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.

AI/ML Overview

The provided document is a 510(k) summary for the HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE, demonstrating its substantial equivalence to a predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing, animal testing, biocompatibility testing, EMC + Electrical Safety testing, shelf life testing, packaging validation, sterilization validation, and bacterial endotoxin testing conducted to show the device is safe and effective and comparable to the predicate.

Here's the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily established by demonstrating compliance with recognized performance standards and showing substantial equivalence to a legally marketed predicate device. The reported device performance is presented as a summary of various tests, all of which "passed testing" or "met the requirements."

Test Category	Acceptance Criteria (Implicit from Test Method Summary)	Reported Device Performance
Performance Bench Testing
Visual and Dimensional Inspection	No damage, dimensions meet product specifications.	All test samples passed testing.
Simulated Use	In vitro performance under simulated use conditions.	All test samples passed testing.
Arc Integrity	No visual damage after successful arcing.	All test samples passed testing.
Tensile Strength	Minimum force to break guidewire per ISO 11070.	All test samples passed testing.
Corrosion Resistance	No visual evidence of corrosion after immersion.	All test samples passed testing.
Torque Strength	Number of turns-to-failures meets standard.	All test samples passed testing.
Torqueability	Rotational input to output ratio comparable to predicate.	All test samples passed testing.
Fracture Resistance and Flexing Test	Resistance to damage by flexing and fracture per ISO 11070.	All test samples passed testing.
Tip Flexibility	Force required to induce buckling deformation comparable to predicate.	All test samples passed testing.
Particulate Characterization	Quantity of particulate matter in injections meets standards.	All test samples passed testing.
Design Verification and Packaging Validation	Meets product specification requirements at t=1 year after gamma irradiation.	All test samples passed testing.
Performance Animal Testing
Animal Testing (GLP)	Satisfactory in vivo performance, trackability, handling, radiopacity, compatibility, and absence of thrombogenicity in acute porcine model.	All test samples passed testing.
Biocompatibility Testing
MEM Elution Cytotoxicity Assay	No cell lysis or toxicity (grade <= 2).	Non-toxic.
Guinea Pig Maximization Test	No delayed dermal contact sensitization.	Did not elicit sensitization response.
Intracutaneous Reactivity Test	Difference between test article and control extract mean scores is 0.0.	Non-irritant.
Acute Systemic Toxicity Test	No mortality or systemic toxicity from extracts in mice.	Non-toxic.
Material Mediated Pyrogenicity Test	Absence of pyrogens.	Non-pyrogenic.
ASTM Hemolysis Assay	Non-hemolytic (hemolytic index 0.00%).	Non-hemolytic.
Complement Activation Assay	Non-activator of the complement system.	Passed.
In Vivo Thrombogenicity Evaluation	No thrombus formation (score of 0), comparable to predicate.	Passed Comparison to the in vivo implant revealed a lack of thrombus formation.
Heparinized Platelet and Leukocyte Count Assay	Platelet count 80-120% of vehicle, platelet percentage >=30% above positive control.	Passed.
Other Performance Testing
EMC + Electrical Safety	Meets applicable requirements of IEC 60601-1 Ed. 3.2, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, and IEC 62366-1.	HOTWIRE™ is safe and meets applicable requirements.
Shelf Life	Meets all acceptance criteria for 1-year accelerated aging.	All acceptance criteria were met, 1-year shelf life.
Packaging Validation	Meets acceptance criteria from accelerated aging.	All acceptance criteria were met, adequate protection and sterile barrier.
Sterilization	Achieves an SAL of 10^-6.	Validated to achieve SAL of 10^-6.
Bacterial Endotoxin (LAL)	Meets regulation requirements, device does not inhibit or enhance detection of bacterial endotoxins.	All acceptance criteria were met.

Study Details:

The document describes pre-market testing to establish substantial equivalence for a medical device (HOTWIRE™ RF Guidewire) rather than a study typically associated with AI/software devices (which would involve human readers, ground truth establishment, etc.). Therefore, many of the requested points are not applicable in this context.

Here's how the information aligns with the provided document:

A table of acceptance criteria and the reported device performance: Provided above.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document repeatedly states "All test samples passed testing," but does not specify the exact number of samples used for each test. This information is typically detailed in the full test reports, not the 510(k) summary.
- Data Provenance: Not explicitly stated but assumed to be laboratory testing conducted by or for the device manufacturer (Atraverse Medical, Inc.). The animal testing was a GLP (Good Laboratory Practice) study, implying a controlled, prospective design for that component. Country of origin not specified, but the submission is to the U.S. FDA.
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. This device is a guidewire, not an AI/software device requiring human expert annotation for ground truth. "Ground truth" here refers to objective measurements and biological responses verified through standard laboratory and animal testing protocols.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review and consensus for data labeling/ground truth in AI/software studies, not physical device performance testing.
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: Not applicable. This device is a physical medical device (guidewire), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device. The "standalone" performance is established through bench and animal testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established through:
- Validated Test Methods and Standards: (e.g., ISO 11070 for tensile strength, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety).
- Visual Inspection and Dimensional Measurements: Objective assessments against defined specifications.
- Biological Responses: Measured in in vitro and in vivo (animal) models, such as cytotoxicity, sensitization, pyrogenicity, hemolysis, and thrombogenicity.
- Functional Performance: Assessment of characteristics like trackability, handling, and radiopacity in simulated and animal use.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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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.

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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

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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) 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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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 YangVP 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)]

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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

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

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Feature	ProTrack RF AnchorWireK150709[Predicate Device]	HOTWIRE TMRADIOFREQUENCY(RF) GUIDEWIRE[Subject Device]	Effect on SubstantialEquivalence
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 UseStatement	Indicated for the creationof an atrial septal defect inthe heart.	Same	None. Identical
Intended Use	Intended for the creationof an atrial septal defect inthe heart.	Same	None. Identical

Performance
AnatomicalLocation	General intravascular use,including cardiovasculature.	Same	None. Identical
Energy Source	Compatible RFelectrosurgical generatorsuch as BMC RFP-100APuncture Generator(K122278).	Compatible RFelectrosurgical generatorsuch as Valleylab FT10Electrosurgical Platform(K151649).	Both devices can be used with510(k) cleared compatible RFelectrosurgical generator. TheHOTWIRE™ is determined tobe equivalent to the predicate.The difference in RF generatorsource does not raise newquestions of safety oreffectiveness
Design
Overall Length	180 cm and 230 cm	180 cm and 230 cm	None. Identical
Guidewire OuterDiameter	0.035"	0.032" and 0.035"	Identical:0.035" Outer DiameterSimilar:Subject device also offered in0.032". The additional diameteroption does not raise newquestions of safety oreffectiveness
Core wireconfiguration	180cm – 230cmStainless SteelInsulated Polymer	180 cm – 230 cmStainless SteelInsulated Polymer	None. Identical
Tip Configuration	J TipPigtail	StraightJ TipPigtail	Identical:Both devices offered in J-tip andPigtail configurations.Similar:Subject device also offered in aStraight configuration. Theadditional configuration does notraise new questions of safety oreffectiveness
Other Attributes
Method of supply	Sterile and single use	Same	None. Identical
Sterilization method	Ethylene oxide gas	Gamma irradiation	Both the HOTWIRE™ andpredicate device are suppliedsterile with a Sterility AssuranceLevel of 10-6 and labeled forSingle Use. The HOTWIRE™ isdetermined to be equivalent tothe predicate. The difference insterilization method does notraise new questions of safety oreffectiveness
DisposalInstructions	Treat the used device(s) asbiohazardous waste anddispose of in compliancewith standard hospitalprocedures.	Same	None. Identical
Accessories	Connector Cable, TipStraightener	Adaptor Pin, TipStraightener	Identical:Both devices offer a tipstraightener.Similar:The HOTWIRE™ utilizes anadaptor pin for compatibilitywith electrosurgical pencil /generator. The minor differencein connector types does not raisenew questions of safety oreffectiveness
Packageconfiguration	Placed into a Dispenserhoop, sterile barrierpouch, shelf box, andshipper	Same	None. Identical

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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 DimensionalInspection	Test samples were visually inspected fordamage under 2.5X magnification.Inspect dimensions for overall length,outer diameter, distal shape per productspecification, marker locations, andminimum marker length.	All test samples passed testing.
Simulated Use	Verify the in vitro performance ofcardiovascular guidewires undersimulated 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 gammairradiation sterilization.
Performance Animal Testing
Animal Testing (GLP)	Animal testing is to evaluate the in vivoperformance of the device in an acuteporcine model. Trackability and handlingof the guidewire, radiopacity,compatibility with introducer kits andaccessories, and thrombogenicity wereassessed.	All test samples passed testing.

Table 2: Performance Bench Testing and Animal Testing Summary

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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 ElutionCytotoxicity Assay(ISO)ISO 10993-5	The test article extract showed no evidence of causingcell lysis or toxicity. The test article extract met therequirements of the test since the grade was less than orequal to a grade 2 (mild reactivity).	Non-toxic
Guinea PigMaximization Test, 2Extracts (ISO)ISO 10993-10	The test article extract showed no evidence of causingdelayed dermal contact sensitization in the guinea pig.The test article was not considered a sensitizer in theguinea pig maximization test.	Did not elicit sensitizationresponse
IntracutaneousReactivity Test, 2Extracts (ISO)ISO 10993-23	The test article met the requirements of the test sincethe difference between each test article extract overallmean score and corresponding control article extractoverall mean score was 0.0 and 0.0 for the NS and SSOtest article extracts, respectively.	Non-irritant
Test	Results	Conclusion
Acute SystemicToxicity Test, 2Extracts (ISO)ISO 10993-11	There was no mortality or evidence of systemic toxicityfrom the extracts injected into mice. Each test articleextract met the requirements of the study.	Non-toxic
Material MediatedPyrogenicity Test(ISO / USP)ISO 10993-11	The test article met the requirements for the absence ofpyrogens.	Non-pyrogenic
ASTM HemolysisAssay, Direct andExtract Methods(ISO)ISO 10993-4	The test article in direct contact with blood had a meanblank corrected % hemolysis (hemolytic index) of0.00% when compared to the negative control, and thetest article extract had a mean blank corrected %hemolysis (hemolytic index) of 0.00% when comparedto the negative control. Both the test article in directcontact with blood and the test article extract wereNon-Hemolytic.	Non-Hemolytic
ComplementActivation Assay,SC5b-9 Method(ISO)ISO 10993-4	The mean concentration of SC5b-9 in the test articlesample was 9219.4 ng/mL and was higher, but was notstatistically different (p = 0.2594) than the activatedNHS (at 37°C) control and was higher, but was notstatistically different (p = 0.5832) than the negativecontrol. As a result, the test article was considered to bea non-activator of the complement system.	Passed
In VivoThrombogenicityEvaluationISO 10993-4	An in vivo evaluation of the HOTWIRE™ wasperformed to identify any potential thrombus formationassociated with the HOTWIRE™ both locally andsystemically.The thrombogenicity assessment was successfullycompleted for the HOTWIRE™ and Predicate Device.The HOTWIRE™ and Predicate Device both receiveda 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".	PassedComparison to the in vivoimplant revealed a lack ofthrombus formationassociated with the articleor in the major organsfollowing acuteimplantation in a clinicallyrelevant, heparinizedmodel.
Test	Results	Conclusion
Heparinized Plateletand Leukocyte CountAssay (ISO)Extraction Ratio:12cm^2/mLISO 10993-4	The test article average platelet count was 80 to 120%of the vehicle control and the test article averageplatelet percentage value was at least 30% above thepositive control. As a result, the test article met therequirements of the test.	Passed

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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.

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Performance Standards

The HOTWIRE™ has been developed in conformance with the following standards and FDA guidance, as applicable:

Standard	Title
EN ISO 13485:2016EN ISO 13485:2016/AC:2018EN ISO 13485:2016/A11:2021	Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14971:2019EN 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 11137-1:2015EN 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 ofdevelopment, validation and routine control
EN ISO 11737-1:2018EN ISO 11737-1:2018/A1:2021	Sterilization of medical devices - Microbiological methods - Part 1: Estimation of populationof microorganisms on products.
ISO 11737-2:2020	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterilityperformed 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 forforming, sealing and assembly processes
ASTM D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components forTesting
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 VisualInspection.
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 riskmanagement process
ISO 10993-4:2017	Biological Evaluation of Medical Devices – Part4: Selection of Tests for Interactions withblood
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 medicaldevice constituents
ISO 10993-18:2020 AMD 1:2022	Biological evaluation of medical devices - Part 18: Chemical characterization of medicaldevice materials within a risk management process
ISO/TR 10993-19:2020	Biological evaluation of medical devices - Part 19: Physico-chemical, morphological andtopographical 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 DeviceMaterials 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 BatchTesting.
IEC 60601-1, Ed. 3.2 EN:2020	Medical electrical equipment - Part 1: General requirements for basic safety and essentialperformance
IEC 60601-1-2:2014+AMD1:2020	Medical electrical equipment - Part 1-2: General requirements for basic safety and essentialperformance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2:2018	Medical electrical equipment-Particular requirements for the basic safety and essentialperformance 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 essentialperformance. Collateral standard: Usability
IEC 62366-1:2015+A1:2020	Application of usability engineering to medical devices
EN ISO 11070:2014EN 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 <85>, Bacterial Endotoxin Test
USP <788> 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: Evaluationand testing within a risk management process""
FDA Guidance (2019) "Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - LabelingConsiderations"
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"

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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)

Regulation Number and Section

§ 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).