(104 days)
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.
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).
The provided text is a 510(k) summary for the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter. It focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional/safety testing, rather than an AI-driven medical device requiring a study with acceptance criteria for a new clinical indication or improved diagnostic performance.
Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic context, a study proving the device meets that criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.
The "acceptance criteria" referred to in the document are for bench testing to validate and verify that the device is substantially equivalent to a predicate device, focusing on physical and functional characteristics of the catheter. This is different from the type of acceptance criteria and study design you're asking for, which typically apply to AI/software as a medical device (SaMD) or diagnostic devices that provide clinical information or assist human readers.
To be specific, the document explicitly states:
"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."
The listed tests are all bench tests (e.g., Biocompatibility, Kink Radius, Tensile Testing, Retrieval Force Testing, Device Recovery, Accessory PTA Balloon Catheter burst pressure, Torque, Cycling, Scoring Capability Assessment).
In summary, the provided text does not describe the type of study and acceptance criteria you've requested for an AI-driven or diagnostic device.
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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
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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 AffairsUniversity of Utah/ Center for Medical Innovation10 North 1900 East, Rm. 22BSalt Lake City, UT 84112(801) 708-2238Spencer.walker@hsc.utah.edu |
| Date Prepared: | October 5, 2022 |
| Trade Name: | XO Score LP Percutaneous Transluminal Angioplasty ScoringCatheterXO Score LP Catheter |
| Classification Name: | Percutaneous Catheter21 CFR §870.1250, Product Code PNO |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K193495Model: XO Score Percutaneous Transluminal Angioplasty ScorinCatheterManufacture: Transit Scientific, LLCClassification: PNO |
| Reference Device: | 510(k) No.: K193420Model: XO Cross Support CatheterManufacture: Transit Scientific, LLCClassification: 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 LPCatheter | S3.20-150 | XO Score LP Catheter – 2.2 Fr (0.76 mm)and 3.8 Fr (1.27 mm) diameter catheter shaftin 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 TransluminalAngioplasty Scoring Catheter is intendedto be used in conjunction with a PTAballoon to facilitate dilation and appositionof the scoring surface to the stenoticmaterial in the iliac, femoral, ilio-femoral,popliteal, infra-popliteal, and renalarteries, and for treatment of obstructivelesions of native or syntheticarteriovenous dialysis fistulae. Not for usein the coronary or neuro-vasculature. | The XO Score LP PercutaneousTransluminal Angioplasty ScoringCatheter is intended to be used inconjunction with a PTA balloon to facilitatedilation and apposition of the scoringsurface to the stenotic material in the iliac,femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and fortreatment of obstructive lesions of nativeor synthetic arteriovenous dialysis fistulae.Not for use in the coronary or neuro-vasculature. | ||
| ClassificationName | Cardiovascular Device - PercutaneousCatheter21 CFR §870.1250Product Code: PNOClass II | Same | ||
| Single Use | Yes | Same | ||
| FundamentalScientificTechnology | Dilation and treatment of obstructivelesions | Same | ||
| Prescription(Rx Only) | Yes | Same | ||
| AnatomicalAccess | The iliac, femoral, ilio-femoral, popliteal,infra-popliteal, renal arteries andarteriovenous dialysis fistulae | Same | ||
| Effective Length(cm) | 65 cm, 125 cm | 150 cm | ||
| Shaft OuterDiameter | 6.4Fr (0.085") | D15: 2.2 Fr (0.030")D20: 3.8 Fr (0.050") | ||
| ScoringLength(s) | 5cm, 7cm, 11.5cm, 13.5cm | 23 cm | ||
| PTA BalloonLength | Compatible with PTA balloon lengths of20-40 mm | Compatible with PTA balloon lengths of20-200 mm | ||
| ScoringMembers | D25: 22 Struts,D35: 14 Struts,D50: 14 Struts | D15: 10 StrutsD20: 12 Struts | ||
| ExpandedScoringElementDiameter | D25: 4.5 - 8.5 mmD35: 4.7 - 8.7 mmD50: 5 - 9 mm | D15: 1.8 - 4.3 mmD20: 3.4 - 7.4 mm | ||
| Scoring Depth | D25: 0.25 mm scoring depthD35: 0.35 mm scoring depthD50: 0.50 mm scoring depth | D15: 0.15 mm scoring depthD20: 0.20 mm scoring depth | ||
| IntegratedBalloon | No | No | ||
| Table 2: Substantial Equivalence Comparison Chart | ||||
| Predicate - K193495(XO Score Catheter) | Subject Device -(XO Score LP Catheter) | |||
| Scoringmember fixed toBalloon | No | No | ||
| Scoringmember Profile(Design) | Rectangular Edges/ Diamond Pattern | Same | ||
| Scoringmember size(thickness) | 0.0025" | D15: 0.0025"D20: 0.0030" | ||
| Rated BurstPressure | Dependent on RBP of Balloon Used | Same | ||
| Visibility | Radiopaque catheter body and tip | Radiopaque catheter body, polymer tipwith radiopaque filler | ||
| GuidewireCompatibility | 0.014", 0.018", 0.035" | D15: 0.014"D20: 0.014", 0.018" | ||
| Sheath /IntroducerCompatibility | 1 French Size Larger than the PTAlabeling | 1 French Size Larger than the PTAlabeling | ||
| 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 (<24hrs) to circulating blood.
- Additional material biocompatibility data was leveraged from the K193420 O reference device, to support the modified subject device since the device materials and manufacturing processes are the same.
- Cytotoxicity testing was completed for the Accessory Loading Tool. O
- o Design Verification - Performance bench testing was conducted to ensure that the XO Score LP 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 Score LP Catheter.
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Image /page/7/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 font.
- Kink Radius O
- O Tensile Testing
- Retrieval Force Testing O
- Device Recovery o
- Accessory PTA Balloon Catheter burst pressure within XO Score LP Catheter O
- Torque O
- XO Score LP Catheter Cycling with Accessory PTA Balloon catheter o
- Scoring Capability Assessment O
- Packaging The proposed changes to the XO Score LP Catheter did not affect the . packaging or its configuration.
- Sterilization The proposed changes to the XO Score LP Catheter did not affect the . sterilization cycle or its parameters.
Conclusion:
The minor differences between the subject XO Score LP catheter and the predicated device did not raise new questions of safety or effectiveness during the design verification testing. The subject device is substantially equivalent to the predicate device.
§ 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).