(72 days)
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No
The document describes a physical vascular access device and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a vascular access device for hemodialysis, which is a supportive device for medical treatment, not a therapeutic device that directly treats a condition.
No
The device is described as a "Vascular Access Device" intended for maintaining long-term hemodialysis access in patients. Its function is to provide a physical pathway for dialysis, not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like silicone, ePTFE, and titanium, indicating it is a hardware device, not software-only.
Based on the provided text, the HeRO™ Vascular Access Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HeRO™ Device Function: The description clearly states that the HeRO™ Vascular Access Device is a physical implantable device used to maintain long-term hemodialysis access. It is a synthetic vascular access device composed of a graft and a venous outflow component.
- Lack of Diagnostic Activity: The device's intended use and description focus on providing a physical pathway for hemodialysis, not on analyzing biological samples to diagnose or monitor a condition.
Therefore, the HeRO™ Vascular Access Device is a medical device, but it falls under the category of an implantable device for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HeRO™ Vascular Access Device is intended for use in maintaining long-term The HeRO™ Vascular Access Device is intents who have exhausted peripheral vasoular "doess sites suitable for fistulas or grafts.
The HeRO™ Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheterdependent patients are readily identified using the K/DOQI guidelines 1 as patients who:
- Have become cathefer-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.
- 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 history or 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. K/DOQl guidelines recommend a minimum Kt/V of 1.4.
Product codes
DSY, LJS, MSD
Device Description
The HeRO™ Vascular Access Device is a non-autogenous (i.e., synthetic) vascular access device composed of three components: HeRC™ Arterial Graft Component, Kero Jenous Outflow device composed of three component. HeRO Outflow Component and HERO -- Accessory on inforcing braided filaments that Component is made of radiopaque slitche commiss of the component is sized to fit the impart kink and crush resistance. Duthig Sunger), the barbs of the connector on the patient by cutting it to the proper length and shiding it over the band in patient by cutting it to the proper length and shange it over tional ePTFE hemodialysis graft component. The HeRO™ Arterial Graft Component is a conventional encreasers Comp graft component. The HeRO " Antenal Gran Sompononial Kit (and States org Component Kit (a convenience kit) contains tools that assist in the implantation of the HeRO™ Vascular Access Device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of design vermication and validated. The risk assessment results, together as modified is as sale as the prediouts as well this submission, with the results of design vehicles and villanter as modified, raises no new questions confirm that the HeRO™ Vascular Access Device, as modified, The HeRO™ Vascular contirm that the HeRO - Vasoular Associate device. The HeRO™ Vascular of safety or effectiveness compared to the predicate to the logolly marketed of safety of enectiveness comparou to the proAccess Device has been shown to be substantially equivalent to the legally marketed device for the purpose of 510(k) clearance.
Summary of Non 211 Packaging vehication and Stemled. Of Values in The acceptance criteria. demonstrated that the HeRO™ Vascular Access Device met its acceptance criteria.
Additional clinical performance data was not required to support the modification of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
X0914191
510(k) Summary (per 21 CFR 807.87(h))
JUL 3 1 2009
| Common/Usual Name: | Vascular access device |
|---|---|
| Product Trade Name: | HeRO™ Vascular Access Device |
| Classification Name: | 21 CFR 870.3450; Vascular access prosthesis; Class |
| II; DSY, LJS, MSD, Cardiology | |
| Predicate Device: | K071778, HeRO™ Vascular Access Device |
| Manufacturer: | Hemosphere, Inc. |
| 6545 City West Parkway | |
| Eden Prairie, MN 55344 | |
| Contact: | W. Allen Putnam |
| Regulatory Consultant | |
| Date Prepared: | May 18, 2009 |
Device Description:
Device Docemption is a non-autogenous (i.e., synthetic) vasular access
The HeRO™ Vascular Access Device is a non-autogenous (i.e., synthelic) Croft Component HeRO™ Venous The HeRO™ Vascular Access Device's a non attegement, HeRO™ Venous
device composed of three components: HeRC™ Arterial Graft Component, Kero Jenous Outflow device composed of three component. HeRO Outflow Component and HERO -- Accessory on inforcing braided filaments that Component is made of radiopaque slitche commiss of the component is sized to fit the impart kink and crush resistance. Duthig Sunger), the barbs of the connector on the
patient by cutting it to the proper length and shiding it over the band in patient by cutting it to the proper length and shange it over tional ePTFE hemodialysis
graft component. The HeRO™ Arterial Graft Component is a conventional encreasers Comp graft component. The HeRO " Antenal Gran Sompononial Kit (and States org Component Kit (a
graft that has been attached to a titanium connector. The HeRO™ Vascular Access graft that has been attached to a titanium connector. The HeRO™ Vascular Access
convenience kit) contains tools that assist in the implantation of the HeRO™ Vascular Access Device.
Intended Use:
Intended Use:
The HeRO™ Vascular Access Device is intended for use in maintaining long-term The HeRO™ Vascular Access Device is intents who have exhausted peripheral vasoular "doess sites suitable for fistulas or grafts.
1
Indications for Use:
indications for USB.
The HeRO™ Vascular Access Device is indicated for end stage renal disease patients. The HeRO™ Vascular Access Device in the sacess options. These catheteron hemodialysis who have exhausted all other KIDOOL quidelines' as patient on hemodialysis who have extrausted all other dobes op
dependent patients are readily identified using the K/DOQ! guidelines1 as patients who:
- e we become catheter-dependent or who are approaching catheter-dependency . Have become catheredependent of who are app
(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 . Are not candidates for upper extremity freatures or venography.
outflow as determined by a history of previous access failures or venography. - o a failing fistulas or grafts due to poor venous outflow as determined by access . failure or venography.
- 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
via ) ● Have a compromised central vehous by comptomatic CVS (i.e., via
determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.- Are receiving inadequate dialysis clearance (i.e., low Kf/V) via catheters. . K/DOQI guidelines recommend a minimum Kt/V of 1.4.2
Substantial Equivalence Comparison:
The predicate device is the GRAFTcath, Inc. HeRO™ Vascular Access Device, The predicate device is the GRAF Toath, the News
K071778. The company name has been changed from GRAFTcath to Hemosphere, Inc.
mor Results of design vermication and validated. The risk assessment results, together as modified is as sale as the prediouts as well this submission, with the results of design vehicles and villanter as modified, raises no new questions
confirm that the HeRO™ Vascular Access Device, as modified, The HeRO™ Vascular contirm that the HeRO - Vasoular Associate device. The HeRO™ Vascular
of safety or effectiveness compared to the predicate to the logolly marketed of safety of enectiveness comparou to the proAccess Device has been shown to be substantially equivalent to the legally marketed device for the purpose of 510(k) clearance.
Summary of Non-Clinical & Clinical Performance Data:
Summary of Non 211 Packaging vehication and Stemled. Of Values in The acceptance criteria.
demonstrated that the HeRO™ Vascular Access Device met its acceptance criteria.
Additional clinical performance data was not required to support the modification of the device.
1 National Kidney Foundation, K/DOQ! Clinical Practice Guidelines for Vascular Access, 2000.
1 National Kidney Foundation, S181, 2001 (suppl 1).
Am J Kidhey Disease 37:5131, 2001 (Suppr 1).
2006 "K/DOQl—Clinical Practice Guidelines for Hemodialysis Adequacy Guideline 4." Minimally Adequate Hemodialysis.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2009 2 8 1 2009
Hemosphere, Inc. c/o Mr. W. Allen Putnam Regulatory Consultant 6545 City West Parkway Eden Prairie, MN 55344
Re: K091491
Trade Name: HeRO™ (Hemodialysis Reliable Qutflow) Vascular Access Device Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY, LJS, MSD Dated: June 29, 2009 Received: July 1, 2009
Dear Mr. Putnam:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nove and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of produced device Amendments or to devices that have been reclassified in accordance with the the Medical Deviec Americand, Drug, and Cosmetic Act (Act). You may, therefore, market the provisions of the general controls provisions of the Act. However, you are responsible to device, subject to the godical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) detenmed as subblannally on the market prior to May 28, 1976, the enactment date of the of the act, or were regarry of all institution of the components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before (1.6., allimitished) and farent prover (it/tray. The general controls provisions of the Act include moraining areos for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is elassillional controls. Existing major regulations affecting your device can be It may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Cour of cements concerning your device in the Federal Register.
3
Page 2 - Mr. W. Allen Putnam
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 yours,
M. A. Lillehammer
Bram D. Zuckerman, M.D. S Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Current 510(k) Number: Ko91491
Device Name:
HeRO™ Vascular Access Device
Indications for Use:
The HeRO™ Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheterdependent patients are readily identified using the K/DOQI guidelines 1 as patients who:
- Have become cathefer-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.
- 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 history or 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. K/DOQl guidelines recommend a minimum Kt/V of 1.4.6
1 National Kidney Foundation, K/DQQI Clinical Practice Guidelines for Vascular Access, 2000. Am J Kidney Disease 37:S137-S181, 2001 (suppl 1).
2 2006 "K/DOQ1-Clinical Practice Guidelines for Hemodialysis Adequacy Guideline 4." Minimally Adequate Hemodialysis.
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 IF NEEDED)
Coffcurrence of CDRH, Office of Device Evaluation (ODE)
Wm. A. Villebenne
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K011491