(167 days)
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
The UnBalloon Non-Occlusive Modeling Catheter consists of an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.
The provided text describes a medical device, the "UnBalloon Non-Occlusive Modeling Catheter," and its premarket notification (510(k) summary). It focuses on demonstrating the device's substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria for performance as an AI/ML product.
Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to performance testing of AI/ML devices.
However, I can extract information related to the device's functional performance and safety as described in the "Summary of Product Testing" and "Summary of OUS Post Market Surveillance" sections.
Here's the breakdown of what can be populated based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML device would have for metrics like sensitivity, specificity, etc. Instead, it lists various assessments performed and their outcomes, indicating successful performance or minimal issues.
| Acceptance Criteria (Implicit from Tests Performed) | Reported Device Performance |
|---|---|
| Product Characterization and Validation: | |
| Worst case Simulated use | Assessed (Implicitly successful) |
| Inflation/Deflation time | Assessed (Implicitly successful) |
| Freedom from leakage | Assessed (Implicitly successful) |
| Kink resistance | Assessed (Implicitly successful) |
| Fatigue | Assessed (Implicitly successful) |
| Hemostasis | Assessed (Implicitly successful) |
| Bond tensile strength | Assessed (Implicitly successful) |
| Radial outward force | Assessed (Implicitly successful) |
| Compatibility with endoprostheses | Assessed (Implicitly successful) |
| Physiological insult (Acute and 28-day) | Assessed via animal testing (Implicitly successful) |
| OUS Post Market Surveillance: | |
| Technical success rate | 100% technical success (13 cases) |
| Adverse events/device related malfunctions | No reported adverse events or device related malfunctions |
| Resheathing of Nitinol cage | Resheathed in all cases without issues |
| Nitinol cage getting hooked/caught | No reports of getting hooked or caught |
| Other complications/adverse events | No other complications or adverse events were reported |
| Blood loss through device | Minimal; 1 recorded result of 3ml through guidewire lumen (as expected) |
| Radiopacity | Overall rating of 'good' in most cases; 2 cases reported some difficulty seeing inner marker bands or sheath marker. |
| Applied modeling force (radial force) | "Appropriate" in 8 (62%) cases; "unknown/cannot judge" in 5 (37%) |
| Device failures | No device failures reported |
| Performance as intended, safe, and effective | "These initial clinical results indicate that the UnBalloon Non-Occlusive Modeling Catheter performs as intended and is as safe and effective as the predicate devices." |
| Biocompatibility | Tested per ISO10993-1 (Implicitly successful) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 13 cases (OUS Post Market Surveillance).
- Data Provenance: Retrospective collection of data from 13 cases attended by LeMaitre Vascular in Brazil and the European Union. Dates: June 14, 2011 to August 16, 2011.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The "Summary of OUS Post Market Surveillance" describes direct observation and recording of outcomes by LeMaitre Vascular staff during cases rather than a formal expert-adjudicated ground truth process. The clinicians performing the procedures are the "evaluative experts" in a practical sense, but their specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies, which is not the nature of this device's evaluation. The data seems to be collected directly from the surgical cases by LeMaitre Vascular personnel.
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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted. The evaluation is a direct assessment of the device's performance in clinical use, and a comparison to human readers with/without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "OUS Post Market Surveillance," the "ground truth" is operational and clinical outcomes observed directly during surgical procedures, reported by LeMaitre Vascular personnel attending the cases. This includes observations on technical success, device performance (e.g., resheathing, non-occlusion), and adverse events, as well as subjective assessments like "radiopacity" and "appropriate modeling force."
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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SEP 1 3 2011
SECTION 5: 510(k) SUMMARY
| Submitter: | LeMaitre Vascular, Inc.63 Second AvenueBurlington, MA 01803 |
|---|---|
| Contact Person: | Andrew HodgkinsonVice President, Clinical, Regulatory and Quality AffairsPhone: 781-221-2266 x108Fax: 781-425-5049Email: ahodgkinson@lemaitre.com |
| Date Prepared: | 9/13/2011 |
| Trade Name: | The UnBalloon Non-Occlusive Modeling Catheter |
| Common Name: | Modeling Catheter |
| Classification Name: | Percutaneous Catheter |
| Predicate Devices: | Cook Coda Balloon Catheter - K032869Medtronic Reliant Balloon Catheter - K050038Gore Tri-Lobe Balloon Catheter - K033670 |
| Device Description: | The UnBalloon Non-Occlusive Modeling Catheter consists of anexpandable Nitinol mesh in a 14F retractable sheath. The Nitinolmesh design allows for expansion without occluding blood flow. TheNitinol mesh and radiopaque markers are highly visible underfluoroscopy and assist in the positioning of the device. The innerlumen allows for a 0.035 or 0.038 inch guidewire for over-the-wireaccess. Side ports and clear handle/luer allow the device andguidewire lumen to be flushed. The blue handle allows the device tobe sheathed/unsheathed while the clear handle/luer controls theexpansion of the Nitinol mesh. |
| Intended Use: | The UnBalloon Non-Occlusive Modeling Catheter is intended to assistin the modeling of self-expanding endoprostheses in large diametervessels. |
| Summary of | The UnBalloon is a percutaneous catheter designed to assist in |
| TechnologicalCharacteristics: | modeling of self-expanding endoprostheses without obstructing bloodflow. This device differs from the predicate devices as it is designedto eliminate the pressure that typically builds up on the proximal endof those devices when inflated. By eliminating occlusion (or partialocclusion), the risks associated with occlusion during ballooning of anendovascular prosthesis may be minimized, potentially allowing thesurgeon to more accurately model grafts that have been deployed. |
| Summary of ProductTesting: | The following has been assessed through product characterization andvalidation:Worst case Simulated useInflation/Deflation timeFreedom from leakageKink resistanceFatigueHemostasisBond tensile strengthRadial outward forceCompatibility with endoprosthesesPhysiological insult – animal testing (Acute and 28-day) |
| Summary of OUSPost MarketSurveillance | Between 14-June-2011 and 16-August-2011, LeMaitre Vascularattended 13 cases in Brazil and the European Union using theUnBalloon Non-Occlusive Modeling Catheter. In all cases weachieved technical success with no reported adverse events or devicerelated malfunctions. The device performed successfully in 4 thoraciccases and 9 abdominal cases using a variety of stent grafts. Theendoprostheses that were modeled included the LeMaitre TAArget(n=1, 8%); Gore Excluder (n=1, 8%); Cook Zenith TX2, Proform(n=2, 16%); Medtronic Endurant (n=1, 8%); Jotec E-Vita (n=2, 16%);Gore TAG or C-TAG (n=1, 8%); Aorfix (n=1, 8%) and 1 (8%)unknown. Devices ranged in size from 24mm to 40mm at the mostproximal diameter.The UnBalloon was used to enhance primary attachment in the landingzone (n=8; 62%) while it was used 1 time (8%) to successfully treat atype 1a endoleak. Other uses included: Enhancement of PrimaryAttachment Zone + Modeling of device overlap (n=2; 15%); Modelingof Mainbody (n=1; 7.7%); Modeling of overlapping zone (n=1; 7.7%).The UnBalloon was deployed a median 3 times per case with meandeployment time of 36.6 sec +/- 39.2sec (Range 5 - 110sec.).Blood loss through the device was minimal with only 1 recorded resultof 3ml that emanated through the guidewire lumen as expected.Radiopacity received an overall rating of 'good' in most cases with 2cases relaying some difficulty seeing the inner marker bands or sheathmarker.The applied modeling force (radial force) was estimated as"appropriate" in 8 (62%) cases while 5 (37%) rated it as"unknown/cannot judge."No device failures were reported in any case. The Nitinol cage wasresheathed in all cases without any issues and there were no reports ofthe Nitinol cage getting hooked or caught in any Endovasculardevices. No other complications or adverse events were reported.These initial clinical results indicate that the UnBalloon Non-Occlusive Modeling Catheter performs as intended and is as safe andeffective as the predicate devices. |
| Summary of Pre-clinical Study: | The biocompatibility of the device was tested per ISO10993-1. |
| Conclusion: | LeMaitre Vascular has demonstrated that The UnBalloon Non-Occlusive Modeling catheter is substantially equivalent to thepredicate devices based on its indications for use and fundamentalscientific technology. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LeMaitre Vascular, Inc. c/o Mr. Andrew Hodgkinson Vice President. Clinical, Regulatory and Quality Affairs 63 Second Avenue Burlington, MA 01803
1 3 2011
Re: K110891
Trade Name: UnBalloon Non-Occlusive Modeling Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 30, 2011 Received: August 31, 2011
Dear Mr. Hodgkinson:
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.
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Page 2 – Mr. Andrew Hodgkinson
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutl7DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Juc
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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SECTION 4: INDICATION FOR USE STATEMENT
510(k) Number : _ K 110891
Device Name: The UnBalloon Non-Occlusive Modeling Catheter
Indications for Use:
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
Prescription Use______________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K110891
§ 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).