(60 days)
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System represents a line extension to the original Cordis premounted PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System (ref. 510(k) #K012590) with no change to the indication for use or to the fundamental scientific technology of the predecessor device.
Stent:
The PALMAZ GENESIS Transhepatic Biliary stent is a balloon expandable, laser cut stent mounted on a Cordis balloon catheter (OPTA PRO) and is currently provided in ten (10) nominal unexpanded stent lengths from 12mm to 79 mm. The stent is designed for expansion to diameters from 4mm to 10 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ Genesis stent is laser cut from a 316L stainless steel tube that meets the chemical analysis requirements of American Society for Testing Materials (ASTM) standard F138.
Delivery system:
The delivery system features the same OPTA PRO PTA balloon catheter, which was recently cleared by FDA via 510(k) #K032737, determined substantially equivalent on October 02, 2003), which incorporated this modified hub.
Accessory:
The delivery system features the same accessory (a 304 stainless steel Introducer Tube), which is packaged in the device packaging.
This is a 510(k) premarket notification for a medical device (a stent and its delivery system), not an AI/ML device. Therefore, the concepts of acceptance criteria, device performance, sample sizes for test and training sets, expert adjudication, MRMC studies, or standalone performance as they relate to AI/ML models are not applicable in this context.
The document discusses the substantial equivalence of the "Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System" to an existing predicate device. The "acceptance criteria" in this context are related to the device's physical and biological properties and its intended use, rather than a quantifiable performance metric for an AI algorithm.
Here's a breakdown of the relevant information provided, adapted to the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with specific numerical targets and results for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/ML device. Instead, it relies on demonstrating that the new device is substantially equivalent to a legally marketed predicate device.
| Acceptance Criteria Category (Implied by 510(k)) | Reported Device "Performance" (Evidence provided) |
|---|---|
| Biocompatibility | All materials tested according to ISO-10993, Part 1, and found biocompatible. |
| Functional Equivalence | Same stent design (PALMAZ GENESIS) and delivery system (OPTA PRO PTA balloon catheter) as the predicate device (K012590 and K032737). |
| Mechanical/Design Verification | Data collected from non-clinical design verification tests and analyses. |
| Intended Use | Maintains the identical Intended Use as the predicate: "The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree". |
| Material Composition | Stent made from 316L stainless steel meeting ASTM standard F138. |
2. Sample size used for the test set and the data provenance:
- Test Set/Clinical Data: The document explicitly states that the safety and effectiveness were demonstrated "via data collected from non-clinical design verification tests and analyses." This means there was no clinical test set in the sense of patient data. The "tests" here refer to in-vitro or ex-vivo engineering and material tests, not observations on human subjects.
- Data Provenance: Not applicable as it's non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a medical device's physical performance is established through engineering and material science standards and testing protocols, not expert clinical interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for AI/ML performance evaluation where human experts might disagree. For device engineering tests, results are typically objective and measured against established specifications.
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 is for AI/ML devices involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for AI/ML algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be the engineering specifications, material standards (e.g., ASTM F138, ISO-10993), and predetermined test outcomes to ensure the device performs as intended (e.g., stent expansion diameter, material strength, biocompatibility).
8. The sample size for the training set:
- Not applicable. This is a medical device, not an AI/ML model that undergoes a "training" phase with data.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary: This 510(k) submission for the PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through non-clinical design verification tests and biocompatibility testing. It does not involve AI/ML technology, and therefore, the questions posed in the prompt regarding AI/ML performance evaluation are not applicable. The "study" proving it meets criteria refers to these non-clinical tests and the comparison to an already approved device.
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PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO Delivery System Cordis Corporation, a Johnson & Johnson Company
510(k) Premarket Notification
Attachment 1
Ko3394
Summary of Safety and Effectiveness
| Submitter &Contactperson: | Cordis Europa, N.V., a Johnson & Johnson CompanyHarm HovingaSenior Regulatory Affairs AssociateOosteinde 8NL-9301 LJ Roden,The NetherlandsTel .: (+31) (5050) 22479Fax: (+31) (5050)-22456e-mail: hhovinga@crdnl.jnj.com |
|---|---|
| Date Prepared | October 22, 2003 |
| Trade Name | Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"Delivery System. |
| ClassificationName &DeviceClassification | Common Name: Biliary Stent and accessoriesClassification Name: 21 CFR 876.5010: Biliary Catheter and Accessories.Class II; Product Code: 78FGE. |
| Devicedescription | The PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"Delivery System represents a line extension to the original Cordis premountedPALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"Delivery System (ref. 510(k) #K012590) with no change to the indication foruse or to the fundamental scientific technology of the predecessor device.Stent:The PALMAZ GENESIS Transhepatic Biliary stent is a balloon expandable,laser cut stent mounted on a Cordis balloon catheter (OPTA PRO) and iscurrently provided in ten (10) nominal unexpanded stent lengths from 12mmto 79 mm. The stent is designed for expansion to diameters from 4mm to 10mm, depending on the diameter of the associated balloon upon which it ismounted. |
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510(k) Premarket Notification
| The PALMAZ Genesis stent is laser cut from a 316L stainless steel tube thatmeets the chemical analysis requirements of American Society for TestingMaterials (ASTM) standard F138. | |
|---|---|
| Delivery system:The delivery system features the same OPTA PRO PTA balloon catheter,which was recently cleared by FDA via 510(k) #K032737, determinedsubstantially equivalent on October 02, 2003), which incorporated thismodified hub.Accessory: | |
| The delivery system features the same accessory (a 304 stainless steelIntroducer Tube), which is packaged in the device packaging. | |
| Intended Use | The Intended Use has not changed and remains as"The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO.035" Delivery System is indicated for use in the palliation of malignantneoplasms in the biliary tree". |
| Name ofaffecteddevice | Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035"Delivery System. |
| Performancestandards | The FDA under section 514 of the Food, Drug and Cosmetic Act has notestablished performance standards for these devices. |
| Safety andPerformanceData | The safety and effectiveness of the affected balloon expandable stent anddelivery system has been demonstrated via data collected from non-clinicaldesign verification tests and analyses. All materials used in this modifieddevice have been tested according to ISO-10993, Part 1 and were foundbiocompatible. |
| Conclusion | The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO.035" Delivery System is substantially equivalent to the predicate originaldevice. |
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or curves, possibly representing the flow of health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2003
Ms. Karen Wilk Regulatory Affairs Manager Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059
Re: K033394
Trade/Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 24, 2003 Received: November 25, 2003
Dear Ms. Wilk.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. Karen Wilk
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 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 above is added to your labeling, as described.
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 (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K033394
Device Name: _Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System
FDA's Statement of the Indications For Use for device:
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109)
vision of Reproductive. and Radiological Devi-
510(k) Number K033394
§ 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.