(122 days)
The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L.
HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.
The HydroMID catheter is a short term (< 30 days) peripheral venous access device with a single 4F outer diameter lumen that is 20 cm in length. Midlines are usually placed in an arm vein such as the basilic, brachial, or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.
The HydroMID catheter is comprised of radiopaque, hydrophilic base with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. The catheter has a maximum power injection flow rate of 6ml/sec. HydroMID has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
This document is a 510(k) Pre-Market Notification from the FDA, specifically concerning the HydroMID intravascular catheter. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the provided text, the device in question is a physical medical device (intravascular catheter), not an AI/ML powered medical device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, human reader improvement, multi-reader multi-case studies, ground truth establishment for AI/ML models, and sample sizes for training/test sets for AI/ML models is not applicable to this document.
The document describes the non-clinical testing performed for the HydroMID catheter to demonstrate its substantial equivalence to predicate devices. This testing primarily focuses on physical and performance characteristics relevant to a catheter, rather than the diagnostic or interpretation capabilities of an AI/ML algorithm.
Here's what can be extracted from the document regarding the device's performance and supporting studies, framed within the context of a physical medical device's acceptance rather than an AI/ML one:
1. Acceptance Criteria and Device Performance (for a physical medical device):
The "acceptance criteria" for a physical medical device like the HydroMID catheter are typically met by demonstrating comparable performance and safety to existing legally marketed predicate devices, along with meeting relevant industry standards.
| Characteristic / Performance Metric | Acceptance Criteria (Implicit: Comparable to predicate, meet standards) | Reported Device Performance (HydroMID) |
|---|---|---|
| Intended Use | Short-term access to peripheral venous system | Indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including fluid/med administration and blood sampling. Therapies NOT appropriate: continuous vesicant therapy, parenteral nutrition, infusates with pH < 5 or > 9, and infusates with osmolarity > 600mOsm/L. |
| Maximum Power Injection Flow Rate | Up to 6 mL/sec (predicated on BioFlo Midline Catheter) | Rated for a Maximum Power Injection Flow Rate of 6mL/sec. |
| Thrombus Accumulation | Effective in reducing thrombus accumulation (predicated on HydroPICC K193015) | Shown to be effective in reducing thrombus accumulation based on in vitro and in vivo models. (Note: Pre-clinical evaluations do not necessarily predict clinical performance). Demonstrative of enhanced resistance to blood component (platelet and thrombus) accumulation. |
| Material (HydroPhilic) | Same hydrophilic material as cleared HydroPICC (K193015) | Comprised of radiopaque, hydrophilic base. Same hydrophilic material used in HydroPICC (K193015) without modification. |
| Sterility | Meets standards for sterile, single-use device | Sterility leveraged from reference predicate (HydroPICC K193015), with EO/ECH residuals test repeated for HydroMID. Supplied sterile, single-patient use. |
| Biocompatibility | Meets biocompatibility standards | Biocompatibility leveraged from reference predicate (HydroPICC K193015). |
| MRI Compatibility | Meets MRI compatibility standards | MRI compatibility leveraged from reference predicate (HydroPICC K193015). |
| Catheter Length | Specific length difference from reference device | 20 cm in length. This was tested as a difference from the reference device. |
| Other Physical/Performance | Internal product specification, length change, packaging | Tested internal product specification, catheter length/length change, and packaging. |
2. Sample Size and Data Provenance for Device Testing (Non-Clinical):
The document does not specify sample sizes for the non-clinical tests. It refers to "in vitro and in vivo models" for thrombus accumulation and states that "Non-Clinical Test Conclusion" indicates that "the non-clinical testing of the proposed device was leveraged from the reference device."
- Data Provenance: The studies are pre-clinical (in vitro and in vivo models). Explicit geographical provenance is not given, but the manufacturer is based in Bedford, Massachusetts, USA. The studies are assumed to be prospective in design (i.e., conducted specifically for this submission).
3. Number of Experts and Qualifications for Ground Truth:
This is not applicable as the document describes a physical medical device, not an AI/ML system that requires expert interpretation for ground truth establishment.
4. Adjudication Method:
This is not applicable for the same reason as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a physical catheter, not an AI/ML diagnostic aid for human readers.
6. Standalone Performance:
While not framed as "algorithm-only performance," the document describes standalone physical testing of the HydroMID catheter itself for characteristics like power injection flow rate, length, and potentially the repeated EO/ECH residuals test. The studies on thrombus accumulation ("in vitro and in vivo models") were also standalone performance evaluations of the device's material properties.
7. Type of Ground Truth Used:
For a physical device, "ground truth" refers to established scientific and engineering principles, material properties, and performance standards.
- Engineering Specifications/Standards: The device was tested against "Internal product specification," and according to FDA Guidance Documents, EN ISO 10555-1:2013, and EN ISO 10555-3:2013.
- Biological/Physiological Models: In vitro and in vivo models were used to evaluate thrombus accumulation. The "effectiveness in reducing thrombus accumulation" is the specific performance claim being substantiated.
- Reference Device Data: A significant portion of the supporting data (e.g., sterility, biocompatibility, MRI compatibility) was "leveraged" from the previously cleared HydroPICC device (K193015), which serves as a form of "ground truth" or a validated baseline for those shared characteristics.
8. Sample Size for Training Set:
This is not applicable as it's a physical device, not an AI/ML model.
9. How Ground Truth for Training Set was Established:
This is not applicable as it's a physical device, not an AI/ML model.
In summary, the document details the substantial equivalence of a physical medical device (intravascular catheter) to predicate devices through non-clinical performance testing against established standards and internal specifications, rather than the evaluation of an AI/ML-powered diagnostic tool.
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February 8, 2021
Access Vascular Inc. Brian Hanley VP, R&D and Operations 175 Middlesex Turnpike Suite 1A Bedford, Massachusetts 01730
Re: K203069
Trade/Device Name: HydroMID Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 4, 2021 Received: January 5, 2021
Dear Brian Hanley:
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 Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K203069
Device Name HydroMID
Indications for Use (Describe)
The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L.
HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Access Vascular. The logo is in blue and features the word "ACCESS" in a bold, sans-serif font. Below the word "ACCESS" is the word "VASCULAR" in a similar font, but in a lighter shade of blue. The "V" in "VASCULAR" is stylized with a line extending from the bottom left of the "V" to the top right of the "V", creating a visual representation of a blood vessel.
510(k) Summary – K203069
January 25, 2021 Date Prepared:
Submitter:
Access Vascular, Inc. 175 Middlesex Turnpike Suite 1A Bedford, MA 01730 Tel. 781-538-6594
Contact:
Brian Hanley Access Vascular, Inc. Tel. 781-538-6594
Subject Device
| Trade Name: | HydroMID |
|---|---|
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21CFR§880.5200 |
| Regulation Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 days |
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
Primary Predicate Device
| Trade Name: | BioFlo Midline Catheter |
|---|---|
| Manufacturer: | AngioDynamics Inc. (Formerly Navilyst Medical, Inc.) |
| 510(k) Reference: | K150407 |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR§880.5200 |
| Regulation Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 days |
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
| The predicate has not been subject to a design-related recall. |
Reference Device
| Trade Name: | HydroPICC |
|---|---|
| Manufacturer: | Access Vascular, Inc |
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| 510(k) Reference: | K193015 |
|---|---|
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21CFR§880.5970 |
| Regulation Name: | Percutaneous, Implanted, Long-Term Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |
Device Description
The HydroMID catheter is a short term (< 30 days) peripheral venous access device with a single 4F outer diameter lumen that is 20 cm in length. Midlines are usually placed in an arm vein such as the basilic, brachial, or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.
The HydroMID catheter is comprised of radiopaque, hydrophilic base with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. The catheter has a maximum power injection flow rate of 6ml/sec. HydroMID has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
Indications for Use
The HydroMID is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parental nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L.
HydroMID is rated for a Maximum Power Injection Flow Rate of 6 mL/sec.
Substantially Equivalence Discussion
Summary of Similarities and Differences in Technological Characteristics
The proposed HydroMID Catheter is substantially equivalent to the AngioDynamics BioFlo Midline Catheter (K150407). When compared to the predicate, the proposed HydroMID Catheter has equivalent design, components and technological characteristics as well as
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comparable "Indications for Use" statement. Both the propose device and the predicate device are
- available in the same size and length configuration, 4Fr diameter and 20cm length;
- rated for maximum power injection flow rate up to 6 mL/sec;
- clearly labeled as a midline catheter to aid with catheter identification;
- able to be placed without the confirmation of an X-ray (or other imaging methods);
- compatible with StatLock Stabilization device; and
- indicated for short-term (< 30 days) peripheral access for selective intravenous therapies.
Additionally, the proposed HydroMID Catheter contains a hydrophilic material formed into the catheter shaft of the device that reduces the accumulation of thrombus. The same hydrophilic material is used in the Access Vascular cleared HydroPICC device (K193015) without modification to any material characteristic and thus testing associated with the material of the catheter is being leveraged from the reference predicate (K193015). HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation. Both the proposed device and the HydroPICC reference device are
- demonstrative of enhanced resistance to blood component (platelet and thrombus) ● accumulation
Finally, all sterility (with the exception of residual testing which was repeated), packaging, biocompatibility and MRI compatibility testing is being leveraged from the reference predicate, the Access Vascular cleared HydroPICC device (K193015), since the only physical device change for the proposed HydroMID Catheter and its accessories are related to length.
Non-Clinical Test Conclusion
The non-clinical testing of the proposed device was leveraged from the reference device. The following non-clinical testing was the only testing that was actually performed to the proposed device due to the differences in length of the propose device and the reference device:
- Internal product specification
- . Catheter length and length change
- Power Injection
- Sterility testing (EO/ECH residuals test repeated).
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| Characteristic | HydroMID CatheterAccess VascularProposed Device | AngioDynamics BioFloMidline Catheter(K150407)Predicate Device | HydroPICC Catheter(K193015) AccessVascular ReferenceDevice |
|---|---|---|---|
| Intended Use | Intended for short-termaccess to the peripheralvenous system | Same as proposeddevice | Intended for short- orlong-term peripheralaccess to the centralvenous system forintravenous therapy. |
| Indication for Use | The HydroMID isindicated for short termaccess (< 30 days) to theperipheral venousaccess system forintravenous therapy,including but not limitedto, the administration offluids, medications, andthe sampling of bloodand blood products.Therapies notappropriate for midlinecatheters includecontinuous vesicanttherapy, parentalnutrition, infusates withpH less than 5 or greaterthan 9, and infusateswith an osmolaritygreater than600mOsm/L.HydroMID is rated for aMaximumPowerInjection Flow Rate of 6mL/sec. | Same as proposeddevice | HydroPICC is indicatedfor short- or long-termperipheral access to thecentral venous systemfor intravenous therapy,including but not limitedto; the administration offluids, medications, andnutrients; the samplingof blood; central venouspressure monitoring;and power injection ofcontrast media.HydroPICC is rated for aMaximum PowerInjection Flow Rate of3.5mL/sec. |
| IntendedPopulation | Adult and Pediatric use | Adult and Pediatric use(some sizes) | For Adult Use Only |
| Device Class | Class II | Class II | Same as proposeddevice |
| Product Code | FOZ | FOZ | LIS |
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| Regulation Number | 21 CFR 880.5200 | Same as proposeddevice | 21 CFR 880.5970 |
|---|---|---|---|
| Prescription Device | Yes | Same as proposeddevice | Same as proposeddevice |
| Catheter Type | Midline Catheter | Midline Catheter | Peripherally InsertedCentral Catheter (PICC) |
| Catheter ShaftMaterial | Radiopaque hydrophilicpolyol (Same asHydroPICC K193015) | RadiopaquePolyurethane withEndexo Material | Same as proposeddevice |
| Suture Wing | Polyurethane | Polyurethane | Same as proposeddevice |
| Extension Tubing | Polyurethane | Polyurethane | Same as proposeddevice |
| Clamp | Natural Acetal andPolyurethane | Natural Acetal andPolyurethane | Same as proposeddevice |
| Luer | Polyvinyl Chloride | Substantially equivalent:Polyetherimide | Same as proposeddevice |
| Key DeviceComponents | Catheter Shaft, SutureWing, Extension Tube,Luer Hub, Clamp | Substantially equivalent:Catheter Shaft, SutureWing, Extension Tube,Luer Hub, Oversleeve,Clamp | Same as proposeddevice |
| Outside DiameterFrench Size | 4Fr (1.40mm)(Post Hydrated) | Substantially equivalent:3Fr (1.02mm), 4Fr(1.40mm), 5Fr (1.68mm) | Same as proposeddevice |
| Outside Diameteras supplied | 1.30mm(Supplied Dehydrated) | 1.40mm | Same as proposeddevice |
| Usable/EffectiveLength | 20 cm | Substantially equivalent:10 cm and 20 cm | 55 cm |
| Number of Lumens | Single Lumen (SL) | Substantially equivalent:Single Lumen (SL) andDual Lumen (DL) | Same as proposeddevice |
| Flow Rate | 6mL/sec | Same as proposeddevice | 3.5mL/sec |
| X-Ray ConfirmationRequired | No | No | Yes |
| Identified asMidline | Yes | Yes | No -PICC Line |
| Catheter ShaftDesign | Reverse Taper | Same as proposeddevice | Same as proposeddevice |
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| Available KitConfiguration | MST Kit (IR ConvenienceKit) | Substantially equivalent:Catheter Kit, MST Kit (IRConvenience Kit), Max.Barrier | Same as proposeddevice |
|---|---|---|---|
| How Supplied | Sterile, Single-PatientUse | Same as proposeddevice | Same as proposeddevice |
| Hydratable(HydrationRequired) | Yes | No | Yes- same as theproposed device. |
| CatheterPreparation SalineFlush | Yes | Yes | Yes |
The performance evaluation of the propose HydroMID Catheter included testing conducted in accordance with the following FDA Guidance Documents, and international standards:
- . FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters";
- . EN ISO 10555-1:2013 – "Intravascular Catheters – Sterile and Single-Use Catheters – Part 1: General Requirements"
- . EN ISO 10555-3:2013 – "Intravascular Catheters – Sterile and Single-Use Catheters – Part 3: Central Venous Catheters"
Conclusion
Based upon successful results of testing and response to questions posed within FDA's 510(k) Decision Making tree, the proposed device is determined to be substantially equivalent to the predicate device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).