(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.
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June 16, 2023
Chess Medical Inc. % Christopher Sloan President Sloan Regulatory Consulting 322 Hart Road Gaithersburg, MD 20878
Re: K223890
Trade/Device Name: NAJA Gastrointestinal Catheter Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: FGD Dated: May 16, 2023 Received: May 16, 2023
Dear Christopher Sloan:
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/cdrl/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
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(21 CFR Part 801); medical device reporting (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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-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,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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)
K223890
Device Name NAJA Gastrointestinal Balloon Catheter
Indications for Use (Describe)
The NAJA Gastrointestinal Balloon Catheter is intended to administer contrast medium to the small intestine.
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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510(k) Summary NAJA Gastrointestinal Balloon Catheter
Submitter
| Name | Chess Medical |
|---|---|
| Address | 1650 Sherbrooke Street West, Suite 9EMontreal, Quebec H3H 1C9Canada |
| Contact Person | Dr. Yen-I Chen |
| Phone | (514) 291-3154 |
| Email Address | cyen33@gmail.com |
| Date Prepared | December 23, 2022 |
Device
| Trade Name | NAJA Gastrointestinal Balloon Catheter |
|---|---|
| Common Name | Gastrointestinal Balloon Catheter |
| Classification Name | Gastrointestinal Tube and Accessories |
| Classification Number | 21 CFR 876.5980 |
| Product Code | FGD |
| Regulatory Class | II |
Predicate Device
| Name [510(k) Number] | Maglinte Enteroclysis Balloon Catheter [K884379] |
|---|---|
| ---------------------- | -------------------------------------------------- |
Device Description
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
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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.
Indications for Use
The NAJA Gastrointestinal Balloon Catheter is intended to administer contrast medium to the small intestine.
Comparison of Intended Use and Technological Characteristics with the Predicate Device
The proposed NAJA device has the same intended use and similar technological characteristics as the Maglinte Enteroclysis Balloon Catheter ("Maglinte Catheter"). The differences in the design between the devices do not raise different questions of safety and effectiveness. The table below summarizes the comparison between the NAJA device and Maglinte Catheter.
| Attribute | NAJA Device(Subject Device) | Maglinte Catheter(Predicate Device) | |||
|---|---|---|---|---|---|
| 510(k) Number | To be assigned | K884379 | |||
| Applicant | Chess Medical | Lafayette Pharmacal | |||
| Classification Regulation;Device Class | 876.5980 (gastrointestinal tube andaccessories); class II | 876.5980 (gastrointestinal tube andaccessories); class II | |||
| Product Code(Device Type) | FGD(Catheter, Retention, Barium EnemaWith Bag) | FGD(Catheter, Retention, Barium EnemaWith Bag) | |||
| Intended Use / Indications for Use | ...intended to administer contrastmedium to the small intestine. | ...intended to administer contrastmedium to the small intestine. | |||
| Sterile / Single Use | Yes | Yes | |||
| Sterilization Method | Sterile (Ethylene Oxide) | Sterile (Ethylene Oxide) | |||
| Principle of Operation | Inflation of one or two compliantballoons for occlusion of the smallintestine, followed by infusion ofcontrast medium in the smallintestine, distal to the proximalballoon or in the inter-balloonspace. | Inflation of one compliant balloon forocclusion of the small intestine,followed by infusion of contrastmedium in the small intestine, distal tothe balloon. | |||
| Method of Delivery | Oral insertion, through a compatibleworking channel (≥ 3.7 mm) of agastroscope. | Nasal or oral insertion. | |||
| Balloons | Number of Balloons | Two | One | ||
| Balloon Inflation Media | Air | Air | |||
| Balloon Diameter | 20mm - 50mm | 30 mm | |||
| Attribute | NAJA Device(Subject Device) | Maglinte Catheter(Predicate Device) | |||
| Balloon Length | 36 mm – 48 mm | 28 mm | |||
| Inflation Volume | 8 ml – 76 ml | 15 ml | |||
| Balloon Material | Polyurethane | Latex | |||
| Marker Bands | Number of MarkerBands | Five(1) Distal tip, (4) proximal anddistal ends of the two balloons | One(1) Distal tip | ||
| Marker Band Length | Distal tip - 4 mmProximal/Distal balloon ends – 2 mm | Distal tip - 5 mm | |||
| Marker Band Material | Polyether BlockAmide (Pebax®) 5533 SA 01 MEDw/ Tungsten 80% | Metallic (material unknown) | |||
| Working Length | 260 cm | 155 cm | |||
| Number of Layers | TwoInterior – Multi-Lumen ExtrusionExterior – Braided Shaft Extrusion | OneBi-Lumen Extrusion | |||
| Number of Lumens | Four(1) Guidewire lumen(1) Infusion lumen(2) Individual balloon inflationlumens | Two(1) Guidewire lumen,doubles as infusion lumen(1) Balloon inflation lumen | |||
| Number of Inflation ExitPorts | TwoOne inflation exit port per balloon | TwoTwo inflation exit ports to inflate asingle balloon | |||
| Number of Infusion ExitPorts | ThreeIn between the two balloons | FourDistal to the single balloon | |||
| Shaft | Materials | Interior – Multi-Lumen ExtrusionPolyether Block Amide (Pebax®)Exterior – Braided Shaft ExtrusionPolyether Block Amide (Pebax®) | Radiopaque Polyvinyl Chloride | ||
| Outer Diameter | Distal 30cm (Multi-LumenExtrusion)Outer Diameter: 7.5 FrProximal 206cm (Braided ShaftExtrusion)Outer Diameter: 10 Fr | Outer Diameter: 13 Fr | |||
| Distal Tip | Open lumen at distal tip,guidewire can advance | Closed distal tip,guidewire cannot advance | |||
| Proximal End | Enclosed within a removable hub | Enclosed within a permanent hub | |||
| Attribute | NAJA Device(Subject Device) | Maglinte Catheter(Predicate Device) | |||
| Proximal Hub | Detachable | YesAble to attach/detach proximal hubto/from proximal end of shaft | NoPermanently fixed to proximal end ofshaft | ||
| Number of Ports | Four(1) Guidewire port(1) Infusion port(2) Individual balloon inflation ports | Two(1) Guidewire port, doubles as infusionport(1) Balloon inflation port | |||
| Mechanism to maintaininflation volume | One-way Stopcock | Check Valve | |||
| Guidewire Compatibility | 0.035in | 0.065in |
Comparison of NAJA Device to Maglinte Catheter
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Biocompatibility Testing
The following biocompatibility testing was performed on the NAJA device.
| BiocompatibilityTest | Acceptance CriteriaOrigin | Result | Conclusion |
|---|---|---|---|
| CytotoxicityStudy Using theISO ElutionMethod | ISO 10993-5: 2009,Biological Evaluation ofMedical Devices -Part 5: Tests for in vitrocytotoxicity | The test article extract showed no evidence ofcausing cell lysis or toxicity. The test articleextract met the requirements of the test sincethe grade was less than a grade 2 (mildreactivity). | Pass |
| ISOIntracutaneousStudy | ISO 10993-23: 2021,Biological Evaluation ofMedical Devices -Part 23: Tests forirritation | The test article met the requirements of thetest since the difference between each testarticle extract overall mean score andcorresponding control extract overall meanscore was 0.0 and 0.0 for the SC and SO testarticle extracts, respectively. | Pass |
| ISOMaximizationSensitizationStudy | ISO 10993-10: 2021,Biological Evaluation ofMedical Devices -Part 10: Tests for skinsensitization | The test article extracts showed no evidenceof causing delayed dermal contactsensitization in the guinea pig. The test articlewas not considered a sensitizer in the guineapig maximization test. | Pass |
Bench and Performance Testing
The following bench and performance testing were conducted on the NAJA device.
| Design Verification Test | Specification | Test Result |
|---|---|---|
| Package Performance Testing | ||
| Legibility of Markings | IFU, pouch label, and carton label are legible. | Pass |
| Design Verification Test | Specification | Test Result |
| Seal Width | Pouch seal width is $\ge$ 0.19". | Pass |
| Pouch Seal VisualInspection | Pouch seals are free of channels or otherdamages that could impair sterility. | Pass |
| Bubble Emission Test | No evidence of leakage through any surface ofpouch. | Pass |
| Pouch Seal Strength | Pouch seal can withstand a force $\ge$ 3.35N overa 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 easilyremovable from backboard. | Pass |
| Component VisualInspection | Device components are free of damages thatcould affect performance of product, such as:kinks, cracks, separated components, etc. | Pass |
| Surface Defects | All surfaces and open channels of device arefree of loose foreign matter, pores, cracks, andremainders of tooling agents. | Pass |
| Atraumatic Tip | Distal tip is smooth, rounded, and free fromsharp edges. | Pass |
| Atraumatic Infusion Holes | Infusion holes are smooth and free from sharpedges. | Pass |
| Radiopaque Markers | Five (5) markers are present on device. | Pass |
| 0.035" GW Loading -Front/Back | Device accommodates front- and back-loadingof a 0.035" GW. | Pass |
| Proximal ExtrusionDimensions | Dimensions suitable for insertion into hubconnector. | Pass |
| 10.5Fr ChannelCompatibility | Distal 30cm of device fits through a 10.5Frchannel. | Pass |
| Working Length | Device working length is 2360 $\pm$ 20mm. | Pass |
| Tip Length | Tip length is 20 $\pm$ 2mm. | Pass |
| Scaffold Length | Scaffold length is 120 $\pm$ 2mm. | Pass |
| Catheter Outer Diameter | Outer diameter is $\le$ 3.5mm for the cathetershaft, balloon welds, distal tip. | Pass |
| Simulated Use | ||
| Number of Balloonsand Size | Device has two balloons that can be inflated toa diameter of 50mm. | Pass |
| Hub ConnectorDetachability | Hub connector is detachable from device andcan be attached for fluid delivery. | Pass |
| Shaft Insertion Feature | Shaft marker is no longer visible once insertedinto hub connector. | Pass |
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| Design Verification Test | Specification | Test Result | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gastroscope Compatibility | Device fits through working channel ofgastroscope. | ||||||||||||
| Simulated Use Testing | The device remains functional throughout thelifecycle of one clinical procedure. | ||||||||||||
| Unique Hub ConnectorIdentification | Proximal terminations of hub assembly areappropriately identified. Proximalterminations of the hub assembly areappropriately identified. | ||||||||||||
| Legibility of DeviceMarkings | Wording on hub assembly labels is legible. | ||||||||||||
| Functional Testing | |||||||||||||
| Hub Connector and HubAssembly Pressure | Pressure decay specification is met. | Pass | |||||||||||
| Balloon Pressure andCrosstalk | Pressure decay specification is met. | Pass | |||||||||||
| Balloon OD/L Ratio –unconfined | Unconfined balloon shape specification is met. | Pass | |||||||||||
| Balloon Diameter andInflation VolumeRelationship | Relationship between balloon diameter andinflation volume shall be determined. | Balloon ComplianceVolume [mL]OD [mm]920203044407650 (MAX) | |||||||||||
| Balloon OD/L Ratio –confined | Confined balloon shape specification is met. | Pass | |||||||||||
| Inflation Time | Injection of 30mL of air in $\le$ 4s. | Pass | |||||||||||
| Deflation Time | Removal of 30mL of air in $\le$ 17s. | Pass | |||||||||||
| Infusion Time | Infusion of 30mL of water in $\le$ 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)$\ge$ 81.5mL. | Pass | |||||||||||
| Bend Radius | No shaft kink and/or fracture when wrapped180° 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 toExtrusion | Tensile force of proximal shaft to extrusion is$\ge$ 15N. | Pass | |||||||||||
| Tensile - Distal Shaft toExtrusion | Tensile force of distal shaft to extrusion is$\ge$ 15N. | Pass |
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| Design Verification Test | Specification | Test Result |
|---|---|---|
| Tensile -Extrusion atScaffold | Tensile force of scaffold shall be ≥ 15N. | Pass |
| Shear – Balloon Distal Neck | Shear force of distal balloon neck to extrusionbond is ≥ 15N. | Pass |
| Peel - Balloon ProximalNeck | Peel force of proximal balloon neck toextrusion bond is ≥ 15N. | Pass |
| Tensile - Extension Tube toHub Connector | Tensile force of extension tube to hubconnector bond is ≥ 15N. | Pass |
| Tensile - Luer to ExtensionTube | Tensile force of luer to extension tube bond is≥ 15N. | Pass |
Conclusions
The NAJA Gastrointestinal Balloon Catheter (subject device) is substantially equivalent to the legally marketed Maglinte Enteroclysis Balloon Catheter (predicate device) for administering contrast medium to the small intestine. The two devices have intended use and similar technological characteristics. The differences in the design between the devices do not raise different questions of safety and effectiveness. The results of biocompatibility testing confirm that the materials of construction of the NAJA device are safe, and the results of bench and performance (design verification) testing demonstrate that the NAJA device can function adequately in accordance with its intended use.
Chess Medical Inc. concludes that the NAJA Gastrointestinal Balloon Catheter (subject device) is substantially equivalent to the Maglinte Enteroclysis Balloon Catheter (predicate 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.