(29 days)
Ultimum EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.
The Ultimum™ EV Hemostasis Introducer consists of a polyethylene introducer and dilator with a radiopaque marker band at the distal end. The introducer is fitted with a hemostasis valve for use during catheter introduction and/or exchange over a guidewire. The hub is located on the proximal end of the introducer, where a sideport with a three-way stopcock is provided for aspiration, fluid infusion, blood sampling, and pressure monitoring. The dilator is tapered at the distal tip with an internal lumen designed to accept guidewires that have a maximum diameter of 0.035" (0.889 mm).
The provided information describes a medical device, the Ultimum™ EV Hemostasis Introducer, and its regulatory submission (K140327). This submission focuses on modifications to an existing predicate device and demonstrates substantial equivalence through non-clinical testing. It does not describe an AI/ML-driven device or a clinical study involving human readers. Therefore, many of the requested categories related to AI performance, human reader improvement, and ground truth for deep learning models are not applicable or cannot be extracted from this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | Sheath Configuration; Device Outer Diameter (OD); Effective Sheath Length; Dilator Configuration; Dilator Sheath ID; Hemostasis Maintenance; Introducer Assembly Clot Management; Flushing Assembly (Kink Resistance); Insertion (Kink Resistance); Functional Use During Procedure; Tip Integrity; Suture Ring Seal Performance; Device Exchange; Device Integrity (Hemostasis Sheath Break Force); Device Integrity (Dilator Sheath Break Force); Device Integrity (Hemostasis Hub and Aspiration Tube Break Force); Device Integrity (Hub and Cap Break Force); Dilator Flushing; Device Compatibility (Sheath Hub); Device Compatibility (Dilator Hub ID) | All pre-determined acceptance criteria were met. |
| Biocompatibility Testing | Cytotoxicity; Sensitization; Intracutaneous Reactivity; Systemic Toxicity (Acute); Pyrogenicity; Hemocompatibility; Chemical Characterization. (Performed in accordance with ISO 10993-1). | All pre-determined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical bench and biocompatibility testing. It does not involve a "test set" in the context of AI/ML or a clinical study with human patients. Thus, there is no information on sample size for a test set or data provenance related to country of origin or retrospective/prospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for device performance in this context would be defined by engineering specifications, safety standards, and physiological limits demonstrated through bench and biocompatibility testing. There's no indication of clinical experts establishing ground truth for a test set in the traditional sense of diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This is not a study involving expert adjudication for diagnostic tasks.
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 not an AI-driven device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established through adherence to pre-determined engineering specifications, design requirements, and international standards (e.g., ISO 10993-1 for biocompatibility). Performance metrics are objectively measured in bench tests (e.g., break force, dimensions, hemostasis maintenance).
8. The Sample Size for the Training Set
Not applicable. This is not an AI-driven device. No training set was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI-driven device. No training set was used, and therefore, no ground truth for a training set was established.
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St. Jude Medical
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| 510(k) Summary | |
|---|---|
| 510(k) Number | K140327 |
| Submitter Information: | |
| Date Prepared: | March 6, 2014 |
| Submitter Name &Address: | St. Jude Medical5050 Nathan LanePlymouth, MN 55442 |
| Contact Person: | Loucinda BjorklundPrincipal Regulatory Affairs SpecialistPhone (651) 756-3230Fax (651) 756-5744PMehta@sjm.com |
| Device Information: | |
| Trade Name: | Ultimum™ EV Hemostasis Introducer |
| Common Name: | Catheter Introducer |
| Class | II |
| Classification Name: | 870.1340 Catheter introducer |
| Predicate Device: | Ultimum EV Hemostasis Introducer (K023447) |
| Device Description: | The Ultimum™ EV Hemostasis Introducer consists of a polyethyleneintroducer and dilator with a radiopaque marker band at the distal end. Theintroducer is fitted with a hemostasis valve for use during catheterintroduction and/or exchange over a guidewire. The hub is located on theproximal end of the introducer, where a sideport with a three-waystopcock is provided for aspiration, fluid infusion, blood sampling, andpressure monitoring. The dilator is tapered at the distal tip with an internallumen designed to accept guidewires that have a maximum diameter of0.035" (0.889 mm). |
| Intended Use:(Indications for Use) | Ultimum EV Hemostasis Introducers are designed for the introduction ofangiographic catheters, closed end catheters, balloon catheters andelectrodes into a vessel where minimizing blood loss is essential. |
| Comparison to PredicateDevices | The modified Ultimum EV Hemostasis Introducer has the same intendeduse and fundamental scientific technology as the predicate device. Themodified Ultimum EV has a redesigned hemostasis seal, minordimensional and polymer material changes on the introducer hubassembly, and the use of an adhesive to bond the extension tube to the hub.The dilator packaged with the modified Ultimum EV is yellow. Inaddition, the modified Ultimum EV packaging is a PVC tray placed into apouch. The technological characteristics of the modified Ultimum EVHemostasis Introducer are substantially equivalent to the predicate deviceincluding packaging, biocompatibility, sterilization, and labeling.Biocompatibility and bench performance testing demonstrated that the |
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St. Jude Medical
K140327 – 510(k) Summary
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| Summary on Non-Clinical | Performance bench testing and biocompatibility testing were performed to verify the device modifications met the pre-determined acceptance criteria. |
|---|---|
| Testing | The following performance bench tests were performed: |
| Sheath Configuration; Device Outer Diameter (OD) Effective Sheath Length Dilator Configuration; Dilator Sheath ID Hemostasis Maintenance; Introducer Assembly Clot Management; Flushing Assembly (Kink Resistance) Insertion (Kink Resistance) Functional Use During Procedure Tip Integrity Suture Ring Seal Performance; Device Exchange Device Integrity; Hemostasis Sheath Break Force Device Integrity; Dilator Sheath Break Force Device Integrity; Hemostasis Hub and Aspiration Tube Break Force Device Integrity; Hub and Cap Break Force Dilator Flushing Device Compatibility; Sheath Hub Device Compatibility; Dilator Hub ID | |
| Biocompatibility testing was performed in accordance with ISO 10993-1, | |
| the devices were tested for cytotoxicity, sensitization, intracutaneous | |
| reactivity, systemic toxicity (acute), pyrogencity, hemocompatibility and | |
| chemical characterization. The results of the non-clinical data | |
| demonstrates that the subject device has met the acceptance criteria for performance bench testing and biocompatibility. | |
| Statement of Equivalence | The modified Ultimum EV Hemostasis Introducer has the same |
| indications for use and technological characteristics as the predicate | |
| device. Based on this and the data provided in this pre-market notification, | |
| the subject device and predicate device has been shown to be substantially | |
| equivalent. |
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
March 11, 2014
St. Jude Medical Loucinda Bjorklund Sr. Regulatory Affairs Specialist 5050 Nathan Lane N Plymouth, MN 55442
Re: K140327
Trade/Device Name: 19F Ultimum EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 7, 2014 Received: February 10, 2014
Dear Ms. Bjorklund,
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. Iisting 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
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Page 2 - Loucinda Bjorklund
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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,
for 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
K140327 510(k) Number (if known): Device Name: Ultimum EV Hemostasis Introducer
Indications for Use:
Ultimum EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
X ============================================================================================================================================================================ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (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)
M. A. Gilliam
§ 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).