HydroMID

K203069 · Access Vascular, Inc. · FOZ · Feb 8, 2021 · General Hospital

Device Facts

• Record ID: K203069
• Device Name: HydroMID
• Applicant: Access Vascular, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 8, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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, 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.

Device Story

HydroMID is a 4F, 20cm single-lumen midline catheter for peripheral venous access. Device features radiopaque hydrophilic polyol shaft designed to reduce thrombus accumulation; includes suture wing, Luer lock hub, and extension tube. Placed in arm veins (basilic, brachial, or cephalic) without X-ray confirmation. Operated by clinicians in clinical settings. Supports power injection up to 6mL/sec. Provides alternative to short peripheral IVs and PICCs for non-vesicant, non-parenteral nutrition therapies. Benefits include reduced thrombus formation and short-term venous access.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via in vitro and in vivo models to assess thrombus accumulation resistance and mechanical integrity (catheter length, power injection, sterility). Testing conducted per FDA guidance for intravascular catheters and ISO 10555-1/3 standards.

Technological Characteristics

4Fr (1.40mm) single-lumen midline catheter, 20cm length. Materials: radiopaque hydrophilic polyol shaft, polyurethane suture wing/extension tubing, natural acetal/polyurethane clamp, PVC Luer. Reverse taper design. Power injection rated to 6mL/sec. Sterile, single-patient use. Hydratable design requiring saline flush. Biocompatibility and MRI compatibility leveraged from K193015.

Indications for Use

Indicated for short-term (<30 days) peripheral venous access in adult and pediatric patients for IV therapy, fluid/medication administration, and blood sampling. Contraindicated for continuous vesicant therapy, parenteral nutrition, infusates with pH <5 or >9, and osmolarity >600mOsm/L.

Regulatory Classification

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.

Predicate Devices

• BioFlo Midline Catheter (K150407)

Reference Devices

• HydroPICC (K193015)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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. [phone]

#### Contact:

Brian Hanley Access Vascular, Inc. Tel. [phone]

#### 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 Catheter<br>Access Vascular<br>Proposed Device | AngioDynamics BioFlo<br>Midline Catheter<br>(K150407)<br>Predicate Device | HydroPICC Catheter<br>(K193015) Access<br>Vascular Reference<br>Device |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for short-term<br>access to the peripheral<br>venous system | Same as proposed<br>device | Intended for short- or<br>long-term peripheral<br>access to the central<br>venous system for<br>intravenous therapy. |
| Indication for Use | The HydroMID is<br>indicated for short term<br>access (< 30 days) to the<br>peripheral venous<br>access system for<br>intravenous therapy,<br>including but not limited<br>to, the administration of<br>fluids, medications, and<br>the sampling of blood<br>and blood products.<br>Therapies not<br>appropriate for midline<br>catheters include<br>continuous vesicant<br>therapy, parental<br>nutrition, infusates with<br>pH less than 5 or greater<br>than 9, and infusates<br>with an osmolarity<br>greater than<br>600mOsm/L.<br>HydroMID is rated for a<br>Maximum<br>Power<br>Injection Flow Rate of 6<br>mL/sec. | Same as proposed<br>device | HydroPICC is indicated<br>for short- or long-term<br>peripheral access to the<br>central venous system<br>for intravenous therapy,<br>including but not limited<br>to; the administration of<br>fluids, medications, and<br>nutrients; the sampling<br>of blood; central venous<br>pressure monitoring;<br>and power injection of<br>contrast media.<br>HydroPICC is rated for a<br>Maximum Power<br>Injection Flow Rate of<br>3.5mL/sec. |
| Intended<br>Population | Adult and Pediatric use | Adult and Pediatric use<br>(some sizes) | For Adult Use Only |
| Device Class | Class II | Class II | Same as proposed<br>device |
| Product Code | FOZ | FOZ | LIS |

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| Regulation Number | 21 CFR 880.5200 | Same as proposed<br>device | 21 CFR 880.5970 |
|---------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Prescription Device | Yes | Same as proposed<br>device | Same as proposed<br>device |
| Catheter Type | Midline Catheter | Midline Catheter | Peripherally Inserted<br>Central Catheter (PICC) |
| Catheter Shaft<br>Material | Radiopaque hydrophilic<br>polyol (Same as<br>HydroPICC K193015) | Radiopaque<br>Polyurethane with<br>Endexo Material | Same as proposed<br>device |
| Suture Wing | Polyurethane | Polyurethane | Same as proposed<br>device |
| Extension Tubing | Polyurethane | Polyurethane | Same as proposed<br>device |
| Clamp | Natural Acetal and<br>Polyurethane | Natural Acetal and<br>Polyurethane | Same as proposed<br>device |
| Luer | Polyvinyl Chloride | Substantially equivalent:<br>Polyetherimide | Same as proposed<br>device |
| Key Device<br>Components | Catheter Shaft, Suture<br>Wing, Extension Tube,<br>Luer Hub, Clamp | Substantially equivalent:<br>Catheter Shaft, Suture<br>Wing, Extension Tube,<br>Luer Hub, Oversleeve,<br>Clamp | Same as proposed<br>device |
| Outside Diameter<br>French Size | 4Fr (1.40mm)<br>(Post Hydrated) | Substantially equivalent:<br>3Fr (1.02mm), 4Fr<br>(1.40mm), 5Fr (1.68mm) | Same as proposed<br>device |
| Outside Diameter<br>as supplied | 1.30mm<br>(Supplied Dehydrated) | 1.40mm | Same as proposed<br>device |
| Usable/Effective<br>Length | 20 cm | Substantially equivalent:<br>10 cm and 20 cm | 55 cm |
| Number of Lumens | Single Lumen (SL) | Substantially equivalent:<br>Single Lumen (SL) and<br>Dual Lumen (DL) | Same as proposed<br>device |
| Flow Rate | 6mL/sec | Same as proposed<br>device | 3.5mL/sec |
| X-Ray Confirmation<br>Required | No | No | Yes |
| Identified as<br>Midline | Yes | Yes | No -PICC Line |
| Catheter Shaft<br>Design | Reverse Taper | Same as proposed<br>device | Same as proposed<br>device |

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| Available Kit<br>Configuration | MST Kit (IR Convenience<br>Kit) | Substantially equivalent:<br>Catheter Kit, MST Kit (IR<br>Convenience Kit), Max.<br>Barrier | Same as proposed<br>device |
|-----------------------------------------|---------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------|
| How Supplied | Sterile, Single-Patient<br>Use | Same as proposed<br>device | Same as proposed<br>device |
| Hydratable<br>(Hydration<br>Required) | Yes | No | Yes- same as the<br>proposed device. |
| Catheter<br>Preparation Saline<br>Flush | 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.