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510(k) Data Aggregation
(138 days)
Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.
The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.
The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.
The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).
The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.
This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.
The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:
- Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
- Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
- Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.
In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML device.
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(129 days)
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
The Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
The Super Sheath Introducer Sheaths and Super Sheath Sets are similar to the 4F-9F with the addition of the 3.3 French sheath, compatible dilator and guidewire to the sheath line. The Super Sheath Introducer Sheath is available in 3.3F and lengths of 5 cm and 7 cm. The device is provided sterile and intended for one procedure use only.
The Super Sheath Introducer Sheath is packaged with one dilator. The Super Sheath Introducer Sheath Set consists of one sheath, one dilator, and one guidewire with inserter. The sheath shaft and hub are manufactured of polyamide and ethylene tetrafluoro ethylene; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.
The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The 3.3F Super Sheath Introducer Sheaths and provided dilator are compatible with a maximum recommended 0.025" guidewire. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.
The provided text describes a medical device (Super Sheath Introducer Sheaths and Sets) and its equivalence to a predicate device, rather than the acceptance criteria and study results for a new AI or diagnostic device. As such, most of the requested information (sample sizes, expert qualifications, MRMC studies, ground truth types, training data, etc.) is not applicable or present in this document.
However, I can extract the information related to the functional testing conducted to establish the performance of this medical device.
Acceptance Criteria and Device Performance (Functional Testing)
The document states that "Functional testing was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification." While specific numerical acceptance criteria are not provided, the types of tests performed indicate the performance characteristics that were evaluated and met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sheath Shaft Tensile Strength: Must withstand tensile forces. | Met product specification through testing. |
| Sheath Kink Resistance: Must resist kinking during use. | Met product specification through testing. |
| Connection Strength: Connections must be secure. | Met product specification through testing. |
| Hemostatic Valve Pressure Integrity: Valve must prevent blood leakage under pressure. | Met product specification through testing. |
| Sheath Valve Integrity / Sheath Pressure: Valve and sheath must maintain integrity under pressure. | Met product specification through testing. |
| Sheath Lubricity: Sheath must allow smooth passage. | Met product specification through testing. |
| Sheath Radiopacity: Sheath must be visible under fluoroscopy. | |
| (Note: Predicate had a marker, new device states "Not applicable" for marker. This implies the sheath material itself might be radiopaque or it's not a P.criterion for the 3.3F based on its intended use/size.) | Met product specification through testing. |
| Sheath / Dilator Corrosion Resistance: Must resist corrosion. | Met product specification through testing. |
| Dilator Tensile Strength: Dilator must withstand tensile forces. | Met product specification through testing. |
| Dilator Connection Strength: Dilator connections must be secure. | Met product specification through testing. |
| Guidewire Tensile Strength: Guidewire must withstand tensile forces. | Met product specification through testing. |
| Guidewire Radiopacity: Guidewire must be visible under fluoroscopy. | Met product specification through testing. |
| Guidewire Corrosion Resistance: Guidewire must resist corrosion. | Met product specification through testing. |
| Guidewire Torque Load: Guidewire must withstand torque. | Met product specification through testing. |
| Guidewire Torqueability: Guidewire must be steerable/torqueable. | Met product specification through testing. |
| Sterilization Efficacy: Device must be sterile. | Validated in accordance with ISO 11135-1:2007. |
| Biocompatibility: Device materials must be biocompatible. | Demonstrated by similarity to predicate in K052557. |
| Packaging Integrity: Packaging must maintain sterility and product integrity. | Demonstrated by similarity to predicate in K052557. |
| Product Shelf Life: Device must maintain performance over time. | Demonstrated by similarity to predicate in K052557 (3 years). |
Study Details (for a medical device, not AI)
- Sample size used for the test set and the data provenance: Not explicitly stated. The testing was functional/engineering testing of the device itself, not patient data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, functional tests performed according to protocols. "Ground truth" in this context would refer to engineering specifications and international standards, not expert medical opinion.
- Adjudication method for the test set: Not applicable. Results would be compared against established product specifications and standards.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
- The type of ground truth used: Product Specifications, International Standards (e.g., ISO 11135-1:2007 for sterilization), and in-house requirements.
- The sample size for the training set: Not applicable. This document describes the testing of a physical medical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
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(123 days)
SUPER SHEATH INTRODUCER SHEATH
Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.
The Super Sheath Introducer Sheaths are available in-4F-Device Description 9F diameters and available in lengths ranging from 7 to 25 cm. Some sheaths may be ordered with a suture wing and some sheaths have radiopaque markers. The devices are provided sterile and are intended for one procedure use only.
The Medikit Super Sheath Introducer Sheath is packaged with a dilator. The Super Introducer Sheath Sets consists of a sheath, a dilator and a mini guidewire, with Inserter, as described in this submission or a US commercially available mini guidewire meeting Medikit specifications. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and Ethylene shart and mac mac the (Teflon). Some sheaths have radiopaque markers that are embedded into the shaft 1.5 mm from the distal tip. The hubs, color-coded by French size, contain a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The sidetube extension is used for site management.
The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. It is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. There are two different dilators, 0.038" and a 0.035" guidewire compatible. The 4-8F-dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are pressed into the dilator hub with a bushing. The sheath hub and the dilator hub lock using a rotating motion.
Super Sheaths can be ordered with a Polypropylene suture wing color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures.
The uncoated mini guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The mini guidewire (with Inserter) is available in 45cm and 80cm lengths. The Inserter does not contact blood and is used strictly for guiding the guidewire into a cannula or introducer. A US commercially available mini guidewire (meeting Medikit specifications) may be used in the sets or the mini guidewire that is described in this submission.
This is a medical device submission for a "Super Sheath Introducer Sheath" which is a physical device, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria and study details for an AI/ML device are not applicable to this document. The document describes functional testing of the physical device to demonstrate substantial equivalence to a predicate device, as opposed to performance metrics for an AI/ML algorithm.
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