(266 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the physical components and material properties.
No
The device is described as a catheter for intravenous therapy, including administration and sampling, which are diagnostic and supportive functions, not therapeutic. While it mentions reducing thrombus accumulation, this is a feature of the device, not its primary therapeutic indication.
No
This device is a catheter for intravenous therapy, not a diagnostic device. Its purpose is to provide access for administration and sampling, not to diagnose a condition.
No
The device description clearly describes a physical catheter and associated hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short term access (
N/A
Intended Use / Indications for Use
The HydroMID is indicated for short term access (
§ 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).
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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 ( 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."
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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 (