(127 days)
The OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions.
The OffRoad Re-Entry Catheter System consists of two components; the OffRoad Positioning Balloon Catheter and the OffRoad Micro-Catheter Lancet. Together they assist in accessing the true lumen after bypassing a chronic total occlusion lesion in the peripheral vasculature.
The provided text describes the acceptance criteria and the studies conducted for the OffRoad™ Re-Entry Catheter System.
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint Type | Acceptance Criteria | Reported Device Performance | Device Meets Criteria? |
|---|---|---|---|
| Safety | Composite rate of major adverse events (MAEs) related to the OffRoad System through 30 days post index procedure less than 15%. | 3.3% (3/90) with a one-sided 95% upper confidence bound of 6.5%. | Yes |
| Effectiveness | Device technical success (placement of a guidewire in the true lumen distal to a CTO as confirmed by the angiography core lab) greater than 76%. | Site-reported: 84.8% (78/92) with a one-sided 95% lower confidence bound of 79%. Core Lab Confirmed: 92.1% (70/76) with a one-sided 95% lower confidence bound of 87%. | Yes |
Note: The clinical study also included secondary endpoints (death, perforation requiring intervention, clinically significant peripheral embolism, major amputation), but acceptance criteria were only explicitly stated for the composite MAE rate and device technical success.
2. Sample Size Used for the Test Set and Data Provenance
Human Clinical Study (Re-ROUTE, NCT01500031):
- Sample Size: 92 subjects.
- Data Provenance: Prospective, multi-center clinical study conducted at 12 investigational sites. The document does not specify the country of origin of the data, but it is implied to be within the US given the context of a 510(k) submission to the FDA.
Pre-Clinical Animal Study:
- Sample Size: N=7 OffRoad™ Re-entry Catheter devices and N=5 Cordis OUTBACK® LTD™ Re-Entry Catheter devices (used in 6 common swine).
- Data Provenance: Pre-clinical animal study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Human Clinical Study (Re-ROUTE): The primary effectiveness endpoint (device technical success) was confirmed by an angiography core lab. The number and specific qualifications of experts within this core lab are not detailed in the provided text.
- Pre-Clinical Animal Study: The study noted that two instances of arterial wall perforations were "not considered a safety concern by the Study Pathologist and Study Director." This indicates at least two experts (a Study Pathologist and a Study Director) were involved in establishing the ground truth for the animal study's safety assessment, but their specific qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
- Human Clinical Study (Re-ROUTE): The document mentions "CEC data" (Clinical Event Committee), which suggests that a Clinical Event Committee was responsible for adjudicating adverse events and potentially other study endpoints, ensuring uniformity and reliability of outcome assessment. The specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated. The primary effectiveness endpoint was confirmed by an angiography core lab.
- Pre-Clinical Animal Study: The assessment of safety concerns was done by the "Study Pathologist and Study Director." No specific formal adjudication method (like 2+1) is described beyond their joint assessment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
- This device (OffRoad™ Re-Entry Catheter System) is a physical medical device (catheter system) and not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done.
- As explained above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Human Clinical Study (Re-ROUTE):
- Safety: Composite Major Adverse Events (MAEs) were defined by specific clinical outcomes (death, perforation requiring intervention, clinically significant peripheral embolism, major amputation). These are objective clinical endpoints, likely confirmed by the Clinical Event Committee based on patient records and diagnostic evidence.
- Effectiveness: Device technical success was defined as "placement of a guidewire in the true lumen distal to a CTO as confirmed by the angiography core lab." Angiography provides visual evidence of guidewire placement, serving as the ground truth.
- Pre-Clinical Animal Study: Ground truth was established through histological characterization and direct observation of vessel wall effects after using the devices, assessed by a Study Pathologist and Study Director.
8. The Sample Size for the Training Set
- The provided text does not mention a training set. This is consistent with the device being a physical catheter system, for which the concepts of "training set" and "test set" in the context of machine learning or AI models are not directly applicable. The studies described are performance and safety evaluations for human use and pre-clinical testing, not algorithm development.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable and not mentioned, the method for establishing its ground truth is also not mentioned.
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OCT 3 1 2013
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact NameandInformation | Carol TiffanyRegulatory Affairs SpecialistPhone: 763-494-1106Fax: 763-494-2222e-mail: carol.tiffany@bsci.com |
| Date Prepared | 20 September 2013 |
| ProprietaryName | OffRoad™ Re-Entry Catheter System |
| Common Name | Percutaneous Catheter |
| Product Code | PDU - Catheter for Crossing Total Occlusions |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter |
| PredicateDevice | Cordis Outback Re-Entry CatheterK083814January 13, 2009 |
| DeviceDescription | The OffRoad Re-Entry Catheter System consists of two components;the OffRoad Positioning Balloon Catheter and the OffRoad Micro-Catheter Lancet. Together they assist in accessing the true lumen afterbypassing a chronic total occlusion lesion in the peripheral vasculature. |
| Intended Use/Indications forUse of Device | The OffRoad Re-Entry Catheter System is intended to facilitate theplacement and positioning of guidewires within the peripheralvasculature beyond stenotic lesions, including sub and chronic totalocclusions. |
| Comparison ofTechnologicalCharacteristics | The OffRoad Re-Entry Catheter System is substantially equivalent tothe Cordis Outback Re-Entry Catheter (K083814) (the Predicate Device)that the Food and Drug Administration (FDA) has already cleared foruse to facilitate placement and positioning of quidewires and catheterswithin the peripheral vasculature. The OffRoad Re-Entry CatheterSystem and the predicate device have the same intended use andsimilar indications, technological characteristics, and principles ofoperation. The minor technological differences between the OffRoadRe-Entry Catheter System and its predicate device do not raise any newissues of safety or effectiveness. |
| PerformanceData | Currently no FDA mandated or voluntary performance standards existfor this device. Bench testing, biocompatibility testing, and pre-clinicalanimal testing were performed to support a determination of substantialequivalence. The results of these tests provide reasonable assurancethat the proposed device has been designed and tested to assureconformance to the requirements for its intended use. No new safety orperformance issues were raised during the testing and, therefore, thesedevices may be considered substantially equivalent to the predicatedevices. |
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The following biocompatibility and bench testing were completed on the OffRoad ™ Re-Entry Catheter System:
Biocompatibility
- MEM Elution Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Pyrogenicity USP Physicochemical Complement Activation
Hemolysis (Direct Contact) Ames Mutagenicity Mouse Lymphoma Coaqulation In Vitro Hemocompatibility Partial Thromboplastin Time Natural Rubber Latex
The following in-vitro performance tests were completed on the OffRoad™ Re-Entry Catheter System:
Bench Tensile Strength Catheter Effective Length
Deflation Time Balloon Rated Burst Pressure (RBP)
Balloon Repeat Inflation Surface Finish and Cleanliness Balloon Catheter/Micro Catheter Compatibility Flexibility and Kink
Shaft Outer Diameter (OD) Shaft to Y-Connector Tensile Strength Balloon Nominal Diameter Proximal Balloon Bond Tensile Strength Corrosion Guidewire Compatibility Sheath Compatibility
Simulated Use and Coating Integrity Torque after Conditioning
Particulate Evaluation
Pre-Clinical Animal Testing
BSC conducted a Preclinical study in naïve peripheral arteries of six common swine to evaluate the acute performance of the OffRoad™ Reentry Catheter System in comparison to the predicate Cordis OUTBACK® LTD Re-Entry Catheter.
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| Devices | Evaluation Criteria | OffRoad Testing Summary |
|---|---|---|
| OffRoad™ Re-entry CatheterN=7 | Pass all required performance criteria during use:Device preparation Support product compatibility Proper positioning and use of Re-entry device Confirm re-entry Withdrawal after use | OffRoad received passing ratings for all performance criteria.Device preparation was rated acceptable in all cases Compatibility with all support product was rated acceptable Positioning and use was rated acceptable in all cases Re-entry was confirmed with all devices. Withdrawal of all devices was rated acceptable |
| CordisOUTBACK®LTD™ Re-EntryCatheterN=5 | Histological characterization, and comparison of vessel wall effects after use of devices | Two instances of small arterial wall perforations associated with very limited perivascular hemorrhage near the site of re-entry were observed. Based on the data collected, neither perforation was considered a safety concern by the Study Pathologist and Study Director. |
Study Results Conclusion:
OffRoad and Outback devices met all protocol-specified evaluation criteria, and were used successfully to gain re-entry into the true lumen from within a vascular subintimal track created in the porcine naïve peripheral artery model. Vascular effects attributed to re-entry procedures using OffRoad and Outback devices were similar.
Two instances of arterial wall perforations near the site of re-entry were observed, and were not considered a safety concern. This is based on the small size, limited perivascular hemorrhage, aggressive study procedures, which required creation of a subintimal track using a wire prior to any re-entry device use, and the fact that porcine non-diseased peripheral vessels are thinner than human diseased peripheral arteries. 1. 2
Results from the study support safety of the OffRoad™ Re-entry Catheter System during clinical use in the peripheral vasculature.
References
-
- Sarkola T, Transcutaneous very-high resolution ultrasound to quantify arterial wall layers of muscular and elastic arteries: Validation of a method. Atherosclerosis. 2010 Oct; 212(2); 516-23 Wong M et al, Ultrasonic – Pathological Comparison of the Human Arterial 2. Wall Arterioscler Thromb Vasc Biol. 1993; 13;482-486 A prospective clinical study of 92 subjects was conducted at 12 Performance investigational sites to provide additional clinical data regarding the Data - Clinical safety and technical success of the OffRoad Re-Entry Catheter System for subintimal recanalization of chronic total occlusion (CTO) in the femoropopliteal arteries (Re-ROUTE, NCT01500031). Study Subjects Study subjects were required to have claudication or critical limb ischemia (Rutherford Category 2-5) and a de novo or re-occluded CTO (99-100%) lesion in a native femoropopliteal artery.
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Traditional 510(k) Submission OffRoad™ Re-Entry Catheter System
| StudyEndpoints | The primary safety endpoint was a composite rate of major adverseevents (MAEs) related to the OffRoad System through 30 days postindex procedure including: death, perforation requiring intervention,clinically significant peripheral embolism, and major amputation(amputation of the treated lower limb at the ankle level or above). |
|---|---|
| The primary effectiveness endpoint was device technical success,defined as the placement of a guidewire in the true lumen distal to aCTO as confirmed by the angiography core lab. | |
| Clinical StudyResults | The composite rate of major adverse events (MAEs) related to theOffRoad System at 30 days was 3.3%. The single sample z-approximation one-sided 95% upper confidence bound was 6.5%, whichwas less than the threshold value of 15%, thus, the primary safetyendpoint has been met. The site-reported device technical success ratewas 84.8%. The single sample z-approximation one-sided 95% lowerconfidence bound was 79%, which was greater than the threshold valueof 76%, thus, the primary effectiveness endpoint has been met. Theprimary safety and effectiveness endpoint results are summarized inTable 1. |
| Characteristics | Overall | 95% CI | Non-Inferiority Analysis | |
|---|---|---|---|---|
| Safety (at 30-Day) | Upper 1-Sided95% CI | Performancegoal (PG) | ||
| MAE (Device-related) | 3.3%(3/90) | [0.0%,7.0%] | 6.5%b | 15% |
| Death | 0.0%(0/90) | [0.0%,0.0%] | ||
| Perforation requiringintervention | 0.0%(0/90) | [0.0%,0.0%] | ||
| Clinically significantperipheral embolism | 3.3%(3/90) | [0.0%,7.0%] | ||
| Major amputation atankle level or above | 0.0%(0/90) | [0.0%,0.0%] | ||
| MAE (Regardless ofrelatedness to device) | 7.8%(7/90) | [2.2%,23.3%] | ||
| Death | 1.1%(1/90) | [0.0%,3.3%] | ||
| Perforation requiringintervention | 1.1%(1/90) | [0.0%,3.3%] | ||
| Clinically significantperipheral embolism | 5.6%(5/90) | [0.8%,10.3%] | ||
| Major amputation atankle level or above | 0.0%(0/90) | [0.0%,0.0%] | ||
| Effectiveness (On the dayof Procedure) | Lower 1-Sided95% CI | PG | ||
| Device Technical Successa | ||||
| Site Reported | 84.8%(78/92) | [77.4%,92.1%] | 78.6%c | 76% |
| Core Lab Confirmed | 92.1%(70/76) | [86.0%,98.2%] | 87.0% | 76% |
Table 1 Primary Endpoints - Subjects: N=92
Numbers are % (Count/Sample Size)
Denominators are based on 1) subjects with events, and 2) subjects with no events but have been enrolled at least 23 days.
4 Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a CTO as confirmed by angiography core lab.
6 Event rate was lower than the pre-specified acceptable threshold
" Technical success rates exceeded the pre-specified performance goal Events are based on CEC data.
Abbreviations: MAE= major adverse event, PG= performance goal, CEC= Clinical Event Committee
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Traditional 510(k) Submission OffRoad™ Re-Entry Catheter System
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. . . . . . .
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| Clinical StudyConclusion | The Re-ROUTE results are consistent with published data on other re-entry devices. The results of the Re-ROUTE study support the safetyand performance of the OffRoad Re-Entry Catheter System and thedetermination of substantial equivalence. |
|---|---|
| Conclusion | Based on the indications for use, technological characteristics, safetyand performance testing, pre-clinical studies, and the Re-ROUTEclinical study, the OffRoad Re-Entry Catheter System has been shownto be appropriate for its intended use and is considered to besubstantially equivalent to the Cordis Outback Re-Entry Catheter,K083814. |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2013
Boston Scientific Corporation c/o Ms. Carol Tiffany Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K131914
.
Trade/Device Name: OffRoadTM Re-Entry Catheter System Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: September 25, 2013 Received: September 26, 2013
Dear Ms. Tiffany:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carol Tiffany
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131914
Device Name: OffRoad™ Re-Entry Catheter System
Indications for Use:
The OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram D. Zucke 2013.10.31 08:5
Boston Scientific Corporation
Page 1 of 1
§ 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).