(270 days)
The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.
The Dornier EQUINOX Balloon Dilatation Catheter is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.
The Dornier EQUINOX Balloon Dilatation Catheters are sterile, single-use devices. The EQUINOX Balloon Dilatation Catheters are available in 5.8 French (Fr) diameter, with a catheter length of 80 centimeters (cm). There will be three (3) balloon diameters, (4mm, 5mm and 6mm) and two (2) balloon lengths (4cm and 10cm)
The Dornier EQUINOX Balloon Dilatation Catheters are constructed of a medical grade nylon material. This material has been USP Class VI tested. The base material is compounded with BaSO4 to render the Dornier EQUINOX Balloon Dilatation Catheter radiopaque under x-ray fluoroscopy. The catheter also has radio-opaque marker bands on the proximal and distal ends of the balloon for visualization during use. All colorants used are compliant with FDA standards.
This FDA 510(k) summary describes a medical device, the Dornier EQUINOX Balloon Dilatation Catheter, and its substantial equivalence to a predicate device, rather than providing details of a study on AI or diagnostic performance. Therefore, most of the requested information about acceptance criteria, study details, expert involvement, and ground truth is not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests but does not provide specific quantitative acceptance criteria or detailed numerical results. Instead, it states that "All testing was found to be acceptable and substantially equivalent to those of the predicate device."
| Test Category | Acceptance Criteria (Not explicitly stated with numerical values in the document) | Reported Device Performance |
|---|---|---|
| Sterility | (Implied: Device must be sterile) | Found to be acceptable |
| Packaging | (Implied: Packaging integrity maintained) | Found to be acceptable |
| Biocompatibility | (Implied: Material is biocompatible) | Found to be acceptable (USP Class VI tested material) |
| Balloon Burst Durability Test | (Implied: Balloon withstands pressure, does not burst prematurely) | Found to be acceptable |
| Balloon Deflation Time | (Implied: Balloon deflates within an acceptable time) | Found to be acceptable |
| Balloon/Scope Compatibility | (Implied: Compatible with endoscopic scopes) | Found to be acceptable |
| Radiopacity | (Implied: Visible under x-ray fluoroscopy) | Found to be acceptable (compounded with BaSO4, marker bands) |
| Effective Working Length | (Implied: Meets specified length) | Found to be acceptable |
| Catheter Tip Length | (Implied: Meets specified length) | Found to be acceptable |
| Balloon Diameter @ RBP (Rated Burst Pressure) | (Implied: Achieves specified diameter at rated pressure) | Found to be acceptable |
| Balloon Length @ OP (Operating Pressure) | (Implied: Achieves specified length at operating pressure) | Found to be acceptable |
| Catheter Shaft OD (Outer Diameter) | (Implied: Meets specified diameter) | Found to be acceptable |
2. Sample size 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 a 510(k) summary. The document describes bench testing, not clinical studies with patients or data sets.
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):
Not applicable. This document is about a mechanical device's performance characteristics, not a diagnostic or AI device that requires expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical trials or studies where human expert consensus is needed to determine ground truth for diagnostic accuracy, which is not the subject of this 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:
Not applicable. This document is for a medical device (balloon catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a medical device (balloon catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance would be engineering specifications and established test methods (e.g., measuring dimensions, pressure resistance, sterility, biocompatibility standards).
8. The sample size for the training set:
Not applicable. This document does not describe an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established:
Not applicable. This document does not describe an AI/machine learning device.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2019
Dornier MedTech America Inc John Hoffer Vice President Quality, Regulatory, Clinical 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144
Re: K190612 Trade/Device Name: EQUINOX Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN, KOE Dated: October 22, 2019 Received: October 22, 2019
Dear John Hoffer:
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/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.
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
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801); medical device 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-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 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-device-safety/medical-device-reportingmdr-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/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-regulatoryassistance/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,
Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Dornier EQUINOX Balloon Dilatation Catheter
Indications for Use (Describe)
The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY Dornier EQUINOX Balloon Dilatation Catheter
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Dornier MedTech America, Inc. 1155 Roberts Blvd., Suite 00 Kennesaw, GA 30144
Date Prepared: October 18, 2019
Contact Person: John Hoffer
Phone: 770-514- 6163
Name of Device and Name/Address of Sponsor
Dornier EQUINOX Balloon Dilatation Catheter
Dornier MedTech America, Inc. 1155 Roberts Blvd. Kennesaw, GA 30144
Common or Usual Name
Ureteral Balloon Dilatation Catheter
Classification Name
According to 21 C.F.R. § 876.5470, the Food and Drug Administration ("FDA" or "the agency") has classified Ureteral Dilators as Class II devices (performance standards). The Product Code for these Dilators is EZN.
Predicate Device
Boston Scientific's Uromax Ultra Balloon Dilatation Catheter (K130804)
Purpose of the 510(k) Notice
The purpose of this submission is to obtain marketing clearance for the Dornier EQUINOX Balloon Dilatation Catheter product line.
Intended Use/Indications for Use
The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.
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Device Description
The Dornier EQUINOX Balloon Dilatation Catheter is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.
The Dornier EQUINOX Balloon Dilatation Catheters are sterile, single-use devices. The EQUINOX Balloon Dilatation Catheters are available in 5.8 French (Fr) diameter, with a catheter length of 80 centimeters (cm). There will be three (3) balloon diameters, (4mm, 5mm and 6mm) and two (2) balloon lengths (4cm and 10cm)
The Dornier EQUINOX Balloon Dilatation Catheters are constructed of a medical grade nylon material. This material has been USP Class VI tested. The base material is compounded with BaSO4 to render the Dornier EQUINOX Balloon Dilatation Catheter radiopaque under x-ray fluoroscopy. The catheter also has radio-opaque marker bands on the proximal and distal ends of the balloon for visualization during use. All colorants used are compliant with FDA standards.
Technological Characteristics
The Dornier EQUINOX Balloon Dilatation Catheters have the same basic technological characteristics as the predicate device, Boston Scientific's Uromax Ultra Balloon Dilatation Catheter. They both are a multiple lumen catheter with a dilatation balloon mounted at the distal tip. They are both manufactured using PET for the inflation balloon which is the primary functional component of the devices. At the proximal end, they both have leur lock connectors that will attach to the inflation device to inflate the balloon during use. As noted above, both devices are compounded with Barium sulfate and radiopaque marking bands to allow visualization under fluoroscopy.
Performance Data
The Dornier EQUINOX Balloon Dilatation Catheter was subjected to the following tests to assure design and performance under the specified testing parameters:
- Sterilitv Packaging Biocompatibility Balloon Burst Durability Test Balloon Deflation Time Balloon/Scope Compatibility Radiopacity Effective Working Length Catheter Tip Length Balloon Diameter @ RBP Balloon Length @ OP Catheter Shaft OD
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All testing was found to be acceptable and substantially equivalent to those of the predicate device.
Substantial Equivalence
A comparison of design characteristics has been performed and demonstrates that the proposed Dornier EQUINOX Balloon Dilatation Catheter is substantially equivalent to the predicate device in terms of intended use, technological characteristics, type of materials and performance characteristics. Therefore, the proposed Dornier EQUINOX Balloon Dilatation Catheter is as safe, as effective, and performs as well as the predicate device.
Conclusion
Based on the data and information comparing the Dornier EQUINOX Balloon Dilatation Catheter and the predicate device we conclude they are substantially equivalent as they have the same intended use, basic design, principle of operation, technology, materials, and performance to the predicate. Any minor differences between the subject and predicate devices do not raise any concerns regarding the overall safety or effectiveness. Thus, the Dornier EQUINOX Balloon Dilatation Catheter is substantially equivalent to its predicate device.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).