(155 days)
The HeRO® Graft is intended use in maintaining long term vascular access for chronic hemodialysis patients who have exhausted venous access sites suitable for fistulas or grafts.
The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines¹ as patients who:
• Have become catheter-dependent or who are approaching catheter dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.
The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, disposable clamp, and hemostasis plug. The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.
This document describes the premarket notification (510(k)) for the Merit HeRO Graft, a vascular graft prosthesis. The provided text details the device description, indications for use, and a comparison to a predicate device, as well as a list of performance and design validation tests, and an animal study. However, it does not contain the specific acceptance criteria and detailed device performance results in a table format that would directly fulfill all aspects of your request. It rather lists the types of tests conducted and states that the device met the requirements.
Based on the provided text, I can infer and organize the available information to best answer your request, highlighting where direct numerical acceptance criteria or performance values are not explicitly stated in this FDA submission summary.
Here's a breakdown of the information that can be extracted and inferred, structured to align with your questions:
1. A table of acceptance criteria and the reported device performance
The document states that a "battery of tests was performed based upon the risk analysis and the requirements of the following internationally recognized standards and guidance documents pertaining to the device performance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."
While specific numerical acceptance criteria and precise performance values are not given in a table, the document broadly describes the types of tests and the overall outcome.
| Test Category / Parameter | Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Biocompatibility Testing | Conformity to ISO 10993 series and FDA guidance (e.g., Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, etc.) | Met the biocompatibility requirements for implant device with tissue and circulating blood contact for permanent (>30 days) duration. No adverse findings. |
| Performance Testing | Conformity to relevant standards (e.g., specific values for strength, porosity, permeability, leakage, etc. as per ISO 7198, ASTM F756) | Device successfully passed all listed performance tests (Dimension Verification, Longitudinal Tensile Strength, Pressurized Burst Strength, Kink Diameter, Microscopic Porosity, Water Entry Pressure, Integral Water Permeability, Clamp Leakage, Suture Retention Strength, Beading Peel Strength, Strength after Repeated Puncture). |
| Design Validation Testing | Conformity to relevant standards for functionality and handling (e.g., ability to accept guidelines, resistance to kinks, ease of handling/cutting). | Device successfully passed all listed design validation tests (Guideline Acceptability, Kink Resistance, Handling, Cutting, Syringe Adapter Compatibility, Suturability). |
| Animal Study (Patency, Stenosis, Thrombogenicity) | Equal to or better performance than the control article in terms of patency, stenosis, thrombogenicity, and cell/tissue response. | Test articles demonstrated equal to or better patency, stenosis, thrombogenicity, cell and tissue response compared to control articles at 30, 90, and 180 days. |
| Animal Study (Adverse Events/Mortality) | No premature deaths or adverse clinical sequelae related to the test article or control article. | No premature deaths related to test/control articles. No adverse clinical sequelae or animal mortality related to the presence of the test article. |
| Overall Safety and Performance | Meets requirements for intended use, comparable to predicate in safety and performance. | The Merit test article was as safe and performed as well as the control article. Substantially equivalent to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Study Test Set Sample Size: 18 sheep.
- Data Provenance: The document does not specify the country of origin of the animal study data or if the performance/design validation tests were conducted externally. The animal study was generally described as "chronic study" with set time points (30-day, 90-day, 180-day), indicating a prospective setup for that specific component. The other performance and design validation tests are typical of pre-market, laboratory-based testing.
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)
- The document describes a device (vascular graft), not an AI/diagnostic software. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The ground truth for device performance is established through physical and biological testing against established standards and controls (e.g., precise measurements, chemical analyses, histological assessments in the animal study).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept applies to human interpretation of data, typically in diagnostic studies. As this is a medical device (vascular graft) and not a diagnostic AI, adjudication methods for expert interpretation are not relevant or described. Device performance testing relies on objective measurements and verified protocols.
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, an MRMC study was not done. This type of study is specific to evaluating the clinical performance of diagnostic AI systems in conjunction with human readers. The Merit HeRO Graft is a physical implantable device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is also not applicable. The device is a physical vascular graft, not an algorithm. Performance tests are inherently "standalone" in the sense that they evaluate the device's physical and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Biocompatibility Testing: Ground truth is established by standardized laboratory assays and results against accepted biological safety limits (e.g., no cytotoxicity, no irritation, no genotoxicity).
- For Performance and Design Validation Testing: Ground truth is established by engineering specifications, physical measurements, and conformity to recognized international standards (e.g., ISO 7198, ASTM F756).
- For the Animal Study: Ground truth was established by direct observation, angiographic evaluation, and histopathologic evaluations (pathology) of the implanted grafts and non-target organs. Patency, stenosis, thrombogenicity, and cellular/tissue response were assessed and compared to control articles.
8. The sample size for the training set
- This question is for AI models. As this is a physical medical device, there is no "training set" in the AI sense. Device development involves design, prototyping, and testing, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no AI training set.
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May 25, 2021
Merit Medical Systems, Inc. Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K203724
Trade/Device Name: Merit HeRO Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY, MSD, LJS Dated: April 15, 2021 Received: April 16, 2021
Dear Susan Christensen:
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 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
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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 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,
for Carmen Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular 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) K203724
Device Name Merit HeRO Graft
Indications for Use (Describe)
The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who:
• Have become catheter-dependent or who are approaching catheter dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
· Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistulal graft salvage).
· Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
· Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095 |
|---|---|
| Contact Person: | Susan ChristensenTelephone (801) 208 4789Email suchristensen@merit.com |
| Date of Summary: | 25 MAY 2021 |
| Trade or ProprietaryName: | Merit HeRO® Graft |
| Common or Usual Name: | Vascular Graft Prosthesis |
| Classification Name: | Prosthesis, Vascular Clamp, of 6mm and greater diameter |
| Regulation Number | 21 CFR 870.3450 |
| Classification: | Class II |
| Product Code: | DSY, MSD, LJS |
| Review Panel: | Cardiovascular |
| Predicate Device: | HeRO Graft, K172637 |
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| Device Description: | The HeRO Graft is a non-autogenous (i.e., synthetic) vasculargraft prosthesis which provides arterial venous access withcontinuous outflow into the central venous system. The HeROGraft is composed of the following components: (1) VenousOutflow Component (VOC), (2) Arterial Graft Component(AGC) or HeRO Adapter with Support Seal (used inconjunction with commercial vascular grafts), and (3)Accessory Component Kit (ACK). The VOC consists of aradiopaque silicone base tube, a nitinol braid (imparts kink andcrush resistance), a distal radiopaque marker band, and an outersilicone elastomer encapsulation layer. During surgery, theVOC is cut to length for the patient anatomy and then advancedover the barbs of the AGC Connector or HeRO Adapter. TheAGC is a conventional ePTFE vascular graft with a guidelineand beading near the custom titanium alloy connector to providekink resistance. As an alternative to the AGC, the titanium alloyHeRO Adapter with Support Seal allow the clinician to chooseone of the commercially available 6mm ID vascular graftsqualified for use with the HeRO Graft. The ACK (aconvenience kit) contains instruments that aid in theimplantation of the HeRO Graft including, introducers, dilators,delivery stylet, hemostasis valve with stopcock, disposableclamp, and hemostasis plug. The HeRO Graft is a fullysubcutaneous surgical implant single-use device provided sterilevia ethylene oxide for long-term (>30 day) use. |
|---|---|
| Intended Use: | The HeRO® Graft is intended use in maintaining long termvascular access for chronic hemodialysis patients who haveexhausted venous access sites suitable for fistulas or grafts. |
| Indications for Use: | The HeRO® Graft is indicated for end stage renal diseasepatients on hemodialysis who have exhausted all other accessoptions. These catheter-dependent patients are readily identifiedusing the KDOQI guidelines¹ as patients who:• Have become catheter-dependent or who are approachingcatheter dependency (i.e., have exhausted all other accessoptions, such as arteriovenous fistulas and grafts).• Are not candidates for upper extremity fistulas or graftsdue to poor venous outflow as determined by a history ofprevious access failures or venography.• Are failing fistulas or grafts due to poor venous outflow asdetermined by access failure or venography (e.g.fistula/graft salvage).• Have poor remaining venous access sites for creation of afistula or graft as determined by ultrasound or venography. |
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• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.2
1Vascular Access Work Group. National Kidney Foundation KDOQI clinical practice guidelines for vascular access. Guideline 1: patient preparation for permanent hemodialysis access. Am J Kidney Dis 2006;48(1Suppl1):S188-91.
2Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQI clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006;48(Suppl 1):S2-S90.
There is no change in the Indications for Use Statement from the predicate to the subject device.
Comparison to Predicate Device:
The subject HeRO Graft device is similar in design and technological characteristics to the predicate HeRO Graft device.
The comparison between the subject device and predicate device is based on the following:
- Same Clinical use
- Same Indications for use
- Same Basic Design
- Same fundamental technology/principle of operation
- Same Labeling
- Same Packaging
- Same Sterilization Methods
- Same Intended Use
The following technological differences exist between the subject device and predicate device:
- o Different (similar) material types
- . Dimensional differences
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Technological Characteristics:
FDA guidance documents and recognized performance standards have been established for Vascular Prostheses under Section 514 of the Food, Drug and Cosmetic Act. A battery of tests was performed based upon the risk analysis and the requirements of the following internationally recognized standards and guidance documents pertaining to the device performance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy.
FDA Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Nov 1, 2000
FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process''
ISO 7198, Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches.
ISO 11135, Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routing control of a sterilization process for medical devices
ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
ISO 10993-3, Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
ISO 10993-4, Biological evaluation of medical devices – Part 4: Selection of tests for interaction with blood
ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests for irritation and delayed type hypersensitivity
ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
ISO 10993-17, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substance
ISO 10993-18, Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
ASTM F756, Standard Practice for Assessment of Hemolytic
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Properties of Materials
United States Pharmacopeia, National Formulary 37, General Chapter <151>, Pyrogen Test.
The following performance data were provided in support of the substantial equivalence determination.
Performance Data
Biocompatibility Testing
The biocompatibility evaluation for the HeRO Graft was conducted in accordance with the FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, " as recognized by FDA.
- · Cytotoxicity
- Sensitization
- · Irritation
- · Acute Systemic Toxicity
- · Pyrogenicity
- · Hemolysis
- · Genotoxicity
- · Thrombogenicity
- Complement Activation
- · Implantation and Subacute/Subchronic toxicity
- Chemical Characterization
The HeRO Graft met the biocompatibility requirements for implant device with tissue and circulating blood contact for a permanent (> 30 days) duration.
The following performance tests were conducted to support substantial equivalence:
Performance Testing:
- · Dimension Verification
- Longitudinal Tensile Strength
- Pressurized Burst Strength
- · Kink Diameter
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- Microscopic Porosity .
- . Water Entry Pressure
- Integral Water Permeability
- Clamp Leakage •
- . Suture Retention Strength
- . Beading Peel Strength
- . Strength after Repeated Puncture
Design Validation Testing:
- Guideline Acceptability
- Kink Resistance
- Handling •
- Cutting .
- Syringe Adapter Compatibility •
- Suturability
Animal Study:
| In the animal study, 18 sheep were implanted with a test articleand a control article. There were no premature deaths related tothe test article or control article. The three (3) time points forthe chronic study were Group 1, 30-day, Group 2, 90-day, andGroup 3, 180-day. | |
|---|---|
| Per angiographic and histopathologic evaluations, the testarticles demonstrated equal to or better patency, stenosis,thrombogenicity, cell and tissue response when compared tothe control articles at termination on day 30, 90 and 180. Thetest article exhibited a favorable overall biological responsewhen compared to the control article. | |
| Per pathology of non-target organs (e.g., brain, lungs, kidneys,spleen, heart, and liver), there were no adverse clinical sequalaeand no animal mortality related to the presence of the testarticle. | |
| The Merit test article was as safe and performed as well as thecontrol article. | |
| Summary of SubstantialEquivalence | Based on the indication for use, design, safety, andperformance testing, the subject HeRO Graft meets therequirements that are considered essential for its intended useand is substantially equivalent to the predicate device, theHeRO Graft K172637. |
§ 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.”