(207 days)
No
The device description and performance studies focus on the mechanical and material properties of a guidewire, with no mention of AI or ML capabilities.
No.
The TalWire is a vascular access guidewire used for percutaneous entry into peripheral vessels, specifically for guiding other devices, not for therapeutic intervention itself.
No
The TalWire is a vascular access guidewire used for percutaneous entry into vessels, a procedural tool rather than a device designed to diagnose a condition.
No
The device description clearly details a physical guidewire made of Nitinol and Stainless Steel, with specific dimensions and physical characteristics. It also mentions packaging and sterilization, indicating a tangible hardware device.
Based on the provided information, the TalWire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "percutaneous entry of peripheral vessels using the Seldinger Technique." This describes a surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical guidewire used for navigating blood vessels. This is a medical device used in vivo (within the body), not in vitro (in glass/outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the guidewire (tensile strength, torqueability, kink resistance, etc.) and its biocompatibility, which are typical for interventional medical devices. They do not involve evaluating diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TalWire does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vessels
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
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 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.
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 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:
• Dimensional Attributes
• Visual Inspection
• Simulated use
• Tensile strength
• Torque strength
• Torqueability
• Corrosion resistance
• Kink resistance
• Tip flexibility
• Radiopacity
• Flex resistance
• Fracture resistance
• Prolapse force
All tests passed and met the predefined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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, including | |
| the time to review instructions, search existing data sources, gather and maintain the data needed and | |
| complete and review the collection of information. Send comments regarding this burden estimate or any | |
| other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human | |
| Services Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork 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 of | |
| information 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
3
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:
4
| 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 for
percutaneous entry of peripheral
vessels using the Seldinger
Technique. The TalWire is not
intended for use in the coronary
or cerebral vasculature. | The VSI Guidewire is indicated
for percutaneous entry of
peripheral vessels using the
Seldinger Technique. The device
is not indicated for use in the
coronary or cerebral vasculature. | Same |
| Anatomical Location | Peripheral vessels | Peripheral vessels | Same |
| Wire Diameter | 0.018"-0.021" | 0.018" | SE
Within the range of
cleared guidewires
Successful
verification testing
confirmed the
equivalence |
| Device Length | 40-80cm | 40cm - 130cm | SE
Within the predicate
range |
| Tip Type and Shape | Straight | Straight or Angled | SE
Within the predicate
range |
| Wire Mandrel (core)
Material | Nitinol | Stainless Steel or Nitinol | SE
Within the predicate
range |
| Coating Material,
Length and Location | None | None or PTFE coated | SE
Within the predicate
range |
| Coil Material | Stainless Steel | Stainless Steel, Tungsten | SE
Within the predicate
range |
| Accessories | None | None or may be supplied in a
micro-introducer access kit | SE |
| Packaging
configuration | The wire is placed in a protective
polymer dispenser hoop in a
labeled TyveK pouch.
5 pack configuration | The wire is placed in a
protective polymer dispenser
hoop in a labeled TyveK pouch.
5 or 10 pack configuration | SE
Within the predicate
range |
| Single Use or
Reusable | 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 |
5
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.
6
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.