The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Device Description

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

AI/ML Overview

The device under consideration is the XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter.

Based on the provided text, the device's acceptance criteria are addressed through a series of Functional/Safety Testing and Animal Testing. The manufacturer, Transit Scientific, LLC, states that "All data met pre-determined acceptance criteria" for these tests and that the device is "substantially equivalent to the cited predicate device."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets predefined acceptance criteria, but it does not explicitly state specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it broadly states that "All data met pre-determined acceptance criteria."

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Verified according to ISO 10993-1 and FDA guidance for an external communicating device with limited exposure (<24hrs) to circulating blood. All specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis Assay, Complement Activation Assay, Partial Thromboplastin Time (PTT) Assay, Heparinized Blood Platelet and Leukocyte Count Assay, LAL Bacterial Endotoxin Pyrogenicity) successfully met pre-determined acceptance criteria.
Design Verification (Performance Bench Testing)	Ensured the device met applicable design and performance requirements throughout its shelf life, conformed to applicable standards, and demonstrated substantial equivalence to the predicate system. All specific performance tests (Material Verification, Dimensional Verification, Visual Verification, Functional/Simulated Use Testing, PTA/PTCA Cycling, Rewrap/Recovery, Retrieval Force, PTA/PTCA Burst Pressure, Torque Testing, Kink Radius, Tensile Testing, Particulate Testing, Corrosion Testing, Packaging, Sterilization, Finite Element Analysis (FEA)) successfully met pre-determined acceptance criteria.
Animal Testing (Safety, Usability, Scoring Performance)	Assessed safety, usability, and scoring performance. All data met pre-determined acceptance criteria.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the tests (biocompatibility, performance bench testing, or animal testing).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies internal testing by Transit Scientific, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes engineering and biological testing, not clinical studies involving expert interpretation of data.

4. Adjudication method for the test set

This information is not applicable/provided. The tests described are laboratory and animal studies, not clinical trials requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI assistance in this document. The device is a physical medical device (catheter), not an AI/software device that would involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the biocompatibility and design verification (performance bench testing), the "ground truth" would be the established international standards (ISO 10993-1) and internal design specifications and requirements, as well as the performance of the predicate device (K221986).
For animal testing, the "ground truth" for safety, usability, and scoring performance would be observed physiological responses, usability metrics, and observable effects on the treated vessels within the animal models. No mention of expert consensus, pathology, or outcomes data specifically as "ground truth" is made for the animal study.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the text is in a clear, sans-serif font, with "FDA" in a blue square.

June 17, 2024

Transit Scientific, LLC % Spencer Walker Director of Regulatory Affairs University of Utah, Center for Medical Innovation 10 North 1900 East, EHSL Rm. 22 Salt Lake City, Utah 84112

Re: K232258

Trade/Device Name: XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: PNO Dated: Mav 28, 2024 Received: June 3, 2024

Dear Spencer Walker:

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.

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"

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(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 OS 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.

Image /page/1/Picture/7 description: The image shows the name Lydia S. Glaw -S, along with the words "Digitally signed by". The image also includes the date 2024.06.17 and the time 15:38:24 -04'00'. This suggests that the image is a digital signature of Lydia S. Glaw -S.

Gregory O'Connell for Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices

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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) K232258

Device Name

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter

Indications for Use (Describe)

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the words "TRANSIT" in large, bold letters on the top line. Below that, the word "SCIENTIFIC" is written in smaller letters. The logo has a clean and modern design.

510(K) SUMMARY

(21 CFR 807.92)

GENERAL INFORMATION

Submitter:	Transit Scientific, LLC
Contact Person:	Spencer Walker, MSc - Director of Regulatory AffairsUniversity of Utah/ Center for Medical Innovation350 East 400 SouthSalt Lake City, UT 84111(801) 708-2238Spencer.walker@hsc.utah.edu
Date Prepared:	May 31, 2024
Trade Name:	XO Constrain Percutaneous Transluminal AngioplastyConstraining Catheter
Classification Name:	Percutaneous Scoring Catheter21 CFR §870.1250, Product Code PNO
Device Class:	Class II
Predicate Device:	510(k) No.: K221986Model: XO Score LP Percutaneous Transluminal AngioplastyScoring CatheterManufacture: Transit Scientific, LLCClassification: PNO
Reference Device:	510(k) No .: K150634Model: AngioSculpt PTA Scoring Balloon CatheterManufacture: Spectranetics Co.Classification: PNO

Device Description:

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Image /page/5/Picture/1 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the words "TRANSIT" in large, bold letters on the top line. Below that, the word "SCIENTIFIC" is written in a smaller, thinner font. The logo has a modern and clean design.

PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

Indications for Use:

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenotic material in the iliac, femoral, illo-popliteal, infrapopliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Comparative Analysis:

It has been demonstrated that the XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The XO Constrain Catheter has been fully assessed within the Transit Scientific Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness.

It has been demonstrated that the XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is comparable to the predicate device in the following manner:

Same intended use ●
Similar indications for use
Same fundamental scientific technology ●
Same or similar material properties
Same operating principle
Same or similar performance specifications
Same patient-user interface

Table 1: Substantial Equivalence Comparison Chart
	Subject Device – (XOConstrain Catheter)	Predicate - K221986 (XOScore LP Catheter)	Reference - K150634 –(AngioSculpt PTACatheter)
Ind. for Use	The XO Constrain PercutaneousTransluminal AngioplastyConstraining Catheter is intendedto be used in conjunction with aPTA balloon to facilitate dilationand apposition of thescoring/constraining surface to thestenotic material in the iliac,femoral, ilio-femoral, popliteal,infra-popliteal, and renal arteries,	The XO Score LP PercutaneousTransluminal Angioplasty ScoringCatheter is intended to be usedin conjunction with a PTA balloonto facilitate dilation andapposition of the scoring surfaceto the stenotic material in theiliac, femoral, ilio-femoral,popliteal, infra-popliteal, andrenal arteries, and for treatmentof obstructive lesions of native or	For dilatation of lesions in theiliac, femoral, ilio-femoral,popliteal, infra popliteal, andrenal arteries, and for thetreatment of obstructive lesionsof native or syntheticarteriovenous dialysis fistulae.Not for use in the coronary orneuro-vasculature.
Table 1: Substantial Equivalence Comparison Chart
	Subject Device – (XOConstrain Catheter)	Predicate - K221986 (XOScore LP Catheter)	Reference - K150634 –(AngioSculpt PTACatheter)
	and for treatment of obstructivelesions of native or syntheticarteriovenous dialysis fistulae. Notfor use in the coronary or neuro-vasculature.	synthetic arteriovenous dialysisfistulae. Not for use in thecoronary or neuro-vasculature.
AnatomicalAccess	Peripheral Vasculature	Peripheral Vasculature	Peripheral Vasculature
ShaftConstruction	Wire with Polymer Covering	Wire with Polymer Covering	Two-Lumen Polymer Shaft
Constraining/ScoringStructure	Metal Alloy Hypotube	Metal Alloy Hypotube	3-5 Wires
EffectiveLength (cm)	145cm	150 cm	50 cm, 90 cm, 137 cm
CrossingProfile	Distal tip: 1.5Fr	2.2Fr distal tip: 1.5Fr3.8Fr distal tip: 1.9Fr	.014" GW Compatible: 1.5F.018" GW Compatible: 1.9F
BalloonDiameter	Compatible with 1.5mm –4.0mm compliant and semi-compliant balloons	2.2Fr: 1.5 – 4.0mm3.8Fr: 3 - 7mm	2-8 mm
BalloonLength	Compatible with 6mm –20mm compliant and semi-compliant balloons	Compatible with PTAballoon lengths of 20-200mm	10 mm – 200 mm
ConstrainingStructure(InflatedDiameter)	1.7mm – 4.2mm max	2.2Fr: 1.8 – 4.3mm3.8Fr: 3.4 - 7.4 mm	2-8 mm (balloon profileonly)
Visibility/Radiopacity	The catheter tip and thescoring/constrainingstructure are radiopaque.The balloon catheter markerbands are visible through theconstraining structure wheninflated.	The catheter tip and thescoring structure areradiopaque. The ballooncatheter marker bands arevisible through theconstraining structure wheninflated.	The balloon catheter hastwo marker bands arevisible through the balloonmaterial.
GuidewireCompatibility	Max 0.014"	2.2Fr: Max 0.014"3.8Fr: Max 0.018"	Max 0.018"

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Functional/Safety Testing:

The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria.

Biocompatibility - Biocompatibility of the complete and finished XO Constrain Catheter has been verified according to the requirements and testing prescribed in ISO 10993-1 and in

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Image /page/7/Picture/1 description: The image shows the logo for Transit Scientific. The logo is in black and consists of two words stacked on top of each other. The top word is "TRANSIT" and the bottom word is "SCIENTIFIC" with a trademark symbol to the right of the word.

accordance with FDA quidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (<24hrs) to circulating blood.

Cytotoxicity O
Sensitization O
O Irritation/ Intracutaneous Reactivity
Acute Systemic Toxicity O
Material Mediated Pyrogenicity O
Hemolysis Assay O
Complement Activation Assay O
Partial Thromboplastin Time (PTT) Assay O
Heparinized Blood Platelet and Leukocyte Count Assay O
LAL Bacterial Endotoxin Pyrogenicity O

Design Verification - Performance bench testing was conducted to ensure that the XO Constrain Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system. The following performance testing was performed or fulfilled with the XO Constrain Catheter.

Material Verification O
Dimensional Verification O
Visual Verification O
Functional/ Simulated Use O Testing
PTA/PTCA Cycling O
Rewrap/ Recovery o
Retrieval Force O
PTA/PTCA Burst Pressure O
Torque Testing O
Kink Radius O
Tensile Testing o
Particulate Testing O
Corrosion Testing O
Packaging O
Sterilization O
Finite Element Analysis (FEA) o

Animal Testing: Animal testing was conducted to assess the safety, usability, and scoring performance of the subject device.

Conclusion:

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is substantially equivalent to the cited predicate device and met all acceptance criteria

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).