The 14 Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

Device Description

The Abiomed 14Fr Low Profile Introducer Set is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Set consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" quidewire. The 14Fr Low Profile Introducer Set is kitted with an 0.035" access quidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.

The 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14 Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14 Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Abiomed 14Fr Low Profile Introducer Set. The information provided heavily focuses on the comparison to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a quantitative format, nor does it detail a clinical study with human patients, as the clearance was based on bench testing and substantial equivalence to predicate devices.

Let's break down the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that the device "met the acceptance criteria," but it does not specify what those criteria are in a numerical or categorical table format for each test. Instead, it lists the types of tests performed.

Test Type	Reported Device Performance Statement
Visual Inspection and Dimensional Verification	Met acceptance criteria (implied by overall conclusion)
Sheath System Verification	Met acceptance criteria (implied by overall conclusion)
Simulated Use Testing	Met acceptance criteria (implied by overall conclusion)
Packaging Validation	Met acceptance criteria (implied by overall conclusion)
Biocompatibility Testing	Met acceptance criteria, safe for patient contact and duration (in accordance with ISO 10993-1)
Sterilization Assessment	Met acceptance criteria (implied by overall conclusion)
Leak Testing	Met acceptance criteria (implied by overall conclusion)
Mechanical Testing	Met acceptance criteria (implied by overall conclusion)
Coating Integrity	Met acceptance criteria (implied by overall conclusion)
Particulate	Met acceptance criteria (implied by overall conclusion)
Radiopacity	Radiopaque (sheath has internal metal coil)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified for each individual bench test. The document mentions "Performance testing (bench) was completed," but doesn't detail the number of units tested for each specific test.
Data Provenance: The document does not specify the country of origin of the data. The study was a retrospective evaluation based on bench testing, as it states "No clinical data were required to demonstrate substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as there was no test set involving human data or expert review to establish ground truth in the traditional sense for medical imaging or diagnostic devices. The acceptance was based on engineering and biocompatibility bench testing.

4. Adjudication method for the test set:

Not applicable. There was no human-reviewed test set requiring adjudication in the context of this 510(k) submission.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data were required to demonstrate substantial equivalence." This type of study would involve human readers and clinical cases, which was not part of this clearance process.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical introducer set, not an AI algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The performance evaluated was the device's physical and functional attributes through bench testing.

7. The type of ground truth used:

The "ground truth" for this device's performance was established via engineering specifications, material science standards, and biocompatibility standards (e.g., ISO 10993-1). For example, "leak testing" would have a pre-defined maximum allowable leak rate as its ground truth, based on engineering requirements for a safe and effective introducer.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. As stated above, there is no "training set" for this type of device.

Summary

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October 13, 2022

Abiomed Inc. Ken Ryder Sr. Director, Regulatory Affairs 22 Cherry Hill Drive Danvers. Massachusetts 01923

Re: K222113

Trade/Device Name: Abiomed 14Fr Low Profile Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 15, 2022 Received: July 18, 2022

Dear Ken Ryder:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222113

Device Name Abiomed 14 Fr Low Profile Introducer Set

Indications for Use (Describe)

The 14 Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Abiomed 14Fr Low Profile Introducer Set 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807.92.

A. Application Information:

Date Prepared:	July 15, 2022
Submitter's Name & Address:	ABIOMED, Inc.22 Cherry Hill DriveDanvers, MA 01923
Contact Person:	J. Kenneth RyderSenior Director, Global Regulatory AffairsPh: 978-646-1707E-mail: kryder@abiomed.com

B. Device Information:

Trade or Proprietary Name:	Abiomed 14Fr Low Profile Introducer Set
Common or Usual Name:	Introducer, Catheter
FDA Classification:	Class II, DYB, 21 CFR 870.1340
Regulation Description:	Catheter Introducer

ﻦ Predicate Device:

The primary predicate device was the Gore DrySeal Flex Introducer Sheath, which is cleared under K160254. The reference device was the Teleflex 10 Fr Arrow Sheath, which is cleared under K780532.

The predicate and reference devices have not been subjected to any design-related recall.

D. Device Description:

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devices. The 14 Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

E. Indications for Use:

INDICATIONS FOR USE:

The 14Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

F. Technological Characteristics Comparison of Subject and Predicate and Reference Devices:

The subject device, 14 Fr Low Profile Sheath, is identical to the predicate and reference devices in Intended Use, general system components, sterilization, guidewire compatibility, insertion profile, and general mechanism of action. Differences between the subject device and the predicate and reference devices were all determined to be minor, have no adverse impact on safety or effectiveness, and raise no different questions of safety or effectiveness compared to the predicate devices. These minor differences include Indications for Use, length, sheath design, hub design, dilator design, coating location, and method for achieving radiopacity.

Property	Primary Predicate	Reference Device	Subject Device
Manufacturer/Model Name/510k Clearance	Gore DrySeal Flex IntroducerSheath/K160254	Teleflex 10Fr Arrow Sheath/K780532	Abiomed 14 Fr LowProfile Introducer Set/this submission
Intended Use	The GORE DrySeal Sheath isintended to facilitate accessinto the vascular system.	The Arrow Sheath is intendedto facilitate access into thevascular system.	The 14Fr Low ProfileIntroducer Set is intendedto facilitate access into thevascular system.
Indications forUse	The GORE DrySeal Sheath isintended to be inserted in thevasculature to provide aconduit for the insertion ofendovascular devices whileminimizing blood lossassociated with such insertions.	The Arrow Sheath is intendedfor use in the hospitalcatheterization laboratory forthe percutaneous introductionof various devices into veinsand/or arteries in a variety ofdiagnostic and therapeuticprocedures.	The 14Fr Low ProfileIntroducer Set is intendedto facilitate access to thevascular system for theintroduction and removalof the Impella CP Catheterand ancillary devices
General SystemComponents	A sheath consisting of hub with hemostasis valve, extension tube with stopcock, and a dilatorwith luer.
Sterilization	Ethylene Oxide
Guidewire	0.035" (or smaller) compatible guidewire

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Property	Primary Predicate	Reference Device	Subject Device
Manufacturer/Model Name/510k Clearance	Gore DrySeal Flex IntroducerSheath/K160254	Teleflex 10Fr Arrow Sheath/K780532	Abiomed 14 Fr LowProfile Introducer Set/this submission

Length	32-64 cm	11 cm	13, 25 cm
Insertion Profile	14 Fr	10 Fr	14 Fr
Sheath	Stainless steel reinforcedhydrophilic coated Pebax tubewith PTFE liner	Rigid composite tube(polymer coated metal coil)	Stainless steel reinforcedPebax tube
Hub	Cap (polymer) w/ hemostasisvalve (polymer), extension tube(polymer) w/ stopcock(polymer), suture eyelet	Cap (polymer) w/ hemostasisvalve (polymer), extensiontube (polymer) w/ stopcock(polymer)	Cap (polymer) w/hemostasis valve(polymer), extension tube(polymer) w/ stopcock(polymer), suture pad(polymer)
Dilator	Tapered dilator (polymer) w/Luer (polymer)	Dilator (polymer) w/ Luer(polymer)	Tapered dilator (polymer)w/ Luer (polymer) withhydrophilic coating atdilator tip
Coating	Hydrophilic coating	Hydrophilic coating	Hydrophilic coating atdilator tip
Mechanism ofAction, General		Inserted manually using standard techniques. Sheath left indwelling (in vessel) after insertionand dilator removal.
Radiopacity	Radiopaque (sheath has marker at distal tip)		Radiopaque (sheath hasinternal metal coil)

G. Performance Testing:

The following performance testing was conducted on the Abiomed 14Fr Low Profile Introducer Set.

Bench Testing:

. Visual Inspection and Dimensional Verification
Sheath System Verification ●
. Simulated Use Testing
Packaging Validation .
. Biocompatibility Testing
Sterilization Assessment .
Leak Testing ●
Mechanical Testing ●
Coating Integrity ●
Particulate ●
Radiopacity .

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H. Conclusions:

Performance testing (bench) was completed and showed that the subject device, Abiomed 14Fr Low Profile Introducer Set, met the acceptance criteria and demonstrated substantial equivalence for its intended use. Biocompatibility safety testing conducted in accordance with ISO 10993-1 demonstrates that the device is safe for its patient contact and duration. No clinical data were required to demonstrate substantial equivalence. No new safety or performance issues were identified during the testing; therefore, the subject device may be considered substantially equivalent to the predicate and reference device.

Regulation Number and Section

§ 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).