(160 days)
No
The 510(k) summary describes a mechanical steerable sheath and does not mention any AI or ML components or functionalities. The performance studies focus on mechanical properties, sterilization, biocompatibility, and user evaluation in a simulated model, none of which indicate the presence of AI/ML.
No.
The device is a steerable sheath and dilator used to facilitate placing other cardiovascular catheters into the heart. It does not directly provide therapy.
No
The device is described as a steerable sheath intended for introducing other cardiovascular catheters into the heart. Its purpose is to facilitate the placement of other devices, not to diagnose conditions itself.
No
The device description clearly outlines physical components such as a steerable shaft, handle, Tuohy-Borst adapter, side port, and dilator. Performance studies also include mechanical testing and sterilization validation, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing various cardiovascular catheters into the heart." This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device (sheath, dilator, handle, etc.) used for accessing anatomical sites.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are designed to perform tests on biological samples to diagnose diseases or conditions.
The VizaraMed Multiflex Steerable Sheath is a medical device used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The VizaraMed Multiflex Steerable Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The VizaraMed Multiflex Steerable Sheath is a deflectable, sterile, single-use, percutaneous steerable sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The sheath is available in two sizes and consists of a steerable shaft capable of threedimensional shapes, a handle with lockable steering controls, a Tuohy-Borst adapter with a hemostasis valve, a side port, and atraumatic soft distal tip. The shaft is radiopaque for visualization under fluoroscopy. The accompanying dilator is packaged with the sheath in a pouch for removal.
The 12.5F sheath can accommodate devices of 3F(0.039") - 12.5F (0.162"). The 15.5F sheath can accommodate devices sized 3F (0.039") - 15.5F (0.203").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy (for visualization of the radiopaque shaft)
Anatomical Site
Heart, including the left side of the heart through the interatrial septum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians (in a simulated heart model)
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)
Mechanical Properties: Mechanical testing, including dimensional verification, tensile testing, and leak testing, were conducted to ensure the Multiflex Steerable Sheath meets design requirements to support substantial equivalence to the predicate.
Sterilization and Packaging: Sterilization validation via ethylene oxide (EO) per ISO 11135 was conducted to ensure design requirements and to support substantial equivalence to the predicate. Sterilization validation used fractional and full cycles, and appropriate sample size of final preconditioned, packaged product that incorporated the use of biological indicators (BI) for the inoculated product (IP).
Usability Assessment: Subjective and objective evidence was obtained via questionnaire from physicians to assess critical tasks in a simulated heart model. Training was provided followed by user evaluation while manipulating the device.
Biocompatibility: Testing was conducted for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity and hemocompatibility. All tests were found to meet acceptance criteria, supporting substantial equivalence to the predicate.
Key Results: The results of the tests support the conclusion that the VizaraMed Steerable Sheath meets design input requirements based on the intended use and that it is substantially equivalent to the predicate.
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.
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
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November 14, 2022
VizaraMed, Inc. Jack P Douglas, PhD Vice President, Regulatory Affairs 1914 O'Toole Way San Jose, California 95131
Re: K221655
Trade/Device Name: Multiflex Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: June 3, 2022 Received: June 7, 2022
Dear Dr. Jack Douglas:
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
1
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 (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 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,
S
Ankurita Datta - Digitally signed by Ankurita Datta -S Date: 2022.11.14 14:35:55 -05'00'
for Rachel Neubrander 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) K221655
Device Name Multiflex Steerable Sheath
Indications for Use (Describe)
The VizaraMed Multiflex Steerable Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 1. Date prepared | June 1, 2022 |
|---|---|
| 2. Manufacturer | VizaraMed, Inc. |
| 3. Contact | Jack P Douglas, PhD |
| Vice President, Regulatory Affairs | |
| VizaraMed, Inc. | |
| 1914 O'Toole Way | |
| San Jose, CA 95131 | |
| (510) 792-7477 | |
| 4. Contract Manufacturer Name | Novel Cath |
| (A Cirtec Company) | |
| 90 Great Oaks Blvd. | |
| San Jose, CA 95119 | |
| 5. Device Identification | Trade Name: Multiflex Steerable Sheath |
| Common Name: Introducer, Catheter | |
| Classification Name: Catheter Introducer | |
| Class: Class II, 21 CFR 870.1340 | |
| Product Code: DYB | |
| Classification Panel: Cardiovascular |
510(k) SUMMARY
6. Device Description
The VizaraMed Multiflex Steerable Sheath is a deflectable, sterile, single-use, percutaneous steerable sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The sheath is available in two sizes and consists of a steerable shaft capable of threedimensional shapes, a handle with lockable steering controls, a Tuohy-Borst adapter with a hemostasis valve, a side port, and atraumatic soft distal tip. The shaft is radiopaque for visualization under fluoroscopy. The accompanying dilator is packaged with the sheath in a pouch for removal.
The 12.5F sheath can accommodate devices of 3F(0.039") - 12.5F (0.162"). The 15.5F sheath can accommodate devices sized 3F (0.039") - 15.5F (0.203").
4
-
- Intended Use
The VizaraMed Multiflex Steerable Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
- Intended Use
-
- Predicate Device
- St. Jude Medical Agilis Steerable Introducer [K081645]
-
- Reference Device
- Cook, Inc. Extra Large Check-Flow Introducer [K203670] ●
-
- Characteristics of Substantial Equivalence
The VizaraMed Multiflex Steerable Sheath is substantially equivalent to the predicate device based on the following:
- Indications for Use
- Specifications ●
- Product features ●
- Technological characteristics ●
- Product design
- Materials
- Sterilization method
- Mechanical testing
- Biocompatibility testing ●
The subject device was subjected to applicable testing to ensure reliable design and performance under testing parameters. The testing performed is described below:
5
11. Mechanical Properties
Mechanical testing, including dimensional verification, tensile testing, and leak testing, were conducted to ensure the Multiflex Steerable Sheath meets design requirements to support substantial equivalence to the predicate.
12. Sterilization and Packaging
Sterilization validation via ethylene oxide (EO) per ISO 11135 was conducted to ensure design requirements and to support substantial equivalence to the predicate. Sterilization validation used fractional and full cycles, and appropriate sample size of final preconditioned, packaged product that incorporated the use of biological indicators (BI) for the inoculated product (IP).
13. Usability Assessment
Subjective and objective evidence was obtained via questionnaire from physicians to assess critical tasks in a simulated heart model. Training was provided followed by user evaluation while manipulating the device.
14. Biocompatibility
The Vizaramed Sheath is considered to be a limited contact (≤24 hrs.), externally communicating device used in circulating blood. Testing was conducted for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity and hemocompatibility. All tests were found to meet acceptance criteria, supporting substantial equivalence to the predicate.
15. Conclusions
The results of the tests support the conclusion that the VizaraMed Steerable Sheath meets design input requirements based on the intended use and that it is substantially equivalent to the predicate.