NAJA Gastrointestinal Catheter

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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). 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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling {1}------------------------------------------------ (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). 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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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary NAJA Gastrointestinal Balloon Catheter #### Submitter | Name | Chess Medical | |----------------|-----------------------------------------------------------------------------| | Address | 1650 Sherbrooke Street West, Suite 9E<br>Montreal, Quebec H3H 1C9<br>Canada | | 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 {4}------------------------------------------------ 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<br>(Subject Device) | Maglinte Catheter<br>(Predicate Device) | | | |--------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----| | | 510(k) Number | To be assigned | K884379 | | | | | Applicant | Chess Medical | Lafayette Pharmacal | | | | | Classification Regulation;<br>Device Class | 876.5980 (gastrointestinal tube and<br>accessories); class II | 876.5980 (gastrointestinal tube and<br>accessories); class II | | | | | Product Code<br>(Device Type) | FGD<br>(Catheter, Retention, Barium Enema<br>With Bag) | FGD<br>(Catheter, Retention, Barium Enema<br>With Bag) | | | | | Intended Use / Indications for Use | ...intended to administer contrast<br>medium to the small intestine. | ...intended to administer contrast<br>medium 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 compliant<br>balloons for occlusion of the small<br>intestine, followed by infusion of<br>contrast medium in the small<br>intestine, distal to the proximal<br>balloon or in the inter-balloon<br>space. | Inflation of one compliant balloon for<br>occlusion of the small intestine,<br>followed by infusion of contrast<br>medium in the small intestine, distal to<br>the balloon. | | | | | | Method of Delivery | Oral insertion, through a compatible<br>working channel (≥ 3.7 mm) of a<br>gastroscope. | Nasal or oral insertion. | | | Balloons | | | Number of Balloons | Two | One | | | | | Balloon Inflation Media | Air | Air | | | | Balloon Diameter | 20mm - 50mm | 30 mm | | | | | Attribute | NAJA Device<br>(Subject Device) | Maglinte Catheter<br>(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 Marker<br>Bands | Five<br>(1) Distal tip, (4) proximal and<br>distal ends of the two balloons | One<br>(1) Distal tip | | | | | Marker Band Length | Distal tip - 4 mm<br>Proximal/Distal balloon ends – 2 mm | Distal tip - 5 mm | | | | | Marker Band Material | Polyether Block<br>Amide (Pebax®) 5533 SA 01 MED<br>w/ Tungsten 80% | Metallic (material unknown) | | | | | Working Length | 260 cm | 155 cm | | | | | Number of Layers | Two<br>Interior – Multi-Lumen Extrusion<br>Exterior – Braided Shaft Extrusion | One<br>Bi-Lumen Extrusion | | | | | Number of Lumens | Four<br>(1) Guidewire lumen<br>(1) Infusion lumen<br>(2) Individual balloon inflation<br>lumens | Two<br>(1) Guidewire lumen,<br>doubles as infusion lumen<br>(1) Balloon inflation lumen | | | | | Number of Inflation Exit<br>Ports | Two<br>One inflation exit port per balloon | Two<br>Two inflation exit ports to inflate a<br>single balloon | | | | | Number of Infusion Exit<br>Ports | Three<br>In between the two balloons | Four<br>Distal to the single balloon | | | | Shaft | Materials | Interior – Multi-Lumen Extrusion<br>Polyether Block Amide (Pebax®)<br>Exterior – Braided Shaft Extrusion<br>Polyether Block Amide (Pebax®) | Radiopaque Polyvinyl Chloride | | | | | Outer Diameter | Distal 30cm (Multi-Lumen<br>Extrusion)<br>Outer Diameter: 7.5 Fr<br>Proximal 206cm (Braided Shaft<br>Extrusion)<br>Outer Diameter: 10 Fr | Outer Diameter: 13 Fr | | | | | Distal Tip | Open lumen at distal tip,<br>guidewire can advance | Closed distal tip,<br>guidewire cannot advance | | | | | | | | | | | | Proximal End | Enclosed within a removable hub | Enclosed within a permanent hub | | | | | Attribute | NAJA Device<br>(Subject Device) | Maglinte Catheter<br>(Predicate Device) | | | | Proximal Hub | Detachable | Yes<br>Able to attach/detach proximal hub<br>to/from proximal end of shaft | No<br>Permanently fixed to proximal end of<br>shaft | | | | | Number of Ports | Four<br>(1) Guidewire port<br>(1) Infusion port<br>(2) Individual balloon inflation ports | Two<br>(1) Guidewire port, doubles as infusion<br>port<br>(1) Balloon inflation port | | | | | Mechanism to maintain<br>inflation volume | One-way Stopcock | Check Valve | | | | | Guidewire Compatibility | 0.035in | 0.065in | | | #### Comparison of NAJA Device to Maglinte Catheter {5}------------------------------------------------ {6}------------------------------------------------ # Biocompatibility Testing The following biocompatibility testing was performed on the NAJA device. | Biocompatibility<br>Test | Acceptance Criteria<br>Origin | Result | Conclusion | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Cytotoxicity<br>Study Using the<br>ISO Elution<br>Method | ISO 10993-5: 2009,<br>Biological Evaluation of<br>Medical Devices -<br>Part 5: Tests for in vitro<br>cytotoxicity | The test article extract showed no evidence of<br>causing cell lysis or toxicity. The test article<br>extract met the requirements of the test since<br>the grade was less than a grade 2 (mild<br>reactivity). | Pass | | ISO<br>Intracutaneous<br>Study | ISO 10993-23: 2021,<br>Biological Evaluation of<br>Medical Devices -<br>Part 23: Tests for<br>irritation | The test article met the requirements of the<br>test since the difference between each test<br>article extract overall mean score and<br>corresponding control extract overall mean<br>score was 0.0 and 0.0 for the SC and SO test<br>article extracts, respectively. | Pass | | ISO<br>Maximization<br>Sensitization<br>Study | ISO 10993-10: 2021,<br>Biological Evaluation of<br>Medical Devices -<br>Part 10: Tests for skin<br>sensitization | The test article extracts showed no evidence<br>of causing delayed dermal contact<br>sensitization in the guinea pig. The test article<br>was not considered a sensitizer in the guinea<br>pig 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 Visual<br>Inspection | Pouch seals are free of channels or other<br>damages that could impair sterility. | Pass | | Bubble Emission Test | No evidence of leakage through any surface of<br>pouch. | Pass | | Pouch Seal Strength | Pouch seal can withstand a force $\ge$ 3.35N over<br>a seal length of 25.4mm. | Pass | | Pouch Ease of Opening | Pouch is easily opened with gloved hands,<br>while keeping internal contents stable.<br>Components inside pouch are easily<br>removable from backboard. | Pass | | Component Visual<br>Inspection | Device components are free of damages that<br>could affect performance of product, such as:<br>kinks, cracks, separated components, etc. | Pass | | Surface Defects | All surfaces and open channels of device are<br>free of loose foreign matter, pores, cracks, and<br>remainders of tooling agents. | Pass | | Atraumatic Tip | Distal tip is smooth, rounded, and free from<br>sharp edges. | Pass | | Atraumatic Infusion Holes | Infusion holes are smooth and free from sharp<br>edges. | Pass | | Radiopaque Markers | Five (5) markers are present on device. | Pass | | 0.035" GW Loading -<br>Front/Back | Device accommodates front- and back-loading<br>of a 0.035" GW. | Pass | | Proximal Extrusion<br>Dimensions | Dimensions suitable for insertion into hub<br>connector. | Pass | | 10.5Fr Channel<br>Compatibility | Distal 30cm of device fits through a 10.5Fr<br>channel. | 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 catheter<br>shaft, balloon welds, distal tip. | Pass | | Simulated Use | | | | Number of Balloons<br>and Size | Device has two balloons that can be inflated to<br>a diameter of 50mm. | Pass | | Hub Connector<br>Detachability | Hub connector is detachable from device and<br>can be attached for fluid delivery. | Pass | | Shaft Insertion Feature | Shaft marker is no longer visible once inserted<br>into hub connector. | Pass | {7}------------------------------------------------ {8}------------------------------------------------ | Design Verification Test | Specification | Test Result | | | | | | | | | | | | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--| | Gastroscope Compatibility | Device fits through working channel of<br>gastroscope. | | | | | | | | | | | | | | Simulated Use Testing | The device remains functional throughout the<br>lifecycle of one clinical procedure. | | | | | | | | | | | | | | Unique Hub Connector<br>Identification | Proximal terminations of hub assembly are<br>appropriately identified. Proximal<br>terminations of the hub assembly are<br>appropriately identified. | | | | | | | | | | | | | | Legibility of Device<br>Markings | Wording on hub assembly labels is legible. | | | | | | | | | | | | | | Functional Testing | | | | | | | | | | | | | | | Hub Connector and Hub<br>Assembly Pressure | Pressure decay specification is met. | Pass | | | | | | | | | | | | | Balloon Pressure and<br>Crosstalk | Pressure decay specification is met. | Pass | | | | | | | | | | | | | Balloon OD/L Ratio –<br>unconfined | Unconfined balloon shape specification is met. | Pass | | | | | | | | | | | | | Balloon Diameter and<br>Inflation Volume<br>Relationship | Relationship between balloon diameter and<br>inflation volume shall be determined. | Balloon ComplianceVolume [mL]OD [mm]920203044407650 (MAX) | | | | | | | | | | | | | Balloon OD/L Ratio –<br>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)<br>$\ge$ 81.5mL. | Pass | | | | | | | | | | | | | Bend Radius | No shaft kink and/or fracture when wrapped<br>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<br>Extrusion | Tensile force of proximal shaft to extrusion is<br>$\ge$ 15N. | Pass | | | | | | | | | | | | | Tensile - Distal Shaft to<br>Extrusion | Tensile force of distal shaft to extrusion is<br>$\ge$ 15N. | Pass | | | | | | | | | | | | {9}------------------------------------------------ | Design Verification Test | Specification | Test Result | |----------------------------------------------|--------------------------------------------------------------------|-------------| | Tensile -Extrusion at<br>Scaffold | Tensile force of scaffold shall be ≥ 15N. | Pass | | Shear – Balloon Distal Neck | Shear force of distal balloon neck to extrusion<br>bond is ≥ 15N. | Pass | | Peel - Balloon Proximal<br>Neck | Peel force of proximal balloon neck to<br>extrusion bond is ≥ 15N. | Pass | | Tensile - Extension Tube to<br>Hub Connector | Tensile force of extension tube to hub<br>connector bond is ≥ 15N. | Pass | | Tensile - Luer to Extension<br>Tube | Tensile force of luer to extension tube bond is<br>≥ 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).