(104 days)
No
The summary describes a mechanical device (a scoring catheter) and its functional and safety testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is used to facilitate dilation and apposition of scoring surfaces to stenotic material in arteries and for treatment of obstructive lesions, which are therapeutic actions.
No
Explanation: The device description states that the XO Score LP is a "Percutaneous Transluminal Angioplasty Scoring Catheter" designed to facilitate "dilation and apposition of the scoring surface to the stenotic material." This indicates a therapeutic function (treating stenosis), not a diagnostic one (identifying or characterizing a condition).
No
The device description explicitly states it is a physical catheter with a metal alloy shaft, polymer jacket, and a balloon expandable scoring element. It is a hardware device used in a medical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) to facilitate angioplasty procedures in various arteries and arteriovenous fistulae. This is a therapeutic and interventional use, not a diagnostic one performed in vitro (outside the body) on biological samples.
- Device Description: The description details a catheter with a scoring element designed to be used with a PTA balloon. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is mechanical and interventional, not diagnostic.
N/A
Intended Use / Indications for Use
The XO Score LP 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, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lessions 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 LP (Low Profile) Percutaneous Transluminal Angioplasty Scoring Catheter is a 2.2 Fr (0.76 mm) and 3.8 Fr (1.27 mm) diameter, single-lumen, metal alloy 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 LP 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 the one catheter length (150 cm), and longitudinal scoring element length (23cm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional/Safety Testing:
- Biocompatibility - Biocompatibility of the complete and finished XO Score LP 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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 18, 2022
Transit Scientific, LLC % Spencer Walker Director of Regulatory Affairs University of Utah 10 North 1900 East, EHSL Rm, 22B Salt Lake City, Utah 84112
Re: K221986
Trade/Device Name: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: September 29, 2022 Received: September 29, 2022
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 (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
1
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 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,
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) K221986
Device Name
XO SCORE LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Indications for Use (Describe)
The XO Score LP 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, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lessions 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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Image /page/3/Picture/0 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the words "TRANSIT" stacked on top of "SCIENTIFIC". The font is modern and sans-serif, with rounded corners on some of the letters.
510(K) SUMMARY
(21 CFR 807.92)
GENERAL INFORMATION
| Submitter: | Transit Scientific, LLC |
|---|---|
| Contact Person: | Spencer Walker, MSc – Director of Regulatory Affairs |
| University of Utah/ Center for Medical Innovation | |
| 10 North 1900 East, Rm. 22B | |
| Salt Lake City, UT 84112 | |
| (801) 708-2238 | |
| Spencer.walker@hsc.utah.edu | |
| Date Prepared: | October 5, 2022 |
| Trade Name: | XO Score LP Percutaneous Transluminal Angioplasty Scoring |
| Catheter | |
| XO Score LP Catheter | |
| Classification Name: | Percutaneous Catheter |
| 21 CFR §870.1250, Product Code PNO | |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K193495 |
| Model: XO Score Percutaneous Transluminal Angioplasty Scorin | |
| Catheter | |
| Manufacture: Transit Scientific, LLC | |
| Classification: PNO | |
| Reference Device: | 510(k) No.: K193420 |
| Model: XO Cross Support Catheter | |
| Manufacture: Transit Scientific, LLC | |
| Classification: DQY |
Device Description:
The XO Score LP (Low Profile) Percutaneous Transluminal Angioplasty Scoring Catheter is a 2.2 Fr (0.76 mm) and 3.8 Fr (1.27 mm) diameter, single-lumen, metal alloy 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 LP catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at
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Image /page/4/Picture/1 description: The image shows the logo for Transit Scientific. The logo is in black and consists of two words, "TRANSIT" on the top line and "SCIENTIFIC" on the bottom line. The letters are all capitalized and have a modern, sans-serif font. The trademark symbol is located to the right of the word "SCIENTIFIC".
its distal end. It is available in the one catheter length (150 cm), and longitudinal scoring element length (23cm).
| Table 1: XO Score LP Catheter Model Numbers | ||
|---|---|---|
| Product Family | Model No. | Description |
| XO Score LP | ||
| Catheter | S3.20-150 | XO Score LP Catheter – 2.2 Fr (0.76 mm) |
| and 3.8 Fr (1.27 mm) diameter catheter shaft | ||
| in 150cm lengths. | ||
| S2.15-150 |
Indications for Use:
The XO Score LP 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, illo-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.
Comparative Analysis:
Modifications in design, materials, and size range to the previously 510(k) cleared XO Score Catheter (K193495) resulted in new product codes. The following modifications were made to the subject catheter:
- Catheter Shaft Design ●
- Catheter Sizes (Diameter)
- Catheter Effective Length o
- Number of Scoring Struts ●
- Scoring Element Diameter when Expanded
- Scoring Depth
- Balloon Length Compatibility
- Tip Material
- . Accessory Loading Tool
It has been demonstrated that the modified XO Score LP catheter is comparable to the predicate device in fundamental scientific technology, design, materials, principles of operation and functional performance evaluations and is substantial equivalent as summarized in Table 2. Furthermore, the XQ Score LP catheter has been fully assessed within the Transit Scientific Risk Management and Design Controls systems. The differences raise no additional or different questions of safety or effectiveness from that already identified for the predicate device.
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| Table 2: Substantial Equivalence Comparison Chart | ||||
|---|---|---|---|---|
| Predicate - K193495 | ||||
| (XO Score Catheter) | Subject Device - | |||
| (XO Score LP Catheter) | ||||
| Ind. 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, 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 XO Score LP 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 | |||
| Single Use | Yes | Same | ||
| Fundamental | ||||
| Scientific | ||||
| Technology | Dilation and treatment of obstructive | |||
| lesions | Same | |||
| Prescription | ||||
| (Rx Only) | Yes | Same | ||
| Anatomical | ||||
| Access | The iliac, femoral, ilio-femoral, popliteal, | |||
| infra-popliteal, renal arteries and | ||||
| arteriovenous dialysis fistulae | Same | |||
| Effective Length | ||||
| (cm) | 65 cm, 125 cm | 150 cm | ||
| Shaft Outer | ||||
| Diameter | 6.4Fr (0.085") | D15: 2.2 Fr (0.030") | ||
| D20: 3.8 Fr (0.050") | ||||
| Scoring | ||||
| Length(s) | 5cm, 7cm, 11.5cm, 13.5cm | 23 cm | ||
| PTA Balloon | ||||
| Length | Compatible with PTA balloon lengths of | |||
| 20-40 mm | Compatible with PTA balloon lengths of | |||
| 20-200 mm | ||||
| Scoring | ||||
| Members | D25: 22 Struts, | |||
| D35: 14 Struts, | ||||
| D50: 14 Struts | D15: 10 Struts | |||
| D20: 12 Struts | ||||
| Expanded | ||||
| Scoring | ||||
| Element | ||||
| Diameter | D25: 4.5 - 8.5 mm | |||
| D35: 4.7 - 8.7 mm | ||||
| D50: 5 - 9 mm | D15: 1.8 - 4.3 mm | |||
| D20: 3.4 - 7.4 mm | ||||
| Scoring Depth | D25: 0.25 mm scoring depth | |||
| D35: 0.35 mm scoring depth | ||||
| D50: 0.50 mm scoring depth | D15: 0.15 mm scoring depth | |||
| D20: 0.20 mm scoring depth | ||||
| Integrated | ||||
| Balloon | No | No | ||
| Table 2: Substantial Equivalence Comparison Chart | ||||
| Predicate - K193495 | ||||
| (XO Score Catheter) | Subject Device - | |||
| (XO Score LP Catheter) | ||||
| Scoring | ||||
| member fixed to | ||||
| Balloon | No | No | ||
| Scoring | ||||
| member Profile | ||||
| (Design) | Rectangular Edges/ Diamond Pattern | Same | ||
| Scoring | ||||
| member size | ||||
| (thickness) | 0.0025" | D15: 0.0025" | ||
| D20: 0.0030" | ||||
| Rated Burst | ||||
| Pressure | Dependent on RBP of Balloon Used | Same | ||
| Visibility | Radiopaque catheter body and tip | Radiopaque catheter body, polymer tip | ||
| with radiopaque filler | ||||
| Guidewire | ||||
| Compatibility | 0.014", 0.018", 0.035" | D15: 0.014" | ||
| D20: 0.014", 0.018" | ||||
| Sheath / | ||||
| Introducer | ||||
| Compatibility | 1 French Size Larger than the PTA | |||
| labeling | 1 French Size Larger than the PTA | |||
| labeling | ||||
| Sterility | Sterile - EO | Same | ||
| Biocompatibility | ISO 10993 | Same |
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Image /page/6/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 top of the word "SCIENTIFIC" in smaller letters. The logo has a modern and clean design.
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 Score LP 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 (