(107 days)
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
The Arrow PICC have the following characteristics: Radiopaque polyurethane catheters; 4 Fr Single Lumen, trimmable; 5 Fr Double Lumen, trimmable and BlueFlex® Tip; Usable lengths of 5 French catheter is 40 and 60 cm; Usable length of 4 French catheter is 60 cm; Catheters are provided sterile kit configurations. The catheter is labeled for "4cc/pressure injectable" on the catheter distal hub to facilitate the proper use of the device.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (Summary of Results) |
|---|---|
| Dynamic Flow Rate test | Demonstrates substantial equivalence by performing favorably when compared to the AngioDynamic's catheter. |
| Catheter whip test | Demonstrates substantial equivalence by performing favorably when compared to the AngioDynamic's catheter. |
| Repeat Injection Test | Demonstrates substantial equivalence by performing favorably when compared to the AngioDynamic's catheter. (Specifically to verify the new intended use of power injection of contrast media up to 300 psi). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical trials or AI/algorithm performance. The performance tests described ("Dynamic Flow Rate test," "Catheter whip test," "Repeat Injection Test") are bench tests conducted on the physical device itself. Therefore, sample sizes for these tests are not provided in terms of patient data, nor is data provenance like country of origin or retrospective/prospective mentioned, as these are not relevant to bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for these bench tests would be the measured physical properties or performance characteristics of the device under specific test conditions, compared against established engineering standards or the performance of a predicate device. This doesn't involve expert human assessment in the way clinical ground truth does.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are bench tests, not clinical evaluations that would require adjudication of human interpretation.
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
No, an MRMC comparative effectiveness study was not done. This device is a medical catheter, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests would be based on objective measurements and engineering standards, compared directly to the performance of the legally marketed predicate devices (AngioDynamic's Morpheus™ CT PICC and Arrow International's existing PICC). The "Repeat Injection Test" specifically verifies the ability to withstand power injection of contrast media at a maximum pressure of 300 psi, which would be a measured performance characteristic.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this device.
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AUG 2 4 2006
P.O. Box 12888 Reading, PA 19612
ARROW
INTERNATIONAL
2400 Bernville Road
510 (k) Summary
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
|---|---|
| ------------ | -------------------------------------------------------------------------------- |
| Reading, PA 19605 | |
|---|---|
| (610) 378-0131 | |
| FAX: (610) 374-5360 |
| Contact person: | Elizabeth DuncanSenior Regulatory Affairs SpecialistPhone: 610-378-0131, ext. 3220Fax: 610-478-3172Email: elizabeth.duncan@arrowintl.com |
|---|---|
| ----------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Date summary prepared: | May 5, 2006 |
|---|---|
| ------------------------ | ------------- |
| Device trade name: | Pressure Injectable Peripherally Inserted Central Catheter(21 CFR 880.5970, Product Code LJS) |
|---|---|
| -------------------- | --------------------------------------------------------------------------------------------------- |
| Device common name: | PICC |
|---|---|
| --------------------- | ------ |
| Device classification name: | Catheter, intravascular, therapeutic, long-term greater than 30 days |
|---|---|
| ----------------------------- | ---------------------------------------------------------------------- |
| Legally marketed devices to which the device is substantially equivalent: | AngioDynamic's Morpheus™ CT PICC and Procedure Kit (K041420) and Arrow International's Peripherally Inserted Central Catheter (K042126) |
|---|---|
| --------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------- |
| Description of the device: | The Arrow PICC have the following characteristics: |
|---|---|
| Radiopaque polyurethane catheters4 Fr Single Lumen, trimmable5 Fr Double Lumen, trimmable and BlueFlex® TipUsable lengths of 5 French catheter is 40 and 60 cmUsable length of 4 French catheter is 60 cmCatheters are provided sterile kit configurations.The catheter is labeled for "4cc/pressure injectable" on the catheter distal hub to facilitate the proper use of the device. |
| Intended use of the device: | The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. |
|---|---|
| ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
:
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| Indications for use: | The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi. |
|---|---|
| Technological characteristics: | The proposed peripherally inserted central catheters have the same technological design characteristics as the predicate devices. |
| Performance tests: | The following tests were performed to demonstrate substantial equivalence: Dynamic Flow Rate testCatheter whip testRepeat Injection Test |
| Assessment of non-clinical performance data: | The results of the bench tests demonstrate that Arrow's peripherally inserted central catheter is as safe, as effective and performs favorably when compared to the AngioDynamic's catheter. |
| Summary | Arrow International's peripherally inserted central catheter has the same intended use as the AngioDynamic's predicate device. Based on the assessment of non-clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrrow's peripherally inserted central catheter is substantially equivalent to the legally marketed predicate device. The Arrow International's predicate device was used as a reference device to show the primary design has not changed significantly and that proper verification was done to prove the catheter can be used safely for its new indications for use. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2006
Ms. Elizabeth Duncan Senior Regulatory Affairs Specialist ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K061289
Trade/Device Name: Arrow Pressure Injectable PICCs, Models
5 French 2 lumen 60 cm Trimmable
5 French 2 lumen 40 cm Blue Flex Tip (nontrimmable)
4 French 1 lumen 60 cm Trimmable
Regulation Number: 880.5970
Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 19, 2006 Received: July 20, 2006
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
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Page 2 - Ms. Duncan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carl
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Pressure Injectable PICC
Indications For Use: The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. m
of Anesthesiology, General Hospital, :on Control, Dental Devices ) { umber:
§ 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.”