(56 days)
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.
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.
This document is a 510(k) summary for the EXTesia Introducer Sheath Set, not a study report that details specific acceptance criteria and device performance in a clinical study with human data. Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets cannot be extracted from this document.
However, based on the provided text, I can infer some information relevant to performance testing and the lack of clinical studies.
1. Table of acceptance criteria and the reported device performance:
The document broadly states that the device "meets the requirements for product specifications" but does not provide specific quantitative acceptance criteria or detailed performance results for each test.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Successfully passed (implied, as stated studies were "completed successfully" and device "meets the requirements for product specifications") |
| Sterilization | Successfully passed (implied, as stated studies were "completed successfully" and device "meets the requirements for product specifications") |
| Mechanical Integrity | Successfully passed (explicitly stated: "has been validated to maintain its mechanical integrity") |
| Functionality | Successfully passed (explicitly stated: "has been validated to maintain its... functionality") |
| Product Specifications | Successfully passed (explicitly stated: "meets the requirements for product specifications during use within 3 years of shelf life") |
| Simulated Usability | Passed by the EXTesia Introducer Sheath Set |
| Shelf Life | Validated to maintain mechanical integrity, functionality, and meet product specifications for 3 years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not specify sample sizes for mechanical, functionality, biocompatibility, sterilization, or simulated usability tests.
- Data Provenance: Not specified, but these are typically in-house laboratory and engineering tests, not clinical studies with human data from specific countries. The testing would be prospective (designed and executed for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable for performance testing described. The "ground truth" for mechanical and functional tests is typically based on engineering specifications and validated test methods, not expert human assessment in the way clinical studies would require. Simulated usability implies expert observation or evaluation but details on the number or qualifications of "experts" are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for performance testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies where there's a need to resolve discrepancies in human expert interpretations of ground truth. The performance testing outlined here (biocompatibility, sterilization, mechanical, functionality, simulated usability) would follow pre-defined test protocols with objective pass/fail criteria, not consensus-based adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. The document explicitly states: "No Clinical Testing was required for this product." This makes it clear that there was no study involving human readers/users in a comparative effectiveness setting as described for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The EXTesia Introducer Sheath Set is a physical medical device (catheter introducer), not a software algorithm or AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The performance testing focused on the physical characteristics and function of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance testing mentioned (biocompatibility, sterilization, mechanical integrity, functionality, product specifications, simulated usability), the "ground truth" would be established by engineering specifications, international standards, and established laboratory test methods. For example, biomechanical tests would have defined load limits, and sterility tests would have defined microbial reduction rates. Outcomes data, pathology, or expert consensus (in a clinical sense) are not relevant to these types of bench and simulated tests.
8. The sample size for the training set:
- Not applicable. This product is a physical medical device, 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, no training set was used.
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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.
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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 Chiu830 Stewart Dr. Sunnyvale, CA 94085(408) 773-8839jchiu@curatiamed.com |
| Submission Correspondent:Address:Phone:Email: | Breanne Butler, Regulatory Affairs Consultant1321 Upland Dr. Suite 6792 Houston, TX 77043(860) 810-5594bbutler@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 SlenderTerumo 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.
§ 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).