(142 days)
The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments. The target population is for adults only (at least 22 years old).
The Dornier MAGELLAN Ureteral Access Sheath is a two component ureteral dilatation system that provides an open conduit to the upper urinary tract to facilitate Ureteroscopy, which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic-coated sheath with hub. The Access Sheath is a sterile, single use, disposable device that allows access to the ureter to facilitate scope and urological tool passage. The Dornier MAGELLAN Ureteral Access Sheaths are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested. All colorants used are compliant with FDA standards.
This FDA 510(k) summary describes the Dornier MAGELLAN Ureteral Access Sheath, a medical device, and its substantial equivalence to a predicate device. As such, it does not detail acceptance criteria and a study that proves the device meets specific performance metrics in the way that an AI/ML device submission would. Instead, the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through a comparison of characteristics and performance tests.
Here's a breakdown of the requested information based on the provided text, and where certain details are not applicable (N/A) because this is a traditional medical device submission, not an AI/ML B.S.E submission:
Acceptance Criteria and Device Performance
The submission states that the Dornier MAGELLAN Ureteral Access Sheath underwent various performance tests, and "All testing was found to be acceptable and substantially equivalent to those of the predicate device." While specific numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion for each test is that the device's performance must be comparable to, or meet the established benchmarks for, the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sterility | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Packaging | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Biocompatibility | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Radiopacity | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Sheath ID | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Dilator OD | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Sheath Distal Tip ID | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Dilator Taper length | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Kink Resistance | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Assembly Flexibility-3 point bend test | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Sheath/Hub Tensile | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
| Dilator /Hub Tensile | Performance comparable to predicate device / established standards | "All testing was found to be acceptable" |
Study Details
-
Sample size used for the test set and the data provenance:
This information is N/A for this type of submission. The performance data section lists the types of tests conducted (e.g., kink resistance, tensile strength), which are typically bench tests or material tests, not clinical studies with patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective in the way an AI/ML device would report it. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is N/A. The "ground truth" for these types of mechanical and material tests is defined by engineering specifications and established test methodologies, not by expert medical interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is N/A. Adjudication methods are relevant for clinical studies where multiple experts evaluate cases that might have ambiguous findings, which is not applicable to the performance tests listed. -
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 N/A. This device is a physical ureteral access sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is N/A. This is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance tests described (e.g., sterility, biocompatibility, kink resistance, tensile strength), the "ground truth" is typically based on engineering specifications, material standards, and validated test methods. It's not based on expert medical consensus, pathology, or outcomes data. For example, the ground truth for "kink resistance" would be defined by a specific force or angle at which the sheath begins to kink, as measured by a standardized physical test. -
The sample size for the training set:
This information is N/A. This device does not involve a training set as it is not an AI/ML model. -
How the ground truth for the training set was established:
This information is N/A. This device does not involve a training set or ground truth establishment in the context of AI/ML.
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November 20, 2020
Dornier MedTech America Inc John Hoffer Vice President Quality, Regulatory, Clinical 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144
Re: K201815 Trade/Device Name: Dornier MAGELLAN Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: II Product Code: FED Dated: October 21, 2020 Received: October 22, 2020
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 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-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,
Mark J. Antonino, M.S. 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 MAGELLAN Ureteral Access Sheath
Indications for Use (Describe)
The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.
The target population is for adults only (at least 22 years old).
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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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:
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510(k) SUMMARY
Dornier MAGELLAN Ureteral Access Sheath
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Dornier MedTech America, Inc. 1155 Roberts Blvd., Suite 100 Kennesaw, GA 30144
Date Prepared: 06/08/2020
Phone: 770-514- 6163 Contact Person: John Hoffer
Name/Address of Sponsor and Name of Device
Dornier MedTech America, Inc. 1155 Roberts Blvd. Kennesaw, GA 30144
| Trade Name: | Dornier MAGELLAN Ureteral Access Sheath |
|---|---|
| Common Name: | Ureteral Access Sheath |
| Classification Name: | Endoscopic Overtube |
| Regulation: | 21 CFR §876.1500 |
| Regulatory Classification: | II |
| Product Code: | FED |
Predicate Device
C.R. Bard Proxis™ Ureteral Access Sheath (K160861)
Purpose of the 510(k) Notice
The purpose of this submission is to obtain marketing clearance for the Dornier MAGELLAN Ureteral Access Sheath product line.
Intended Use/Indications for Use
The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments. The target population is for adults only (at least 22 years old).
Device Description
The Dornier MAGELLAN Ureteral Access Sheath is a two component ureteral dilatation system that provides an open conduit to the upper urinary tract to facilitate Ureteroscopy, which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic-coated sheath with hub. The Access Sheath is a sterile, single use, disposable device that allows access to the ureter to facilitate scope and urological tool passage.
The Dornier MAGELLAN Ureteral Access Sheaths are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested. All colorants used are compliant with FDA standards.
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K201815 Page 2 of 2
Technological Characteristics
The Dornier MAGELLAN Ureteral Access Sheath has similar technological characteristics as the predicate device, The Proxis™ Ureteral Access Sheath. The subject and predicate devices are based on the following technological elements:
- Similar indications for use
- Similar design features
- Provided sterile for single-use
- Composed of biocompatible materials
The basic characteristics of the Dornier MAGELLAN Ureteral Access Sheath are substantially equivalent to the predicate device. They are both made from medical grade material and are a single lumen design with a Hydrophilic-coated sheath with hub pen tip.
Performance Data
The Dornier MAGELLAN Ureteral Access Sheath was subjected to the following tests to assure design and performance under the specified testing parameters:
- Sterility Packaging Biocompatibility Radiopacitv Sheath ID Dilator OD Sheath Distal Tip ID Dilator Taper length Kink Resistance Assembly Flexibility-3 point bend test Sheath/Hub Tensile Dilator /Hub Tensile
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 MAGELLAN Ureteral Access Sheath is substantially equivalent to the predicate device in terms of intended use, technological characteristics, type of materials and performance characteristics. Therefore, the proposed Dornier MAGELLAN Ureteral Access Sheath is as safe, as effective, and performs as well as the predicate device.
Conclusion
Based on the data and information comparing the Dornier MAGELLAN Ureteral Access Sheath 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 MAGELLAN Ureteral Access Sheath is substantially equivalent to its predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.