(21 days)
A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.
The Arrow International Peripherally Inserted Central Catheters are similar to the currently marketed Arrow Trimmable and Blue FlexTip® single and double lumen catheters. The catheter juncture has been modified to improve overall catheter strength. The hub colors and catheter labeling have changed to distinguish the new Arrow catheters. The catheter is available in lengths of 40 cm - 60 cm.
Here's an analysis of the provided information regarding the Arrow International Peripherally Inserted Central Catheters:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Flex Test | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Burst | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Fatigue | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
| Leakage | Not explicitly stated, implied to be comparable to predicate devices. | Results demonstrate substantial equivalence to predicate devices. |
Explanation of "Acceptance Criteria (Stated or Implied)":
The document does not provide explicit numerical or qualitative acceptance criteria for these tests. Instead, it relies on the concept of "substantial equivalence" to predicate devices. This implies that the performance of the new device in these tests must be comparable to or not worse than the legally marketed predicate devices (Arrow International's Peripherally Inserted Central Catheter (K930129) and Two Lumen PICC with Blue FlexTip® Catheter with Integral Needle Protection (K003006)).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The term "laboratory tests" is used, implying a controlled environment, but the number of devices tested for each performance characteristic is not detailed.
- Data Provenance: The data is generated from "laboratory tests" and is therefore likely prospective, as it was specifically conducted to demonstrate the safety and effectiveness of the new device for regulatory submission. The country of origin of the data is not explicitly stated, but given the submitter's location (Reading, PA, USA) and the submission to the FDA, it's highly probable the testing was conducted in the USA or by a facility adhering to US standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device submission. The "ground truth" for the performance tests (tensile strength, flex, burst, fatigue, leakage) is established through standardized engineering and materials testing methods, not through expert consensus on medical images or clinical outcomes. These are objective physical tests with quantifiable results.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective interpretation (e.g., image reading) to resolve discrepancies among multiple expert evaluations. The tests performed here are objective, mechanical evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically relevant for diagnostic imaging devices where human readers interpret results, and the impact of AI algorithms on reader performance is being assessed. This submission is for a physical medical device (catheter) and focuses on engineering performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This device is a physical medical instrument, not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests is based on objective measurement against established engineering and material science principles and comparison to the performance of predicate devices. For example, the "ground truth" for tensile strength is the maximum force a material can withstand before breaking, measured according to a standard test method. The comparison to predicate devices then establishes "substantial equivalence."
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device submission. Training sets are used for machine learning algorithms. The development of this medical device involves engineering design, material selection, and manufacturing processes, followed by performance testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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AUG 27 2004
ATTACHMENT 1: 510 (K) SUMMARY
| Submitter | ARROW International Inc2400 Bernville RoadReading, PA 19605-9607 USA |
|---|---|
| Contact person: | Suzanne SchorleRegulatory Affairs AssociatePhone: 610-378-0131, ext. 3443Fax: 610-478-3167Email: suzanne.schorle@arrowintl.com |
| Date summary prepared: | August 4, 2004 |
| Device trade name: | Peripherally Inserted Central Catheters |
| Device common name: | PICC |
| Device classification name: | Catheter, intravascular, therapeutic, long-term greater than30 days |
| Legally marketed devices towhich the device issubstantially equivalent: | Arrow International's Peripherally Inserted CentralCatheter (K930129) and Two Lumen PICC with BlueFlexTip® Catheter with Integral Needle Protection(K003006) |
| Description of the device: | The Arrow International Peripherally Inserted CentralCatheters are similar to the currently marketed ArrowTrimmable and Blue FlexTip® single and double lumencatheters. The catheter juncture has been modified toimprove overall catheter strength. The hub colors andcatheter labeling have changed to distinguish the newArrow catheters. The catheter is available in lengths of 40cm - 60 cm. |
| Intended use of the device: | The Arrow International Peripherally Inserted CentralCatheter is intended for short-term peripheral venousaccess to the central circulation. It offers an alternativemethod of intravenous therapy for select adult andpediatric patients. |
| Technologicalcharacteristics: | The proposed peripherally inserted central catheters havethe same technological design characteristics as thepredicate devices. |
| Performance tests: | The following tests were performed to demonstratesubstantial equivalence:• Tensile Strength• Flex Test• Burst• Fatigue• Leakage |
| Assessment of non-clinicalperformance data: | The results of the laboratory tests demonstrate that theArrow peripherally inserted central catheter aresubstantially equivalent to the legally marketed predicatedevices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
Ms. Suzanne Schorle Regulatory Affairs Associate Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605
Re: K042126
Trade/Device Name: Peripherally Inserted Central Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter. Regulatory Class: II Product Code: LJS Dated: August 5, 2004 Received: August 6, 2004
Dear Ms. Schorle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller by 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 Interstate conninetee prior to ria, 20, 1778, as a see and the provisions of Amendments, of to devices that ha 70 Act (Act). You may, therefore, market the device, the rederal rood, Drag, and Cosmonions of the Act and the limitations described below. subject to the general controls provisions of the Act include requirements for annual registration, I he general controls provisions turing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that The Office of Device Draiaator inded use not identified in your Indications For Use this device will be used for an menava sharm. Therefore, in accordance with Section Statement and that such as ecure can in the Warnings of device's labeling:
- The safety and effectiveness of this device for the use with power injection and high t power infusion systems has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the I icase not that the above laboring mirred before these limitations are modified in any way or removed from the device's labeling.
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Page-2 Mr. Schorle
The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA Inding of substantial equivalence or your device and permits your device to proceed to the device results in a classification for your de rice as described in your market. This letter will anow you to begin marteeining your marketing on and ed to vour labeling.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into cols. Existing major regulations affecting your (PMA), It may be subject to adultions, Title 21, Parts 800 to 898. In device can be louind in the Code of Peachards, rought in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 ISSuance of a bases on a base on plies with other requirements mean that IDA has made a decommanen in administered by other Federal agencies. of the Act of ally rederal statues and regaranents, including, but not limited to: registration You must continue with an the Free 5 rog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idooling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to II you desire specific information as our art appear and compliance at (301) 594-4692. your device (21 CFR Part 607), presided, "Misbranding by reference to premarket Also, please note the regulation entitled, "You may obtain other general information on your notification (21 CFR Part 007.77): Touring Schall Manufacturers, International, and responsibilities under the Net Hom and Division of (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
[signature]
Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2: INDICATIONS FOR USE STATEMENT
| 510(k) Number: | |
|---|---|
| Device Name: | Peripherally Inserted Central Catheter |
| Indications for Use: | A Peripherally inserted Central Catheter permits venous access to thecentral circulation through a peripheral vein. It offers an alternativemethod of intravenous therapy for select adult and pediatric patients. |
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
- Use
(part C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Antin Dint
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”