(30 days)
No
The device description focuses on mechanical components and steerability via pull-wires, with no mention of AI or ML. The Special 510(k) is for IFU updates, not technological changes.
No.
The device facilitates the delivery of a therapeutic device (Amplatzer™ Amulet™ Left Atrial Appendage Occluder), but it is a delivery sheath itself, not a therapeutic device.
No
The device is described as a delivery sheath whose sole function is to provide a pathway for another device (Amplatzer™ Amulet™ Left Atrial Appendage Occluder). It does not gather information about the patient's condition for diagnosis.
No
The device description clearly outlines physical components such as a sheath, dilator, flush adapter, distal tip, sheath body, sheath handle, pull-wires, hemostasis valve, and side port. This indicates it is a hardware medical device, not software-only.
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 the delivery of the Amplatzer™ Amulet™ Left Atral Appendage Occluder." This describes a device used in vivo (within the body) to deliver another medical device.
- Device Description: The description details a physical sheath, dilator, and adapter designed for insertion into the body to create a pathway for another device. It mentions features like a steerable tip, radiopacity for fluoroscopy, and a hemostasis valve. These are characteristics of devices used in interventional procedures, not for testing samples in vitro (outside the body).
- Anatomical Site: The anatomical site is the "Left Atral Appendage," which is an internal part of the heart. IVDs typically analyze samples taken from the body (like blood, urine, tissue) in a laboratory setting.
- Input Imaging Modality: The mention of "fluoroscopy" indicates the device is used in conjunction with imaging techniques to visualize its placement within the body during a procedure. IVDs do not typically involve real-time imaging of the device within a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostic testing.
In summary, the Amplatzer™ Steerable Delivery Sheath is a medical device used for delivering another device within the body during a medical procedure. This falls under the category of an interventional or delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atral Appendage Occluder.
Product codes
DQY
Device Description
The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.
The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath, allowing for more accurate device placement. Additionally, a hemostasis valve and side port are integrated in the device handle to support improved procedural hemostasis control and ease of use. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35" guidewire and a 19F introducer.
This Special 510(k) is being submitted to add additional precautions and updated procedural steps to the Instructions for Use (IFU) of the Amplatzer Steerable Delivery Sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
Left Atrial Appendage
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)
A Human Factors evaluation of the Amplatzer Steerable Delivery Sheath was performed to confirm that the updated IFU did not introduced any new user-device interactions per the requirements of ANSI/AAMI/IEC 62366-1. It was concluded that use of the Amplatzer Steerable Delivery Sheath with the updated IFU remains safe and effective for the intended users, uses, and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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March 9, 2022
Abbott Medical Emily Jallen Regulatory Affairs Specialist II 5050 Nathan Lane N Plymouth, Minnesota 55442
Re: K220340
Trade/Device Name: Amplatzer™ Steerable Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 2, 2022 Received: February 7, 2022
Dear Emily Jallen:
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.
1
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 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.
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220340
Device Name Amplatzer™ Steerable Delivery Sheath
Indications for Use (Describe)
The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atral Appendage Occluder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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/0 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" in a blue box on the left, followed by the word "Abbott" in bold, black font on the right. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
SUBMITTER INFORMATION -
Submitter Name: Abbott Medical
| Submitter Address: | 5050 Nathan Lane North |
|---|---|
| Plymouth, MN 55442 | |
| USA | |
| Phone: | +1 (651) 756-3583 |
| Contact Person: | Emily Jallen |
| Date Prepared: | February 2, 2022 |
DEVICE ll.
| Name of Device: | Amplatzer™ Steerable Delivery Sheath |
|---|---|
| Common Name: | Catheter Delivery System |
| Classification Name: | Catheter, Percutaneous (21 CFR 870.1250) |
| Regulatory Class: | II |
| Product Code: | DQY |
111. PREDICATE DEVICES
Primary Predicate: Amplatzer™ Steerable Delivery Sheath (K212026, cleared September 27.2021)
IV. DEVICE DESCRIPTION
The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.
The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath, allowing for more accurate device placement. Additionally, a hemostasis valve and side port are integrated in the device handle to support improved procedural hemostasis control and ease of use. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35" guidewire and a 19F introducer.
This Special 510(k) is being submitted to add additional precautions and updated procedural steps to the Instructions for Use (IFU) of the Amplatzer Steerable Delivery Sheath.
4
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V. INDICATION FOR USE
The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
There are no changes in technological characteristics from the predicate device.
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
A Human Factors evaluation of the Amplatzer Steerable Delivery Sheath was performed to confirm that the updated IFU did not introduced any new user-device interactions per the requirements of ANSI/AAMI/IEC 62366-1. It was concluded that use of the Amplatzer Steerable Delivery Sheath with the updated IFU remains safe and effective for the intended users, uses, and use environments.
VIII CONCLUSION
As there are no changes in the indication for use, intended use, technological characteristics, the Amplatzer Steerable Delivery Sheath is substantially equivalent to the primary predicate device (K212026). The Amplatzer Steerable Delivery Sheath should perform as intended in the specified use conditions.