(208 days)
Not Found
Not Found
No
The summary describes a standard medical device (PICC catheter) and does not mention any AI or ML components, algorithms, or functionalities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a catheter system used to administer fluids and medications, which are therapeutic agents, but the device itself does not directly provide therapy. It is a conduit for therapeutic intervention.
No.
The device is a peripherally inserted central catheter (PICC) used for administering fluids, medications, and nutritional products. Its intended use focuses on delivery and access, not on diagnosing medical conditions.
No
The device description clearly details a physical catheter made of polyurethane and associated hardware components like introducers and insertion trays, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Quick-PICC Catheter System is a medical device designed for direct insertion into the body (specifically, veins) to administer fluids, medications, and nutrition. It is a delivery system, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly describes its function as a means for venous catheterization and long-term IV administration.
- Device Description: The description details the physical components of the catheter and its insertion method, all of which relate to its function within the body.
Therefore, the Quick-PICC Catheter System falls under the category of an invasive medical device used for therapeutic and supportive purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quick-PICC Catheter System is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cut-down as well. The Quick -PICC may be used to administer fluids for hydration and parenteral nutrition, as well as other commonly used intravenous medications such as antibiotics, vasopressors, chemotherapy, and analgesics.
Product codes
FOZ
Device Description
The Argyle Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC) is a sterile, single use indwelling catheter inserted into a venous access site for the infusion of fluids, medications, and/or nutritional products.
The PICC is inserted via an introducer (either a splittable needle or sheath over the needle type). The catheter is composed of polyurethane material and includes a suture or stabilizing wing and an insert-molded luer-lock hub(s). The catheters will have numerical depth markings for insertion depth measurement and assessment. The polyurethane material is completely radiopaque.
Additionally, the product line will include for sale the following: single catheters, single introducers, placement sets (catheter and introducer), and complete insertion trays. Complete insertion trays will contain a PICC, introducer, and common components used for the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous access site
Indicated Patient Age Range
Neonatal/Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Required biocompatibility testing has been performed per ISO 10993 and ANSI/AAMI 10993 for components. The materials are the same and were also used and tested in previously submitted and marketed 510k's.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 1 8 1998
510k Summary of Safety and Effectiveness
Argyle® Quick PICC Neonatal/Pediatric Peripherally Inserted Central Cathter and Accessories
Submitted by : Sherwood Davis and Geck 444 McDonnell Blvd. Hazelwood. MO 63042
- Stephen J. Tamsett, Contact: Requlatory Affairs Manager
Date of Summary: October 17, 1997
The Argyle Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC) is a sterile, single use indwelling catheter inserted into a venous access site for the infusion of fluids, medications, and/or nutritional products.
The PICC is inserted via an introducer (either a splittable needle or sheath over the needle type). The catheter is composed of polyurethane material and includes a suture or stabilizing wing and an insert-molded luer-lock hub(s). The catheters will have numerical depth markings for insertion depth measurement and assessment. The polyurethane material is completely radiopaque.
Additionally, the product line will include for sale the following: single catheters, single introducers, placement sets (catheter and introducer), and complete insertion trays. Complete insertion trays will contain a PICC, introducer, and common components used for the procedure.
The Argyle Neonatal/Pediatric PICC is substantially equivalent to Bard Access System's Per-Q-Cath PICC. The Argyle PICC differs from the Bard PICC in that Bard's product is manufactured from silicone, while the Argyle PICC is manufactured from polyurethane.
The Argyle Neonatal/Pediatric PICC is substantially equivalent to Luther Medical Company's L-Cath PICC in that both are manufactured from polyurethane.
Required biocompatibility testing has been performed per ISO 10993 and ANSI/AAMI 10993 for components. The materials are the same and were also used and tested in previously submitted and marketed 510k's.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 1998
Mr. Stephen Tamsett Manager of Regulatory Affairs, USA Sherwood Davis & Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042-2516
Re : K974015 Trade Name: Argyle Quick-Picc Peripherally Inserted Central Catheter and Accessories Regulatory Class: II Product Code: FOZ Dated: February 25, 1998 Received: February 26, 1998
Dear Mr. Tamsett:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Tamsett
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamaip.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known) | | 97 40 | 5
Device Name: Sherwood-Davis & Geck Argyle® Quick-PICC™ Neonatal/Pediatric Peripherally Inserted Central Catheter and Accessories:
Indications for Use: The Quick-PICC Catheter System is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cut-down as well. The Quick -PICC may be used to administer fluids for hydration and parenteral nutrition, as well as other commonly used intravenous medications such as antibiotics, vasopressors, chemotherapy, and analgesics.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use
OR
(Per 21 CFR 801.109)
Over-the-Counter Use
(optional format 1-2-96)
(Division Sign-off)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974015 |
510(k) Number