(29 days)
The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 7F Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.
The 7F Sherpa NX guide catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary (transition) segment, a primary segment, tungsten marker band, a segment sleeve and a soft tip. The 7F Sherpa NX Guide Catheter design is based on a four layer design with an inner linner of polyethylene.
This 510(k) summary describes a medical device, the Medtronic 7F Sherpa NX Guiding Catheter, and its substantial equivalence to a predicate device. However, it does not contain information related to acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects of a study regarding algorithm performance, ground truth, or expert involvement as requested in the prompt.
The document is a premarket notification for a medical device (a catheter) and focuses on demonstrating its similarity to an already approved device (the 6F Sherpa NX Guiding Catheter). It mentions "performance testing" was conducted, but provides no details about the acceptance criteria or the results of this testing.
Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain the necessary information.
Here's how I would present the information if it were available, along with a note that it's not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "performance testing" but provides no details about the data used for this testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The document describes a physical medical device (catheter) and its "performance testing." It does not involve an algorithm or a test set requiring expert-established ground truth in the way an AI/ML device would.
4. Adjudication method for the test set
- Not applicable. (See explanation for #3).
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 physical catheter, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical catheter, not an AI/ML device.
7. The type of ground truth used
- Not applicable. (See explanation for #3). The "performance testing" likely refers to bench testing of the catheter's physical properties (e.g., tensile strength, flexibility, material compatibility) rather than diagnostic accuracy.
8. The sample size for the training set
- Not applicable. (See explanation for #3 and #6).
9. How the ground truth for the training set was established
- Not applicable. (See explanation for #3 and #6).
Explanation for lack of data:
The provided document is a 510(k) premarket notification for a physical medical device (a catheter). The focus of such a submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, primarily through engineering specifications, material compatibility, and benchtop performance testing of the device's physical attributes, and potentially some animal or limited human use data if very different from the predicate.
The questions in the prompt (regarding "acceptance criteria based on algorithm performance," "test and training sets," "ground truth," "expert adjudication," "MRMC studies," and "standalone algorithm performance") are highly relevant for the evaluation of Artificial Intelligence (AI) or Machine Learning (ML) enabled medical devices. This document, however, describes a conventional, non-AI medical device, and therefore these types of studies and details are not present or applicable. The "performance testing" mentioned likely refers to physical and mechanical property testing of the catheter, not the diagnostic performance of an AI algorithm.
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AUG 5 - 2005
510(k) Summary
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923USA |
|---|---|
| Contact Person: | Fred BoucherDirector, Regulatory Affairs978.739.3116978.777.0390Fred.Boucher@Medtronic.com |
| Date Prepared: | July XX, 2005 |
| Trade Name: | 7F Sherpa NX Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| ClassificationName: | Percutaneous Catheter |
| Predicate Device: | 6F Sherpa NX Guide Catheter (K042489) |
| DeviceDescription: | The 7F Sherpa NX guide catheter consists of a luer hub, strainrelief, a shaft (outer jacket, braid wire, an intermediate layer,and inner liner), a secondary (transition) segment, a primarysegment, tungsten marker band, a segment sleeve and a softtip.The 7F Sherpa NX Guide Catheter design is based on a fourlayer design with an inner linner of polyethylene. |
| Statement ofIntended Use: | Provide a pathway through which therapeutic devices areintroduced. The guiding catheter is intended to be used in thecoronary or peripheral vascular system |
| Summary ofTechnological | In addition to being technologically equivalent to thepredicate devices, the 7F Sherpa NX Guiding Catheter has |
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- been subjected to performance testing and it has been Characteristics: determined that the 7F Sherpa NX Guiding Catheter is suitable for its intended use.
- The 7F Sherpa NX Guiding Catheter is manufactured under Summary of Nonthe same conditions, using the similar processes and clinical Data: equivalent materials, as the 6F Sherpa NX Guiding Catheter; the legally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.
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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
Medtronic Vascular c/o Mr. Fred Boucher Director Regulatory Affairs 37A Cherry Hill Drive Danvers, CA 01923
Re: K051846
Medtronic® 7F Sherpa NX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (Two) Product Code: DQY Dated: July 6, 2005 Received: July 7, 2005
Dear Mr. Boucher:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(t) per levice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it itgains and ment date of the Medical Device Amendments, or to Conninered prior to May 20, 2017) in accordance with the provisions of the Federal Food, DINE, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, chereleve, mains of the Act include requirements for annual registration, listing of general obtired provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elabilition (osmal controls. Existing major regulations affecting your device can may oe subject to back as a subjections, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Fred Boucher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DTT 3 iboastes of our device complies with other requirements of the Act that I DA has made a acterimaliations administered by other Federal agencies. You must of ally it cach statures and regalations and and limited to: registration and listing (21 Comply with an the 11et 6 requirements (1); good manufacturing practice requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro no begin marketing your device as described in your Section 510(k) I mis icher will and w you'll begin finding of substantial equivalence of your device to a legally premarket notification: "The Province of and this, permits your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Compunations on the time (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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/industry/support/index.html.
Sincerely yours,
Duna R. Vadines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K051846 |
|---|---|
| --------------------------- | --------- |
Device Name: Device name: Medtronic® 7F Sherpa NX guiding Catheter
Indications For Use: The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 7F Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko5184(c
Page 1 of
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).