(30 days)
No
The device description and performance studies focus on the physical components, RF power delivery, and standard safety/performance testing, with no mention of AI or ML.
Yes.
Explanation: The device is indicated for "creation of an atrial septal defect in the heart," which is a direct intervention to treat a medical condition.
No.
Explanation: The device description states that the HOTWIRE™ is "indicated for creation of an atrial septal defect in the heart," which is a therapeutic procedure rather than a diagnostic one.
No
The device description clearly states it is a "sterile, single-use guidewire device" comprised of physical components like a stainless steel core wire, insulating polymer, and an uninsulated stainless-steel coil electrode. It is a physical medical device, not software only.
Based on the provided information, the HOTWIRE™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "creation of an atrial septal defect in the heart." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a guidewire device that delivers radiofrequency power to create a defect in the heart. This is a therapeutic device used directly on the patient's tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The HOTWIRE™ does not perform this function.
The HOTWIRE™ is a surgical device used for an interventional procedure.
N/A
Intended Use / Indications for Use
The HOTWIRE™ is indicated for creation of an atrial septal defect in the heart.
Product codes
DXF
Device Description
The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, such as the Agilis NXT Steerable Introducer, St. Jude Medical (K081645), and third-party RF electrosurgical generator(s), such as the Valleylab FT10 Electrosurgical Platform (K151649) which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572).
The HOTWIRETM is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
creation of an atrial septal defect in the heart.
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)
Performance Bench Testing:
Visual and Dimensional Inspection: Test samples were visually inspected for damage under 2.5X magnification. Inspect dimensions for overall length, outer diameter, distal shape per product specification, marker locations, and minimum marker length. All test samples passed testing.
Simulated Use: Verify the in vitro performance of cardiovascular guidewires under simulated use conditions. All test samples passed testing.
Arc Integrity: Test samples were visually inspected for damage under 2.5X magnification after successful arcing of the device. All test samples passed testing.
Tensile Strength: The minimum force to break the guidewire was tested per ISO 11070. All test samples passed testing.
Corrosion Resistance: The test article is immersed in sodium chloride solution before being placed in boiling distilled or deionized water. Subsequently, the test article is examined visually for evidence of corrosion. All test samples passed testing.
Torque Strength: Torque strength was determined by number of turns-to-failures. All test samples passed testing.
Torqueability: Rotational input to output ratio (torqueability value) is compared to the predicate device. All test samples passed testing.
Fracture Resistance and Flexing Test: Testing was conducted to determine the guidewire's resistance to damage by flexing and resistance to fracture per ISO 11070. All test samples passed testing.
Tip Flexibility: Flexibility testing was conducted to determine the force required to induce buckling deformation when the device is held at 5, 10 and 20 mm from distal tip as compared to the predicate device. All test samples passed testing.
Particulate Characterization: Particulate matter in injections of the device were quantified. All test samples passed testing.
Design Verification and Packaging Validation: This test is to evaluate the device design and packaging design and to demonstrate that the device will meet the product specification requirements at t=1 year time-point after exposing to 1x gamma irradiation sterilization. All test samples passed testing.
Animal Testing (GLP):
Performance Animal Testing: Animal testing is to evaluate the in vivo performance of the device in an acute porcine model. Trackability and handling of the guidewire, radiopacity, compatibility with introducer kits and accessories, and thrombogenicity were assessed. All test samples passed testing.
Biocompatibility Testing:
MEM Elution Cytotoxicity Assay (ISO 10993-5): The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than or equal to a grade 2 (mild reactivity). Conclusion: Non-toxic.
Guinea Pig Maximization Test, 2 Extracts (ISO 10993-10): The test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. Conclusion: Did not elicit sensitization response.
Intracutaneous Reactivity Test, 2 Extracts (ISO 10993-23): The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control article extract overall mean score was 0.0 and 0.0 for the NS and SSO test article extracts, respectively. Conclusion: Non-irritant.
Acute Systemic Toxicity Test, 2 Extracts (ISO 10993-11): There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. Conclusion: Non-toxic.
Material Mediated Pyrogenicity Test (ISO / USP 10993-11): The test article met the requirements for the absence of pyrogens. Conclusion: Non-pyrogenic.
ASTM Hemolysis Assay, Direct and Extract Methods (ISO 10993-4): The test article in direct contact with blood had a mean blank corrected % hemolysis (hemolytic index) of 0.00% when compared to the negative control, and the test article extract had a mean blank corrected % hemolysis (hemolytic index) of 0.00% when compared to the negative control. Both the test article in direct contact with blood and the test article extract were Non-Hemolytic. Conclusion: Non-Hemolytic.
Complement Activation Assay, SC5b-9 Method (ISO 10993-4): The mean concentration of SC5b-9 in the test article sample was 9219.4 ng/mL and was higher, but was not statistically different (p = 0.2594) than the activated NHS (at 37°C) control and was higher, but was not statistically different (p = 0.5832) than the negative control. As a result, the test article was considered to be a non-activator of the complement system. Conclusion: Passed.
In Vivo Thrombogenicity Evaluation (ISO 10993-4): An in vivo evaluation of the HOTWIRE™ was performed to identify any potential thrombus formation associated with the HOTWIRE™ both locally and systemically. The thrombogenicity assessment was successfully completed for the HOTWIRE™ and Predicate Device. The HOTWIRE™ and Predicate Device both received a passing result of 0 on the Thrombus Formation Score, "Thrombus non-existent or minimal and, if present, appears to be associated with implant venotomy site. passing results". Conclusion: Passed; Comparison to the in vivo implant revealed a lack of thrombus formation associated with the article or in the major organs following acute implantation in a clinically relevant, heparinized model.
Heparinized Platelet and Leukocyte Count Assay (ISO 10993-4): The test article average platelet count was 80 to 120% of the vehicle control and the test article average platelet percentage value was at least 30% above the positive control. As a result, the test article met the requirements of the test. Conclusion: Passed.
EMC + Electrical Safety:
Results of the EMC + Electrical Safety testing indicate that HOTWIRE™ is safe and is substantially equivalent for its intended use. The HOTWIRE™ meets applicable requirements listed out in IEC 60601-1 Ed. 3.2 en:2020, IEC 60601-1-2:2014+AMD1:2020, IEC 60601-2-2:2018, IEC 60601-1-6:2010+A2:2021, and IEC 62366-1:2015+A1:2020.
Shelf life:
The accelerated shelf life testing for HOTWIRE™ has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that HOTWIRETM will perform as intended to the Design Specification. HOTWIRE™ will be labeled for 1-year shelf life.
Packaging:
The packaging validation, T=1 year accelerated aging was performed on the HOTWIRETM. The results from packaging testing conducted on HOTWIRETN showed that the acceptance criteria were met. Therefore, we can conclude the HOTWIRE™ packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization:
HOTWIRE™ is sterilized using gamma radiation. HOTWIRE™ is sold sterile, for single use and single patient only. The sterilization was performed and is documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve an SAL of 10to for the HOTWIRE™.
Bacterial Endotoxin (LAL):
The bacterial endotoxin (LAL) validation, was performed on the HOTWIRETM. The results from bacterial endotoxin (LAL) testing conducted on HOTWIRE™ showed that the acceptance criteria were met. Therefore, we can conclude the HOTWIRE™ bacterial endotoxin levels meet regulation requirements and that the device does not inhibit or enhance the detection of bacterial endotoxins.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ProTrack RF Anchor Wire (K150709)
Reference Device(s)
Agilis NXT Steerable Introducer, St. Jude Medical (K081645), Valleylab FT10 Electrosurgical Platform (K151649), Valleylab E7507DB (K822572), Medtronic FlexCath Steerable Sheath (K183174)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
May 1, 2024
Atraverse Medical % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K240900
Trade/Device Name: HOTWIRE™ RF Guidewire Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy catheter Regulatory Class: Class II Product Code: DXF Dated: April 1, 2024 Received: April 1, 2024
Dear Prithul Bom:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Katherine N. Trivedi
-S FDA
Katherine Trivedi Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices
2
OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240900
Device Name HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE
Indications for Use (Describe) The HOTWIRE™ is indicated for creation of an atrial septal defect in the heart.
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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4
510(K) SUMMARY
This 510(k) summary for HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Atraverse Medical, Inc. 2611 S Coast Hwv 101 #204 Cardiff by the Sea, CA 92007
| Contact Person: | Charles Yang
VP QA/RA |
|-----------------|-----------------------------------|
| Telephone: | +1 (760) 278-8098 |
| Email: | Charles.yang@atraversemedical.com |
| Date prepared: | March 13, 2024 |
DEVICE [807.92(a)(2)]
| Name of Device: | HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE |
|---|---|
| Common or Usual Name: | Catheter, Septostomy |
| Classification Name: | Catheter, Septostomy |
| Product Code: | DXF |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 870.5175 |
PREDICATE DEVICE [807.92(a)(3)]
ProTrack RF Anchor Wire (K150709)
DEVICE DESCRIPTION [807.92(a)(4)]
The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, such as the Agilis NXT Steerable Introducer, St. Jude Medical (K081645), and third-party RF electrosurgical generator(s), such as the Valleylab FT10 Electrosurgical Platform (K151649) which utilizes a commercially-available Patient Return
5
Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572).
| Manufacturer | Device | 510(k) |
|---|---|---|
| St Jude | Agilis NXT Steerable Introducer | K081645 |
| Medtronic | FlexCath Steerable Sheath | K183174 |
| Valleylab | FT10 Electrosurgical Platform | K151649 |
| Valleylab | E7507 Return Electrode | K822572 |
Table 10-1: Devices that have undergone Compatibility Testing
The HOTWIRETM is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.
INDICATIONS FOR USE [807.92(a)(5)]
The HOTWIRE™ is indicated for creation of an atrial septal defect in the heart.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The technological characteristics of the HOTWIRE™ is highly analogous to the technological characteristics of the ProTrack RF Anchor Wire (K150709). Substantial equivalence is determined based on the following similarities:
- Same intended use/indications for use .
- Same principles of operation ●
- Same fundamental scientific technology ●
- Incorporate similar basic guidewire design
- Incorporate similar guidewire construction material ●
Table 1 comprises the comparison between HOTWIRE™ (Subject Device) and ProTrack RF Anchor Wire (Predicate Device, K150709).
Table 1: Predicate Devices vs. Subject Device Comparison Table
6
| Feature | ProTrack RF Anchor
Wire
K150709
[Predicate Device] | HOTWIRE TM
RADIOFREQUENCY
(RF) GUIDEWIRE
[Subject Device] | Effect on Substantial
Equivalence |
|----------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------|
| Product Code | DXF | Same | None. Identical |
| Regulatory Class | Class II | Same | None. Identical |
| Regulation Number | 21 CFR. 870.5175 | Same | None. Identical |
| Regulation Name | Catheter, Septostomy | Same | None. Identical |
| Generic Name | Catheter, Septostomy | Same | None. Identical |
| Indications for Use
Statement | Indicated for the creation
of an atrial septal defect in
the heart. | Same | None. Identical |
| Intended Use | Intended for the creation
of an atrial septal defect in
the heart. | Same | None. Identical |
| Performance | |||
|---|---|---|---|
| Anatomical | |||
| Location | General intravascular use, | ||
| including cardio | |||
| vasculature. | Same | None. Identical | |
| Energy Source | Compatible RF | ||
| electrosurgical generator | |||
| such as BMC RFP-100A | |||
| Puncture Generator | |||
| (K122278). | Compatible RF | ||
| electrosurgical generator | |||
| such as Valleylab FT10 | |||
| Electrosurgical Platform | |||
| (K151649). | Both devices can be used with | ||
| 510(k) cleared compatible RF | |||
| electrosurgical generator. The | |||
| HOTWIRE™ is determined to | |||
| be equivalent to the predicate. | |||
| The difference in RF generator | |||
| source does not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Design | |||
| Overall Length | 180 cm and 230 cm | 180 cm and 230 cm | None. Identical |
| Guidewire Outer | |||
| Diameter | 0.035" | 0.032" and 0.035" | Identical: |
| 0.035" Outer Diameter | |||
| Similar: | |||
| Subject device also offered in | |||
| 0.032". The additional diameter | |||
| option does not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Core wire | |||
| configuration | 180cm – 230cm | ||
| Stainless Steel | |||
| Insulated Polymer | 180 cm – 230 cm | ||
| Stainless Steel | |||
| Insulated Polymer | None. Identical | ||
| Tip Configuration | J Tip | ||
| Pigtail | Straight | ||
| J Tip | |||
| Pigtail | Identical: | ||
| Both devices offered in J-tip and | |||
| Pigtail configurations. | |||
| Similar: | |||
| Subject device also offered in a | |||
| Straight configuration. The | |||
| additional configuration does not | |||
| raise new questions of safety or | |||
| effectiveness | |||
| Other Attributes | |||
| Method of supply | Sterile and single use | Same | None. Identical |
| Sterilization method | Ethylene oxide gas | Gamma irradiation | Both the HOTWIRE™ and |
| predicate device are supplied | |||
| sterile with a Sterility Assurance | |||
| Level of 10-6 and labeled for | |||
| Single Use. The HOTWIRE™ is | |||
| determined to be equivalent to | |||
| the predicate. The difference in | |||
| sterilization method does not | |||
| raise new questions of safety or | |||
| effectiveness | |||
| Disposal | |||
| Instructions | Treat the used device(s) as | ||
| biohazardous waste and | |||
| dispose of in compliance | |||
| with standard hospital | |||
| procedures. | Same | None. Identical | |
| Accessories | Connector Cable, Tip | ||
| Straightener | Adaptor Pin, Tip | ||
| Straightener | Identical: | ||
| Both devices offer a tip | |||
| straightener. | |||
| Similar: | |||
| The HOTWIRE™ utilizes an | |||
| adaptor pin for compatibility | |||
| with electrosurgical pencil / | |||
| generator. The minor difference | |||
| in connector types does not raise | |||
| new questions of safety or | |||
| effectiveness | |||
| Package | |||
| configuration | Placed into a Dispenser | ||
| hoop, sterile barrier | |||
| pouch, shelf box, and | |||
| shipper | Same | None. Identical |
7
8
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that HOTWIRE™ (Subject Device) meets established performance requirements, and is substantially equivalent for its intended use.
| Performance Bench Testing | ||
|---|---|---|
| Tests | Test Method Summary | Results |
| Visual and Dimensional | ||
| Inspection | Test samples were visually inspected for | |
| damage under 2.5X magnification. | ||
| Inspect dimensions for overall length, | ||
| outer diameter, distal shape per product | ||
| specification, marker locations, and | ||
| minimum marker length. | All test samples passed testing. | |
| Simulated Use | Verify the in vitro performance of | |
| cardiovascular guidewires under | ||
| simulated use conditions. | All test samples passed testing. | |
| Performance Bench Testing | ||
| Tests | Test Method Summary | Results |
| Arc Integrity | Test samples were visually inspected for damage under 2.5X magnification after successful arcing of the device | All test samples passed testing. |
| Tensile Strength | The minimum force to break the guidewire was tested per ISO 11070. | All test samples passed testing. |
| Corrosion Resistance | The test article is immersed in sodium chloride solution before being placed in boiling distilled or deionized water. Subsequently, the test article is examined visually for evidence of corrosion. | All test samples passed testing. |
| Torque Strength | Torque strength was determined by number of turns-to-failures. | All test samples passed testing. |
| Torqueability | Rotational input to output ratio (torqueability value) is compared to the predicate device. | All test samples passed testing. |
| Fracture Resistance and Flexing Test | Testing was conducted to determine the guidewire's resistance to damage by flexing and resistance to fracture per ISO 11070. | All test samples passed testing. |
| Tip Flexibility | Flexibility testing was conducted to determine the force required to induce buckling deformation when the device is held at 5, 10 and 20 mm from distal tip as compared to the predicate device | All test samples passed testing. |
| Particulate Characterization | Particulate matter in injections of the device were quantified. | All test samples passed testing. |
| Design Verification and Packaging Validation | This test is to evaluate the device design and packaging design and to demonstrate that the device will meet the product specification requirements at t=1 year | All test samples passed testing. |
| Performance Bench Testing | ||
| Tests | Test Method Summary | Results |
| time-point after exposing to 1x gamma | ||
| irradiation sterilization. | ||
| Performance Animal Testing | ||
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo | |
| performance of the device in an acute | ||
| porcine model. Trackability and handling | ||
| of the guidewire, radiopacity, | ||
| compatibility with introducer kits and | ||
| accessories, and thrombogenicity were | ||
| assessed. | All test samples passed testing. |
Table 2: Performance Bench Testing and Animal Testing Summary
9
10
Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that HOTWIRE™ (Subject Device) is biocompatible and is substantially equivalent for its intended use.
Table 3: Biocompatibility Test Summary
| Test | Results | Conclusion |
|---|---|---|
| MEM Elution | ||
| Cytotoxicity Assay | ||
| (ISO) | ||
| ISO 10993-5 | The test article extract showed no evidence of causing | |
| cell lysis or toxicity. The test article extract met the | ||
| requirements of the test since the grade was less than or | ||
| equal to a grade 2 (mild reactivity). | Non-toxic | |
| Guinea Pig | ||
| Maximization Test, 2 | ||
| Extracts (ISO) | ||
| ISO 10993-10 | The test article extract showed no evidence of causing | |
| delayed dermal contact sensitization in the guinea pig. | ||
| The test article was not considered a sensitizer in the | ||
| guinea pig maximization test. | Did not elicit sensitization | |
| response | ||
| Intracutaneous | ||
| Reactivity Test, 2 | ||
| Extracts (ISO) | ||
| ISO 10993-23 | The test article met the requirements of the test since | |
| the difference between each test article extract overall | ||
| mean score and corresponding control article extract | ||
| overall mean score was 0.0 and 0.0 for the NS and SSO | ||
| test article extracts, respectively. | Non-irritant | |
| Test | Results | Conclusion |
| Acute Systemic | ||
| Toxicity Test, 2 | ||
| Extracts (ISO) | ||
| ISO 10993-11 | There was no mortality or evidence of systemic toxicity | |
| from the extracts injected into mice. Each test article | ||
| extract met the requirements of the study. | Non-toxic | |
| Material Mediated | ||
| Pyrogenicity Test | ||
| (ISO / USP) | ||
| ISO 10993-11 | The test article met the requirements for the absence of | |
| pyrogens. | Non-pyrogenic | |
| ASTM Hemolysis | ||
| Assay, Direct and | ||
| Extract Methods | ||
| (ISO) | ||
| ISO 10993-4 | The test article in direct contact with blood had a mean | |
| blank corrected % hemolysis (hemolytic index) of | ||
| 0.00% when compared to the negative control, and the | ||
| test article extract had a mean blank corrected % | ||
| hemolysis (hemolytic index) of 0.00% when compared | ||
| to the negative control. Both the test article in direct | ||
| contact with blood and the test article extract were | ||
| Non-Hemolytic. | Non-Hemolytic | |
| Complement | ||
| Activation Assay, | ||
| SC5b-9 Method | ||
| (ISO) | ||
| ISO 10993-4 | The mean concentration of SC5b-9 in the test article | |
| sample was 9219.4 ng/mL and was higher, but was not | ||
| statistically different (p = 0.2594) than the activated | ||
| NHS (at 37°C) control and was higher, but was not | ||
| statistically different (p = 0.5832) than the negative | ||
| control. As a result, the test article was considered to be | ||
| a non-activator of the complement system. | Passed | |
| In Vivo | ||
| Thrombogenicity | ||
| Evaluation | ||
| ISO 10993-4 | An in vivo evaluation of the HOTWIRE™ was | |
| performed to identify any potential thrombus formation | ||
| associated with the HOTWIRE™ both locally and | ||
| systemically. | ||
| The thrombogenicity assessment was successfully | ||
| completed for the HOTWIRE™ and Predicate Device. | ||
| The HOTWIRE™ and Predicate Device both received | ||
| a passing result of 0 on the Thrombus Formation Score, | ||
| "Thrombus non-existent or minimal and, if present, | ||
| appears to be associated with implant venotomy site. | ||
| passing results". | Passed | |
| Comparison to the in vivo | ||
| implant revealed a lack of | ||
| thrombus formation | ||
| associated with the article | ||
| or in the major organs | ||
| following acute | ||
| implantation in a clinically | ||
| relevant, heparinized | ||
| model. | ||
| Test | Results | Conclusion |
| Heparinized Platelet | ||
| and Leukocyte Count | ||
| Assay (ISO) | ||
| Extraction Ratio: | ||
| 12cm^2/mL | ||
| ISO 10993-4 | The test article average platelet count was 80 to 120% | |
| of the vehicle control and the test article average | ||
| platelet percentage value was at least 30% above the | ||
| positive control. As a result, the test article met the | ||
| requirements of the test. | Passed |
11
12
EMC + Electrical Safety: Results of the EMC + Electrical Safety testing indicate that HOTWIRE™ is safe and is substantially equivalent for its intended use. The HOTWIRE™ meets applicable requirements listed out in IEC 60601-1 Ed. 3.2 en:2020, IEC 60601-1-2:2014+AMD1:2020, IEC 60601-2-2:2018, IEC 60601-1-6:2010+A2:2021, and IEC 62366-1:2015+A1:2020
Shelf life: The accelerated shelf life testing for HOTWIRE™ has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that HOTWIRETM will perform as intended to the Design Specification. HOTWIRE™ will be labeled for 1-year shelf life.
Packaging: The packaging validation, T=1 year accelerated aging was performed on the HOTWIRETM. The results from packaging testing conducted on HOTWIRETN showed that the acceptance criteria were met. Therefore, we can conclude the HOTWIRE™ packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: HOTWIRE™ is sterilized using gamma radiation. HOTWIRE™ is sold sterile, for single use and single patient only. The sterilization was performed and is documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve an SAL of 10to for the HOTWIRE™
Bacterial Endotoxin (LAL): The bacterial endotoxin (LAL) validation, was performed on the HOTWIRETM. The results from bacterial endotoxin (LAL) testing conducted on HOTWIRE™ showed that the acceptance criteria were met. Therefore, we can conclude the HOTWIRE™ bacterial endotoxin levels meet regulation requirements and that the device does not inhibit or enhance the detection of bacterial endotoxins.
13
Performance Standards
The HOTWIRE™ has been developed in conformance with the following standards and FDA guidance, as applicable:
| Standard | Title |
|---|---|
| EN ISO 13485:2016 | |
| EN ISO 13485:2016/AC:2018 | |
| EN ISO 13485:2016/A11:2021 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| EN ISO 14971:2019 | |
| EN ISO 14971:2019/A11:2021 | Medical devices - Application of risk management to medical devices |
| ISO/TR 24971:2020 | Medical devices - Guidance on the application of ISO 14971 |
| BS EN 62366-1:2015 + AC:2015 | |
| +A1:2020 | Medical devices-Application of usability engineering to medical devices |
| EN ISO 11137-1:2015 | |
| EN ISO 11137-1:2015/A2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for development, |
| validation and routine control of a sterilization process for medical devices. | |
| ISO 11137-2:2015+A1:2023 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose |
| ISO 11137-3:2017 | Sterilization of health care products. Radiation-Guidance on dosimetric aspects of |
| development, validation and routine control | |
| EN ISO 11737-1:2018 | |
| EN ISO 11737-1:2018/A1:2021 | Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population |
| of microorganisms on products. | |
| ISO 11737-2:2020 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility |
| performed in the validation of a sterilization process. | |
| EN ISO 11607-1:2020 + A1:2023 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, |
| sterile barrier systems and packaging systems | |
| EN ISO 11607-2:2020 + A1:2023 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for |
| forming, sealing and assembly processes | |
| ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for |
| Testing | |
| ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containers and Systems |
| ASTM F2096-11(2019) | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization |
| (Bubble Test) | |
| ASTM F88/F88M-21 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ASTM F1886/F1886M-16 | Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual |
| Inspection. | |
| EN ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - |
| Part 1: General requirements | |
| ISO 7000:2019 | Graphical symbols for use on equipment - Registered symbols |
| EN ISO 20417:2021 | Medical devices - Information to be supplied by the manufacturer |
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk |
| management process | |
| ISO 10993-4:2017 | Biological Evaluation of Medical Devices – Part4: Selection of Tests for Interactions with |
| blood | |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10:2021 | Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization |
| ISO 10993-11:2017 | Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity |
| ISO 10993-17:2002 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical |
| device constituents | |
| ISO 10993-18:2020 AMD 1:2022 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical |
| device materials within a risk management process | |
| ISO/TR 10993-19:2020 | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and |
| topographical characterization of materials | |
| ISO 10993-23:2021 | Biological Evaluation of Medical Devices – Part 23: Tests for irritation |
| ASTM F756-17 | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ASTM F2382-18 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device |
| Materials on Partial Thromboplastin Time (PTT) | |
| ASTM F2888-19 | An In-Vitro Measure For Hemocompatibility Assessment Of Cardiovascular Materials |
| ANSI/AAMI ST72 | Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch |
| Testing. | |
| IEC 60601-1, Ed. 3.2 EN:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential |
| performance | |
| IEC 60601-1- | |
| 2:2014+AMD1:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential |
| performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| IEC 60601-2-2:2018 | Medical electrical equipment-Particular requirements for the basic safety and essential |
| performance of high frequency surgical equipment and high frequency surgical accessories | |
| IEC 60601-1-6:2010+A2:2021 | Medical electrical equipment-General requirements for basic safety and essential |
| performance. Collateral standard: Usability | |
| IEC 62366-1:2015+A1:2020 | Application of usability engineering to medical devices |
| EN ISO 11070:2014 | |
| EN ISO 11070:2014+A1:2018 | Sterile Single Use Intravascular Introducers, Dilators and Guidewires |
| BS EN ISO 10555- | |
| 1:2013+A1:2017 | Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements |
| FDA Guidance (2012) "Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers" | |
| USP Pharmacopeia Chapter , Bacterial Endotoxin Test | |
| USP Particulate Matter in Injections | |
| FDA Guidance (2019) | "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" |
| FDA Guidance (2023) "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation | |
| and testing within a risk management process"" | |
| FDA Guidance (2019) "Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling | |
| Considerations" | |
| FDA Guidance (2014) "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)"] | |
| FDA Guidance (2023) "How to Prepare a Traditional 510(k)" | |
| FDA Guidance (2023) "Electronic Submission Template for Medical Device 510(k) Submissions" | |
| FDA Guidance (2016) "Applying Human Factors and Usability Engineering to Medical Devices" |
14
15
CONCLUSIONS
The HOTWIRE™ met all specified criteria and did not raise new safety or performance questions. Based on the 510(k) summary and information provided herein, we conclude that the subject device, HOTWIRE™, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate device, ProTrack RF Anchor Wire (K150709)