(92 days)
The AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.
Albograft Vascular Prosthesis is a knitted/woven tubular polyester fabric, impregnated with bovine collagen.
The provided text describes a 510(k) summary for the Albograft™ Vascular Prosthesis, but it does not contain acceptance criteria or a study designed to explicitly prove the device meets acceptance criteria in the typical sense of a diagnostic or AI device study.
Instead, this document describes a pre-market notification for a medical device (a vascular prosthesis) seeking substantial equivalence to a predicate device. The "study" mentioned is a retrospective clinical review to demonstrate the device's performance in a real-world setting.
Here's a breakdown of the requested information, addressing what is present and what is absent:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document does not define explicit acceptance criteria in the format of specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that are then directly tested against in a controlled study.
Instead, the "Summary of Retrospective Clinical Review" provides real-world performance data for the Albograft™ Vascular Prosthesis. The implicit "acceptance" for this type of device in a 510(k) process is demonstrating substantial equivalence to a predicate device, which is often supported by showing comparable clinical outcomes. The clinical outcomes presented are intended to support the safety and effectiveness of the device when used for its intended purpose.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance (from Retrospective Clinical Review) |
|---|---|---|
| 30-day Mortality | (Implicit: Low mortality) | 4.5% (n=3) |
| Graft Infection Rate | (Implicit: Low/No infection) | No graft infection recorded during follow-up |
| ABI Improvement | (Implicit: Significant improvement) | Improved significantly from 0.46 to 0.89 |
| Fontaine Stage Improvement | (Implicit: Shift to lower stages) | Majority of patients in Fontaine stage I and IIa at last follow-up visit (Pre-Op: 67.7% IIb, 14.5% III, 17.7% IV; Post-Op: 62.9% I, 17.7% IIa) |
| 12-month Primary Patency Rate | (Implicit: High patency) | 89.4% (SE 4%) |
| 24-month Primary Patency Rate | (Implicit: High patency) | 89.4% (SE 4%) |
| 12-month Secondary Patency Rate | (Implicit: High patency) | 95.1% (SE 2.8%) |
| 24-month Secondary Patency Rate | (Implicit: High patency) | 95.1% (SE 2.8%) |
| 12-month Limb Salvage Rate | (Implicit: High limb salvage) | 98.4% (SE 2.8%) |
| 24-month Limb Salvage Rate | (Implicit: High limb salvage) | 98.4% (SE 2.8%) |
Note: The "Acceptance Criteria" column is filled with "Implicit" as the document does not explicitly define quantitative thresholds that were pre-defined as regulatory "acceptance criteria" for the clinical review. These are observed clinical outcomes. The determination of "substantial equivalence" would involve comparing these outcomes with those expected or reported for the predicate device, or generally accepted clinical outcomes for such procedures.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 66 consecutive patients
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from LeMaitre Vascular, Inc. in Burlington, MA, USA, and the clinical review spans from Jan 1, 2007, to March 31, 2009. The retrospective nature suggests a single clinical site or registry.
- Retrospective or Prospective: Retrospective Clinical Review
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As this is a retrospective review of patient outcomes related to a surgical implant, the "ground truth" would generally be established by the clinical records, diagnostic tests, and assessments made by the treating physicians and hospital staff. There is no mention of an independent panel of experts establishing ground truth for the purpose of a study evaluating a diagnostic device.
4. Adjudication method for the test set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert readers for diagnostic tasks. This retrospective clinical review focuses on observed patient outcomes, not on interpretation of data by multiple experts needing adjudication.
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 document describes a vascular prosthesis (surgical implant), not an AI-assisted diagnostic device. Therefore, no information on human reader improvement with/without AI assistance is applicable or provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this clinical review appears to be patient outcomes data and clinical diagnostics as recorded in medical charts and follow-up visits. This includes:
- Pre-operative diagnoses (aneurysmal or occlusive disease, Fontaine stages, TASC II classification)
- Ankle Brachial Index (ABI) measurements
- Surgical results and post-operative complications (mortality, infection)
- Follow-up assessments (Fontaine stage, ABI, patency rates determined by various clinical methods, limb salvage rate).
8. The sample size for the training set
Not applicable/Not provided. This is not a study of an AI algorithm requiring a training set. The clinical review describes the performance of a physical medical device in patients.
9. How the ground truth for the training set was established
Not applicable/Not provided. As stated above, this is not an AI study, and therefore, no training set with associated ground truth was established for this submission.
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SECTION 6: 510(k) SUMMARY
KIO308
| Submitter: | LeMaitre Vascular, Inc.63 Second AvenueBurlington, MA 01803 |
|---|---|
| Contact Person: | Andrew HodgkinsonVice President, Clinical and Regulatory AffairsPhone: 781-221-2266 x108Fax: 781-425-5049Email: ahodgkinson@lemaitre.com |
| Date Prepared: | October 15, 2010 |
| Trade Name: | Albograft™ Vascular Prosthesis |
| Common Name: | Vascular Prosthesis |
| Classification Name: | Graft, vascular, synthetic/biologic composite |
| Predicate Device: | Hemashield Woven Double Velour Vascular Graft (K954848) |
| Device Description: | Albograft Vascular Prosthesis is a knitted/woven tubular polyesterfabric, impregnated with bovine collagen. |
| Intended Use: | The AlboGraft Double Velour Knitted and Woven Grafts areindicated for use in the replacement or repair of arteries affectedwith aneurysmal or occlusive disease. |
| Summary ofTechnologicalCharacteristics: | AlboGraft Polyester Vascular Prosthesis is a knitted or woventubular polyester fabric, impregnated with bovine collagen. |
| Summary of ProductTesting: | The following tests have been performed per ISO 7198:Burst TestLongitudinal Tensile StrengthRadial Tensile StrengthSuture Pull-90°/45°Wall ThicknessIntegral Water PermeabilityVisual InspectionUsable LengthRelaxed Inner DiameterPressurized Inner Diameter |
| Summary of Pre-clinical Study: | The biocompatibility of the device was tested per ISO10993-1. |
| Summary ofRetrospectiveClinical Review | Patient baseline data, preoperative risk factors, diagnosis andsecondary diseases:Between Jan 1, 2007 and March 31, 2009, 66 consecutive patients havereceived a surgical implant of a peripheral AlboGraft™ vascularprosthesis in the iliac region (prox. anastomosis - common iliac artery /distal anastomosis - proximal superficial femoral artery). The patientsconsisted mainly of males (n= 44 / 66 %) with a mean age of 64.8 years(Mean: H: 171 cm; W: 74 kg; BMI: 25.2 kg/cm²) and demonstrated typical |
:
.
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| risk factors for development of illiac artery peripheral arterial occlusivedisease (pAOD).The majority of patients (88%) suffered from arterial hypertension andhistories of smoking in 92% of the cases (73% of all patients are stillactive smokers). Almost half (49 %) of the patients had additionalcoronary heart disease , while additional risk factors like diabetes mellitusor hyperlipidemia was only present in 9% or 3% of the patientsrespectively. Chronic obstructive pulmonary disease was present in 29%of the patients and cerebro vascular disease in n= 10 (15%) of which n=8had a previous stroke. Also almost half of the patients (49%) hadprevious arterial reconstructions. | ||
|---|---|---|
| Disease / Diagnosis:4 patient suffered from aneurysmal disease (n=2 iliac artery aneurysms;n=2 suture line aneurysms) and 62 patients reported pAOD of the iliacartery with either severe claudication / Fontaine stage IIb (n=42/68%),rest pain / Fontaine III (n=9/15%) or ulcerations or gangrene / Fontainestage IV (n=11/18%). (Table 1).The severity of the iliac artery disease could be confirmed by a meanpain free walking distance of only 89m and a mean Ankle Brachial Index(ABI) on the affected side of 0.46.Only patients with TASC II C (n=37 / 60%) and TASC II D (n=25 / 40%)classification of disease morphology were operated on. | ||
| Operative and postoperative results summary:The 66 patients received either unilateral bypass reconstructions in n=40(61%) or a cross-over bypass procedures in n= 26 (39%) of the cases. | ||
| 30 day mortality was 4.5 % (n=3) and no graft infection has beenrecorded during the complete follow up period. | ||
| Postoperatively the ABI of the affected side improved significantly to 0.89from 0.46 and the majority of patients were in Fontaine stage I and IIa attheir last follow up visit. (Table 1). The primary and secondary patencyrates at 12 and 24 month have been 88.9%/95.1 % and 88.9%/95.1%respectively. The Limb Salvage Rate was 98.4% at 12 and 24 month(Table 2). | ||
| Table 1: Pre and Post Operative (last follow up visit) Fontaine stageClassification for the n= 62 patients with Peripheral Arterial Disease(pAOD). | ||
| Fontaine stage | Pre-Op (n=62) | Last follow upvisit (n=57) |
| I - asymptomatic | 0 (0.0%) | 39 (62.9%) |
| Ila- Lifestyle limitingIntermitted Claudication (IC) | 0 (0.0%) | 11 (17.7%) |
| IIb - Severe IntermittedClaudication (IC) | 42 (67.7%) | 7 (11.3%) |
| III - Restpain | 9 (14.5%) | 0 (0.0%) |
| IV - Ulcerations or Gangrene | 11 (17.7%) . | 0 (0.0%) |
11 - 11
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| Table 2: Patency and Limb Salvage Rates in % analyzed by KaplaMeier Survival Analysis: | ||
|---|---|---|
| n = 66 patients (SE = Standard Error) | ||
| 12 month | 24 month | |
| Primary PatencyRate | 89.4%(SE 4%) n = 51 atrisk | 89.4%(SE 4%) n = 19 at risk |
| SecondaryPatency Rate | 95.1%(SE 2.8%) n = 55 atrisk | 95.1%(SE 2.8%) n = 20 at risk |
| Limb SalvageRate | 98.4%(SE 2.8%) n = 57 atrisk | 98.4%(SE 2.8%) n = 22 at risk |
Vascular Prosthesis is substantially equivalent to the predicate Conclusion: device based on its indications for use and fundamental scientific technology. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird 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 63 Second Avenue Burlington, MA 01803
Re: K103080 AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (Peripheral indication) Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: MAL Dated: October 18, 2010 Received: October 19, 2010
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.
JAN 1 9 2011
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/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/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,
Duma R. Kirchner
Bram D. Zuckerman, M.D. V 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): K103080
Device Name: _LeMaitre AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication)
Indications For Use:
The AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. V. hmes
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_K 103080
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”