(171 days)
The NAJA Gastrointestinal Balloon Catheter is intended to administer contrast medium to the small intestine.
The NAJA Gastrointestinal Balloon Catheter ("NAJA device") is a single-use, single-operator, over the-wire, double balloon catheter that is compatible with 0.035" guidewires. The device is introduced orally and designed for temporary occlusion of the gastrointestinal (GI) lumen (small intestine), allowing infusion of fluids for enteroclysis studies (i.e., imaging tests of the small intestine). The device is designed to fit inside the working channel of a gastroscope and reaches its intended location by tracking over a 0.035" guidewire.
The NAJA device features a separate hub connector that is attachable and detachable from the catheter. This feature allows removal of the gastroscope from the catheter once the balloons are in the correct location and before the hub connector is attached for balloon inflation and infusion of fluids into the GI lumen. The hub connector is supplied with 1-way stopcocks on the inflation and infusion ports. The NAJA device is also provided with a 30cc syringe for balloon inflation and infusion of fluids. The balloons are inflated independently using air.
Here's a breakdown of the acceptance criteria and study information for the NAJA Gastrointestinal Balloon Catheter, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary details various design verification tests. The "Specification" column represents the acceptance criteria, and the "Test Result" column indicates if the device met that criterion (mostly "Pass" or a specific measurement).
| Design Verification Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity Study | No evidence of causing cell lysis or toxicity; grade less than 2 (mild reactivity) per ISO 10993-5:2009. | Pass |
| ISO Intracutaneous Study | Difference between test article extract overall mean score and corresponding control extract overall mean score was 0.0 per ISO 10993-23:2021. | Pass |
| ISO Maximization Sensitization Study | No evidence of causing delayed dermal contact sensitization in guinea pig per ISO 10993-10:2021. | Pass |
| Bench and Performance Testing (Package) | ||
| Legibility of Markings | IFU, pouch label, and carton label are legible. | Pass |
| Seal Width | Pouch seal width is ≥ 0.19". | Pass |
| Pouch Seal Visual Inspection | Pouch seals are free of channels or other damages that could impair sterility. | Pass |
| Bubble Emission Test | No evidence of leakage through any surface of pouch. | Pass |
| Pouch Seal Strength | Pouch seal can withstand a force ≥ 3.35N over a seal length of 25.4mm. | Pass |
| Pouch Ease of Opening | Pouch is easily opened with gloved hands, while keeping internal contents stable. Components inside pouch are easily removable from backboard. | Pass |
| Bench and Performance Testing (Component & Device) | ||
| Component Visual Inspection | Device components are free of damages that could affect performance of product (kinks, cracks, separated components, etc.). | Pass |
| Surface Defects | All surfaces and open channels of device are free of loose foreign matter, pores, cracks, and remainders of tooling agents. | Pass |
| Atraumatic Tip | Distal tip is smooth, rounded, and free from sharp edges. | Pass |
| Atraumatic Infusion Holes | Infusion holes are smooth and free from sharp edges. | Pass |
| Radiopaque Markers | Five (5) markers are present on device. | Pass |
| 0.035" GW Loading - Front/Back | Device accommodates front- and back-loading of a 0.035" GW. | Pass |
| Proximal Extrusion Dimensions | Dimensions suitable for insertion into hub connector. | Pass |
| 10.5Fr Channel Compatibility | Distal 30cm of device fits through a 10.5Fr channel. | Pass |
| Working Length | Device working length is 2360 ± 20mm. | Pass |
| Tip Length | Tip length is 20 ± 2mm. | Pass |
| Scaffold Length | Scaffold length is 120 ± 2mm. | Pass |
| Catheter Outer Diameter | Outer diameter is ≤ 3.5mm for the catheter shaft, balloon welds, distal tip. | Pass |
| Simulated Use Testing | ||
| Number of Balloons and Size | Device has two balloons that can be inflated to a diameter of 50mm. | Pass |
| Hub Connector Detachability | Hub connector is detachable from device and can be attached for fluid delivery. | Pass |
| Shaft Insertion Feature | Shaft marker is no longer visible once inserted into hub connector. | Pass |
| Gastroscope Compatibility | Device fits through working channel of gastroscope. | Pass (implied, as other aspects of simulated use passed) |
| Simulated Use Testing | The device remains functional throughout the lifecycle of one clinical procedure. | Pass (implied, as other aspects of simulated use passed) |
| Unique Hub Connector Identification | Proximal terminations of hub assembly are appropriately identified. | Pass (implied, as other aspects of simulated use passed) |
| Legibility of Device Markings | Wording on hub assembly labels is legible. | Pass (implied, as other aspects of simulated use passed) |
| Functional Testing | ||
| Hub Connector and Hub Assembly Pressure | Pressure decay specification is met. | Pass |
| Balloon Pressure and Crosstalk | Pressure decay specification is met. | Pass |
| Balloon OD/L Ratio – unconfined | Unconfined balloon shape specification is met. | Pass |
| Balloon Diameter and Inflation Volume Relationship | Relationship between balloon diameter and inflation volume shall be determined. | Balloon Compliance: 9mL @ 20mm OD, 20mL @ 30mm OD, 44mL @ 40mm OD, 76mL @ 50mm (MAX) |
| Balloon OD/L Ratio – confined | Confined balloon shape specification is met. | Pass |
| Inflation Time | Injection of 30mL of air in ≤ 4s. | Pass |
| Deflation Time | Removal of 30mL of air in ≤ 17s. | Pass |
| Infusion Time | Infusion of 30mL of water in ≤ 19s. | Pass |
| Channel Occlusion | Device is able to occlude channels 20-50mm. | Pass |
| Destructive Testing | ||
| Rated Burst Volume | Balloons have a rated burst volume (RBV) ≥ 81.5mL. | Pass |
| Bend Radius | No shaft kink and/or fracture when wrapped 180° around a 20mm bend radius. | Pass |
| Shaft Buckling Force | Shaft buckle force specification is met. | Pass |
| Hub to Shaft Slip Force | Hub connector slip force specification is met. | Pass |
| Tensile – Proximal Shaft to Extrusion | Tensile force of proximal shaft to extrusion is ≥ 15N. | Pass |
| Tensile - Distal Shaft to Extrusion | Tensile force of distal shaft to extrusion is ≥ 15N. | Pass |
| Tensile - Extrusion at Scaffold | Tensile force of scaffold shall be ≥ 15N. | Pass |
| Shear – Balloon Distal Neck | Shear force of distal balloon neck to extrusion bond is ≥ 15N. | Pass |
| Peel - Balloon Proximal Neck | Peel force of proximal balloon neck to extrusion bond is ≥ 15N. | Pass |
| Tensile - Extension Tube to Hub Connector | Tensile force of extension tube to hub connector bond is ≥ 15N. | Pass |
| Tensile - Luer to Extension Tube | Tensile force of luer to extension tube bond is ≥ 15N. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench and performance testing (also referred to as design verification testing), and biocompatibility testing. These are typical for medical device submissions and do not involve human subjects or clinical data in the form of a "test set" from patients.
- Sample Size: Not explicitly stated for each individual bench or biocompatibility test, but device verification testing typically uses a statistically relevant number of samples to ensure robust performance across manufacturing batches.
- Data Provenance: The tests are conducted in a laboratory setting using manufactured devices. There is no information regarding country of origin of data in terms of patient demographics, nor is it retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the type of studies presented here.
- The studies are engineering and laboratory tests (bench, performance, and biocompatibility). They do not involve interpretation of medical images or patient data that would require "experts" to establish "ground truth" in a clinical context. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., ISO, internal design specifications).
4. Adjudication Method for the Test Set
This question is not applicable. As explained above, there is no "test set" in a clinical or diagnostic sense requiring human adjudication. The results are based on objective measurements against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a physical medical device (catheter), not a diagnostic algorithm or AI-powered device. The studies focus on the physical and functional aspects of the catheter itself, not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is defined by:
- Engineering Specifications: Numerical ranges, physical properties, and functional requirements established during device design and development (e.g., "Pouch seal width is ≥ 0.19"").
- International Standards: Specifically, ISO standards for biocompatibility (e.g., ISO 10993-5, ISO 10993-23, ISO 10993-10).
- Observed Performance: Direct observation of device functionality and integrity (e.g., "Device components are free of damages").
These are objective, measurable criteria, not subjective interpretations requiring clinical ground truth like pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable. The NAJA Gastrointestinal Balloon Catheter is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, there is no "training set" for this type of device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.