(230 days)
No
The summary describes a powder and delivery system for hemostasis, with no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the physical properties and delivery of the powder.
Yes
The device is used for hemostasis (stopping bleeding), which is a therapeutic intervention for nonvariceal gastrointestinal bleeding.
No
The device is used for hemostasis (stopping bleeding), which is a treatment, not a diagnostic purpose.
No
The device description explicitly states it includes a powder, a delivery system with a spray body, connector, and delivery catheter, which are all hardware components.
Based on the provided text, the Nexpowder device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemostasis of nonvariceal gastrointestinal bleeding." This is a therapeutic intervention performed in vivo (within the body) to stop bleeding.
- Device Description: The description details a powder delivered through an endoscope to a target site within the gastrointestinal tract. This is a direct treatment applied to the patient's tissue.
- Mechanism of Action: While not explicitly stated in detail, the mechanism is clearly related to stopping bleeding in vivo at the site of the hemorrhage.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Nexpowder is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
Nexpowder™ is used for hemostasis of nonvariceal gastrointestinal bleeding.
Product codes
QAU
Device Description
The Nexpowder is used for hemostasis of non-variceal gastrointestinal bleeding. It is a prescription only, single-use device provided with a powder pre-packaged in a vial, and a delivery system, which consists of a spray body, a connector and a delivery catheter is inserted through an endoscope's working channel to deliver the powder to the intended hemostasis target site. Nexpowder is almost identical to the currently marketed device (K202929) and has the same technological characteristics and mechanism of action, but differs in the indications for use, where the subject device is also indicated for lower GI bleeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nonvariceal 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)
The company collected clinical data outside the United States (OUS) in support of the lower GI indication expansion. Clinical data was gathered from a prospective study and retrospective studies conducted in Korea, in addition to aggregated data collected in the European Union (EU). A total sample size of 260 lower GI cases were collected and analyzed. Results were compared to the predicate device- Hemospray. The results of Nexpowder were found to be comparable with that of Hemospray as presented in its De-Novo authorization (DEN170015), further supporting Nexpowder indication expansion to the lower GI.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2024
Nextbiomedical Co., Ltd. % Gali Shrieber Senior Regulatory Affairs Specialist Covidien llc. 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K240994
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: April 11, 2024 Received: October 28, 2024
Dear Gali Shrieber:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Tek N.
Digitally signed by
Tek N. Lamichhane -S
Lamichhane -S Date: 2024.11.27
10:36:14-05'00'
Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240994
Device Name Nexpowder™
Indications for Use (Describe) Nexpowder™ is used for hemostasis of nonvariceal gastrointestinal bleeding.
| Type of Use (Select one or both, as applicable) | |
|---|---|
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4
510(k) SUMMARY (K240994) NextBiomedical CO., LTD. Nexpowder™
I. SUBMITTER
| Submitter Name and Address: | NEXTBIOMEDICAL CO., LTD. |
|---|---|
| 6 Venture-ro 100 beon-gil, Yeonsu-gu | |
| Incheon, 22013 | |
| Republic of Korea | |
| Correspondent Information: | Covidien llc. |
| 15 Hampshire Street | |
| MA, 02048 | |
| USA | |
| Contact person: | Gali Shrieber |
| Senior Regulatory Affairs Specialist | |
| gali.shrieber@medtronic.com | |
| Phone: | 972-73-2501577 |
| Date prepared: | November 26, 2024 |
| II. | DEVICE |
| Name of Device: | Nexpowder |
| Device Common Name: | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Classification: | Class II |
| Regulation 21 CFR 878.4456 Hemostatic device for | |
| intraluminal gastrointestinal use | |
| Product Code: QAU |
PREDICATE DEVICE(S) III.
Hemospray® Endoscopic Hemostat (DEN170015) - Predicate device Nexpowder (K202929) - Reference device
5
IV. DEVICE DESCRIPTION
The Nexpowder is used for hemostasis of non-variceal gastrointestinal bleeding. It is a prescription only, single-use device provided with a powder pre-packaged in a vial, and a delivery system, which consists of a spray body, a connector and a delivery catheter is inserted through an endoscope's working channel to deliver the powder to the intended hemostasis target site. Nexpowder is almost identical to the currently marketed device (K202929) and has the same technological characteristics and mechanism of action, but differs in the indications for use, where the subject device is also indicated for lower GI bleeding.
INDICATIONS FOR USE v.
Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
| | Subject Device
Nexpowder | Predicate Device
Hemospray
Endoscopic
Hemostat
(DEN170015) | Reference Device
Nexpowder
(K202929) | Comparison | |
|------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------|
| Indications
for Use | Nexpowder is
used for
hemostasis of non-
variceal
gastrointestinal
bleeding | The COOK
Hemospray
Endoscopic
Hemostat is used
for hemostasis of
non-variceal
gastrointestinal
bleeding | Nexpowder is used
for hemostasis of
non-variceal, upper
gastrointestinal
bleeding | Identical to
predicate device | |
| | Device main
components | Hemostatic
powder agent and
a delivery system | Hemostatic powder
agent and a delivery
system | Hemostatic powder
agent and a delivery
system | Identical |
TECHNOLOGICAL CHARACTERISTICS VI.
6
| | Subject Device
Nexpowder | Predicate Device
Hemospray
Endoscopic
Hemostat
(DEN170015) | Reference Device
Nexpowder
(K202929) | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Operation
principle | The powder is
delivered by use
of a delivery
system and
through a catheter
inserted through
the working
channel of an
endoscope which
provides access to
the site of the
bleeding | The powder is
delivered by use of
a delivery system
and through a
catheter inserted
through the
working channel of
an endoscope
which provides
access to the site of
the bleeding | The powder is
delivered by use of
a delivery system
and through a
catheter inserted
through the
working channel of
an endoscope
which provides
access to the site of
the bleeding | Identical |
| Powder main
chemical
composition | • Succinic
anhydride (ε-
poly-L-lysine)
• Aldehyded
dextran | • Sodium
bentonite | • Succinic
anhydride (ε-
poly-L-lysine)
• Aldehyded
dextran | Different from
predicate device |
| Delivery method | Powder propelled
by battery power | Powder propelled
by CO2 | Powder propelled
by battery power | Different from
predicate device |
Nexpowder and the primary predicate
Nexpowder and Hemospray (DEN170015) have similar technological characteristics and mechanism of action. In both devices, the powder is delivered using a delivery system and a catheter inserted through the working channel of an endoscope, allowing access to the targeted site for hemostasis.
The main difference in technological characteristics is the composition of the hemostatic powder. Nexpowder contains mainly Aldehyded Dextran and Poly-L-Lysine (Polysaccharide), while the predicate is composed of proprietary components and bentonite powder. Even though the hemostatic agent of Nexpowder differs from the predicate device in chemical composition, it does not raise different questions of safety and effectiveness.
7
In terms of Principles of operation. Nexpowder and the predicate device, Hemospray, differ in the delivery method and energy source that provides the physical force to move the hemostatic powder agent into the delivery catheter.
The Hemospray includes a handle with a pressurized CO2 cartridge and the powder is propelled through the catheter by release of CO2 from the cartridge located in the device.
The Nexpowder hemostatic agent is deployed by insoluble air propellant. It utilizes a pre-installed battery as its power source, allowing air pressure generated from the air pump in the delivery system's spray body to provide effective physical force to move the powder into the delivery catheter.
The air-powered mechanism of Nexpowder results in low-pressure, controlled delivery of material with minimal particle scattering or loss of visualization. Other than the air pressure itself, no mechanical force or direct contact is made with the target hemostasis site during the delivery process of Nexpowder.
Nexpowder and reference device
Nexpowder is technologically identical to the reference device (Nexpowder cleared in K202929). The overall design, materials, chemical composition, and energy source of Nexpowder have not been modified since cleared by the agency.
The only difference from the cleared device is the expansion of indications to the lower GI and several minor device modifications that were assessed by the company and determined to not significantly affect the safety or efficacy of the device.
PERFORMANCE DATA VII.
The company collected clinical data outside the United States (OUS) in support of the lower GI indication expansion. Clinical data was gathered from a prospective study and retrospective studies conducted in Korea, in addition to aggregated data collected in the European Union (EU). A total sample size of 260 lower GI cases were collected and analyzed. Results were compared to the predicate device- Hemospray. The results of Nexpowder were found to be comparable with that of Hemospray as presented in its De-Novo authorization (DEN170015), further supporting Nexpowder indication expansion to the lower GI.
8
All other pre-clinical testing in support of Nexpowder was leveraged from the previously cleared Nexpowder device, cleared under K202929.
CONCLUSIONS VIII.
Nexpowder has the same intended use and indications for use as the predicate device- Hemosprav (DEN170015). The two devices differ in the powder chemical characteristics, delivery method and energy source, but those differences do not raise different questions of safety and effectiveness, as the safety and effectiveness of Nexpowder powder and device design were already established in K202929.
The Nexpowder has the same intended use, technological characteristics, and principles of operation as its reference device (K202929). The expanded indication does not alter the intended use of the device. The safety and effectiveness of the device in the lower GI was established by clinical data and is further supported by comparing Nexpowder data to that of the predicate device, Hemospray, already cleared for the lower GI.