(47 days)
The ParaMount™ Mini™ GPS™ Biliary Stent System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
The modified device is substantially equivalent* to the currently marketed stent and dclivery system in intended use, materials, technological characteristics and performance. The delivery system was modified to reduce retraction force.
Acceptance Criteria and Study for ParaMount™ Mini™ GPS™ Biliary Stent System (K040653)
Based on the provided 510(k) summary, the ParaMount™ Mini™ GPS™ Biliary Stent System (K040653) underwent a submission to the FDA. The submission states that the modified device is "substantially equivalent" to a currently marketed stent and delivery system. This claim is supported by performance testing (bench).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintenance of intended use | "intended use" is maintained |
| Maintenance of materials | "materials" are maintained |
| Maintenance of technological characteristics | "technological characteristics" are maintained |
| Acceptable performance as a palliative treatment for malignant neoplasms in the biliary tree | Meets requirements considered acceptable for the intended use. Specifically, the delivery system was modified to reduce retraction force, and testing confirmed this (implicitly, within acceptable limits). |
| Equivalence in safety | Deemed "substantially equivalent" to the predicate, implying comparable safety profile. |
| Equivalence in effectiveness | Deemed "substantially equivalent" to the predicate, implying comparable effectiveness for palliative treatment. |
| Reduced retraction force in the modified delivery system | Performance testing (bench) supported the reduction in retraction force. |
Note on Acceptance Criteria: The document primarily focuses on establishing "substantial equivalence" rather than explicit, quantifiable acceptance criteria. The criteria are indirectly derived from the claim that the modified device maintains the characteristics and performance of the predicate device.
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a distinct "test set" and thus does not provide a sample size. The testing mentioned is "performance testing (bench)". This typically refers to laboratory-based evaluations rather than clinical trials with patient samples.
- Data Provenance: Not applicable, as the testing was "bench" testing, likely conducted in a laboratory setting by the manufacturer (ev3 Inc. in Plymouth, MN, USA). This is not a retrospective or prospective clinical study with patient data.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. The "ground truth" for the "performance testing (bench)" would be established by engineering specifications, validated test methods, and industry standards, not through expert clinical consensus on patient data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the testing was bench testing, there was no need for clinical adjudication of results in the way it would be for a clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This submission does not describe a multi-reader multi-case comparative effectiveness study. The evaluation focused on bench testing to demonstrate substantial equivalence to a predicate device.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study: No. This device is a physical medical device (stent system), not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant. The performance mentioned refers to the device's physical and functional characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "performance testing (bench)," the ground truth would be based on engineering specifications, established test methodologies, and industry standards for mechanical properties, material integrity, and functional performance (e.g., retraction force measurements, stent deployment accuracy, material biocompatibility). It is not based on expert consensus, pathology, or outcomes data from patients, as this was not a clinical study.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The device design and verification would be based on engineering principles and previous device knowledge.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/machine learning model.
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APR 2 8 2004
Premarket Notification (510(k)) Summary
| 510(k) Number: | K040653 |
|---|---|
| Product Name: | ParaMount™ Mini™ GPS™ Biliary Stent System |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442 |
| Official Contact: | Maria E. BrittleRegulatory Affairs ManagerTelephone: 763-398-7353Fax: 763-398-7200 |
March 11, 2004 Summary Preparation Date:
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the ParaMount™ Mini™ GPS™ Biliary Stent System.
ParaMount™ Mini™ GPS™ Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The modified device is substantially equivalent* to the currently marketed stent and dclivery system in intended use, materials, technological characteristics and performance. The delivery system was modified to reduce retraction force. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the ParaMount™ Mini™ GPS™ Biliary Stent System meets the requirements that are considered acceptable for the intended use.
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.
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Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Ms. Maria E. Brittle Regulatory Affairs Manager ev3. Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920
Re: K040653
Trade/Device Name: ev3 ParaMount™ Mini™ GPS™ Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: April 8, 2004 Received: April 9, 2004
Dear Ms. Brittle:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one ro rowledge 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 ass outled in 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 -- Ms. Maria Brittle
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de fire to additional controls. Existing major regulations affecting your device can be found indy 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 statues 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); 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (2) CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Ruiz C. Schultz, M.D.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K040653
Device Name: ev3 ParaMount™ Mini™ GPS™ Biliary Stent System
FDA's Statement of the Indications For Use for device:
The ParaMount™ Mini™ GPS™ Biliary Stent System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Prescription Use
(Per 21 CFR 801.109)
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Over-the-Counter Use
David R. Leggerson
(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 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.