(208 days)
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.
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 provided text is a 510(k) summary for the Argyle Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC). It states that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating similarity to existing devices, rather than presenting novel performance studies with specific acceptance criteria as would be done for a new or high-risk device.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this 510(k) summary. The document focuses on demonstrating substantial equivalence through material comparison and existing biocompatibility testing, not through new clinical performance studies with specific metrics.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Metric | Reported Device Performance | Comments |
|---|---|---|---|
| Biocompatibility | Per ISO 10993 and ANSI/AAMI 10993 standards | Materials are the same as and passed tests from previously submitted and marketed 510(k)s. | The device's materials were tested for biocompatibility, and their performance met the standards by piggybacking on prior 510(k) clearances. No new specific numeric criteria or results are provided for the Argyle PICC itself, just assurance that the materials are compliant. |
| Substantial Equivalence (Operational/Functional) | Similar indications for use, material properties (e.g., radiopacity), and design (e.g., depth markings, luer-lock hub) to predicate devices. | The Argyle PICC is manufactured from polyurethane, like the Luther Medical Company's L-Cath PICC. It differs from Bard Access System's Per-Q-Cath PICC (made from silicone) but is considered substantially equivalent. | The core "performance" here is demonstrating sufficient similarity to legally marketed devices to establish substantial equivalence, without requiring new clinical performance data against specific metrics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) summary does not describe a new clinical performance study with a test set. The substantial equivalence argument relies on comparing the new device to existing predicate devices and existing biocompatibility data for the materials used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No new ground truth establishment is described for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No new clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a medical device, not an AI diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the purpose of this 510(k), the "ground truth" for substantial equivalence is the existence and established performance/safety profile of the predicate devices and the compliance of materials with recognized biocompatibility standards. No new clinical ground truth was established for this submission.
8. The sample size for the training set
- Not Applicable. No training set for a new algorithm or performance study is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
Summary of Approach for This 510(k) Submission:
The provided document is a 510(k) premarket notification. For devices seeking clearance via substantial equivalence, the primary "study" is a comparative analysis against predicate devices. The "acceptance criteria" are demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety and effectiveness.
In this case, the manufacturer demonstrates substantial equivalence by:
- Identifying legally marketed predicate devices (Bard Access System's Per-Q-Cath PICC and Luther Medical Company's L-Cath PICC).
- Comparing materials (polyurethane vs. silicone) and noting that the polyurethane material is also used and tested in other cleared 510(k)s.
- Stating that required biocompatibility testing was performed per ISO 10993 and ANSI/AAMI 10993 for components, and these materials had also been tested and used in previously submitted and marketed 510(k)s. This leverages existing data and clearances.
- Ensuring the indications for use are consistent with the predicate devices.
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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.
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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
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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
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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
§ 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).