(116 days)
The Elation™ Wireguided Balloon Dilation Catheters are intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilation of the Sphincter of Oddi with or without prior sphincterotomy.
The Elation™ Wireguided Balloon Catheters are multi-lumen 7.5F catheters with a dilation balloon on the distal tip. The catheter is designed to pass through the working channel of an endoscope and accept a guidewire through its guidewire lumen. This catheter comes packaged with a floppy tip guidewire preloaded in the guidewire lumen. A guidewire locking device, packaged in the unlocked position, is attached to the guidewire hub of the catheter. The dilation balloon will be available in catheter lengths of 180 cm and 240 cm, balloon length of 5.5 cm and in six balloon sizes. Each balloon size will inflate to at least three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopaque marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon. The balloon will be available in twelve configurations of multiple lengths and diameters – six are for the Esophageal Pyloric Biliary dilation and six for the Esophageal Pyloric Biliary Colonic dilation.
The document describes the Elation™ Wireguided Balloon Dilation Catheter and its substantial equivalence to a predicate device, but it does not provide acceptance criteria or detailed study results in the format requested.
The document states that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, performance testing was conducted based on risk analysis and international standards and guidance documents.
The performance testing listed includes Bench tests and Biocompatibility tests, but it does not present specific acceptance criteria or quantitative performance outcomes for the device against those criteria. The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against pre-defined acceptance criteria for a new device's efficacy or safety.
Therefore, the requested information cannot be fully extracted from the provided text.
Here's an attempt to answer based only on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document lists performance tests conducted but does not specify the acceptance criteria for each test or the reported performance data in a quantitative manner.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 information is not applicable/provided. The device is a medical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a medical catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. Performance testing for a catheter typically involves bench testing against engineering specifications, not "ground truth" as might be used for diagnostic algorithms.
8. The sample size for the training set
This information is not applicable/provided. The device is a medical catheter, not an algorithmic model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided.
Summary of what is present:
The document indicates that performance testing was conducted based on:
- Risk analysis
- International standards and guidance documents (a list is provided on page 5)
Bench Performance Testing Categories Listed (though no criteria or results are given):
- Radiopacity
- Catheter Length
- Tip Perforation
- Guidewire Insertion
- Endoscope Catheter Insertion and Withdrawal
- Radiopaque Marker Band Location
- Balloon Diameter
- Balloon Deflation Time
- Balloon Burst / Freedom from Leakage
- Distal Catheter Joints Tensile
- Proximal Catheter Joints Tensile
- Catheter Pushability
- Catheter Kink
- Kink Recovery
Biocompatibility Testing Categories Listed:
- Cytotoxicity
- Sensitization
- Irritation
The document's purpose is to demonstrate substantial equivalence (K151925) to a predicate device (Boston Scientific's CRE™ Wireguided Balloon Dilatation Catheter, K112994), not to present detailed acceptance criteria and performance data for the Elation™ device as a novel technology.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like element beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
Merit Medical Systems, Inc. David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K151925
Trade/Device Name: Elation™ Wireguided Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 1, 2015 Received: October 2, 2015
Dear David Thomas,
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. 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.
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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 (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Elation™ Wireguided Balloon Dilation Catheter
Indications for Use (Describe)
The Elation™ Wireguided Balloon Dilation Catheters are intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the 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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5. 510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4956(801) 253-6982David ThomasJuly 10, 20151721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name: | ElationTM Wireguided Balloon DilationCatheterWireguided Balloon Dilation CatheterBiliary catheter and accessories |
| Predicate Device | Trade Name:Classification Name:Premarket Notification:Manufacturer: | CRETM Wireguided Balloon DilatationCatheterBiliary catheter and accessoriesK112994Boston Scientific Corporation |
| Classification | Class II21 CFR § 876.5010FDA Product Code: FGEReview Panel: Gastroenterology/Urology | |
| Intended Use | The ElationTM Wireguided Balloon Dilation Catheters are intended foruse in adult and adolescent populations to endoscopically dilatestrictures of the alimentary tract. Also indicated in adults forendoscopic dilation of the Sphincter of Oddi with or without priorsphincterotomy. |
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| The Elation™ Wireguided Balloon Catheters are multi-lumen 7.5Fcatheters with a dilation balloon on the distal tip. The catheter isdesigned to pass through the working channel of an endoscope andaccept a guidewire through its guidewire lumen. This catheter comespackaged with a floppy tip guidewire preloaded in the guidewirelumen. A guidewire locking device, packaged in the unlocked position,is attached to the guidewire hub of the catheter. | |
|---|---|
| DeviceDescription | The dilation balloon will be available in catheter lengths of 180 cm and240 cm, balloon length of 5.5 cm and in six balloon sizes. Eachballoon size will inflate to at least three different diameters for thespecified inflation pressures. The balloon will be identifiable with bothendoscopic and radiopaque marker bands. A glow-in-the-dark tag thatcan be read in low light conditions is attached to the catheter shaft.The tag indicates diameter and corresponding pressure of the balloon. |
| The balloon will be available in twelve configurations of multiplelengths and diameters – six are for the Esophageal Pyloric Biliarydilation and six for the Esophageal Pyloric Biliary Colonic dilation. | |
| Comparison toPredicate Device | The Elation™ Wireguided Balloon Dilation Catheter has the sametechnological features as the CRE™ Wireguided Balloon DilatationCatheter by Boston Scientific Co.(K112994). Both balloons aremultistage that come in three distinct diameters ranging from 6 to 20mm for six balloon sizes. Both catheters pass through a workingchannel endoscope of an equivalent size. Both systems utilize afloppy tip guidewire of an equivalent size. Both catheters are 180 cmand 240 cm in length and use a 7.5F catheter. The balloons for theCRE™ Balloon and the Elation™ Wireguided Balloon DilationCatheter are both manufactured from Pebax material. |
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No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Elation™ Wireguided Balloon Dilation Catheter was conducted based on the risk analysis and based on the requirements of the following international standards and quidance documents:
ISO 594-1: 1986 (E) Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General Requirements
ISO 594-2: 1998 (E) Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittinas
ISO 10555-1: 2013 - Intravascular catheters - Sterile and single use catheters - Part 1: General Requirements
ISO 10555-4: 2013 - Intravascular catheters - Sterile and single use catheters - Part 4: Balloon dilatation catheters
Safety & ASTM F 640 - 12 Standard Test Methods for Determining Radiopacity Performance for Medical Use Tests
Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010.
ISO 11135:2014, Sterilization of health care products – Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process.
FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008, Biological Evaluation of Medical Devices – Part 7 Ethylene Oxide sterilization residuals
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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AAMI/ANSI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1 – Requirements for materials, sterile barrier systems and packaging systems (Sterility)
ASTM D4169-09, Standards Practice for Performance Testing of Shipping Containers and Systems (Sterility)
ISO 2233 (2000), Packaging - Complete, filled transport packages and unit loads - conditions for testing
Performance Testing-Bench
- Radiopacity
- Catheter Length ●
- Tip Perforation ●
- Guidewire Insertion
- Endoscope Catheter Insertion and Withdrawal ●
- Radiopaque Marker Band Location ●
- Balloon Diameter ●
- Balloon Deflation Time
- Balloon Burst / Freedom from Leakage
- . Distal Catheter Joints Tensile
- Proximal Catheter Joints Tensile
- Catheter Pushability ●
- Catheter Kink ●
- Kink Recovery ●
Biocompatibility
The biocompatibility evaluation for the Elation™ Fixed Wire Balloon Dilation Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
Safety & Performance Tests cont.
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| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performancetesting, the subject Elation™ Wireguided Balloon Dilation Cathetermeets the requirements that are considered essential for its intendeduse and is substantially equivalent to the predicate device, the CRE™Wireguided Balloon Dilatation Catheter, K112994. |
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§ 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.