(87 days)
No
The device description and performance studies focus on the physical components and mechanical performance of a vascular introducer set, with no mention of AI or ML capabilities.
No
Explanation: The device is an introducer set designed to facilitate access to the vascular system for other medical devices (Impella CP Catheter), rather than directly treating a disease or condition itself.
No
This device is an introducer set, intended to facilitate access to the vascular system for the introduction and removal of catheters and ancillary devices. Its description and intended use clearly indicate it is a tool for accessing the body, not for diagnosing conditions.
No
The device description clearly outlines physical components like a sheath, dilator, guidewire, and luer adapter, and the performance studies focus on bench testing of these physical attributes.
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 a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a physical device (introducer sheath, dilator, guidewire) designed to be inserted 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, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies described (bench testing, mechanical testing, biocompatibility, etc.) are typical for in vivo medical devices, not IVDs which would focus on analytical and clinical performance related to diagnostic accuracy.
Therefore, the Abiomed 14Fr Low Profile Introducer Set is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DYB
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.
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)
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.
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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 Drive | |
| Danvers, MA 01923 | |
| Contact Person: | J. Kenneth Ryder |
| Senior Director, Global Regulatory Affairs | |
| Ph: 978-646-1707 | |
| E-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:
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
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Image /page/4/Picture/0 description: The image shows a logo with four rounded squares arranged in a 2x2 grid. The squares in the top-left and bottom-left corners are colored blue, while the squares in the top-right and bottom-right corners are colored red. A small "TM" symbol is located in the top-right corner of the logo, next to the red square.
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 Introducer | ||
| Sheath/ | |||
| K160254 | Teleflex 10Fr Arrow Sheath/ | ||
| K780532 | Abiomed 14 Fr Low | ||
| Profile Introducer Set/ | |||
| this submission | |||
| Intended Use | The GORE DrySeal Sheath is | ||
| intended to facilitate access | |||
| into the vascular system. | The Arrow Sheath is intended | ||
| to facilitate access into the | |||
| vascular system. | The 14Fr Low Profile | ||
| Introducer Set is intended | |||
| to facilitate access into the | |||
| vascular system. | |||
| Indications for | |||
| Use | The GORE DrySeal Sheath is | ||
| intended to be inserted in the | |||
| vasculature to provide a | |||
| conduit for the insertion of | |||
| endovascular devices while | |||
| minimizing blood loss | |||
| associated with such insertions. | The Arrow Sheath is intended | ||
| for use in the hospital | |||
| catheterization laboratory for | |||
| the percutaneous introduction | |||
| of various devices into veins | |||
| and/or arteries in a variety of | |||
| diagnostic and therapeutic | |||
| procedures. | 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 | |||
| General System | |||
| Components | A sheath consisting of hub with hemostasis valve, extension tube with stopcock, and a dilator | ||
| with 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 Introducer | ||
| Sheath/ | |||
| K160254 | Teleflex 10Fr Arrow Sheath/ | ||
| K780532 | Abiomed 14 Fr Low | ||
| Profile Introducer Set/ | |||
| this submission | |||
| Length | 32-64 cm | 11 cm | 13, 25 cm |
| Insertion Profile | 14 Fr | 10 Fr | 14 Fr |
| Sheath | Stainless steel reinforced | ||
| hydrophilic coated Pebax tube | |||
| with PTFE liner | Rigid composite tube | ||
| (polymer coated metal coil) | Stainless steel reinforced | ||
| Pebax tube | |||
| Hub | Cap (polymer) w/ hemostasis | ||
| valve (polymer), extension tube | |||
| (polymer) w/ stopcock | |||
| (polymer), suture eyelet | Cap (polymer) w/ hemostasis | ||
| valve (polymer), extension | |||
| tube (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) with | |||
| hydrophilic coating at | |||
| dilator tip | |||
| Coating | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating at |
| dilator tip | |||
| Mechanism of | |||
| Action, General | Inserted manually using standard techniques. Sheath left indwelling (in vessel) after insertion | ||
| and dilator removal. | |||
| Radiopacity | Radiopaque (sheath has marker at distal tip) | Radiopaque (sheath has | |
| internal 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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Image /page/6/Picture/0 description: The image shows a logo consisting of eight circles arranged in a 2x4 grid. The circles are colored in two shades: blue and red. The top-left four circles are blue, while the bottom-right four circles are red. The circles are arranged in a way that creates a visually appealing and balanced design. The logo also has a trademark symbol in the top right corner.
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.