(49 days)
No
The summary describes a simple introducer sheath kit and explicitly states it is identical to a predicate device cleared under a previous 510(k). There is no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No
The device is described as an introducer sheath and dilators for introducing pacing leads or catheters, which are tools for accessing the body, not for providing therapy directly.
No
The device is described as an "introducer" for pacing leads or catheters, which are tools used for interventional procedures, not for diagnosis. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly lists physical components like a sheath, dilators, and a guidewire, indicating it is a hardware 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 "for introduction of pacing leads or catheters into the body." This describes a device used in vivo (within the body) for procedural purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details components like a sheath, dilators, and a guidewire, which are typical for devices used to access and introduce other instruments into the body. There is no mention of reagents, assays, or anything related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The device is clearly intended for a procedural, interventional use within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.
Product codes
DYB
Device Description
The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Since the Impella CP Introducer is identical to its commercially available predicate device, no additional qualification testing was required for the substantial equivalence determination.
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
§ 870.1340 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 two logos. On the left is the Department of Health & Human Services USA logo. On the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
November 18, 2019
Abiomed, Inc. Robert Stewart Regulatory Affairs Manager 22 Cherry Hill Drive Danvers, Massachusetts 01923
Re: K192769
Trade/Device Name: Impella CP Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 30, 2019 Received: September 30, 2019
Dear Robert Stewart:
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
1
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 (OS) 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,
for
Jessica Paulsen Director Cardiac Electrophysiology, Diagnostics, & Monitoring Devices 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) K192769
Device Name Impella CP Introducer
Indications for Use (Describe)
The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.
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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Impella CP Introducer 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: | September 27, 2019 |
|---|---|
| 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: Impella CP Introducer Common or Usual Name: Introducer, Catheter FDA Classification: Class II, DYB, 21 CFR- 870.1340 Requlation Description: Catheter Introducer Performance standards do not currently exist for these devices. Performance Standard: (i.e. none established under section 514 of the F D & C Act.)
C. Predicate Device:
Oscor Introducer set, Model Adelante-S2 Introducer, K122084
D. Device Description:
The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).
E. Intended Use:
The Impella CP Introducer is intended for introduction of pacing leads and catheters into the bodv.
F. Comparison of Required Technological Characteristics:
All technological characteristics of the Impella CP Introducer are identical to its commercially available predicate, including its design, packaging, manufacturing, sterilization, and labeling.
G. Comparison to Predicate Device:
The Impella CP Introducer is identical to its commercially available predicate device.
H. Qualification Testing:
Since the Impella CP Introducer is identical to its commercially available predicate device, no additional qualification testing was required for the substantial equivalence determination.