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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nexpowder™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which implies that the Nexpowder™ should perform comparably to the predicate for the expanded indications. The reported performance is primarily about showing comparability.

Performance Aspect	Acceptance Criteria (Implied / Indirect)	Reported Device Performance
Hemostasis for lower GI	Comparable safety and effectiveness to the predicate device (Hemospray for lower GI bleeding)	Clinical data from a prospective study and retrospective studies (Korea and EU) for 260 lower GI cases demonstrated results comparable to Hemospray's De-Novo authorization (DEN170015), supporting the lower GI indication expansion.
Overall Safety & Effectiveness	Safety and effectiveness previously established for Nexpowder (K202929) for upper GI, with no new questions of safety/effectiveness arising from changes.	The device's safety and effectiveness (including powder chemical characteristics, delivery method, and energy source) were previously established in K202929. The expanded indication does not alter the intended use, and minor modifications were determined not to significantly affect safety or efficacy.

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

Sample Size: A total of 260 lower GI cases.
Data Provenance: Clinical data was collected:
- Outside the United States (OUS)
- Prospective study conducted in Korea.
- Retrospective studies conducted in Korea.
- Aggregated data collected in the European Union (EU).

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

The document does not specify the number of experts used to establish ground truth for the clinical studies, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience"). It generally refers to "clinical data" without providing these specifics.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with AI vs. without AI assistance. This device is a physical hemostatic device, not an AI/software device, so an MRMC study would generally not be applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as Nexpowder™ is a physical medical device (hemostatic powder and delivery system), not an algorithm or software. There is no "algorithm only" performance to be assessed.

7. Type of Ground Truth Used

The "ground truth" for the clinical studies would be clinical outcomes related to hemostasis of non-variceal gastrointestinal bleeding. This would involve medical assessment of whether bleeding was successfully stopped using the device.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a physical medical device, not an AI/software product, so the concept of a training set as often discussed in AI studies is not applicable here. The "training" for the device would be its prior development and testing, including the clinical data supporting its previous clearance (K202929).

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

As above, the concept of a "training set" in the AI sense is not applicable. For the development and prior clearance (K202929) of Nexpowder, the "ground truth" would have been established through a combination of:

Pre-clinical testing: Laboratory and animal studies to demonstrate the hemostatic properties and safety of the powder and delivery system.
Clinical studies (for K202929): Data from human trials (likely for upper GI bleeding) to establish safety and effectiveness, similar to the type of clinical outcome data described above for the lower GI indication expansion.

Summary

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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.

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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

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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

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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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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

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IV. DEVICE DESCRIPTION

INDICATIONS FOR USE v.

Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.

	Subject DeviceNexpowder	Predicate DeviceHemosprayEndoscopicHemostat(DEN170015)	Reference DeviceNexpowder(K202929)	Comparison
Indicationsfor Use	Nexpowder isused forhemostasis of non-varicealgastrointestinalbleeding	The COOKHemosprayEndoscopicHemostat is usedfor hemostasis ofnon-varicealgastrointestinalbleeding	Nexpowder is usedfor hemostasis ofnon-variceal, uppergastrointestinalbleeding	Identical topredicate device
	Device maincomponents	Hemostaticpowder agent anda delivery system	Hemostatic powderagent and a deliverysystem	Hemostatic powderagent and a deliverysystem	Identical

TECHNOLOGICAL CHARACTERISTICS VI.

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	Subject DeviceNexpowder	Predicate DeviceHemosprayEndoscopicHemostat(DEN170015)	Reference DeviceNexpowder(K202929)	Comparison
Operationprinciple	The powder isdelivered by useof a deliverysystem andthrough a catheterinserted throughthe workingchannel of anendoscope whichprovides access tothe site of thebleeding	The powder isdelivered by use ofa delivery systemand through acatheter insertedthrough theworking channel ofan endoscopewhich providesaccess to the site ofthe bleeding	The powder isdelivered by use ofa delivery systemand through acatheter insertedthrough theworking channel ofan endoscopewhich providesaccess to the site ofthe bleeding	Identical
Powder mainchemicalcomposition	• Succinicanhydride (ε-poly-L-lysine)• Aldehydeddextran	• Sodiumbentonite	• Succinicanhydride (ε-poly-L-lysine)• Aldehydeddextran	Different frompredicate device
Delivery method	Powder propelledby battery power	Powder propelledby CO2	Powder propelledby battery power	Different frompredicate 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.

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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.

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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.

Regulation Number and Section

§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.

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