California 95112
Re: K202929
Trade/Device Name: Nexpowder Regulation Number: 21 CFR 878.4456 Regulation Name: Hemostatic Device For Intraluminal Gastrointestinal Use Regulatory Class: Class II Product Code: QAU Dated: September 24, 2020 Received: September 29, 2020
Dear Kyungyoon Kang:
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,
for Deborah Fellhauer, RN, BSN 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
2
Indications for Use
510(k) Number (if known) K202929
Device Name Nexpowder™
Indications for Use (Describe)
Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
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)
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3
510(k) Summary: Nexpowder™
l. Applicant/Manufacturer Information
Type of 510(k) Submission: Traditional 510(k) Premarket Notification
Applicant's Information
Name of Sponsor: NEXTBIOMEDICAL CO., LTD. Address: 6, Venture-ro 100beon-gil, Yeounsu-gu, Incheon, Republic of Korea Contact Name: Eunhye Lee Telephone No.: 82-32-880-0820 Email Address: ehlee@nextbiomedical.co.kr
Correspondent's Information
Company Name: K-Bio Solutions Correspondent Name: Mr. Kyungyoon Kang Email Address: kyungyoon.kang@kbiotechsolutions.com
Date Prepared: September 9th, 2022
II. Regulatory Information
Proposed Device:
- Trade/Proprietary Name: Nexpowder™ ●
- Classification Name: Hemostatic device for intraluminal gastrointestinal use
- Regulatory Class: Class II, Regulation Number: 878.4456, ●
- Product Code: QAU
- 510(K) number: K202929
Predicate Device:
- Trade/Proprietary Name: Hemospray® Endoscopic Hemostat ●
- Classification Name: Hemostatic device for intraluminal gastrointestinal use .
- Product Code: QAU ●
- De Novo Clearance number: DEN170015 ●
- . 510k Submitter: Wilson-Cook Medical, Inc.
Reference Device:
- Trade/Proprietary Name: PerClot® Topical ●
- Classification Name: Dressing, Wound, Drug
- . Product Code: FRO
- 510(K) number: K132105
- . 510k Submitter: CRYOLIFE, INC.
III. Device Description of the Nexpowder™
The Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding. The Nexpowder™ is a prescription only, single-use device provided with a pre-packaged powder, a vial, and a Delivery System, which consists of a Spray body, a Connector and a Delivery Catheter. The powder vials
4
are provided in a sterile condition with gamma radiation sterilization and the non-sterile external Spray Body delivery system with its sterile Connector and sterile Delivery Catheter.
The hemostatic powder agents of the Nexpowder™ are primarily composed of succinic anhydride ({-poly-L-lysine) and oxidized dextran and are endoscopically applied through a catheter channel of the delivery system to control qastrointestinal bleeding in the upper qastrointestinal tract. Utilizing the installed battery power, air pressures are generated from the air pump placed in the spray body of Nexpowder™ delivery system to provide effective physical force to move the hemostatic powder agent into the delivery catheter. The hemostatic agents of the Nexpowder™ ultimately get sprayed onto the hemostasis target site in the gastrointestinal tract. Nexpowder is excreted from the patient's gastrointestinal or digestive system primarily by peristalsis of the human digestive system within the three days.
IV. Intended Use/ Indications for Use
Nexpowder™ is used for hemostasis of non-variceal, upper gastrointestinal bleeding.
V. Substantial Equivalence Comparison with Predicate Device
| Comparison
Item | Proposed Device | Predicate Device | Assessment of Substantial
Equivalence |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device
Name | Nexpowder™ | Hemospray®
Endoscopic Hemostat | N/A |
| Common Name | Hemostatic Device
for intraluminal
gastrointestinal use | Hemostatic Device
for intraluminal
gastrointestinal use | Identical to the predicate device |
| 510k Number | K202929 | DEN170015 | N/A |
| Manufacturer | NEXTBIOMEDICAL
Co., Ltd | Wilson-Cook Medical,
Inc. | N/A |
| Application/
Device
Overview | The device is applied
by using catheter,
delivery system and a
gastrointestinal
endoscope.
The device is
comprised of a
handheld delivery
system that propels
hemostatic powder
through a catheter to
the GI bleeding site. | The device is applied
by using endoscopic
catheter, delivery
system and a
gastrointestinal
endoscope.
The device is
comprised of a
handheld delivery
system that propels
hemostatic powder
through a catheter to
the GI bleeding site. | Similar to the predicate device |
| Intended Use /
Indications for Use | The device is intended
to be used for
hemostasis of
non-variceal, upper
gastrointestinal
bleeding. | The device is intended
to be used for
hemostasis of
non-variceal
gastrointestinal
bleeding. | The indications for use are a
subset of the indications cleared
for the predicate device. |
| Operation
Principle | When the device
comes in contact with
an actively
bleeding site, the
powder absorbs water,
then acts both
cohesively and
adhesively, forming a
mechanical barrier
over the bleeding site. | When the device
comes in contact with
an actively
bleeding site, the
powder absorbs water,
then acts both
cohesively and
adhesively, forming a
mechanical barrier
over the bleeding site. | Similar to the predicate device |
| | Nexpowder is an inert
powder developed for
endoscopic
hemostasis. The
powder is delivered by
use of a battery
powered delivery
system and through a
catheter inserted
through the working
channel of an
endoscope which
provides access to the
site of the bleed. It
contains no human or
animal proteins or
botanicals | Hemospray is an inert
powder developed for
endoscopic
hemostasis. The
powder is delivered by
use of a carbon
dioxide powered
delivery system and
through a catheter
inserted through the
working channel of an
endoscope which
provides access to the
site of the bleed. It
contains no human or
animal proteins or
botanicals and has no
known allergens. | Similar to the predicate device,
as for the difference in the
delivery system that
NexpowderTM is operated based
on the battery powered delivery
system, while the predicate,
Hemospray® is operated based
on the aerosol delivery system
does not raise different questions
in terms of safety and
effectiveness, given NexpowderTM
delivery system has been verified
to meet the electrical safety and
performance requirements per the
FDA's recognized standards of
IEC 60601-1, IEC 60601-1-2, and
IEC 60601-1-6 and special
controls. The same FDA's
recognized IEC standards have
been applied for the electrical
safety and performance
evaluation of the predicate,
Hemospray Endoscopic Hemostat
(DEN170015, Wilson-Cook
Medical, Inc.). |
| Product
Design | The device system
consists of hemostatic
powder agent and a
delivery system. | The device system
consists of hemostatic
powder agent and a
delivery system. | The overall device system with
hemostatic agent and delivery
system is substantially
equivalent/similar to the predicate
device in terms of the use of
hemostatic agent and a delivery |
| | | | system under gastrointestinal
endoscopy. |
| Hemostatic
Agent | Powder in a vial,
including:
• ε-poly-L-lysine
• Aldehyded dextran
• Polyvinylpyrrolidone
• Brilliant Blue FCF
• Low-substituted
Hydroxypropylcellulose
L-HPC
• Lactose Monohydrate
• Magnesium Stearate | Sodium bentonite | The composition of the
hemostatic powder components
of the subject and predicate
devices is different. |
| Specifications | Catheter French size:
7.5Fr
Catheter Length:
220.0cm | Catheter French size:
7Fr, 10Fr
Catheter Length:
220cm, | Similar dimensional specifications
to the predicate device. The
favorable results of the design
verification and validation testing
demonstrate conformance of the
proposed Nexpowder™ to the
FDA's recognized standards and
the design requirements. The
testing results further
demonstrate the proposed
Nexpowder™ is substantially
equivalent to the predicate
device, Hemospray® Endoscopic
Hemostat, as the proposed
Nexpowder™ and predicate
device are subject to the same
recognized standards of the FDA
for the special controls evaluation
of medical device. |
| Sterilization
Method | Powder: Gamma
radiation
Delivery system
(catheter and
connector): EtO
Sterilization
Spray Body: Non-sterile | Product: Gamma
radiation | Similar Gamma radiation
sterilization for hemostatic agent
as the predicate device |
| Sterilization
Validation
Target | Sterilization Assurance
Level of
10-6 | Sterilization
Assurance Level of 10-6 | Identical to the predicate devices |
| Shelf Life | 15 months | 3 Year | Supported by 15 months shelf life
testing |
Assessment Table of Substantial Equivalence
5
6
Similar to the predicate device, Nexpowder™ is an inert powder developed for endoscopic hemostasis. Nexpowder™ contains Aldehyded Dextran and Poly-L-Lysine (Polysaccharide) derived from microbial extraction. The powder is delivered by use of a battery powered delivery system and through a catheter
7
inserted through the working channel of an endoscope which provides access to the intended hemostasis target site. The overall hemostatic mechanism of Nexpowder™ to form a physical control barrier to achieve hemostasis is similar to the predicate, Hemospray® Endoscopic Hemostatic agent of Nexpowder™ is provided in a form of powder polymer materials, which can be readily sprayed over a bleeding site in the non-variceal upper gastrointestinal tract. The hemostatic agent of powder polymer functions as a physical, mechanical barrier over the bleeding site in the gastrointestinal tract to effectively control bleeding. From the standpoint of forming the mechanical barrier physically, the presence of blood in and of itself is not required. But any type of bodily fluids including digestive fluids excreted in the gastrointestinal tract and blood at the hemostasis target site coming into contact with the Nexpowder™ would lead to the crosslinking gelation effects following the hemostatic agent's rapid absorption of the bodily fluids.
Although the hemostatic agent may differ in chemical composition for each the predicate and subject device, in both of these products, the individual ingredients do not contain human or animal proteins or botanicals and have the same end state, which is a gel that will act as a mechanical barrier and induce hemostasis. In addition, the modified polysaccharide material that comprises the hemostatic agent ingredient of the Nexpowder™ is similar to the polysaccharide material in the reference device, PerClot® Topical (K132105). PerClot® Topical is another class II, hemostat device, intended as a topical wound dressing and used to control bleeding from the skin by rapidly absorbing water and forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding. This demonstrate that polysaccharides used in hemostatic agents are not novel. Moreover, the biocompatibility profile of Nexpowder™ agents has been confirmed with comprehensive biocompatibility testing pursuant to ISO 10993-1.
Utilizing a power source, both the spray body of Nexpowder™ and the predicate provide physical force to push the hemostatic powder agent into the delivery catheter and spray the hemostasis intended site in the gastrointestinal tract. The minor difference in the power source of the delivery system does not raise different questions in terms of safety and effectiveness, since Nexpowder™ delivery system has been verified to meet the electrical safety and performance requirements per the FDA's recognized standards of IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-6.
VI. Biocompatibility Assessment
Nexpowder™ has met the FDA's recognized standards for biocompatibility requirements identified in the FDA Guidance Table A.1, below, Biocompatibility risk assessments have been conducted per FDA Guidance, "Use of ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process (Issued June 16, 2016)". The following biocompatibility testing was performed on Nexpowder™:
| Biocompatibility
| Endpoint | Method and Purpose | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5: MEM Elution Study used to | |
| evaluate device extracts for cytotoxicity risks. | Non-cytotoxic | |
| Sensitization | ISO 10993-10: Guinea Pig Maximization | |
| Sensitization Test used to evaluate device | ||
| extracts for dermal sensitization risks. | Non-sensitizer |
GLP Biocompatibility Testing Completed for the Hemostatic Agent Powder of Nexpowder™:
8
| Irritation | ISO 10993-10: Intracutaneous Initiation Test
used to evaluate device extracts for irritation
risks. | Non-irritant |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Acute Systemic Toxicity | ISO 10993-11: Acute systemic toxicity study
used to evaluate device extracts for systemic
toxicity risks. | No acute systemic
toxicity |
| Material Mediated
Pyrogenicity | ISO 10993-11: Rabbit pyrogen test used to
evaluate device extracts for pyrogenicity
risks. | Non-pyrogenic |
| Hemocompatibility | Hemolytic study (ASTM: F756-17),
Complement Activation, Partial
Thromboplastin Time, Platelet and Leukocyte
Counts (ISO10993-4) used to evaluate
device extracts for hemocompatibility risks. | Hemocompatible |
| Genotoxicity | ISO 10993-3: Genotoxicity study used to
evaluate device extracts for genotoxicity risk. | Non-genotoxic |
| Implantation | ISO 10993-6: Implantation study used to
evaluate device extracts for the local effects
risk. | Non-irritant |
| Subchronic Toxicity | ISO 10993-11: Implantation study used to
evaluate device extracts for subchronic
toxicity risk. | No subchronic
systemic toxicity |
GLP Biocompatibility Testing Completed for the Delivery System Catheter and Connector of Nexpowder™:
| Biocompatibility Endpoint | Method and Purpose | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5: MEM Elution Study used to evaluate device extracts for cytotoxicity risks. | Non-cytotoxic |
| Sensitization | ISO 10993-10: Guinea Pig Maximization Sensitization Test used to evaluate device extracts for de1mal sensitization risks. | Non-sensitizer |
| Irritation | ISO 10993-10: Intracutaneous Initiation Test used to evaluate device extracts for irritation risks. | Non-irritant |
| Acute Systemic Toxicity | ISO 10993-11: Acute systemic toxicity study used to evaluate device extracts for systemic toxicity risks. | No acute systemic toxicity |
| Material mediated pyrogenicity | ISO 10993-11: Rabbit pyrogen test used to evaluate device extracts for pyrogenicity risks. | Non-pyrogenic |
| Endotoxin | USP | Non-pyrogenic |
| Hemocompatibility | ASTM: F756-17: Hemolytic study used to evaluate device extracts for hemocompatibility risks. | Hemocompatible |
9
VII. Design Verification and Validation Testing
Design Verification and Validation (DV&V) testing were performed to verify that the proposed Nexpowder™ meets the pre-determined requirements for design verification, validation, and FDA's special control requirements. Testing was also conducted to verify the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process per ISO 14971: Medical Devices-Application of Risk Management to Medical Devices. The following design verification or performance testing of Nexpowder have been completed with favorable test results, meeting the applicable ISO standards and FDA's recognized standards pertaining to evaluations of Nexpowder™.
Design Verification Performance Testing
T=0 Baseline Sample Testing, T=2 Years, and T=3 Years Accelerated Aging Testing of Finished Hemostatic Powder Agents of Nexpowder™:
- Appearance Test ●
- Weight Test .
- Absorption Test
- Water Content Test ●
- Adhesion Test ●
T=0 Baseline Sample Testing, T=3 Years Accelerated Aging Testing of Catheter and Connector of Nexpowder™ Delivery System:
- Appearance Test
- Dimension Verification Test ●
- Tensile Strength Test ●
- Air Leak Test
- Spray Test
T=0 Baseline Sample Testing, T=3 Years Accelerated Aging Testing of Spray Body of Nexpowder™ Delivery System:
- Appearance Test
- Dimension Verification Test ●
- Air Pressure Test of the Outlet Port
- Power Switch Function Test (Battery Function and Vibration operation Test) ●
- . Battery Protection Film Test
- Battery Cap test ●
- . Spray test
10
Design Validation Testing
- Animal Study ●
| Test | Purpose | Method | Results |
|---|---|---|---|
| Porcine | |||
| Study I | Assess | ||
| hemostatic | |||
| efficacy and | |||
| safety of the | |||
| device | Design: Endoscopic | ||
| submucosal dissection | |||
| (ESD) based bleeding | |||
| models | |||
| Animals: 6 Nexpowder™ | |||
| treated, 6 Hemospray® | |||
| treated, 3 sham controls | |||
| Duration: 30-day follow- | |||
| up followed by termination | Initial hemostasis was achieved in all | ||
| animals (6/6). None of the animals in the | |||
| treatment group showed re-bleeding up | |||
| to the 30-day follow-up time point. There | |||
| was no gastrointestinal perforation, | |||
| obstruction, or gas embolism caused by | |||
| the device. Histopathological evaluation | |||
| of the device application site did not | |||
| reveal any important histological | |||
| differences between treatment group and | |||
| control group animals. | |||
| Porcine | |||
| Study II | Assess | ||
| hemostatic | |||
| efficacy and | |||
| safety of the | |||
| device | Design: Gastroepiploic | ||
| Artery (Forrest 1a) | |||
| Bleeding Model | |||
| Animals: 6 Nexpowder™ | |||
| treated, 3 Hemospray® | |||
| treated | |||
| Duration: 30-day follow- | |||
| up followed by termination | The rate of achieving initial hemostasis | ||
| was 67% (4/6) in the treatment group. | |||
| None of the animals in the treatment | |||
| group showed re-bleeding up to the 30- | |||
| day follow-up time point. There were no | |||
| gastrointestinal perforation, obstruction, | |||
| and gas embolism which caused by | |||
| device. Histopathological evaluation of | |||
| the device application site did not reveal | |||
| any important histological findings. |
In vivo animal studies have 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 Nexpowder™ (compared to the predicate device) in a porcine model for upper gastrointestinal bleeding control. The results demonstrated that the proposed is substantially equivalent to the predicate.
- Simulation System Test
- Usability Engineering Evaluation
- Clinical data
Real-world evidence of device safety in nonvariceal upper gastrointestinal bleeding in the OUS market was provided, including data from 315 patients with an additional 50 patients from a Retrospective Aggregated Data Collection survey (see table below). Hemostasis was achieved in 94-100% of patients with a re-bleed rate of