(207 days)
The TalWire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. The TalWire is not intended for use in the coronary or cerebral vasculature.
The TalWire is a family of vascular access mandrel guidewires. The TalWire is available in various sizes: between 40 to 80 cm in length and in the 0.018" diameter range. The TalWire is available with Nitinol (NiTi) cores and Stainless Steel coils. The TalWire consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A microcoil is wound with a lumen that is then placed over the tapered distal end of the coil is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The TalWire includes an articulatable tip at the distal end of the guidewire. The finished guidewire is placed in a protective polymer dispenser hoop in a labeled Tyvek pouch. The TalWire is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
The provided text describes a 510(k) premarket notification for a medical device called TalWire, a catheter guidewire. It compares the TalWire to a predicate device and includes performance data to support substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests passed and met the predefined acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each performance test. It only lists the types of performance tests conducted.
| Test | Acceptance Criteria (Not Explicitly Stated, Assumed to be "Pass") | Reported Device Performance |
|---|---|---|
| Dimensional Attributes | (Assumed: Meets design specifications) | Passed |
| Visual Inspection | (Assumed: No defects) | Passed |
| Simulated Use | (Assumed: Performs as intended in simulated environment) | Passed |
| Tensile Strength | (Assumed: Meets strength requirements) | Passed |
| Torque Strength | (Assumed: Meets torque requirements) | Passed |
| Torqueability | (Assumed: Adequate torque response) | Passed |
| Corrosion Resistance | (Assumed: No significant corrosion) | Passed |
| Kink Resistance | (Assumed: Resists kinking) | Passed |
| Tip Flexibility | (Assumed: Adequate flexibility) | Passed |
| Radiopacity | (Assumed: Visible under fluoroscopy) | Passed |
| Flex Resistance | (Assumed: Resists fatigue/damage from flexing) | Passed |
| Fracture Resistance | (Assumed: Resists fracture) | Passed |
| Prolapse Force | (Assumed: Meets prolapse force requirements) | Passed |
Biocompatibility:
- Evaluation in compliance with ISO 10993-1.
- Specific tests conducted: Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, ASTM Hemolysis, SC5b-9 Complement Activation Assay, Standard Thrombogenicity in Canine.
- Reported device performance: "The device was found biocompatible."
Sterilization, Packaging and Shelf Life Testing:
- EtO Sterilization validation (SAL 10^-6).
- Shelf life and packaging testing after environmental conditioning and transportation simulation.
- Reported device performance: "All tests were successfully completed."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for any of the performance tests.
The data provenance is not explicitly stated beyond being "performance data." This type of testing is typically done in a lab setting rather than using patient data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable in the usual sense for this kind of device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the tests described are performance tests of the physical properties and functionality of the guidewire, not assessments of diagnostic images or clinical outcomes that would require expert human interpretation as "ground truth." These tests rely on standardized methods and measurement equipment.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Performance tests are typically objectively measured against predefined criteria, not adjudicated by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the substantial equivalence of the device through performance testing against established standards and comparison to a predicate device, not on assessing human reader performance with or without AI assistance. This device is a physical medical device (guidewire), not an AI-driven diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical guidewire, not an algorithm.
7. The Type of Ground Truth Used
For the performance and biocompatibility testing, the "ground truth" is established by:
- Standardized test methods: Based on FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff" and ISO 10993-1 for biocompatibility.
- Predefined acceptance criteria: While not explicitly listed, these criteria would typically be quantitative thresholds or qualitative observations (e.g., "no visible corrosion," "no fracture").
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 14, 2023
Embrace Medical Ltd. % Orly Maor Regulatory Consultant 25 Sirkin Street Kfar Saba, 4442157 Israel
Re: K223791
Trade/Device Name: TalWire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 12, 2023 Received: June 14, 2023
Dear Orly Maor:
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
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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 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. Digitally signed by Lydia S. Lydia S. Glaw Glaw -S Date: 2023.07.14 12:19:11 -04'00'
Lydia Glaw 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 Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
TalWire
Indications for Use (Describe)
The TalWire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. The TalWire is not intended for use in the coronary or cerebral vasculature.
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.The burden time for this collection of information is estimated to average 79 hours per response, includingthe time to review instructions, search existing data sources, gather and maintain the data needed andcomplete and review the collection of information. Send comments regarding this burden estimate or anyother aspect of this information collection, including suggestions for reducing this burden, to:Department of Health and HumanServices Food and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA)Staff PRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." |
FORM FDA 3881 (6/20)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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K223791
Traditional Premarket Notification Submission - 510(k) Embrace Medical Ltd.- TalWire
Date Prepared: December 14, 2022
SUBMITTER I.
Embrace Medical Ltd. 21(B) Habarzel Street. Tel-Aviv, 6971029, Israel Tel: +972-775055645 E-mail: anat@accessmv.com
Contact Person
Orly Maor 25 Sirkin Street Kfar Saba, 4442157 Israel Tel: +972-9-7453607 oram.ma@gmail.com
II. DEVICE
Name of Device: TalWire Common or Usual Name: TalWire Classification Name: 21CFR §870.1330- Wire, Guide, Catheter Regulatory Class: II Product Code: DQX
PREDICATE DEVICE II.
Embrace Medical Ltd. believes that the Tal Wire is substantially equivalent to the following predicate device:
- Vascular Solutions, Inc., VSI Guidewire, cleared under K112631. .
IV. DEVICE DESCRIPTION
The TalWire is a family of vascular access mandrel guidewires. The TalWire is available in various sizes: between 40 to 80 cm in length and in the 0.018" diameter range. The TalWire is available with Nitinol (NiTi) cores and Stainless Steel coils.
The TalWire consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A microcoil is wound with a lumen that is then placed over the tapered distal end of the coil is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The TalWire includes an articulatable tip at the distal end of the guidewire.
The finished guidewire is placed in a protective polymer dispenser hoop in a labeled Tyvek pouch. The TalWire is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
INDICATIONS FOR USE V.
The TalWire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. The TalWire is not intended for use in the coronary or cerebral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
The TalWire has the same intended use as the predicate device. Its indications for use are identical to that of the predicate device.
The TalWire has similar technological characteristics as the predicate device as demonstrated in the table below:
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| Specification | Embrace Medical Ltd.TalWire | Vascular Solutions, Inc.,VSI Guidewire | SE Justification |
|---|---|---|---|
| 510K Number | K 223791 | K112631 | |
| Regulation Number | 21CFR §870.1330 | 21CFR §870.1330 | Same |
| Product Code | DQX | DQX | Same |
| Classification | Class II | Class II | Same |
| Indications for Use | The TalWire is intended forpercutaneous entry of peripheralvessels using the SeldingerTechnique. The TalWire is notintended for use in the coronaryor cerebral vasculature. | The VSI Guidewire is indicatedfor percutaneous entry ofperipheral vessels using theSeldinger Technique. The deviceis not indicated for use in thecoronary or cerebral vasculature. | Same |
| Anatomical Location | Peripheral vessels | Peripheral vessels | Same |
| Wire Diameter | 0.018"-0.021" | 0.018" | SEWithin the range ofcleared guidewiresSuccessfulverification testingconfirmed theequivalence |
| Device Length | 40-80cm | 40cm - 130cm | SEWithin the predicaterange |
| Tip Type and Shape | Straight | Straight or Angled | SEWithin the predicaterange |
| Wire Mandrel (core)Material | Nitinol | Stainless Steel or Nitinol | SEWithin the predicaterange |
| Coating Material,Length and Location | None | None or PTFE coated | SEWithin the predicaterange |
| Coil Material | Stainless Steel | Stainless Steel, Tungsten | SEWithin the predicaterange |
| Accessories | None | None or may be supplied in amicro-introducer access kit | SE |
| Packagingconfiguration | The wire is placed in a protectivepolymer dispenser hoop in alabeled TyveK pouch.5 pack configuration | The wire is placed in aprotective polymer dispenserhoop in a labeled TyveK pouch.5 or 10 pack configuration | SEWithin the predicaterange |
| Single Use orReusable | Single Use | Single Use | Same |
| Sterilization Method | Sterilized by EtO, SAL 10-6 | Sterilized by EtO, SAL 10-6 | Same |
| Specification | Embrace Medical Ltd.TalWire | Vascular Solutions, Inc.,VSI Guidewire | SE Justification |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination: The tests were performed based on Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff. Dated: October 10, 2019
Biocompatibility -
Biocompatibility evaluation in compliance with ISO 10993-1 was performed. The following tests were conducted: Cytotoxicity Study Using the ISO Elution Method ISO Guinea Pig Maximization Sensitization Test ISO Intracutaneous -irritation Study in Rabbits Material Mediated Pyrogenicity in Rabbits Acute Systemic Toxicity ASTM Hemolysis Study SC5b-9 Complement Activation Assay Standard Thrombogenicity in Canine In addition, chemical characterization and Biological Risk Assessment were performed. The device was found biocompatible.
Sterilization, Packaging and Shelf Life Testing
EtO Sterilization validation was performed. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests, including packaging integrity and device performance, were performed after environmental conditioning and transportation simulation. All tests were successfully completed.
Performance Testing
Performance testing per FDA guidance Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff. Dated: October 10, 2019
included the following:
| Tests | |
|---|---|
| • Dimensional Attributes | • Kink resistance |
| • Visual Inspection | • Tip flexibility |
| • Simulated use | • Radiopacity |
| • Tensile strength | • Flex resistance |
| • Torque strength | • Fracture resistance |
| • Torqueability | • Prolapse force |
| • Corrosion resistance |
All tests passed and met the predefined acceptance criteria.
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VIII. CONCLUSIONS
The results of the comparison of design, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate device. Therefore, Embrace Medical Ltd. concludes that the proposed TalWire is substantially equivalent to the identified predicate device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.