(155 days)
The Merit Prelude™ Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/ or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Merit Medical System's Prelude™ Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The device is marketed with and without an appropriately sized guide wire and/ or access needle.
The provided text is a 510(k) Premarket Notification for the Merit Prelude™ Sheath Introducer and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of clinical metrics or AI performance.
This document describes a medical device (a sheath introducer) and its submission for FDA clearance based on substantial equivalence to a predicate device. The "Performance Testing" section states: "Verification and Validation Studies, as identified in the Clinical Risk Assessment, were completed and demonstrated that the modified devices met all of their pre-determined acceptance criteria." However, it does not provide the specific acceptance criteria or the reported device performance in a quantifiable manner (e.g., sensitivity, specificity, accuracy, or other clinical metrics).
Crucially, this is not an AI/ML device, so questions related to AI performance, such as human reader improvement with AI, standalone algorithm performance, training set details, or ground truth establishment for an AI model, are not applicable.
Here's a breakdown of what can be extracted from the provided text, along with explanations for the unanswerable questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| Pre-determined acceptance criteria based on Verification and Validation Studies identified in the Clinical Risk Assessment. | The modified devices met all of their pre-determined acceptance criteria. |
Note: The document does not provide specific quantifiable acceptance criteria (e.g., "burst pressure > X psi", "hemostasis valve leakage < Y mL/min") or their corresponding reported numerical performance. It only states that the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing refers to "Verification and Validation Studies" but does not detail the sample sizes for those tests or the provenance of any data (e.g., country of origin, retrospective/prospective). While medical device testing often involves in-vitro and potentially in-vivo (animal or human) testing, the specifics are not disclosed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided and is generally not applicable in the context of a 510(k) for a physical medical device like a sheath introducer, which is evaluated based on engineering and biocompatibility performance rather than diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for this type of medical device evaluation. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints that require review by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or other output that human readers evaluate, and often for AI/ML-driven diagnostic aids. The Prelude™ Sheath Introducer is a physical surgical access device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done. This question is applicable to algorithms or software as a medical device. The Prelude™ Sheath Introducer is a physical medical device.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in diagnostic performance studies (e.g., pathology, outcomes data, expert consensus for disease presence) is not directly applicable to the performance evaluation described for this physical device. The "ground truth" for a sheath introducer would be its adherence to engineering specifications and safety requirements (e.g., material strength, fluid dynamics, biocompatibility, dimensions), which are assessed through direct measurement and testing rather than comparison to a clinical "truth" about a patient's condition.
8. Sample Size for the Training Set
This information is not provided and is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. As it's not an AI/ML model, there is no "training set" or "ground truth" in that context.
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Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL
Attachment 4
JUN 2 1 2007
510(k) Summary
SAFETY AND EFFECTIVENESS SUMMARY
This information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted by Name/Address: | Merit Medical Systems, Inc1600 West Merit ParkwaySouth Jordan, Utah 84095 |
|---|---|
| Establishment Registration Number: | 1721504 |
| Primary Contact Person: | Jerrie HendricksonRegulatory Affairs Specialist II |
| Telephone: | (801) 208-4119 |
| Fax: | (801) 253-6918 |
| Email: | jhendri@merit.com |
| Alternate Contact Person: | Stephanie A. ErskineVice President Corporate Regulatory Affairs |
| Telephone: | (801) 208-4349 |
| Fax: | (801) 253-6967 |
| Email: | serskine@merit.com |
| Date Summary Prepared: | January 16, 2007 |
| Trade Name: | Prelude™ Sheath Introducer |
| Common Name: | Vessel Dilator for Percutaneous Catheterization |
| Classification Name | Vessel Dilator for Percutaneous Catheterization,Class II, Product Code DRE (per 21 CFR870.1310) |
| Predicate Device | Prelude™ Sheath Introducer (K050962), manufactured by MeritMedical Systems, Inc. |
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Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL
| Device Description: | Merit Medical System's Prelude™ Sheath Introducer consists ofa sheath introducer with compatible vessel dilator that snapssecurely into the sheath introducer hub. The sheath is equippedwith a sideport attached to a segment of extension tubingterminating in a 3-way stopcock. The sheath hub contains anintegral hemostasis valve and suture ring. The device ismarketed with and without an appropriately sized guide wireand/ or access needle. |
|---|---|
| Intended Use | The Merit Prelude™ Sheath Introducer is intended to provideaccess and facilitate the percutaneous introduction of variousdevices into veins and/ or arteries while maintaining hemostasisfor a variety of diagnostic and therapeutic procedures. |
| Technology Comparison | The modified device has the identical intended use and employsthe same fundamental technology as the predicate device.Additional sizes have been added, minor changes in materialshave been made, and the configuration of the dilator tip hasbeen modified to accept smaller size guide wires. In addition,some kits containing the Prelude™ are now marketed withappropriately sized guide wires and access needles. |
| Performance Testing | Verification and Validation Studies, as identified in the ClinicalRisk Assessment, were completed and demonstrated that themodified devices met all of their pre-determined acceptancecriteria. |
Summary of Substantial Equivalence
Based on:
- Merit's conformance with Design Control requirements, .
- Analyses of Risks associated with the Modified Device; and .
- Results of Verification and Validation tests identified in the Risk Analyses . demonstrating that predetermined acceptance criteria have been met:
the modified devices are as safe and effective as, and perform as well as, or better than, the predicate devices.
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Image /page/2/Picture/11 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 a stylized image of an eagle or other bird-like figure, with its wings forming three distinct, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2007
Ms. Jerrie Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re: K070159
Trade/Device Name: Prelude™ Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catherization Regulatory Class: Class II Product Code: DRE Dated: May 21, 2007 Received: May 23, 2007
Dear Ms. Hendrickson:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Jerrie Hendrickson
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 (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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dma R. bohner
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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pg. 141 1 KD 10154
Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer Special [510(k)] PREMARKET NOTIFICATION CONFIDENTIAL
Attachment 2
Indications for Use Statement
510(k) Number (if known):
Device Name:
Merit Prelude™ Sheath Introducer
Indications for Use:
The Merit Prelude™ Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Prescription Use X (Part 21 CFR 901 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart O)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. de Jesus
Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K070159
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).