(104 days)
No
The description focuses on the physical components and intended use of a catheter introducer system and arterial catheter, with no mention of AI or ML capabilities.
No.
The device is used for access, sampling, monitoring, and fluid administration, which are diagnostic and supportive functions rather than direct therapeutic treatment.
No
This device is an arterial catheter and introducer system used for gaining vascular access, administering fluids, sampling blood, and monitoring blood pressure. While blood sampling is mentioned, the device itself is not described as analyzing or interpreting biological samples or physiological signals to provide a diagnosis. Its primary function is access and measurement, not diagnosis.
No
The device description explicitly lists physical components such as a needle, guidewire, dilator hub, and catheter, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to gain access to the vascular system for sampling blood, administering fluids, and monitoring blood pressure intravascularly. This is a direct interaction with the patient's circulatory system.
- Device Description: The device is described as an "intravascular catheter" used to access the vascular system and can be left in place for a period. This confirms its use within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVD devices are used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions.
The ARTERIAL WAND™ is a medical device used for direct patient care and intervention within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DYB
Device Description
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is an all-in-one preassembled device that combines the functionality of a catheter introducer system with an arterial catheter. The ARTERIAL WAND™ is used to gain access to the vascular (e.g. arterial) system to insert the arterial catheter. The arterial catheter may then be left in place for a period of
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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September 26, 2018
Access Scientific, LLC Ms. Martina Nguyen Regulatory Affairs & Ouality Assurance Specialist 3910 Sorrento Valley Boulevard, Suite 200 San Diego, California 92121
Re: K181563
Trade/Device Name: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY, DYB Dated: August 24, 2018 Received: August 27, 2018
Dear Ms. Nguyen:
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 mav, 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the name "Finn E. Donaldson -S" in large, bold font. To the right of the name is a digital signature block. The signature block includes information such as the signer's name, organization, and date.
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=200097967
3, cn=Finn E. Donaldson -S
Date: 2018.09.26 15:36:30 -04'00'
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181563
Device Name
ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology
Indications for Use (Describe)
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly.
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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510(K) SUMMARY
The following 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. SUBMITTER INFORMATION
| Company Name: | Access Scientific, LLC |
|---|---|
| Company Address: | 3910 Sorrento Valley Boulevard |
| Suite 200 | |
| San Diego, CA 92121 | |
| Company Phone: | (858) 259-8333 |
| Company Facsimile: | (858) 259-5298 |
| Contact Person: | Martina Nguyen |
| Regulatory Affairs & Quality Assurance Specialist | |
| mnguyen@accessscientific.com | |
| Date: | September 25, 2018 |
2. PROPOSED DEVICE IDENTIFICATION
| Trade Name: | The ARTERIAL WAND™ Safety Introducer with
Arterial Catheter made of ChronoFlex C® with
BioGUARD™ Technology |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous |
| Classification Regulation: | 21 CFR 870.1250 |
| Device Class: | Class II |
| Product Code(s): | DQY, DYB |
| Advisory Panel: | Cardiovascular |
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3. PREDICATE DEVICE IDENTIFICATION
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the following predicate device:
- K171146 Arrow Seldinger Arterial Catheterization Device ●
4. REFERENCE DEVICE IDENTIFICATION
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the following reference devices:
5. DEVICE DESCRIPTION
The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is an all-in-one preassembled device that combines the functionality of a catheter introducer system with an arterial catheter. The ARTERIAL WAND™ is used to gain access to the vascular (e.g. arterial) system to insert the arterial catheter. The arterial catheter may then be left in place for a period of