(160 days)
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.
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").
The provided document describes the VizaraMed Multiflex Steerable Sheath (K221655), a "Catheter introducer" device. However, it does not contain the detailed acceptance criteria for a device-specific performance study, nor does it present the results of such a study in a manner that would allow filling out the requested table for performance metrics.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (St. Jude Medical Agilis Steerable Introducer [K081645]) through various tests. These tests are described at a high level, but the specific acceptance criteria and the quantitative results are not provided.
Here's a breakdown of what is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document lists types of tests performed (Mechanical properties, Sterilization, Usability, Biocompatibility) but does not provide specific numerical acceptance criteria or the reported device performance against those criteria. For example, for "Tensile Testing," it doesn't state "tensile strength > X MPa" or the actual measured value.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing for most tests.
- For "Sterilization validation," it mentions "appropriate sample size of final preconditioned, packaged product," but doesn't specify the number.
- No information on the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This question typically pertains to studies involving image analysis or diagnostic performance where human experts establish a "ground truth" (e.g., presence/absence of a disease). The studies described here are primarily engineering and safety evaluations of a physical medical device.
- For "Usability Assessment," it mentions "physicians" but doesn't specify the number or their qualifications.
4. Adjudication Method for the Test Set:
- Not applicable. As above, this is for studies where expert disagreement on ground truth needs to be resolved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. An MRMC study is not mentioned. The "Usability Assessment" involved "physicians" evaluating the device, but it wasn't a comparative effectiveness study comparing human readers with and without AI assistance, as the device itself is not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used:
- Varies by test, but not explicitly detailed as "ground truth" in the diagnostic sense.
- For mechanical testing, the "ground truth" would be engineering specifications and standards.
- For sterilization, established protocols and biological indicators.
- For biocompatibility, standard toxicology and material science criteria.
- For usability, physician feedback based on simulated use.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above.
In summary, the provided FDA 510(k) clearance letter and summary discuss the physical and functional characteristics of a medical device (Multiflex Steerable Sheath) and the types of engineering, safety, and performance tests conducted to demonstrate its substantial equivalence to a predicate device. However, it does not provide the detailed quantitative acceptance criteria and results typically found in a clinical performance study for diagnostic AI/ML devices, which the posed questions relate to.
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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
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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, PhDVice President, Regulatory AffairsVizaraMed, Inc.1914 O'Toole WaySan 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 SheathCommon Name: Introducer, CatheterClassification Name: Catheter IntroducerClass: Class II, 21 CFR 870.1340Product Code: DYBClassification 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").
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-
- 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:
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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.
§ 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).