(56 days)
Not Found
No
The description focuses on the mechanical and material properties of a physical introducer sheath set and does not mention any software, algorithms, or data processing related to AI/ML.
No.
This device is an introducer sheath set designed to facilitate the placement of interventional or diagnostic devices into a vessel, not to directly treat a condition. While it enables therapeutic procedures, it is not therapeutic itself.
No
This device is an introducer sheath set used to facilitate the placement of other interventional or diagnostic devices. It does not perform any diagnostic function itself.
No
The device description clearly outlines a physical medical device consisting of a sheath, dilator, needle, guide wire, syringe, and scalpel, all of which are hardware components.
Based on the provided information, the EXTesia Introducer Sheath Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate the insertion of devices into a vessel (vein or artery) for interventional or diagnostic purposes. This is a procedural device used in vivo (within the living body).
- Device Description: The description details a physical device (sheath, dilator, needle, guide wire, etc.) used for accessing blood vessels. It does not describe a device used to examine specimens derived from the human body in vitro (outside the living body).
- Anatomical Site: The device is used on the vein or artery, which are parts of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EXTesia Introducer Sheath Set is a tool used to access the body for other procedures, not to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.
EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel (intravascular; vein or artery)
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)
Testing was conducted to validate the biocompatibility, sterilization, mechanical integrity, functionality, and product specifications of the EXTesia Introducer Sheath Set. Each individual component was subjected to individual testing as well the entire working system as well. Simulated Usability testing was also completed and passed by the EXTesia Introducer Sheath Set. These studies were completed successfully and the EXTesia Introducer Sheath Set has been validated to maintain its mechanical integrity, functionality, and meets the requirements for product specifications during use within 3 years of shelf life.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
April 27, 2022
Curatia Medical Co. % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K220604
Trade/Device Name: EXTesia Introducer Sheath Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 2, 2022 Received: March 2, 2022
Dear Breanne Butler:
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 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.
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention 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) K220604
Device Name EXTesia Introducer Sheath Set
Indications for Use (Describe)
The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.
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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510(k) Summary
A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Curatia Medical Co |
|---|---|
| Company Contact Person: | |
| Address: | |
| Phone: | |
| Email: | Jessica Chiu |
| 830 Stewart Dr. Sunnyvale, CA 94085 | |
| (408) 773-8839 | |
| jchiu@curatiamed.com | |
| Submission Correspondent: | |
| Address: | |
| Phone: | |
| Email: | Breanne Butler, Regulatory Affairs Consultant |
| 1321 Upland Dr. Suite 6792 Houston, TX 77043 | |
| (860) 810-5594 | |
| bbutler@medavice.com | |
| Date Prepared: | February 2022 |
| Proprietary Name: | EXTesia Introducer Sheath Set |
| Common Name: | Introducer Sheath |
| Product Code: | DYB |
| Device Classification: | Class 2 |
| Predicate Device: | |
| Reference Device: | Terumo Medical Glidesheath Slender |
| Terumo Medical Radifocus Introducer Kit |
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Device Description:
The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.
EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.
Indications for Use:
The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.
Comparison to Predicate Devices:
EXTesia Introducer Sheath Set is similar in design, construction, and performance characteristics to the following commercially available world leading products: RADIFOCUS Introducer II Kit and Glidesheath Slender Introducer Sheath Kit, manufactured by Terumo Corporation (K954234, K173831):
- Same indication for use
- Same product code, regulations and class
- Same target population
- o Same components
- Same guide wire types/OD, entry needle types/OD, syringe capacity and scalpel specifications
- Similar sheath size, sheath length and dilator length
- Similar materials
- Same sterile barrier system and method of sterilization
- Same biocompatibility testing
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Performance Testing
Testing was conducted to validate the biocompatibility, sterilization, mechanical integrity, functionality, and product specifications of the EXTesia Introducer Sheath Set. Each individual component was subjected to individual testing as well the entire working system as well. Simulated Usability testing was also completed and passed by the EXTesia Introducer Sheath Set. These studies were completed successfully and the EXTesia Introducer Sheath Set has been validated to maintain its mechanical integrity, functionality, and meets the requirements for product specifications during use within 3 years of shelf life.
Clinical Testing
No Clinical Testing was required for this product.
Statement of Equivalence
EXTesia Introducer Sheath Set
As summarized above, the main differences between the subject (Curatia Medical -EXTesia Introducer Sheath Set) and predicate and reference devices (Terumo Corporation - RADIFOCUS Introducer II Kit and Glidesheath Slider) are:
- Sheath Dimensions
- Dilator Length
- Predicate devices use Bismuth Trioxide as a material
Based on comparison of indications for use, user population, performance testing, mechanical and technological features, the EXTesia Introducer Sheath Set has been shown to be substantially equivalent to the legally marketed predicate device. This device does not raise any new safety or effectiveness questions as compared to the predicate device.