(36 days)
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 Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics: Radiopaque polyurethane catheters 4 Fr single-lumen BlueFlex® Tip and non-BlueFlex® Tip 5 Fr double lumen BlueFlex® Tip and non-BlueFlex® Tip Usable length of 4 Fr catheters are 40cm to 60cm Usable length of 5 Fr catheters are 40cm to 60cm Catheters are provided in sterile kit configurations The 4 Fr BlueFlex® Tip, 4Fr non-BlueFlex® Tip and 5 Fr BlueFlex® Tip catheters are labeled for "4ml/sec, pressure injectable" on the Luer hub(s) to facilitate the proper use of the device The 5 Fr non-BlueFlex® Tip catheter is labeled for "5ml/sec, pressure injectable" on the Luer hubs to facilitate the proper use of the device
The provided text does not contain information about acceptance criteria for a medical device's performance that would typically be evaluated through clinical studies with human patients, algorithms, or expert ground truth. Instead, it describes a 510(k) submission for a Pressure Injectable Peripherally Inserted Central Catheter (PICC) and focuses on bench testing to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information given.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Rate Qualification Test: (Specific criteria not provided in the text, but the test was performed.) | Met performance criteria. |
| Repeat Injection Test: (Specific criteria not provided in the text, but the test was performed.) | Met performance criteria. |
| Catheter Static Burst Pressure: (Specific criteria not provided in the text, but the test was performed after sterilization, simulated shipping, cleaning solutions, repetitive bending, and use of high vesicant fluid.) | Met performance criteria. |
| Substantial Equivalence: To the predicate device Arrow International's PICC (K061289) for safety and effectiveness. | Demonstrated substantial equivalence through bench tests. |
| Power Injection (Implied Criteria based on Indications for Use): Maximum pressure of power injector equipment not to exceed 300 psi. | Catheter is labeled for "4ml/sec, pressure injectable" or "5ml/sec, pressure injectable" on Luer hubs, facilitating proper use within indicated pressure limits. The successful bench tests support this capability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The tests are bench tests, likely involving a representative number of device units.
- Data Provenance: Bench test data; not human clinical data. No country of origin is specified for these bench tests, but the company is based in Reading, PA, USA. The data is prospective, as these are tests conducted specifically for the 510(k) submission.
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 engineering/performance tests is defined by established engineering standards, test methods, and the performance of the predicate device, not by expert medical opinion on a clinical outcome.
4. Adjudication Method for the Test Set
- Not Applicable. As these are bench tests against predetermined engineering criteria, an adjudication method in the sense of reviewing ambiguous clinical cases is not relevant. The pass/fail criteria for each test (e.g., burst pressure, flow rate) would be objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a device submission based on bench testing of physical properties, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device (catheter), not an AI algorithm.
7. The Type of Ground Truth Used
- Engineering Performance Metrics: The ground truth for these tests is the performance of the device against predefined engineering specifications (e.g., flow rates, burst pressures) and comparison to the predicate device's established performance under similar test conditions.
8. The Sample Size for the Training Set
- Not Applicable. This submission is for a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI model or training set, this question is not relevant.
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Kø73451 (P.1 of A2)
:
510(k) Summary
.
.
| Arrow International, Inc.2400 Bernville RoadReading, PA 19605-9607 USAJAN 15 2008 | |
|---|---|
| Contact person: | Kevin LentzRegulatory Affairs Project ManagerPhone: 610-378-0131Fax: 610-478-3172Email: kevin.lentz@teleflexmedical.com |
| Date summary prepared: | December 7, 2007 |
| 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 than30 days |
| Legally marketed deviceswhich the device issubstantially equivalent: | Arrow International's Peripherally Inserted CentralCatheter (K061289) |
| Description of the device: | The Pressure Injectable Peripherally Inserted Central Cathetershave the following characteristics:Radiopaque polyurethane catheters4 Fr single-lumen BlueFlex® Tip and non-BlueFlex® Tip5 Fr double lumen BlueFlex® Tip and non-BlueFlex® TipUsable length of 4 Fr catheters are 40cm to 60cmUsable length of 5 Fr catheters are 40cm to 60cmCatheters are provided in sterile kit configurationsThe 4 Fr BlueFlex® Tip, 4Fr non-BlueFlex® Tip and 5 FrBlueFlex® Tip catheters are labeled for "4ml/sec, pressureinjectable" on the Luer hub(s) to facilitate the proper use ofthe deviceThe 5 Fr non-BlueFlex® Tip catheter is labeled for"5ml/sec, pressure injectable" on the Luer hubs to facilitatethe proper use of the device |
. .
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K473451 (0.2002)
Intended use of the device: The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Performance tests: The following tests were performed to demonstrate substantial equivalence:
- . Flow Rate Qualification Test
- . Repeat Injection Test
- Catheter Static Burst Pressure (after sterilization, simulated . shipping conditions, cleaning solutions, repetitive bending of catheter, and use of high vesicant fluid on catheter)
The Arrow International Pressure Injectable PICC met performance data: performance criteria of the safety and effectiveness tests performed based on FDA recognized standards and guidance. The results of bench tests demonstrate that Arrow's PICC's are as safe and effective as compared to the predicate Arrow International PICC (K061289).
Summary: Arrow International's Pressure Injectable Peripherally Inserted Central Catheter (PICC) has the same intended use as the predicate device, Arrow International's PICC, (K061289). Based on the assessment of non-clinical performance data, Arrow International's Pressure Injectable Peripherally Inserted Central Catheter (PICC) is substantially equivalent to the legally marketed predicate device.
The Arrow International predicate device (K061289) was used as a reference device to show the primary design has not changed significantly and that proper verification was done to prove that the catheter can be used safely for its intended use.
Assessment of non-clinical
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
JAN 15 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Lentz Regulatory Affairs Project Manager Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K073451
Trade/Device Name: Pressure Injectable PICC Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: January 4, 2008 Received: January 7, 2008
Dear Mr. Lentz:
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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lentz
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); 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 device as described in your Section 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), 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,
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 : K073451
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.
X Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
signature
on of Ancementology, General Houpes), caon Clumbl, Chrisal Devices
15473451
§ 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.”