(164 days)
Not Found
No
The description focuses on the mechanical function of a scoring catheter and does not mention any AI/ML components or capabilities.
Yes
The device is described as "Percutaneous Transluminal Angioplasty Scoring Catheter," which is used to facilitate dilation and apposition of the scoring surface to stenotic material in arteries for treatment of obstructive lesions, indicating a direct therapeutic action on the body.
No
This device is described as a "Percutaneous Transluminal Angioplasty Scoring Catheter," which is used to treat stenotic material by facilitating dilation and apposition of a scoring surface. Its function is to add "lesion scoring / cutting capability" to a standard PTA balloon catheter. This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly outlines physical components like a metal alloy hypotube shaft, polymer outer jacket, and a balloon expandable scoring element, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a physical device used within the body during a medical procedure (angioplasty). It's designed to mechanically score or cut stenotic material in blood vessels.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's anatomy, not the analysis of a biological sample.
Therefore, this device falls under the category of an interventional or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
PNO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal, and renal arteries; native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals and Clinics
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)
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 (
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
Indications for Use
510(k) Number (if known) K193495
Device Name
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
Indications for Use (Describe)
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.
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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3
| 510(k) Summary | |
|---|---|
| Submitter: | Transit Scientific, LLC. |
| Contact Person: | Srividya Pothana, MS – Regulatory Affairs Specialist |
| Center for Medical Innovation | |
| 10 North 1900 East, Rm 22B | |
| Salt Lake City, UT 84112 | |
| (801) 587-1456 | |
| Date Prepared: | December 27, 2019 |
| Trade Name: | XO Score Percutaneous Transluminal Angioplasty Scoring |
| Catheter | |
| Classification Name: | Percutaneous Catheter |
| 21 CFR §870.1250, Product Code PNO | |
| Device Class: | Class II |
| Predicate Device: | • K150634 - AngioSculpt PTA Scoring Catheter - |
| Spectranetics Corporation | |
| • K113103 - Splitwire Percutaneous Transluminal | |
| Angioplasty Scoring Device - Rex Medical |
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).
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.
4
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 – K150634 | |||
| AngioSculpt PTA | |||
| Scoring Balloon Catheter | Predicate – K113103 | ||
| SplitWire PTA Scoring | |||
| Catheter | Subject Device – | ||
| XO Score PTA Scoring | |||
| Catheter | |||
| Ind. for Use | The AngioSculpt PTA Scoring | ||
| Balloon Catheter is intended for | |||
| dilation of lesions in the iliac, | |||
| femoral, ilio-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. | The SplitWire Percutaneous | ||
| Transluminal Angioplasty | |||
| Scoring device is indicated for | |||
| the use with PTA balloon to | |||
| facilitate dilation of stenosis in | |||
| the iliac, femoral, ilio-femoral, | |||
| popliteal, infra-popliteal, and | |||
| renal arteries; and for | |||
| treatment of obstructive | |||
| lesions of native or synthetic | |||
| arteriovenous dialysis fistulae. | 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, 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. | |||
| Classification | |||
| Name | Cardiovascular Device – | ||
| Percutaneous Catheter | |||
| 21 CFR §870.1250 | |||
| Product Code: PNO | |||
| Class II | Same | Same | |
| Fundamental | |||
| Scientific | |||
| Technology | Dilation and treatment of | ||
| obstructive lesions | Same | Same | |
| Single Use | Yes | Same | Same |
| Table 11-2: Substantial Equivalence Comparison Chart | |||
| Predicate - K150634 | |||
| AngioSculpt PTA | |||
| Scoring Balloon Catheter | Predicate - K113103 | ||
| SplitWire PTA Scoring | |||
| Catheter | Subject Device – | ||
| XO Score PTA Scoring | |||
| Catheter | |||
| Prescription (Rx | |||
| Only) | Yes | Same | Same |
| Anatomical Access | The iliac, femoral, ilio- | ||
| femoral, popliteal, infra- | |||
| popliteal, renal arteries and | |||
| arteriovenous dialysis | |||
| fistulae | 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 balloon | |
| lengths of 20-80 mm | Compatible with balloon | ||
| lengths of 20-40 mm | |||
| Expanded | |||
| Scoring Element | |||
| Diameter | 2-8 mm (balloon) | Unlimited | S6.25: 4.5 - 8.5 mm |
| S6.35: 4.7 - 8.7 mm | |||
| S6.50: 5 - 9 mm | |||
| Integrated | |||
| Balloon | Yes | No | No |
| Scoring member | |||
| fixed to Balloon | No | No | No |
| Scoring | |||
| Members | 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 member | |||
| Profile (Design) | Rectangular Edges/ | ||
| Helical Pattern | Triangular Wedge, Straight | ||
| Pattern | Rectangular Edges/ | ||
| Diamond Pattern | |||
| Scoring member | |||
| size (thickness) | ~.008"-.010" | 0.014" | 0.0025" |
| Rated Burst | |||
| Pressure | 2-20 atm | Dependent on RBP of | |
| Balloon Used | Dependent on RBP of | ||
| Balloon Used | |||
| Visibility | Radiopaque Markers | 2 Radiopaque Markers | Radiopaque catheter body |
| and tip | |||
| Guidewire | |||
| Compatibility | 0.018" | 0.035" or 0.018" | 0.014", 0.018", 0.035" |
| Sheath / | |||
| Introducer | |||
| Compatibility | 5 – 6 Fr | Dependent on the | |
| introducer compatibility of | |||
| the balloon used | 7 Fr | ||
| Sterility | EO Sterile | Same | Same |
| Biocompatibility | ISO 10993 | Same | Same |
5
6
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 (