The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, popliteal, infra-popliteal, 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.

Device Description

The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a 6.3 Fr (2.08 mm) diameter, single-lumen, metal alloy hypotube shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in various catheter lengths (65cm, 125cm), and longitudinal scoring element lengths (5cm, and 7cm).

AI/ML Overview

The provided text describes the "XO Score Percutaneous Transluminal Angioplasty Scoring Catheter" and its substantial equivalence to predicate devices, without directly presenting acceptance criteria in a table format with reported performance. However, it does state that "All necessary verification steps met pre-determined acceptance criteria to support substantial equivalence." and "All data met pre-determined acceptance criteria." It also mentions "The XO Score catheter met all acceptance criteria to support substantial equivalence."

Based on the information provided, here's an attempt to infer and structure the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of quantitative acceptance criteria alongside specific reported performance values for each criterion. Instead, it generally states that the device met "pre-determined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicate devices.

However, based on the "Functional Testing" and "Comparative Analysis" sections, we can infer areas where performance was assessed and accepted:

Acceptance Criteria Category	Reported Device Performance (Implicitly Met)
Design Verification	Met or exceeded Transit Scientific's in-house requirements and ISO 10555-1 requirements.
Packaging Integrity	Validated in conjunction with sterilization studies.
Biocompatibility	Verified according to ISO 10993-1 and FDA guidance for external communicating device with limited exposure (<24hrs) to circulating blood. Specific tests (Cytotoxicity, Irritation/Intracutaneous Toxicity, Sensitization, Systemic Injection, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity) were conducted and presumably met their respective acceptance limits.
Functionality (Animal Study)	At least equivalent to the predicate catheter in functionality, safety, and performance (Ovine model).
Safety (Animal Study)	At least equivalent to the predicate catheter in functionality, safety, and performance (Ovine model).
Performance (Animal Study)	At least equivalent to the predicate catheter in functionality, safety, and performance (Ovine model).
Intended Use	Same or similar to predicate devices.
Indications for Use	Same or similar to predicate devices.
Fundamental Scientific Technology	Same or similar to predicate devices.
Material Properties	Same or similar to predicate devices.
Operating Principle	Same or similar to predicate devices.
Performance Specifications	Same or similar to predicate devices.
Patient-User Interface	Same or similar to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "An animal study (Ovine model)" was conducted. However, the specific number of animals or anatomical sites used in this Ovine model is not provided.
Data Provenance: The animal study data would be considered prospective data, specifically for a pre-clinical assessment in an animal model. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The animal study would likely involve veterinary scientists or surgeons, but the specific number and qualifications of experts for establishing "ground truth" (e.g., assessing lesion scoring effectiveness or adverse events) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

An MRMC study is not mentioned or implied. The device is a physical catheter, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the provided context.

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

This question is not applicable as the device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the animal study:

The "ground truth" would be established through direct observation and assessment of the anatomical effects of the catheter on the Ovine model, likely involving histological examination, imaging, and macroscopic evaluation to determine functionality, safety (e.g., lack of perforation, dissection), and performance (e.g., successful scoring of lesions). This falls under a combination of pathology and outcomes data (clinical outcomes in the animal model).

For other verification tests (biocompatibility, design verification):

Ground truth would be established by conformance to established international standards (ISO 10993-1, ISO 10555-1) and Transit Scientific's in-house requirements.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

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

Summary

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May 29, 2020

Transit Scientific Ms. Srividya Pothana Regulatory Affairs Specialist University of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, Utah 84112

Re: K193495

Trade/Device Name: XO Score Percutaneous Transluminal Angioplasty Scoring Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 29, 2020 Received: April 30, 2020

Dear Ms. Pothana:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193495

Device Name

XO Score Percutaneous Transluminal Angioplasty Scoring 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)

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	510(k) Summary
Submitter:	Transit Scientific, LLC.
Contact Person:	Srividya Pothana, MS – Regulatory Affairs SpecialistCenter for Medical Innovation10 North 1900 East, Rm 22BSalt Lake City, UT 84112(801) 587-1456
Date Prepared:	December 27, 2019
Trade Name:	XO Score Percutaneous Transluminal Angioplasty ScoringCatheter
Classification Name:	Percutaneous Catheter21 CFR §870.1250, Product Code PNO
Device Class:	Class II
Predicate Device:	• K150634 - AngioSculpt PTA Scoring Catheter -Spectranetics Corporation• K113103 - Splitwire Percutaneous TransluminalAngioplasty Scoring Device - Rex Medical

Device Description:

Indications for Use:

The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, 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 neurovasculature.

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Comparative Analysis:

It has been demonstrated that the XO Score catheter is comparable to the predicate devices in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The XO Score 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 support substantial equivalence.

It has been demonstrated that the XO Score catheter is comparable to the predicate devices in the following manner:

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

Table 11-2: Substantial Equivalence Comparison Chart
	Predicate – K150634AngioSculpt PTAScoring Balloon Catheter	Predicate – K113103SplitWire PTA ScoringCatheter	Subject Device –XO Score PTA ScoringCatheter
Ind. for Use	The AngioSculpt PTA ScoringBalloon Catheter is intended fordilation of lesions in the iliac,femoral, ilio-femoral, popliteal,infra-popliteal, and renalarteries; and for treatment ofobstructive lesions of native orsynthetic arteriovenous dialysisfistulae. Not for use in thecoronary or neuro-vasculature.	The SplitWire PercutaneousTransluminal AngioplastyScoring device is indicated forthe use with PTA balloon tofacilitate dilation of stenosis inthe iliac, femoral, ilio-femoral,popliteal, infra-popliteal, andrenal arteries; and fortreatment of obstructivelesions of native or syntheticarteriovenous dialysis fistulae.	The XO Score PercutaneousTransluminal AngioplastyScoring catheter is intended tobe used in conjunction with aPTA balloon to facilitate dilationand apposition of the scoringsurface to the stenotic materialin the iliac, femoral, ilio-femoral,popliteal, infra-popliteal, andrenal arteries; and for treatmentof obstructive lesions of nativeor synthetic arteriovenousdialysis fistulae.Not for use in the coronary orneuro-vasculature.
ClassificationName	Cardiovascular Device –Percutaneous Catheter21 CFR §870.1250Product Code: PNOClass II	Same	Same
FundamentalScientificTechnology	Dilation and treatment ofobstructive lesions	Same	Same
Single Use	Yes	Same	Same
Table 11-2: Substantial Equivalence Comparison Chart
	Predicate - K150634AngioSculpt PTAScoring Balloon Catheter	Predicate - K113103SplitWire PTA ScoringCatheter	Subject Device –XO Score PTA ScoringCatheter
Prescription (RxOnly)	Yes	Same	Same
Anatomical Access	The iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries andarteriovenous dialysisfistulae	Same	Same
Where used	Hospitals and Clinics	Same	Same
Effective Length	50 cm, 90 cm, 137 cm	90 cm, 180 cm, 260 cm	65 cm, 125 cm
Balloon Length	10 mm – 200 mm	Compatible with balloonlengths of 20-80 mm	Compatible with balloonlengths of 20-40 mm
ExpandedScoring ElementDiameter	2-8 mm (balloon)	Unlimited	S6.25: 4.5 - 8.5 mmS6.35: 4.7 - 8.7 mmS6.50: 5 - 9 mm
IntegratedBalloon	Yes	No	No
Scoring memberfixed to Balloon	No	No	No
ScoringMembers	Image: AngioSculpt PTA Scoring Balloon Catheter	Image: SplitWire PTA Scoring Catheter	Image: XO Score PTA Scoring Catheter
	3-5 Struts	1 Strut/ wire	S6.25: 22 Struts,S6.35: 14 Struts,S6.50: 14 Struts
Scoring memberProfile (Design)	Rectangular Edges/Helical Pattern	Triangular Wedge, StraightPattern	Rectangular Edges/Diamond Pattern
Scoring membersize (thickness)	~.008"-.010"	0.014"	0.0025"
Rated BurstPressure	2-20 atm	Dependent on RBP ofBalloon Used	Dependent on RBP ofBalloon Used
Visibility	Radiopaque Markers	2 Radiopaque Markers	Radiopaque catheter bodyand tip
GuidewireCompatibility	0.018"	0.035" or 0.018"	0.014", 0.018", 0.035"
Sheath /IntroducerCompatibility	5 – 6 Fr	Dependent on theintroducer compatibility ofthe balloon used	7 Fr
Sterility	EO Sterile	Same	Same
Biocompatibility	ISO 10993	Same	Same

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Functional 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.

Design Verification -The XO Score catheter meet or exceeded both Transit . Scientific's in-house requirements, and requirements listed in ISO 10555-1. Packaging integrity was validated in conjunction with the sterilization studies.
Biocompatibility - Biocompatibility of the complete and finished XO Score catheter has been verified according to the requirements and testing prescribed in ISO 10993-1 and in accordance with FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (<24hrs) to circulating blood. Per ISO 10993-1, testing included the following:
- Cytotoxicity O
- o Irritation/ Intracutaneous Toxicity
- Sensitization O
- Systemic Iniection O
- Material Mediated Pyrogenicity O
- Hemolysis Complete O
- Complement Activation o
- o Thrombogenicity

Preclinical Data: .

An animal study (Ovine model) was done as a comparative study to demonstrate and compare the functionality, safety, and performance of the subject XO Score catheter to the predicate device. The results of the study demonstrated that the subject XO Score catheter is at least equivalent to the predicate catheter in the areas of functionality, safety, and performance.

Conclusion:

Based on the similarities in design between the subject and predicate devices, and the performance testing performed, the subject XO Score catheter is substantially equivalent to the cited predicate devices. Additionally, the XO Score catheter met all acceptance criteria to support substantial equivalence.

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).