(231 days)
Not Found
No
The description focuses on the mechanical design and materials of a catheter, with no mention of AI or ML capabilities.
No.
The primary purpose of this device is for sampling blood or administering fluids, not for treating a disease or condition. While fluid administration can be part of a therapeutic regimen, the device itself is a delivery mechanism, not a therapy.
No
The device is described as a catheter used for sampling blood or administering fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a catheter, introducer needle, sheathing cannula, and integrated housing, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sample blood or administer fluids intravenously." This is a direct interaction with the patient's vascular system for therapeutic or diagnostic sampling purposes, not for testing a sample in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into the body for fluid administration and blood sampling. It does not describe any components or processes related to analyzing a sample in a laboratory setting.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used on the patient, not with a specimen from the patient for analysis.
The Stiletto Extended Dwell Catheter is a medical device used for direct patient care, specifically for vascular access.
N/A
Intended Use / Indications for Use
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use ( 1 for all compounds and populations)
- Particulate Matter: Sizing and Counting Particulate Matter: Light Obscuration Method (Acceptable per USP and Legally Marketed Comparative Device)
Key results: Through performance bench testing results, it has been demonstrated that the subject device is substantially equivalent to the predicate device, PowerGlide Pro™ Midline Catheter (K162377)with respect to the intended use, target populations, treatment method, and technological characteristics. The identified differences between the devices do not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 27, 2021
Piper Access, LLC Jay Muse President and CEO 6030 W. Harold Gatty Dr. Salt Lake City, Utah 84116
Re: K210047
Trade/Device Name: Stiletto Extended Dwell Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: January 7, 2021 Received: January 8, 2021
Dear Jay Muse:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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) K210047
Device Name
Stiletto Extended Dwell Catheter
Indications for Use (Describe)
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use ( 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."
3
Image /page/3/Picture/0 description: The image contains the logo for Piper Access. The logo consists of a stylized, curved line drawing above the company name. The word "PIPER" is in gray, while "ACCESS" is in orange, with a trademark symbol next to it.
510(k) Summary (21 CFR 807.92(c))
SUBMITTER I.
| Submitter Name: | Piper Access, LLC |
|---|---|
| Address: | 6030 West Harold Gatty Dr. |
| Salt Lake City, UT 84116 | |
| Telephone: | 801-210-2886 |
| Contact Person: | Jay Muse |
|---|---|
| Email of Contact: | jay.muse@piperaccess.com |
| Date Prepared: | 26 August 2021 |
II. DEVICE
| Trade Name: | Stiletto Extended Dwell Catheter |
|---|---|
| Common/Usual Name: | Midline Catheter |
| Regulation Name: | Intravascular catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Product Code: | PND |
| Device Class: | Class II |
| Review Panel: | General Hospital |
III. PREDICATE DEVICE
| Predicate Name: | PowerGlide Pro™ Midline Catheter |
|---|---|
| Common/Usual Name: | Intravascular Catheter, Therapeutic |
| Short-Term Less Than 30 Days | |
| Classification Name: | Intravascular catheter |
| Premarket Notification: | K162377 |
| Product Code: | FOZ |
| Manufacturer: | Bard Access Systems, Inc. |
DEVICE DESCRIPTION IV.
The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration ( 1 for all
compounds and
populations | |
| | Particulate Matter | Sizing and Counting Particulate
Matter: Light Obscuration
Method | Acceptable per USP
and Legally
Marketed
Comparative Device |
VIII. CONCLUSION
Through performance bench testing results, it has been demonstrated that the subject device is substantially equivalent to the predicate device, PowerGlide Pro™ Midline Catheter (K162377)with respect to the intended use, target populations, treatment method, and technological characteristics. The identified differences between the devices do not raise any new questions of safety or effectiveness.