(266 days)
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
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 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.
The provided text describes the 510(k) summary for the HydroMID 4F Single Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) rather than presenting a performance study with specific acceptance criteria and reported device performance in the format requested.
Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set and data provenance," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," the document does not provide the requested quantitative information typically found in clinical or AI algorithm performance studies.
Instead, the document primarily addresses the following:
1. Acceptance Criteria and Device Performance (Qualitative Description):
The device is deemed to meet its intended purpose and be substantially equivalent to the predicate device based on various bench tests and biocompatibility testing. The "acceptance criteria" are implied to be adherence to various consensus standards and FDA guidance.
| Test | Consensus Standard/FDA Guidance/Description | Reported Device Performance |
|---|---|---|
| Bench testing (Catheter length, marking spacing, surface continuity, in-life durability) | "Confirm that the device meets intended product specifications" | The device passed these tests, confirming it meets intended product specifications. |
| Biocompatibility testing | FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 2020) | The device passed biocompatibility testing according to the specified FDA guidance and ISO 10993 standards (1, 4, 5, 10, 12). |
The document states, "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."
Regarding the other requested information:
- Sample size used for the test set and the data provenance: Not specified. The document mentions "test units representative of finished devices" for bench testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This type of information is typically for AI/diagnostic device studies.
- Adjudication method: Not applicable or not specified.
- 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: Not applicable. This is not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical catheter, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical characteristics, the ground truth would be engineering specifications and measurements. For biocompatibility, it's the results of standardized biological assays.
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document focuses on instead:
The document focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) by highlighting:
- Identical intended use, principle of operation, and similar technological characteristics.
- Minor differences (e.g., removal of certain warnings for midline therapies, addition of Copper Phthalocyanine Blue 15:1 material for catheter markings, addition of catheter markings) are addressed and supported by bench testing and biocompatibility data.
- Adherence to various international and FDA consensus standards for medical devices (ISO 10555, ISO 11135, AAMI TIR28, ISO 15223, ISO 10993).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 781.538.6594 x101 bhanley@accessvascularinc.com
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 SingleLumenAccess Vascular Inc.Subject Device | HydroMID-142 4FAccess Vascular Inc.Predicate DeviceK203069 | Comparison |
|---|---|---|---|
| Intended Use | Intended for short-term access to theperipheral venoussystem | Intended for short-termaccess to the peripheralvenous 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 isindicated for shortterm access (< 30 days)to the peripheralvenous access systemfor intravenoustherapy, including butnot limited to, theadministration of fluids,medications, and thesampling of blood andblood products.Maximum PowerInjection Flow Rate:-4Fr Single Lumen,20cm: 6 mL/sec | 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 aMaximum PowerInjection Flow Rate of 6mL/sec. | Difference - seecomment #1: TheInfusion Nurses Society(INS) standards languageslightly changed, butintended use is still thesame. |
| Warnings | Do Not use midlinecatheter for continuousvesicant therapy, PN, orinfusates withextremes of pH orosmolarity | Therapies notappropriate for midlinecatheters includecontinuous vesicanttherapy, parentalnutrition, infusates withpH less than 5 or greaterthan 9, and infusateswith an osmolaritygreater than600mOsm/L | Difference - seecomment #1: The INSstandards languageslightly changed, butintended use is still thesame. |
| 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 SingleLumenAccess Vascular Inc.Subject Device | HydroMID-142 4FAccess Vascular Inc.Predicate DeviceK203069 | Comparison |
| Catheter OuterDiameter French Size | 4Fr (1.40mm)(Post Hydrated) | 4Fr (1.40mm)(Post Hydrated) | Same |
| Catheter OuterDiameter as supplied | 1.30mm(Supplied Dehydrated) | 1.30mm(Supplied Dehydrated) | Same |
| Catheter InnerDiameter | 1mm | 1mm | Same |
| Useable Length | 20 cm | 20 cm | Same and 20 cm |
| Priming Volume | < 1.0mL | < 1.0mL | Same |
| GuidewireCompatibility | Ø.018" | Ø.018" | Same |
| Catheter ShaftDesign | Taper | Taper | Same |
| Number of Lumens | Single Lumen (SL) | Single Lumen (SL) | Same |
| Key DeviceComponents | Catheter Shaft, SutureWing, Extension Tube,Luer Hub, Clamp | Catheter Shaft, SutureWing, Extension Tube,Luer Hub, Clamp | Same |
| Short or Long TermAccess | Short | Short | Same |
| Use with PowerInjection andSpecified Flow Rate | Yes6mL/sec | Yes6mL/sec | Same |
| Catheter Materials | Radiopaque hydrophilicpolyol catheter withCopper PhthalocyanineBlue 15:1 cathetermarkings, Luer lockhub, polyurethaneextension tubing, andsuture wing | Radiopaque hydrophilicpolyol catheter withLuer lock hub,polyurethane extensiontubing, and suture wing | Difference - seecomment #2:Copper PhthalocyanineBlue 15:1 material isadded to the outersurface of the cathetershaft to incorporatecatheter markings assupported by benchtesting andbiocompatibility testing. |
| X-Ray ConfirmationRequired | 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:Basic IR KitFull Nursing KitMaximal Barrier Kit | Convenience Kit:Basic IR KitFull Nursing KitMaximal Barrier Kit | Same |
| Catheter Markings | Markings (every cm) | None | Difference – seecomment #3:Catheter markings areadded to the subjectdevice to assist the user |
| Specification | HydroMID 4F SingleLumenAccess Vascular Inc.Subject Device | HydroMID-142 4FAccess Vascular Inc.Predicate DeviceK203069 | Comparison |
| catheter and monitoringcatheter 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 productspecifications |
| Biocompatibility testing | FDA Final Guidance Document, "Use ofInternationalStandard ISO 10993-1, "Biological evaluation ofmedicaldevices - Part 1: Evaluation and testing within ariskmanagement 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.
§ 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).