(322 days)
No
The device description and performance studies focus on mechanical properties and functional testing, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended to facilitate dilation and apposition of a scoring/constraining surface to a stenosis in various arteries and for treatment of obstructive or synthetic arteriovenous dialysis fistulae, which are therapeutic medical interventions.
No
Explanation: The device is described as a "Percutaneous Transluminal Angioplasty Constraining Catheter" used to facilitate dilation and apposition, and vessel scoring. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly outlines a physical catheter with a metal alloy wire shaft and expandable constraining structure, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is used within the body to facilitate dilation and apposition of a scoring/constraining surface to a stenosis in arteries and fistulae. It's a therapeutic device used during a medical procedure.
- Intended Use: The intended use describes a procedure performed directly on the patient's vascular system, not the analysis of samples.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
PNO
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 off-the-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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 Constrain 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 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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232258
Device Name
XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
Indications for Use (Describe)
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.
| 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 Affairs |
| University of Utah/ Center for Medical Innovation | |
| 350 East 400 South | |
| Salt Lake City, UT 84111 | |
| (801) 708-2238 | |
| Spencer.walker@hsc.utah.edu | |
| Date Prepared: | May 31, 2024 |
| Trade Name: | XO Constrain Percutaneous Transluminal Angioplasty |
| Constraining Catheter | |
| Classification Name: | Percutaneous Scoring Catheter |
| 21 CFR §870.1250, Product Code PNO | |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K221986 |
| Model: XO Score LP Percutaneous Transluminal Angioplasty | |
| Scoring Catheter | |
| Manufacture: Transit Scientific, LLC | |
| Classification: PNO | |
| Reference Device: | 510(k) No .: K150634 |
| Model: AngioSculpt PTA Scoring Balloon Catheter | |
| Manufacture: Spectranetics Co. | |
| Classification: PNO |
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
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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 – (XO | |||
| Constrain Catheter) | Predicate - K221986 (XO | ||
| Score LP Catheter) | Reference - K150634 – | ||
| (AngioSculpt PTA | |||
| Catheter) | |||
| Ind. 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, ilio-femoral, popliteal, | |||
| infra-popliteal, and renal arteries, | 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 | For dilatation of lesions in the | ||
| iliac, femoral, ilio-femoral, | |||
| popliteal, infra popliteal, and | |||
| renal arteries, and for the | |||
| treatment of obstructive lesions | |||
| of native or synthetic | |||
| arteriovenous dialysis fistulae. | |||
| Not for use in the coronary or | |||
| neuro-vasculature. | |||
| Table 1: Substantial Equivalence Comparison Chart | |||
| Subject Device – (XO | |||
| Constrain Catheter) | Predicate - K221986 (XO | ||
| Score LP Catheter) | Reference - K150634 – | ||
| (AngioSculpt PTA | |||
| Catheter) | |||
| and for treatment of obstructive | |||
| lesions of native or synthetic | |||
| arteriovenous dialysis fistulae. Not | |||
| for use in the coronary or neuro- | |||
| vasculature. | synthetic arteriovenous dialysis | ||
| fistulae. Not for use in the | |||
| coronary or neuro-vasculature. | |||
| Anatomical | |||
| Access | Peripheral Vasculature | Peripheral Vasculature | Peripheral Vasculature |
| Shaft | |||
| Construction | Wire with Polymer Covering | Wire with Polymer Covering | Two-Lumen Polymer Shaft |
| Constraining/ | |||
| Scoring | |||
| Structure | Metal Alloy Hypotube | Metal Alloy Hypotube | 3-5 Wires |
| Effective | |||
| Length (cm) | 145cm | 150 cm | 50 cm, 90 cm, 137 cm |
| Crossing | |||
| Profile | Distal tip: 1.5Fr | 2.2Fr distal tip: 1.5Fr | |
| 3.8Fr distal tip: 1.9Fr | .014" GW Compatible: 1.5F | ||
| .018" GW Compatible: 1.9F | |||
| Balloon | |||
| Diameter | Compatible with 1.5mm – | ||
| 4.0mm compliant and semi- | |||
| compliant balloons | 2.2Fr: 1.5 – 4.0mm | ||
| 3.8Fr: 3 - 7mm | 2-8 mm | ||
| Balloon | |||
| Length | Compatible with 6mm – | ||
| 20mm compliant and semi- | |||
| compliant balloons | Compatible with PTA | ||
| balloon lengths of 20-200 | |||
| mm | 10 mm – 200 mm | ||
| Constraining | |||
| Structure | |||
| (Inflated | |||
| Diameter) | 1.7mm – 4.2mm max | 2.2Fr: 1.8 – 4.3mm | |
| 3.8Fr: 3.4 - 7.4 mm | 2-8 mm (balloon profile | ||
| only) | |||
| Visibility/ | |||
| Radiopacity | The catheter tip and the | ||
| scoring/constraining | |||
| structure are radiopaque. | |||
| The balloon catheter marker | |||
| bands are visible through the | |||
| constraining structure when | |||
| inflated. | The catheter tip and the | ||
| scoring structure are | |||
| radiopaque. The balloon | |||
| catheter marker bands are | |||
| visible through the | |||
| constraining structure when | |||
| inflated. | The balloon catheter has | ||
| two marker bands are | |||
| visible through the balloon | |||
| material. | |||
| Guidewire | |||
| Compatibility | Max 0.014" | 2.2Fr: Max 0.014" | |
| 3.8Fr: Max 0.018" | Max 0.018" |
6
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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accordance with FDA quidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (