HydroMID 4F Single Lumen Midline Catheter

K220772 · Access Vascular, Inc. · FOZ · Dec 7, 2022 · General Hospital

Device Facts

• Record ID: K220772
• Device Name: HydroMID 4F Single Lumen Midline Catheter
• Applicant: Access Vascular, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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. Maximum Power Injection Flow Rate: -4Fr Single Lumen, 20cm: 6 mL/sec

Device Story

HydroMID 4F Single Lumen Midline Catheter provides short-term peripheral venous access for IV therapy and blood sampling. Device consists of radiopaque hydrophilic catheter, suture wing, Luer lock hub, and extension tube. Used in clinical environments by healthcare professionals; placed via guidewire. Features catheter markings to assist in positioning and monitoring migration. Power injectable up to 6 mL/sec. Designed to reduce thrombus accumulation and thrombotic occlusions. Output is venous access for fluid/medication delivery or blood withdrawal. Benefits patient by providing reliable short-term access while minimizing thrombotic complications.

Clinical Evidence

Bench testing only. Testing included catheter length, marking spacing, surface continuity, in-life durability, and biocompatibility (ISO 10993-1, -4, -5, -10, -12). No clinical data presented.

Technological Characteristics

4F single lumen midline catheter; radiopaque hydrophilic polyol shaft; Copper Phthalocyanine Blue 15:1 markings; polyurethane extension tubing. Dimensions: 1.30mm (dehydrated), 1.40mm (hydrated), 1mm ID, 20cm length. Power injection rated (6 mL/sec). Sterilization: Ethylene Oxide. Standards: EN ISO 10555-1/3, ISO 11135, ISO 10993 series.

Indications for Use

Indicated for short-term (< 30 days) peripheral venous access for IV therapy (fluids, medications, blood sampling) in adult and pediatric patients.

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

• HydroMID-142 4F (K203069)

Reference Devices

• BioFlo Midline Catheter (K161866)

Submission Summary (Full Text)

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December 7, 2022

Access Vascular, Inc. Brian Hanley VP. R&D and Operations 749 Middlesex Turnpike Billerica, Massachusetts 01821

Re: K220772

Trade/Device Name: HydroMID 4F Single Lumen Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: November 4, 2022 Received: November 7, 2022

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

David Walloschek

David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220772

Device Name HydroMID 4F Single Lumen Midline Catheter

Indications for Use (Describe)

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 administrations, and the sampling of blood and blood products.

Maximum Power Injection Flow Rate: -4Fr Single Lumen, 20cm: 6 mL/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/1 description: The image shows the logo for Access Vascular. The word "ACCESS" is in a dark blue font, and the word "VASCULAR" is in a lighter blue font. There is a line that connects the two words, starting from the bottom left of the "A" in "ACCESS" and ending at the top left of the "V" in "VASCULAR".

## K220772 510(k) Summary

#### Preparation Date: December 7, 2022

#### Submitter:

Access Vascular Inc. 749 Middlesex Turnpike Billerica, MA 01821

#### Contact:

Brian M. Hanley VP, R&D and Operations Phone: [phone] x101 [e-mail]

#### Subject Device

| Trade Name: | HydroMID 4F Single Lumen Midline Catheter |
|--------------------|--------------------------------------------------------------------|
| Regulation Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Common Name: | Catheter, Intravascular, therapeutic, Short-Term less than 30 days |
| Regulatory Class: | Class II |
| Product Code: | FOZ |

| Manufacturer: | Access Vascular Inc |
|-------------------|---------------------|
| Manufacturer ERN: | 3015060232 |

## Predicate Device

| Trade Name: | HydroMID 4F Single Lumen Catheter |
|--------------------|--------------------------------------------------------------------|
| Manufacturer: | Access Vascular |
| 510(k) Number: | K203069 |
| Regulation Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Common Name: | Catheter, intravascular, therapeutic, Short-Term less than 30 days |
| Regulatory Class: | Class II |
| Product Code: | FOZ |

#### Reference Device

| Trade Name: | BioFlo Midline Catheter |
|----------------|-------------------------|
| 510(k) Number: | K161866 |

The reference devices are provided because they are a comparable midline catheter, with catheter markings.

#### Description of Use

#### HydroMID

The HydroMID catheter is a 4 French, single lumegemidfifie catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tube made from materials

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Image /page/4/Picture/1 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 "Access" is the word "Vascular" in a lighter shade of blue. The "A" in "Access" and the "V" in "Vascular" are connected to form a stylized "AV" symbol.

commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

## Indication 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.

Maximum Power Injection Flow Rate:

-4Fr Single Lumen, 20cm: 6 mL/sec

## Comparison of Technological Characteristics with the Predicate Device

The Proposed Devices and Predicate Devices, respectively, are similar in indications for use, intended use, technological characteristics, and principles of operation.

The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.

| Specification | HydroMID 4F Single<br>Lumen<br>Access Vascular Inc.<br>Subject Device | HydroMID-142 4F<br>Access Vascular Inc.<br>Predicate Device<br>K203069 | Comparison |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for short-<br>term access to the<br>peripheral venous<br>system | Intended for short-term<br>access to the peripheral<br>venous system | Same |
| Specification | HydroMID 4F Single | HydroMID-142 4F | Comparison |
| | Lumen | Access Vascular Inc. | |
| | Access Vascular Inc. | Predicate Device | |
| | Subject Device | K203069 | |
| Indications for Use | The HydroMID is<br>indicated for short<br>term access (< 30 days)<br>to the peripheral<br>venous access system<br>for intravenous<br>therapy, including but<br>not limited to, the<br>administration of fluids,<br>medications, and the<br>sampling of blood and<br>blood products.<br><br>Maximum Power<br>Injection Flow Rate:<br>-4Fr Single Lumen,<br>20cm: 6 mL/sec | 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><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><br>HydroMID is rated for a<br>Maximum Power<br>Injection Flow Rate of 6<br>mL/sec. | Difference - see<br>comment #1: The<br>Infusion Nurses Society<br>(INS) standards language<br>slightly changed, but<br>intended use is still the<br>same. |
| Warnings | Do Not use midline<br>catheter for continuous<br>vesicant therapy, PN, or<br>infusates with<br>extremes of pH or<br>osmolarity | 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 | Difference - see<br>comment #1: The INS<br>standards language<br>slightly changed, but<br>intended use is still the<br>same. |
| Device Classification | Class II | Class II | Same |
| Product Code | FOZ | FOZ | Same |
| Regulation | 21 CFR 880.5200 | 21 CFR 880.5200 | Same |
| Prescription Device | Yes | Yes | Same |
| Intended population | Adult and Pediatric use | Adult and Pediatric use | Same |
| Specification | HydroMID 4F Single<br>Lumen<br>Access Vascular Inc.<br>Subject Device | HydroMID-142 4F<br>Access Vascular Inc.<br>Predicate Device<br>K203069 | Comparison |
| Catheter Outer<br>Diameter French Size | 4Fr (1.40mm)<br>(Post Hydrated) | 4Fr (1.40mm)<br>(Post Hydrated) | Same |
| Catheter Outer<br>Diameter as supplied | 1.30mm<br>(Supplied Dehydrated) | 1.30mm<br>(Supplied Dehydrated) | Same |
| Catheter Inner<br>Diameter | 1mm | 1mm | Same |
| Useable Length | 20 cm | 20 cm | Same and 20 cm |
| Priming Volume | < 1.0mL | < 1.0mL | Same |
| Guidewire<br>Compatibility | Ø.018" | Ø.018" | Same |
| Catheter Shaft<br>Design | Taper | Taper | Same |
| Number of Lumens | Single Lumen (SL) | Single Lumen (SL) | Same |
| Key Device<br>Components | Catheter Shaft, Suture<br>Wing, Extension Tube,<br>Luer Hub, Clamp | Catheter Shaft, Suture<br>Wing, Extension Tube,<br>Luer Hub, Clamp | Same |
| Short or Long Term<br>Access | Short | Short | Same |
| Use with Power<br>Injection and<br>Specified Flow Rate | Yes<br>6mL/sec | Yes<br>6mL/sec | Same |
| Catheter Materials | Radiopaque hydrophilic<br>polyol catheter with<br>Copper Phthalocyanine<br>Blue 15:1 catheter<br>markings, Luer lock<br>hub, polyurethane<br>extension tubing, and<br>suture wing | Radiopaque hydrophilic<br>polyol catheter with<br>Luer lock hub,<br>polyurethane extension<br>tubing, and suture wing | Difference - see<br>comment #2:<br>Copper Phthalocyanine<br>Blue 15:1 material is<br>added to the outer<br>surface of the catheter<br>shaft to incorporate<br>catheter markings as<br>supported by bench<br>testing and<br>biocompatibility testing. |
| X-Ray Confirmation<br>Required | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Single Use | Yes | Yes | Same |
| MRI Safety | MRI Conditional | MRI Conditional | Same |
| How Supplied | Convenience Kit:<br>Basic IR Kit<br>Full Nursing Kit<br>Maximal Barrier Kit | Convenience Kit:<br>Basic IR Kit<br>Full Nursing Kit<br>Maximal Barrier Kit | Same |
| Catheter Markings | Markings (every cm) | None | Difference – see<br>comment #3:<br>Catheter markings are<br>added to the subject<br>device to assist the user |
| Specification | HydroMID 4F Single<br>Lumen<br>Access Vascular Inc.<br>Subject Device | HydroMID-142 4F<br>Access Vascular Inc.<br>Predicate Device<br>K203069 | Comparison |
| | | | catheter and monitoring<br>catheter migration |

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Image /page/5/Picture/1 description: The image is a logo for Access Vascular. The word "ACCESS" is in a dark blue, sans-serif font, stacked on top of the word "VASCULAR" which is in a lighter blue, sans-serif font. The "A" in "ACCESS" has a line extending from the bottom left of the "A" to the top of the "V" in "VASCULAR", creating a visual connection between the two words.

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Image /page/6/Picture/1 description: The image is a logo for Access Vascular. The word "Access" is in a dark blue font, and the word "Vascular" is in a lighter blue font. There is a line that connects the two words, and it looks like a heartbeat. The logo is simple and modern.

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Image /page/7/Picture/1 description: The image shows the logo for Access Vascular. The word "ACCESS" is in a dark blue font, and the word "VASCULAR" is in a lighter blue font. A blue line connects the two words, starting from the bottom left of the "A" in "ACCESS" and ending at the bottom left of the "V" in "VASCULAR".

The purpose of listing the K161866 reference device in this submission is intended to provide information that PICC catheters with distance markings are effective in assisting users in both positioning the catheter and monitoring catheter migration. In prior Access Vascular submission K203069 we utilized the BioFlo Midline device a predicate device and demonstrated substantial equivalence despite minor differences in technological characteristics (i.e. catheter shaft material).

## Comment #1 – Removal of statement about therapies not appropriate for midlines

The proposed HydroMID Catheter indication for use statement removes mention of restricted therapies for midline catheters to align with slight changes to INS standards without impacting the intended use. The proposed indication for use is identical to other marketed midline catheters. A warning was related to therapies not appropriate for midline catheters include those requiring central access. The difference between the subject device and the predicate device are minor and do not raise any different question of safety and effectiveness.

## Comment #2 – Addition of Copper Phthalocyanine Blue 15:1 material

Materials of construction of the HydroMID Catheter with catheter markings are the same as those of the HydroMID catheter (K203069), with minor changes to accommodate the introduction of catheter markings. Bench testing and biocompatibility testing was done to support the ink used in the catheter distance markings. The difference between the subject device and predicate device are minor and do not raise any different question of safety and effectiveness as determined through testing.

## Comment #3 - Addition of Catheter Markings

The addition of catheter markings to the subject device assists the user in positioning the catheter and monitor catheter migration. This change is proposed in response to user feedback and is consistent with currently marketed Midline catheters. Testing included bench testing and biocompatibility testing. The difference between the subject device and predicate device are minor and do not raise any different question of safety and effectiveness as determined through testing.

The HydroMID is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the HydroMID can be considered substantially equivalent to the predicate device.

## Performance Data

All necessary performance testing has been conducted on the HydroMID to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device passed the following tests, which were conducted in accordance with noted

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Image /page/8/Picture/0 description: The image contains the logo for Access Vascular. The logo is comprised of the word "ACCESS" in a dark blue font, stacked on top of the word "VASCULAR" in a lighter blue font. To the left of the words is a stylized "A" that is also in a dark blue font.

standards:

| Test | Consensus Standard/FDA Guidance/Description |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench testing, including Catheter length testing Catheter marking spacing Surface continuity In-life durability testing | Confirm that the device meets intended product<br>specifications |
| Biocompatibility testing | FDA Final Guidance Document, "Use of<br>International<br>Standard ISO 10993-1, "Biological evaluation of<br>medical<br>devices - Part 1: Evaluation and testing within a<br>risk<br>management process" (September 2020) |

The following standards were used to support testing:

- 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
- . EN ISO 11135:2014 Sterilization of Healthcare Products - Ethylene Oxide - Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
- AAMI TIR28:2016 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization
- ISO 15223-1:2016 – Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General Requirements
- . ISO 10993-1: 2018 - Biological evaluation of medical devices – Evaluation and testing within a risk management process
- ISO 10993-4: 2017 - Biological evaluation of medical devices – Selection of tests for interactions with blood
- . ISO 10993-5: 2009 - Biological evaluation of medical devices - Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 - Biological evaluation of medical devices – Tests for irritation and skin sensitization
- ISO 10993-12: 2021 - Biological evaluation of medical devices - sample preparation and reference materials

## Conclusion:

Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the HydroMID 4F Single Lumen Midline Catheter is substantially equivalent to existing legally marketed devices.