(114 days)
No
The document describes a physical medical device (a catheter) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for the administration of fluids, medications, and nutrients, which are therapeutic interventions.
No
The device is a peripheral inserted central catheter (PICC) used for intravenous therapy, blood sampling, central venous pressure monitoring, and contrast media injection. While sampling blood and monitoring pressure can provide data, the device itself does not interpret that data to provide a diagnosis. Its primary function is to provide access to the central venous system, not to diagnose a condition.
No
The device description clearly states that the HydroPICC is a physical catheter and is supplied in a kit with accessories, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for accessing the central venous system for intravenous therapy, blood sampling, and pressure monitoring. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes within the body.
- Device Description: The description confirms it's a peripherally inserted central catheter (PICC), a device inserted into a vein to reach the central venous system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, analyzers, etc., which are not described here.
Therefore, the HydroPICC is a medical device used for direct patient care and intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.
HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/sec.
Product codes
LJS
Device Description
The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC) while maintaining a reduced level of thrombus accumulation. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter. The patient population for the proposed and predicate devices are identical, namely patients who require short- and long-term vascular access.
The following accessories are provided with the HydroPICC:
- Tear-away Introducer
- Introducer needle
- Guidewire
- Male Cap Plug
- 60cm. Paper Tape Measure
- Needle-Free Valve
- Luer Lock Syringe
- Adhesive Fixation Device - Bard StatLock
- Scalpel
- Transparent Film Dressing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation tests have been performed in accordance with Design Controls per 21 CFR §820.30. The subject devices met all predetermined acceptance criteria derived from the applicable guidance documents, standards and in-house protocols, which were used to determine appropriate methods for evaluating the performance of the device.
The following performance tests were performed in support of the substantial equivalence determination:
Mechanical and Performance Testing
The testing and test methods that were performed for HydroPICC-142 are substantially equivalent to testing and tests methods that were performed for the predicate, the HydroPICC-141 (K172885). Testing was conducted in accordance with the following FDA Guidance Document and international standards:
- . FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravenous Catheter"
- . 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 Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation and Routine Control Of A Sterilization Process For Medical Device"
- . EN ISO 13868:2014 "Catheters – Test method for kinking of single lumen catheters and medical tubing"
- . ASTM F2052:2015 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
- ASTM F2182: 2011 "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging"
- . ASTM F2213: 2017 "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
- . ASTM F2119: 2013 "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"
- USP Particulate Matter in Injections (Method 1)
- Evaluation of Humectant change on Thrombus accumulation compared to predicate (internal specifications)
The following tests were conducted in accordance with the standards identified above as applicable:
- . Power Injection Flow Rate
- Static Burst Strength
- Multiple Power Injections
- Catheter Length
- Dimensional Verification (including ID, OD, Length)
- Catheter Kink/Flex Resistance
- . Tensile Testing (of Catheter and Assembly)
- Particulate testing
- Shelf life testing
- Sterility testing
- Packaging distribution testing
- MR Compatibility testing
Biocompatibility Testing
Risk assessment evaluation that the proposed modifications did not impact biocompatibility
Conclusion
Based on the performance testing, intended use, materials, design, and components the HydroPICC-142 is determined to be substantially equivalent to the predicate HydroPICC-141 (K172885).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 20, 2020
Access Vascular, Inc Brian Hanley Sr. Director, Operations 175 Middlesex Turnpike Suite 1A Bedford, Massachusetts 01730
Re: K193015
Trade/Device Name: HydroPICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: January 17, 2020 Received: January 21, 2020
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 Geeta Pamidimukkala 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
2
Indications for Use
510(k) Number (if known) K193015
Device Name
HydroPICC
Indications for Use (Describe)
HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.
HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 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. The bottom of the "A" in "ACCESS" is connected to the "V" in "VASCULAR" by a blue line.
K193015 510(k) Summary for the HydroPICC PICC
Date prepared: 18 February, 2020
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: | HydroPICC |
|---|---|
| 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 |
Primary Predicate Device
| Trade Name: | HydroPICC |
|---|---|
| Manufacturer: | Access Vascular |
| 510(k) Reference: | K172885 |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR§880.5970 |
| Regulation Name: | Percutaneous, Implanted, Long-Term Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |
4
Device Description
The device description of HydroPICC-142 is the same as the predicate device, HydroPICC-141 (K172885).
The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC) while maintaining a reduced level of thrombus accumulation. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter. The patient population for the proposed and predicate devices are identical, namely patients who require short- and long-term vascular access.
The following accessories are provided with the HydroPICC:
- Tear-away Introducer
- Introducer needle
- Guidewire
- Male Cap Plug
- 60cm. Paper Tape Measure
- Needle-Free Valve
- Luer Lock Syringe
- Adhesive Fixation Device - Bard StatLock
- Scalpel
- Transparent Film Dressing
Indications for Use
HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5ml/sec. The Indications for Use statement for the HydroPICC-142 is identical to the predicate device, HydroPICC-141 (K172885).
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the HydroPICC-142 are substantially equivalent to the predicate, the HydroPICC-141 (K172885), in terms of intended use, application, user population, basic design, performance, and labeling. The hydration aid, nominal catheter dimensions, and product packaging were modified in order to reduce the time it takes for the catheter to hydrate during procedural setup. A radiopaque additive was removed from the suture wing overmold. The labeling of the HydroPICC-142 was revised to indicate MRI Safety Information following the evaluation of the device.
Briefly, both the subject and predicate device are,
5
- intended for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.
- available in 4 French size
- rated for maximum power injection flow rate up to 3.5mL/sec
- available kitted with a range of procedural accessories for user convenient; and
- demonstrative of enhanced resistance to blood component (platelet and thrombus) accumulation
| | HydroPICC-142
Access Vascular
Proposed Device | HydroPICC-141
Access Vascular
K172885 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Specification | | |
| Intended Use | intended for short- or long-term
peripheral access to the central
venous system for intravenous
therapy. | Same |
| Indication for Use | HydroPICC is indicated for short- or
long-term peripheral access to the
central venous system for
intravenous therapy, including but
not limited to; the administration
of fluids, medications, and
nutrients; the sampling of blood;
central venous pressure
monitoring; and power injection of
contrast media.
HydroPICC is rated for a Maximum
Power Injection Flow Rate of
3.5mL/sec. | Same |
| Device Class | Class II | Same |
| Product Code | LJS | Same |
| Regulation Number | 880.5970 | Same |
| Prescription Device | Yes | Same |
| Catheter Type | Peripherally Inserted Central
Catheter (PICC) | Same |
| Catheter Outer Diameter | 4 French | Same |
| Catheter Inner Diameter | 1mm | Substantially equivalent |
| Usable Catheter Length | 55cm | Same |
| Guidewire compatibility | 0.018" | Same |
| Catheter Shaft Design | No Taper | Same |
| Number of Catheter Lumens | Single | Same |
Table 1 Summary of Technological Characteristics of Proposed and Predicate Devices
6
| Specification | HydroPICC-142
Access Vascular
Proposed Device | HydroPICC-141
Access Vascular
K172885 |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Key Device Components | Catheter Shaft, Suture Wing,
Extension Tube, Luer Hub | Same |
| Short or Long Term Access | Yes | Same |
| Use with Power Injection
Power Settings Flow Rate | Yes
Flow rate: 3.5mL/sec | Same |
| Catheter Materials | Radiopaque hydrophilic polyol
catheter with luer lock hub,
polyurethane extension tub, and
suture wing without radiopaque
additive | Same - suture wing contained
radiopaque additive |
| X-Ray Confirmation
Required | Yes | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Single Use | Yes | Same |
| How supplied | Convenience kit | Same |
| MRI Safety | Evaluated – labeled with MRI
Safety Information | Not evaluated – labeled with
contraindication to use in a MR
environment |
Performance Data
Verification and validation tests have been performed in accordance with Design Controls per 21 CFR §820.30. The subject devices met all predetermined acceptance criteria derived from the applicable guidance documents, standards and in-house protocols, which were used to determine appropriate methods for evaluating the performance of the device.
The following performance tests were performed in support of the substantial equivalence determination:
Mechanical and Performance Testing
The testing and test methods that were performed for HydroPICC-142 are substantially equivalent to testing and tests methods that were performed for the predicate, the HydroPICC-141 (K172885). Testing was conducted in accordance with the following FDA Guidance Document and international standards:
- . FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravenous Catheter"
- . 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:
7
- . EN ISO 11135:2014 "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation and Routine Control Of A Sterilization Process For Medical Device"
- . EN ISO 13868:2014 "Catheters – Test method for kinking of single lumen catheters and medical tubing"
- . ASTM F2052:2015 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
- ASTM F2182: 2011 "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging"
- . ASTM F2213: 2017 "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
- . ASTM F2119: 2013 "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"
- USP Particulate Matter in Injections (Method 1)
- Evaluation of Humectant change on Thrombus accumulation compared to predicate (internal specifications)
The following tests were conducted in accordance with the standards identified above as applicable:
- . Power Injection Flow Rate
- Static Burst Strength
- Multiple Power Injections
- Catheter Length
- Dimensional Verification (including ID, OD, Length)
- Catheter Kink/Flex Resistance
- . Tensile Testing (of Catheter and Assembly)
- Particulate testing
- Shelf life testing
- Sterility testing
- Packaging distribution testing
- MR Compatibility testing
Biocompatibility Testing
Risk assessment evaluation that the proposed modifications did not impact biocompatibility
Conclusion
Based on the performance testing, intended use, materials, design, and components the HydroPICC-142 is determined to be substantially equivalent to the predicate HydroPICC-141 (K172885).