(24 days)
The Prelude® 7F Short 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
The Prelude® 7F Short Sheath Introducer consists of a sheath introducer with integral hemostasis valve and side port extension tubing extending from the sheath hub. A detachable 3-way stopcock is connected to the side port extension tubing. A compatible vessel dilator is provided with the introducer. The device is available in 7F size with a sheath tubing length of 11cm. The French size designates the size of the catheter the sheath will accept. The 11cm effective length of the sheath introducer refers to the usable length of the sheath. The French size and wire tip size are printed on the dilator hub indicating the size of the catheter and guide wire that the sheath will accept.
The provided document describes the Prelude® 7F Short Sheath Introducer and its premarket notification (510(k)). The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove specific clinical performance criteria of a novel AI-powered diagnostic device. Therefore, many of the requested points related to AI performance, ground truth, and expert studies are not applicable to this type of medical device submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from International Standard ISO 11070:1998) | Reported Device Performance |
|---|---|
| Dimensional verification | Met pre-determined acceptance criteria |
| Force at break - junction between sheath introducer and sheath hub | Met pre-determined acceptance criteria |
| Surface imperfections | Met pre-determined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "significant testing was successfully completed" but doesn't provide specific sample sizes for each test.
- Data Provenance: Not applicable in the context of device performance testing. The tests are laboratory-based and conducted on the manufactured device itself, not necessarily using patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a physical medical instrument, and its performance is evaluated through engineering and material testing, not through expert-reviewed clinical "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
- Not applicable. Performance testing for this type of device typically involves objective measurements against established engineering specifications and international standards, rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess reader performance with and without AI assistance. The Prelude® 7F Short Sheath Introducer is an interventional device, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study was not done. This is not an AI algorithm. Its performance is evaluated based on its physical properties and mechanical integrity.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance testing is defined by the technical specifications and criteria outlined in the ISO 11070:1998 standard ("Sterile, single-use intravascular catheter introducers") and the internal risk analysis. This involves objective measurements of physical properties (dimensions, force at break, surface imperfections) against predefined acceptable ranges.
8. Sample Size for the Training Set
- Not applicable. This device does not involve a training set as it's not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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K122190 Page 1 of 2
Prelude® 7F Short Sheath Introducer Section 5, 510(k) Summary Special Premarket Notification 510(k)
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AUG 1 7 2012
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Section 5
510(k) Summary
| GeneralProvisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | (801) 316-4831 | |
| Fax Number: | (801) 826-4113 | |
| Contact Person: | Dan Clark | |
| Date of Preparation: | July 23, 2012 | |
| Registration Number: | 1721504 | |
| SubjectDevice | Trade Name: | Prelude® 7F Short Sheath Introducer |
| Common/Usual Name: | Introducer Catheter | |
| Classification Name: | Introducer, Catheter | |
| PredicateDevice | Trade Name: | Prelude® Short Sheath Introducer |
| Classification Name: | Introducer, Catheter | |
| Premarket Notification: | K082063 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II | |
| 21 CFR § 870.1340 | ||
| FDA Product Code: DYB | ||
| Review Panel: Cardiovascular | ||
| Intended Use | The Prelude® 7F Short Sheath Introducer is intended to provide accessand facilitate the percutaneous introduction of various devices intoveins and/or arteries while maintaining hemostasis for a variety ofdiagnostic and therapeutic procedures. This device can also provideaccess to a native or synthetic graft used for hemodialysis. The sideport of the sheath allows adequate flow to perform temporaryhemodialysis. The device is not indicated for long term vascular orhemodialysis access. | |
| DeviceDescription | The Prelude® 7F Short Sheath Introducer consists of a sheathintroducer with integral hemostasis valve and side port extension tubingextending from the sheath hub. A detachable 3-way stopcock isconnected to the side port extension tubing. A compatible vessel dilatoris provided with the introducer. The device is available in 7F size with asheath tubing length of 11cm. The French size designates the size ofthe catheter the sheath will accept. The 11cm effective length of thesheath introducer refers to the usable length of the sheath. The Frenchsize and wire tip size are printed on the dilator hub indicating the size ofthe catheter and guide wire that the sheath will accept. | |
| Comparison toPredicateDevice | The subject device has the same technological characteristics (i.e.,design, material, chemical composition, energy source) as predicatedevice. The only difference is the sheath tubing on the subject device is11cm in length without a black marker tip and the sheath tubing on thepredicate device is 4cm in length with a black marker tip. | |
| Safety &PerformanceTests | No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject Prelude® 7F Short Sheath Introducer wasconducted based on the risk analysis and based on the requirements ofthe following international standard:ISO 11070:1998: Sterile, single-use intravascular catheterintroducers The following is a list of all significant testing that was successfullycompleted: Dimensional verification Force at break - junction between sheath introducerand sheath hub Surface imperfections The results of the testing demonstrated that the subject Prelude® 7FShort Sheath Introducer met the pre-determined acceptance criteriaapplicable to the safety and efficacy of the device. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performancetesting, the subject Prelude® 7F Short Sheath Introducer meets therequirements that are considered essential for its intended use and issubstantially equivalent to the predicate device, the Prelude® ShortSheath Introducer, manufactured by Merit Medical Systems, Inc. |
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Prelude® 7F Short Sheath Introducer
Section 5, 510(k) Summary
Special Premarket Notification 510(k)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 17 2012
Merit Medical Systems, Inc. % Dan Clark 1600 West Merit Pkwy. South Jordan, UT 84095 US
Re: K122190
Trade/Device Name: Prelude 7F Short Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: July 23, 2012 Received: July 24, 2012
Dear Mr. Clark:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Dan Clark
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
.g. Holleber
C. 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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Prelude® 7F Short Sheath Introducer Section 4, Indications for Use Special Premarket Notification 510(k)
Section 4
Indications for Use
510(k) Number (if known):
Device Name: Prelude® 7F Short Sheath Introducer
Indications for Use:
The Prelude® 7F Short 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
Prescription Use × (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)
ChyAillel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ 1122190
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).