(177 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its materials, intended use, and performance testing against recognized standards. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is used for "peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients," which are therapeutic actions.
No
The device is a peripherally inserted central catheter (PICC) used for fluid administration, medication delivery, nutrient delivery, blood sampling, central venous pressure monitoring, and contrast media injection. None of these functions are primarily diagnostic. While it can be used for blood sampling, which can then be used for diagnostic purposes, the device itself does not perform the diagnosis.
No
The device description clearly states it is a physical catheter made of radiopaque hydrophilic material with physical components like a suture wing, Luer lock hubs, and extension tubes. It also mentions being packaged in kit configurations with accessories for placement. This indicates a hardware medical 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 describes a device used for direct patient care, specifically for accessing the central venous system for administering fluids, medications, nutrients, blood sampling, pressure monitoring, and contrast media injection. These are all procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The device is a catheter designed to be inserted into the body. This is consistent with a medical device used for treatment or monitoring, not an IVD which analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The performance studies focus on the physical properties and safety of the catheter itself, not on the accuracy or reliability of any diagnostic measurements.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on accessing the central venous system for therapeutic and monitoring purposes directly on the patient.
N/A
Intended Use / Indications for Use
Indicated for short-or long-term peripheral access to the central venous 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.
Rated for maximum power injection flow rate of 3.5ml/s
Product codes
LJS
Device Description
The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of 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 each lumen is indicated on each extension tube clamp.
HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system / peripheral access
Indicated Patient Age Range
Adult
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
The sterile single lumen HydroPICC 5 F Dual lumen Catheter (PICC 251) described in this summary was tested and demonstrated to be in conformance with the following FDA recognized standards.
- . 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 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"
Key Metrics
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
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May 4, 2022
Access Vascular Inc Brian Hanley VP, R&D and Operation 749 Middlesex Turnpike Billerica, Massachusetts 01820
Re: K213550
Trade/Device Name: HydroPICC 5F Dual Lumen Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: April 29, 2022 Received: May 2, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Payal Patel 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) K213550
Device Name HydroPICC 5F Dual Lumen Catheter
Indications for Use (Describe)
Indicated for short-or long-term peripheral access to the central venous 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.
Rated for maximum power injection flow rate of 3.5ml/s
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for Access Vascular. The logo is in blue and features the words "ACCESS VASCULAR" stacked on top of each other. The "A" in "ACCESS" is stylized with a line extending down and to the left, creating a visual element that resembles a vascular pathway. The word "ACCESS" is in a darker shade of blue than the word "VASCULAR."
K213550 510(k) Summary
Preparation Date: May 5, 2022
Submitter:
Access Vascular Inc. 749 Middlesex Turnpike Billerica, MA 01820
Contact:
Brian M. Hanley VP, R&D and Operations Tel: 781.538.6594 x101
Subject Device
| Trade Name: | HydroPICC 5F Dual Lumen Catheter |
|---|---|
| Manufacturer: | Access Vascular Inc. |
| Common Name: | Intravascular Catheter |
| Regulation: | 21 CFR 880.5970 |
| Regulation Name: | Percutaneous, Implanted, Long Term Intravascular Catheter |
| Regulatory Class: | II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |
Predicate Device:
| 510(k) Reference: | K193015 |
|---|---|
| Trade Name: | HydroPICC-142 Catheter |
Device Description
The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of 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 each lumen is indicated on each extension tube clamp.
HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
Indication for Use
| Characteristics | Predicate Device
HydroPICC-142 | Subject Device
HydroPICC-251 |
|---------------------|---------------------------------------------------------------------------------------------|---------------------------------|
| | K193015 | K213550 |
| Indications for Use | Indicated for short- or long-
term peripheral access to the
central venous system for | Same |
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Image /page/4/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 "ACCESS" is the word "VASCULAR" in a similar font, but in a lighter shade of blue. The "A" in "ACCESS" has a line extending from the left side of the "A" to the top of the "V" in "VASCULAR".
| | 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.
Rated for a maximum power
injection flow rate of 3.5ml/s | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Prescription Only or
Over the counter | Prescription Only | Same |
Discussions of differences in Indications for Use statement:
The indications for use statement for the subject device is identical to the predicate device. The HydroPICC 5F Dual Lumen Catheter is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the HydroPICC 5F Dual Lumen Catheter can be considered substantially equivalent to the predicate device.
Technological Characteristics
The following table shows a comparison of the technological characteristics between the HydroPICC 5F Dual Lumen Catheter and the cited predicate is sufficient detail to provide an understanding of the basis for determining substantial equivalence.
| Technological Characteristics | Predicate Device | Subject Device | Comment |
|---|---|---|---|
| HydroPICC-142 4F | |||
| K193015 | HydroPICC-251 5F DL | ||
| Catheter K213550 | |||
| Device Classification | II | II | Same |
| Product Code | LJS | LJS | Same |
| Regulation | 21 CFR 880.5970 | 21 CFR 880.5970 | Same |
| Prescription Device | Yes | Yes | Same |
| Intended population | Adult | Adult | Same |
| Catheter Type | Peripherally Inserted | ||
| Central Catheter (PICC) | Peripherally Inserted | ||
| Central Catheter (PICC) | Same | ||
| Catheter Outer Diameter | |||
| French Size | 4 French (1.40mm) | ||
| (Post Hydrated) | 5 French (1.67 mm) | ||
| (Post Hydrated) | Difference: see | ||
| comment # 1 | |||
| Catheter Outer Diameter as | |||
| supplied | 1.30 mm | ||
| (Supplied dehydrated) | 1.60 mm | ||
| (Supplied dehydrated) | Difference - see | ||
| comment # 1 | |||
| Catheter Inner Diameter | 1mm | D-shaped lumens each | |
| greater than or equal to | |||
| 0.48mm² | Difference - see | ||
| comment # 2 | |||
| Useable Length | 55cm | Same | Same |
| Priming Volume |