(122 days)
No
The document describes a standard medical device (a midline catheter) and its physical characteristics, intended use, and performance testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on physical properties and sterility, not algorithmic performance.
No.
The device is a catheter used for intravenous therapy, not a therapeutic agent itself. It facilitates treatment but does not provide therapy.
No
Explanation: The device is indicated for short-term access to the peripheral venous access system for intravenous therapy and sampling of blood, which are therapeutic and procedural uses, not diagnostic.
No
The device description clearly describes a physical catheter and associated hardware components (suture wing, Luer lock hub, extension tube) made from specific materials. It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This examination is performed outside of the body (in vitro).
- HydroMID Function: The HydroMID is a catheter designed for direct access to the peripheral venous system within the body (in vivo). Its purpose is to administer fluids, medications, or blood products, and to sample blood directly from the vein. It does not involve the examination of specimens outside the body for diagnostic purposes.
The description clearly states its use for "intravenous therapy" and "sampling of blood and blood products" directly from the "peripheral venous access system." This is a therapeutic and access device, not a diagnostic one.
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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February 8, 2021
Access Vascular Inc. Brian Hanley VP, R&D and Operations 175 Middlesex Turnpike Suite 1A Bedford, Massachusetts 01730
Re: K203069
Trade/Device Name: HydroMID Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 4, 2021 Received: January 5, 2021
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,
For Payal Patel 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) K203069
Device Name HydroMID
Indications for Use (Describe)
| The HydroMID is indicated for short term access ( ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K203069
January 25, 2021 Date Prepared:
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: | HydroMID |
|---|---|
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21CFR§880.5200 |
| Regulation Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 days |
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
Primary Predicate Device
| Trade Name: | BioFlo Midline Catheter |
|---|---|
| Manufacturer: | AngioDynamics Inc. (Formerly Navilyst Medical, Inc.) |
| 510(k) Reference: | K150407 |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR§880.5200 |
| Regulation Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 days |
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
| The predicate has not been subject to a design-related recall. |
Reference Device
| Trade Name: | HydroPICC |
|---|---|
| Manufacturer: | Access Vascular, Inc |
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| 510(k) Reference: | K193015 |
|---|---|
| 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 |
Device Description
The HydroMID catheter is a short term (