(175 days)
This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.
According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.
Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.
The provided FDA 510(k) summary for the "Single-use Balloon Dilatation Catheter" (K241888) details a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than an AI/ML software performance study. Therefore, most of the requested information regarding AI/ML device acceptance criteria, human reader studies, and ground truth establishment for AI/ML models is not applicable to this document.
The document describes performance testing for a physical medical device. Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide a specific table detailing the exact quantitative acceptance criteria for each test and the corresponding measured performance values. It lists the types of tests performed.
| Test Category | Acceptance Criteria (Generic Statement) | Reported Device Performance (Generic Statement) |
|---|---|---|
| Dimension Test | Met predefined dimensional specifications | Met specifications |
| Appearance | Conformed to visual quality standards | Conformed to standards |
| Compatibility Test | Compatible with intended accessories/systems | Demonstrated compatibility |
| Delivery and Retrieval Force | Within acceptable force limits for safe delivery/retrieval | Met force limits |
| Peak Tensile Force | Withstood specified tensile forces without failure | Withstood forces |
| Burst Pressure | Withstood specified internal pressures without bursting | Met burst pressure requirements |
| Kink Stability | Demonstrated resistance to kinking | Demonstrated good kink stability |
| Corrosion Resistance Test | Resisted corrosion in specified environments | Showed resistance to corrosion |
| Air Leakage | No detectable air leakage at specified pressures | No air leakage detected |
| Liquid Leakage | No detectable liquid leakage at specified pressures | No liquid leakage detected |
| Luer Connector | Conformed to ISO 80369-7 standards for luer connectors | Complied with ISO 80369-7 |
| Radiopacity | Met ASTM F640-20 standards for radiopacity | Complied with ASTM F640-20 |
| Balloon Burst Pressure | Withstood specified pressures before rupturing | Met burst pressure requirements |
| Balloon Compliance | Exhibited expected compliance characteristics | Demonstrated expected compliance |
| Balloon Deflation Time | Deflated within specified time limits | Deflated within limits |
| Balloon Fatigue | Withstood specified fatigue cycles without failure | Passed fatigue testing |
| Sterilization (SAL) | SAL of 10^-6 (ISO 11135:2014) | Achieved 10^-6 SAL |
| EO & ECH Residuals | Below limits specified in ISO 10993-7:2008 | Below specified limits |
| Bacterial Endotoxins | Below 20 EU/device (USP <85>) | Below 20 EU/device |
| Shelf-life | Demonstrated performance for proposed 3-year shelf-life (ASTM F1980-16) | Validated 3-year shelf-life |
| Package Integrity (Visual Insp.) | Conform to ASTM F1886/F1886M-16 | Conformed |
| Package Integrity (Seal Strength) | Conform to ASTM F88/F88-21 | Conformed |
| Package Integrity (Dye Penetration) | Conform to ASTM F1929-15 | Conformed |
| Biocompatibility (Cytotoxicity) | No cytotoxicity (ISO 10993-5:2009) | No cytotoxicity |
| Biocompatibility (Sensitization) | No sensitization (ISO 10993-10:2021) | No sensitization |
| Biocompatibility (Intracutaneous Reactivity) | No intracutaneous reactivity (ISO 10993-10:2021) | No intracutaneous reactivity |
| Biocompatibility (Systemic Toxicity) | No acute systemic toxicity (ISO 10993-11:2017) | No acute systemic toxicity |
| Biocompatibility (Pyrogen) | No pyrogen (USP<151>) | No pyrogen |
2. Sample sizes used for the test set and data provenance:
The document states "The performance testing conducted on subject device and predicate device are listed below." and mentions "ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices". This suggests that standard device testing sample sizes were used in accordance with this guideline, but the specific sample sizes for each test are not explicitly stated in this summary.
Data provenance: This is a physical device, so "data provenance" would refer to the testing conditions and results. The tests were performed in a lab setting to verify design specifications and compliance with international standards (e.g., ISO, ASTM, USP). The country of origin for the testing is not specified, but the applicant company is Leo Medical Co., Ltd. in China. The data is prospective as it's generated through device testing.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This question is not applicable as this is a physical device performance study, not a study involving human reader interpretation of images or AI/ML model output requiring "ground truth" established by experts in a clinical context. The "ground truth" for these tests are the physical measurements and compliance with engineering and material standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's a physical device performance study. Adjudication methods are typically for clinical consensus on ground truth in image interpretation or diagnosis, not for engineering performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. No MRMC study was performed as this is not an AI/ML-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this physical device, the "ground truth" for the non-clinical tests is based on established engineering and material science standards, measurements, and pre-defined acceptance criteria. For example, burst pressure is measured against a standard, biocompatibility is assessed against ISO 10993, and sterility against ISO 11135.
8. The sample size for the training set:
This is not applicable. No training set was used as this is a physical device, not an AI/ML model being "trained."
9. How the ground truth for the training set was established:
This is not applicable. No training set was used.
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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.
December 20, 2024
Leo Medical Co., Ltd. % Diana Hong Official Correspondent Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, Shanghai 200120 China
Re: K241888
Trade/Device Name: Single-use Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: November 25, 2024 Received: November 25, 2024
Dear Diana Hong:
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,
Anthony Lee -S
Anthony Lee, 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
Submission Number (if known)
Device Name
Single-use Balloon Dilatation Catheter
Indications for Use (Describe)
This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K241888
-
- Date of Preparation: 06/21/2024
- Sponsor Identification 2.
Leo Medical Co., Ltd.
No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
Contact Person: Guojun Zhang Position: Senior RA Manager Tel: +86-15961165897 Email: gjzhang@leomed.cn
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Single-use Balloon Dilatation Catheter Common Name: Biliary catheter and accessories
- Identification of Proposed Device
Regulatory Information Classification Name: stents, drains and dilators for the biliary ducts Classification: II,
{5}------------------------------------------------
Product Code: FGE, Regulation Number: 21 CFR 876.5010. Review Panel: Gastroenterology/Urology
Indications for Use
This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Oddi with or without prior sphincterotomy.
Device Description
According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.
Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.
- Identification of Predicate Devices and Reference Device న.
Predicate Device 1 510K Number: K112994 Trade Name: CRE Dilatation Balloon
Predicate Device 2 510K Number: K172520 Trade Name: CRE™ RX Biliary Balloon Dilatation Catheter
Reference device 510K Number: K122924 Trade Name: CRE Fixed Wire Balloon Dilatation Catheter
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-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
A ISO 10993-7:2008 Biological Evaluation Of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
-
A ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity
-
A ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
-
A ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
-
ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation.
-
ASTM F88/F88M-21 Standard test method for seal strength of flexible barrier materials
-
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration
-
A ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
-
USP<151> Pyrogen Test
-
ISO10555-4:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters.
-
A ISO 10555-1:2013/A1:2017 Intravascular catheters -Sterile and single-use catheters -Part 1: General requirements.
-
ISO20696:2018(E) Sterile urethral catheters for single-use.
-
ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use A
-
A ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
A USP<85> Bacterial Endotoxins Test
-
ISO 80369-7:2023 Small-bore connectors for liguids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
-
ISO 80369-20:2023 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
-
A ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
The performance testing conducted on subject device and predicate device are listed below. All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses.
- . Dimension Test
- o Appearance
- o Compatibility Test
- o Delivery and Retrieval Force
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- Peak Tensile Force
- . Burst Pressure
- . Kink Stability
- Corrosion Resistance Test ●
- Air Leakage
- Liquid Leakage
- . Luer connector
- Radiopacity
- o Balloon Burst Pressure
- . Balloon Compliance
- . Balloon Deflation Time
- . Balloon Fatigue
The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10 6). EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP <85>. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 3-year shelf-life.
- Package Integrity Test after environmental conditioning, simulated transportation testing in ● accordance to ASTM D4169-22 on final, packaged, and sterile device.
- . Sterile Barrier Packaging performed on the proposed device:
- o Visual Inspection per ASTM F1886/F1886M-16
- 0 Seal Strength per ASTM F88/F88-21
- o Dye Penetration per ASTM F1929-15
- Shelf-life of 3 years is validated using FDA recognized standard ASTM F1980-16 Standard Guide for ● Accelerated Aging of Sterile Barrier Systems for Medical Devices.
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity and pyrogen tests were performed to demonstrate the biocompatibility of the device.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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8. Substantially Equivalent (SE) Comparison
| Table 1. General Comparison | |||||
|---|---|---|---|---|---|
| Item | Proposed Device | Predicate Device 1K112994 | Predicate Device 2K172520 | Reference DeviceK122924 | Remark |
| Device Name | Single-use BalloonDilatation Catheter | GRE Dilatation Balloon | CRE™ RX Biliary BalloonDilatation Catheter | CRE Fixed Wire BalloonDilatation Catheter | / |
| Product Code | FGE | FGE | FGE | KNQ | Same |
| Regulation No. | 21 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 876.5365 | Same |
| Class | II | II | II | II | Same |
| Indications forUse | This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy. | The CRE™ WireguidedBalloon Dilatation Catheteris indicated for use in adultand adolescent populationsto endoscopically dilatestrictures of the alimentarytract.It is also indicated in adultsfor endoscopic dilatation ofSphincter of Oddi with orwithout priorsphincterotomy. | CRE™ RX Biliary BalloonDilatation Catheter isindicated for use in adultsfor endoscopic dilatation ofthe Sphincter of Oddi withor without priorsphincterotomy.The CRE™ RX Biliary BalloonDilatation Catheters maybe used for injection ofcontrast medium forfluoroscopic visualizationof the bile ducts. | The CRE™ BalloonDilatation Catheter isintended for use in adult andadolescent populations toendoscopically dilatestrictures of the esophagus. | Similar |
| Catheter Type | Rx, OTW,OTW(Stainless Wire-guided) | OTW(StainlessWire-guided) | RX | OTW (Fixed wire) | Different |
| Components | Rx: Tip, Balloon, Markerband, Shaft, Sleeve, Stressdiffusion tube, Hub | Tip, balloon, marker band,handle junction, andguidewire | Tip, balloon, marker bandand handle junction | Tip, balloon, marker band,tube and handle junction. | Different |
| Table 1. | General Comparison |
|---|---|
| ---------- | -------------------- |
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| OTW(StainlessWire-guided):Tip,balloon, marker band,Shaft, Sleeve, Stressdiffusion tube , Hub,Guide wire lockingdevice, Stainless GuidewireOTW: Tip, balloon,marker band, Shaft, Stressdiffusion tube, Hub, | |||||
|---|---|---|---|---|---|
| MarkerBandsPresent | Yes | Yes | Yes | Yes | Same |
| Single Use | Single Use | Single Use | Single Use | Single Use | Same |
| 6-7-8, | 6-7-8, | 6-7-8, | 6-7-8, | ||
| 8-9-10, | 8-9-10, | 8-9-10, | 8-9-10, | ||
| BalloonDiameter(mm) | 10-11-12, | 10-11-12, | 10-11-12, | 10-11-12, | Same |
| 12-13.5-15, | 12-13.5-15, | 12-13.5-15, | 12-13.5-15, | ||
| 15-16.5-18, | 15-16.5-18, | 15-16.5-18, | 15-16.5-18, | ||
| 18-19-20 | 18-19-20 | 18-19-20 | 18-19-20 | ||
| Balloonlength(mm) | 30, 55, 80 | 55 | 30,55 | 80 | Different |
| Workinglength(mm) | 1800,2400 | 1800,2400 | 1800 | 1800 | Same |
| Patient-contact Material | |||||
| Tip | Pebax 3533 SA01 Med | Guide head (Pebax) | Unknown | Unknown | Different |
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| Shaft | Pebax 7233 SA01 Med | Catheter (Pebax) | |||
|---|---|---|---|---|---|
| Balloon | Nylon 12 ML21 | Balloon (Pebax) | |||
| Stainless Guidewire (OTW withStainlessWire-guided) | SUS 304 | Guidewire (stainless steel) | |||
| Sterilization | |||||
| Sterile/non-sterile: | Sterile | Sterile | Sterile | Sterile | Same |
| Method | EO sterilized | EO sterilized | EO sterilized | EO sterilized | Same |
| SAL | 10-6 | 10-6 | 10-6 | 10-6 | Same |
| Biocompatibility | |||||
| Cytotoxicity | No cytotoxicity | ||||
| IntracutaneousReactivity | No intracutaneousreactivity | ||||
| Sensitization | No sensitization | Conform with ISO 10993standards | Conform with ISO 10993standards | Conform with ISO 10993standards | Same |
| Acute SystemToxicity | No acute system Toxicity | ||||
| Pyrogen | No pyrogen |
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Similar - Indications for Use
The indication for use of the proposed device and the indication for use of the predicate device 1 are exactly the same. The indication for use of the proposed device 2 are slightly different, but the intend use "indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy." can be covered by predicate device 2. The clinical application site and applicable population of the proposed device can be completely covered by two predicate devices. Therefore, the similar indication for use will not affect the safety and effectiveness of the proposed device.
Different - Catheter Type
The catheter type of the proposed device is different to that of the predicate device 1 and predicate device 2. The proposed device includes Rx, OTW and OTW (Stainless Wire-guided). The Rx type catheter and OTW (Stainless Wire-guided) type catheter can be covered by the predicate device 1 and predicate device 2. The OTW type catheter is very similar to OTW (Stainless Wire-guided) catheter, and the difference with OTW (Stainless Wire-guided) catheter is only the lack of preinstalled guide wire and the structure of OTW (Stainless Wire-guided) catheter same with OTW catheter. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different – Components
The component of the proposed device is different to that of the predicate device 1 and predicate device 2. Different manufacturers have different claims on the name of the device components, the difference in the component is only the difference in the name. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Balloon length
The balloon length of the predicate device 1 is 55mm, the balloon length of the predicate device 2 is 30mm and 55mm, the 30mm and 50mm balloon length of the proposed device is same as the balloon length of the predicate device 2. The 80 mm balloon length of proposed device can be covered by the reference device. Besides, the 80 mm balloon length proposed device was tested for performance and the test results meet the acceptance criteria. Therefore, this difference will not affectiveness of the proposed device.
Different - Material
The materials of the proposed device are different from those of the predicate device. The biocompatibility tests were also performed on the proposed device and the test results showed that there was no adverse effect. Therefore, this difference does not raise new safety and efficacy issues.
9. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and perform as well as or better than the legally marketed predicate device 1 K112994 and
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predicate device 2 K172520.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.