(116 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML capabilities.
Yes
The device is intended to dilate strictures, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a dilation catheter used to open strictures in the alimentary tract, not to diagnose medical conditions. Its function is interventional, not diagnostic.
No
The device description clearly outlines physical components such as catheters, balloons, guidewires, and marker bands, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Elation™ Wireguided Balloon Dilation Catheter is a therapeutic device. It is used to physically dilate strictures within the alimentary tract and the Sphincter of Oddi. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states "to endoscopically dilate strictures" and "endoscopic dilation of the Sphincter of Oddi." This describes a physical intervention, not a diagnostic test.
- Device Description: The description focuses on the physical components of the catheter and balloon, designed for insertion and dilation.
- Performance Studies: The performance studies listed are related to the physical and mechanical properties of the device (e.g., balloon diameter, burst strength, pushability), not the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Elation™ Wireguided Balloon Dilation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
FGE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, Sphincter of Oddi, Esophageal, Pyloric, Biliary, Colonic
Indicated Patient Age Range
adult and adolescent populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
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
Key result: Based on the indications for use, design, safety and performance testing, the subject Elation™ Wireguided Balloon Dilation Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the CRE™ Wireguided Balloon Dilatation Catheter, K112994.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
5. 510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-4956
(801) 253-6982
David Thomas
July 10, 2015
1721504 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name: | ElationTM Wireguided Balloon Dilation
Catheter
Wireguided Balloon Dilation Catheter
Biliary catheter and accessories |
| Predicate Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | CRETM Wireguided Balloon Dilatation
Catheter
Biliary catheter and accessories
K112994
Boston Scientific Corporation |
| Classification | Class II
21 CFR § 876.5010
FDA Product Code: FGE
Review Panel: Gastroenterology/Urology | |
| Intended Use | The ElationTM 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. | |
4
| | 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. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | 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. |
| Comparison to
Predicate Device | The Elation™ Wireguided Balloon Dilation Catheter has the same
technological features as the CRE™ Wireguided Balloon Dilatation
Catheter by Boston Scientific Co.(K112994). Both balloons are
multistage that come in three distinct diameters ranging from 6 to 20
mm for six balloon sizes. Both catheters pass through a working
channel endoscope of an equivalent size. Both systems utilize a
floppy tip guidewire of an equivalent size. Both catheters are 180 cm
and 240 cm in length and use a 7.5F catheter. The balloons for the
CRE™ Balloon and the Elation™ Wireguided Balloon Dilation
Catheter are both manufactured from Pebax material. |
5
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.
6
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.
7
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing, the subject Elation™ Wireguided Balloon Dilation Catheter
meets the requirements that are considered essential for its intended
use and is substantially equivalent to the predicate device, the CRE™
Wireguided Balloon Dilatation Catheter, K112994. |
| ------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|