(262 days)
No
The summary describes a physical medical device (catheter introducer system) and its intended use, materials, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used to gain access to the vascular system for administering fluids and sampling blood, and for power injection of contrast media; these are diagnostic and delivery functions, not therapeutic.
No
The device is described as an introducer and catheter system for gaining access to the vascular system to sample blood and administer fluids, and for power injection of contrast media. Its functions are for access and delivery, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, all-in-one preassembled device combining a catheter introducer system and an IV catheter. It mentions materials (ChronoFlex C® with BioGUARD™ Technology) and physical mechanisms (passive needle stick safety), indicating it is a hardware device.
Based on the provided information, 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 to sample blood and administer fluids intravenously." This describes a device used in vivo (within the body) for direct patient care, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces its use for inserting a catheter into the vascular system for blood sampling and fluid administration, which are clinical procedures performed on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on testing biological specimens in vitro.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to access the vascular system for direct intervention and sample collection, not for the in vitro analysis of those samples.
N/A
Intended Use / Indications for Use
The POWERWAND™ Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Product codes
DYB
Device Description
The POWERWAND™ Safety Introducer with an Extended Dwell 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 extended dwell (
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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July 25, 2019
Access Scientific, LLC Martina Nguyen Sr. Manager Quality & Regulatory Affairs 3910 Sorrento Valley Boulevard, Suite 200 San Diego, California 92121
Re: K183066
Trade/Device Name: The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 11, 2019 Received: June 12, 2019
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 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
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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 medical devices and radiation-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
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183066
Device Name
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology - 3 Ft, 4 Fr, and 5 Fr Model
Indications for Use (Describe)
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
| 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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K183066
510(K) SUMMARY
1.0 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 Fax: | (858) 259-5298 |
| Contact Person: | Martina Nguyen |
| Sr. Manager Quality & Regulatory Affairs | |
| mnguyen@accessscientific.com | |
| Date: | July 25, 2019 |
2.0 PROPOSED DEVICE IDENTIFICATION
| Trade Name: | The POWERWAND TM Safety Introducer with an
Extended Dwell Catheter made of ChronoFlex C ® with
BioGUARDTM Technology-3 Fr, 4 Fr, and 5 Fr Model |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Catheter Introducer |
| Classification Name: | Introducer, Catheter |
| Classification Regulation: | 21 CFR 870.1340 |
| Device Class: | Class II |
| Product Code(s): | DYB |
| Advisory Panel: | Cardiovascular |
3.0 PREDICATE DEVICE IDENTIFICATION
The POWERWAND™ Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology has the following predicate device:
- K162322 POWERWAND™ Safety Introducer with an Extended Dwell . Catheter, 3 Fr Model
4
4.0 REFERENCE DEVICE IDENTIFICATION
The POWERWAND™ Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology has the following reference device:
- K131300 POWERWAND™ Safety Introducer with an Extended Dwell ● Catheter, 4 Fr and 5 Fr Model
5.0 DEVICE DESCRIPTION
The POWERWAND™ Safety Introducer with an Extended Dwell 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 extended dwell (