(54 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of an introducer kit, with no mention of AI or ML capabilities.
No
The device is described as an introducer kit intended to facilitate access to the vascular system for the introduction and removal of other devices, specifically the Impella CP Catheter. It is an access tool rather than a device that provides therapy itself.
No
The device is an introducer kit designed to facilitate access to the vascular system for the introduction and removal of other medical devices (Impella CP Catheter), rather than for diagnosing conditions.
No
The device description explicitly details physical components like an introducer sheath, dilator, guidewire, and luer adapter, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical introducer sheath and dilator designed for insertion into the vascular system. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
- Anatomical Site: The anatomical site is the "Vascular system," which is an in vivo location.
Therefore, the Abiomed 14Fr Low Profile Introducer Kit is a medical device used for a procedural purpose within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Abiomed 14Fr Low Profile Introducer Kit (Gen 2) is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, 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 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14Fr 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted on the Abiomed 14Fr Low Profile Introducer Kit (Gen2).
Bench Testing:
- Visual Inspection and Dimensional Verification ●
- . Sheath System Verification
- Simulated Use Testing Assessment .
- Packaging Validation Assessment .
- Biocompatibility Testing Assessment .
- . Sterilization Assessment
- . Leak Testing
- . Mechanical Testing
- Coating Integrity ●
- Particulate ●
- Radiopacity Assessment .
Performance testing (bench) was completed and showed that the subject device, Abiomed 14Fr Low Profile Introducer Kit (Gen2), 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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 6, 2024
Abiomed Inc. Anshul Shah Director, Regulatory Affairs 22 Cherry Hill Drive Danvers, Massachusetts 01923
Re: K241708
Trade/Device Name: Abiomed 14Fr Low Profile Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 6, 2024 Received: June 13, 2024
Dear Anshul Shah:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 M. Gillette -S
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
2
Indications for Use
510(k) Number (if known) K241708
Device Name Abiomed 14Fr Low Profile Introducer Kit
Indications for Use (Describe)
The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a logo with a grid of four squares. The top-left and bottom-left squares are blue, while the top-right and bottom-right squares are maroon. The squares are arranged in a 2x2 grid, creating a simple and abstract design.
Abiomed 14Fr Low Profile Introducer Kit 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 30, 2024 |
|---|---|
| Submitter's Name & Address: | ABIOMED, Inc. |
| 22 Cherry Hill Drive | |
| Danvers, MA 01923 | |
| Contact Person: | Anshul Shah |
| Director, Regulatory Affairs | |
| Ph: 323-541-5318 | |
| E-mail: anshah@abiomed.com |
B. Device Information:
| Trade or Proprietary Name: | Abiomed 14Fr Low Profile Introducer Kit |
|---|---|
| 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 Abiomed 14Fr Low Profile Introducer Set, which is cleared under K222113.
D. Device Description:
The Abiomed 14Fr Low Profile Introducer Kit (Gen 2) is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, 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 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end,
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Image /page/4/Picture/1 description: The image shows a logo with a grid-like pattern. The logo consists of four squares arranged in a 2x2 grid. The top-left and bottom-left squares are blue, while the top-right and bottom-right squares are red. The squares have rounded corners and are slightly separated from each other.
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 Abiomed 14Fr Low Profile Introducer Kit 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 Devices:
The subject device, 14Fr Low Profile Introducer (Gen2), is identical to the predicate device in Intended Use, general system components, sterilization, guidewire compatibility, insertion profile, and general mechanism of action. Differences between the subject device and the predicate 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 sheath materials, sidearm design, and hub component.
| Property | Primary Predicate | Subject Device |
|---|---|---|
| Manufacturer/ | ||
| Model Name/ | ||
| 510k Clearance | Abiomed 14Fr Low Profile Introducer Set | |
| (Gen1)/ | ||
| K222113 | Abiomed 14Fr Low Profile Introducer Kit | |
| (Gen2)/ | ||
| this submission | ||
| Intended Use | The 14Fr Low Profile Introducer Set is | |
| intended to facilitate access into the | ||
| vascular system. | The 14Fr Low Profile Introducer Kit is | |
| intended to facilitate access into the | ||
| vascular system. | ||
| 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. | The 14Fr Low Profile Introducer Kit is | |
| intended to facilitate access to the vascular | ||
| system for the introduction and removal of | ||
| the Impella CP Catheter and ancillary | ||
| devices. | ||
| General System | ||
| Components | A sheath consisting of hub with hemostasis valve, sidearm with stopcock, and a dilator with | |
| luer. | ||
| Sterilization | Ethylene Oxide | |
| Guidewire | 0.035" (or smaller) compatible guidewire | |
| Length | 13, 25 cm | 13, 25 cm |
| Insertion Profile | 14Fr | 14Fr |
| Sheath | Stainless steel reinforced Pebax tube | Stainless steel reinforced Pebax tube |
| Hub | Cap (polymer) w/ hemostasis valve | |
| (polymer),sidearm (polymer) w/ stopcock | ||
| (polymer), suture pad (polymer) | Cap (polymer) w/ hemostasis valve | |
| (polymer),sidearm (polymer) w/ stopcock | ||
| (polymer), suture pad (polymer) |
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Image /page/5/Picture/1 description: The image shows a logo consisting of eight circles arranged in a 2x4 grid. The circles are colored in two different shades: blue and red. The four circles on the left side of the logo are blue, while the four circles on the right side are red. The circles are arranged in a way that creates a visually appealing and balanced design.
| Property | Primary Predicate | Subject Device |
|---|---|---|
| Manufacturer/ | ||
| Model Name/ | ||
| 510k Clearance | Abiomed 14Fr Low Profile Introducer Set | |
| (Gen1)/ | ||
| K222113 | Abiomed 14Fr Low Profile Introducer Kit | |
| (Gen2)/ | ||
| this submission | ||
| Dilator | Tapered dilator (polymer) w/ Luer (polymer) | |
| with hydrophilic coating at dilator tip | Tapered dilator (polymer) w/ Luer (polymer) | |
| with hydrophilic coating at dilator tip | ||
| Coating | Hydrophilic coating at dilator tip | Hydrophilic coating at dilator tip |
| Mechanism of | ||
| Action, General | Inserted manually using standard | |
| techniques. Sheath left indwelling (in vessel) | ||
| after insertion and dilator removal. | Inserted manually using standard | |
| techniques. Sheath left indwelling (in | ||
| vessel) after insertion and dilator removal. | ||
| Radiopacity | Radiopaque (sheath has internal metal coil) | Radiopaque (sheath has internal metal coil) |
G. Performance Testing:
The following performance testing was conducted on the Abiomed 14Fr Low Profile Introducer Kit (Gen2).
Bench Testing:
- Visual Inspection and Dimensional Verification ●
- . Sheath System Verification
- Simulated Use Testing Assessment .
- Packaging Validation Assessment .
- Biocompatibility Testing Assessment .
- . Sterilization Assessment
- . Leak Testing
- . Mechanical Testing
- Coating Integrity ●
- Particulate ●
- Radiopacity Assessment .
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Image /page/6/Picture/1 description: The image shows a logo with four squares arranged in a 2x2 grid. The top-left and bottom-left squares are blue, while the top-right and bottom-right squares are red. There is a small trademark symbol in the top-right corner of the logo.
H. Conclusions:
Performance testing (bench) was completed and showed that the subject device, Abiomed 14Fr Low Profile Introducer Kit (Gen2), 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 device.