(18 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's Prelude consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 3-way stopcock is affixed to the proximal end of the side port extension. The Prelude assembly includes a vessel dilator that snaps securely into the sheath introducer hub.
The provided document is a 510(k) summary for the Merit Prelude™ Sheath Introducer, submitted by Merit Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving device performance against specific acceptance criteria in the context of AI/ML or diagnostic accuracy.
Therefore, many of the requested sections regarding AI/ML study specifics (e.g., sample size for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, data provenance) are not applicable to this type of regulatory submission for a medical device like a sheath introducer.
This 510(k) summary describes bench testing to establish equivalence, not a clinical study involving human readers or AI algorithms for diagnostic purposes.
Here's the information that can be extracted or inferred from the provided text, adapted to the questions:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the way typically seen for diagnostic accuracy studies or AI/ML evaluations. Instead, it describes comparative testing to demonstrate substantial equivalence to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Radiodetectability of sheath introducer and vessel dilator: The Merit Prelude should be radiodetectable similar to the predicate device. | "Comparative testing with the predicate device performed includes radiodetectability of the sheath introducer and vessel dilator." (Implies satisfactory performance). |
| Valve leak pressure: The Merit Prelude should exhibit similar valve leak characteristics as the predicate device. | "Comparative testing... includes... valve leak pressure." (Implies satisfactory performance and comparison to predicate). |
| Tip insertion force: The Merit Prelude should have similar tip insertion force as the predicate device. | "Comparative testing... includes... tip insertion force." (Implies satisfactory performance and comparison to predicate). |
| Sheath hub/cap snap fit: The Merit Prelude's snap fit should be secure. | "Comparative testing... includes... sheath hub/cap snap fit." (Implies satisfactory performance). |
| Dilator snap fit to sheath hub: The Merit Prelude's dilator snap fit should be secure. | "Comparative testing... includes... dilator snap fit to sheath hub." (Implies satisfactory performance). |
| Guide wire compatibility: The Merit Prelude should be compatible with guide wires. | "Comparative testing... includes... guide wire compatibility." (Implies satisfactory performance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The testing was "bench testing" of the physical device, not related to patient data or image sets.
- Data provenance: Not applicable. The testing was conducted in-house by Merit Medical Systems, Inc. ("Merit's in-house protocols") in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a sheath introducer, not an AI/ML diagnostic tool. Ground truth for its performance would involve engineering specifications, physical measurements, and materials science, not expert medical opinion on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical studies. This involved bench testing of a physical medical device.
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
- No MRMC study was done. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance of the sheath introducer was based on engineering specifications, physical measurements, and comparison to the characteristics of the legally marketed predicate device (Cordis Avanti®+ Catheter Sheath Introducer System). This is a "substantial equivalence" determination based on technical and performance characteristics of similar devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device and thus does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a combination of solid black and outlined letters. The word "MEDICAL" is outlined, and there is a small circle above and to the right of the "A" in "MEDICAL".
MAY - 6 2005
Merit Medical Systems, Inc. I 500 W/EST MERIT PARKWAY SOUTH JORDAN, UTAH 84095 PHONE 801-253-1600 FAX 801-253-1688 www.merit.com
Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)
Premarket Notification [510(k)] Summary of Safety and 11.0 Effectiveness
| Submitter | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, Utah 84095-2416 USA |
|---|---|
| Establishment Registration Number | 1721504 |
| Contact Person(s) | |
| Primary Contact Person | Jerrie Hendrickson |
| Title | Regulatory Affairs SpecialistMerit Medical Systems, Inc. |
| Phone | (801) 208-4119 |
| Fax | (801) 253-6918 |
| jhendri@merit.com | |
| Alternate Contact Person | Stephanie A. Erskine |
| Title | Vice President Regulatory Affairs |
Phone Fax e-mail
Date Prepared
Merit Medical Systems, Inc. (801) 208-4349 (801) 253-1684
March 2, 2005
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Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer ABBREVIATED PREMARKET NOTIFICATION [510(k)} CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)
| Name of Medical Device | Merit Prelude Sheath Introducer |
|---|---|
| Classification Name: | Vessel Dilator for PercutaneousCatheterization(21 CFR 870.1310) |
| Common/Usual Name: | Vessel Dilator/Introducer Sheath |
| Trade/Proprietary Name: | Merit Prelude Sheath Introducer |
| Device Classification | |
| Panel: | Cardiovascular |
| Device Class: | Class II |
| Product Code: | 74 DRE |
| Regulation Number: | 21 CFR 870.1310 |
| Predicate Device Identification | |
| Device Brand Name | Cordis Avanti®+ Catheter SheathIntroducer System |
| Classification Name | Dilator, Vessel, For PercutaneousCatheterization |
| Device Class | Class II |
| Classification Panel Number | 870 Cardiovascular Devices |
| Product Code | DRE |
Device Description
Manufacturer
Registration Number
Merit's Prelude consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 3-way stopcock is affixed to the proximal end of the side port extension. The Prelude assembly includes a vessel dilator that snaps securely into the sheath introducer hub.
Cordis Corporation
1016427
Intended Use
The Prelude 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.
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Summary of Characteristics in Relation to Predicate Device
Does the new device have the same indication statement as the predicate device? Yes.
Although there are minor differences, the intended use is the same, (i.e., to gain intravascular access).
Does the new device have the same technological characteristics, e.g., design, materials, etc. as the predicate device?
Yes.
The Merit Prelude Sheath Introducer employs a similar method of operation and design as compared to the predicate device. Both devices consist of a sheath introducer that has a side port extension tube with a stopcock attached to it and a vessel dilator. Both devices are comprised of similar materials and are the same sizes.
Are the descriptive characteristics precise enough to ensure equivalence to the predicate device?
No.
Bench testing was conducted on the Prelude in order to establish substantial equivalence. Comparative testing with the predicate device performed includes radiodetectability of the sheath introducer and vessel dilator, valve leak pressure, tip insertion force, sheath hub/cap snap fit, dilator snap fit to sheath hub, and guide wire compatibility.
Are performance data available to assess effects of the new device as compared to the predicate device?
Yes.
Performance testing was conducted according to international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Prelude, comparison with the predicate device was conducted (i.e., valve leak, tip insertion force).
Does performance data demonstrate equivalence?
Yes.
Performance data demonstrate that the Prelude is substantially equivalent to the predicate device.
Conclusion: "Substantial Equivalence" Determination
Based on CDRH's substantial equivalence decision tree, the Prelude is substantially equivalent to the predicate device.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
MAY - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kema Quality B.V. c/o Ms. Jerry Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095-2416
K050962 Re: Trade Name: Merit Prelude™ Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: II Product Code: DRE Dated: April 15, 2005 Received: April 18, 2005
Dear Ms. Hendrickson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booseer a red the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the entrobate) in the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 2017 11:31 in accordance with the provisions of the Federal Food, DNIg, devices that have occh recuired in assee approval of a premarket approval application (PMA). and Cosmetic Act (1107 market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 If your device is onashined (600 world) als. Existing major regulations affecting your device can may be subject to sable additions, 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. Jerry Hendrickson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a buceaux complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA nas made a decertifications administered by other Federal agencies. You must light or any Federal statures and regulations daministered of registration and listing (21 l
ecomply with all the Act's requirements, including, but not limited to: set comply with an the Act s requirements, moreans, and manufacturing practice requirements as sets CHR Part 807); labeling (21 CFR Part 800); government 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (Decisions of the as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your dev I his letter will anow you to oegin manoling of substantial equivalence of your device to a legally premarket nothleation. THC PDF maining of basessification 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 (1 CFR Part 801), please If you desire specific advice for your acon 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Complaned at (210) 276 - 17 - 17 807.97). You may obtain " Misoranaling by telefonec to promantee nowlite as act from the Division of Small other general information on your responsible in a sais and its toll-free number (800) 638-2041 or and index bttps: Manufacturers, International and Consulter Prosisions of the more of the many of the states html.
Sincerely yours,
Ouma R. Kidner
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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Merit Medical Systems, Inc. Merit Prelude™ Sheath Introducer ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL
INDICATION(S) FOR USE STATEMENT *
510(k) Number (if known): Kb50962
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.
X Prescription Use (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. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K 050962
§ 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).