(115 days)
The 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media, and allows for central venous pressure monitoring. 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
- 6 Fr Triple Lumen BlueFlex® Tip
- Usable length of catheters are 40 cm to 55 cm
- Catheters are provided in sterile kit configurations
- The 6 Fr BlueFlex® Tip catheter is labeled for "6 ml/sec, pressure injectable" on the Luer hub to facilitate the proper use of the device
The provided document is a 510(k) summary for Arrow International's Pressure Injectable Peripherally Inserted Central Catheter (PICC). This document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical and mechanical properties, not clinical performance or diagnostic accuracy. Therefore, many of the requested categories related to clinical studies, human readers, and ground truth are not applicable or cannot be extracted from this type of regulatory document.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Liquid Leakage Under Pressure | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Air Leakage During Aspiration | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Air Leakage Under Pressure | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Catheter and Blue Flex Tip Stiffness | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Catheter Collapse | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Tensile Testing | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Catheter Radiopacity | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Non-Pressure Injectable Lumen Static Burst Pressure | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Repeat Pressure Injection | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Static Burst Pressure under power injection | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
| Central Venous Pressure Monitoring | Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance. | Met performance criteria. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of bench tests conducted by Arrow International, Inc., as described in the "Performance tests" section of the 510(k) summary. These tests are physical and mechanical characterizations of the device and are not clinical trials.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each test. Regulatory bench tests typically involve a statistically relevant number of units, but the exact count isn't provided.
- Data Provenance: The data is from in-house bench testing conducted by Arrow International, Inc. The country of origin is implicitly the USA, where the company is located. The tests are prospective in the sense that they were conducted on the new device model to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation involved physical/mechanical bench testing, not image analysis or clinical diagnosis requiring expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation involved physical/mechanical bench testing, not image analysis or clinical diagnosis requiring adjudication.
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
This information is not applicable. The device is a physical medical catheter, not an AI or diagnostic imaging device involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these physical performance tests is based on engineering specifications, industry standards, and regulatory guidance. For example, a "burst pressure" test would have an engineering specification for the minimum pressure the device must withstand without failure.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of physical medical device bench testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no "training set" in the context of physical medical device bench testing.
{0}------------------------------------------------
510(k) Summary
JUN 2 7 2008
Arrow International, Inc. 2400 Bernville Road Reading, PA 19605-9607 USA
Contact person: Julie Lawson Regulatory Affairs Specialist Phone: 610-378-0131 Fax: 610-478-3172 Email: julie.lawson@teleflexmedical.com February 29, 2008 Date summary prepared:
Device trade name:
Pressure Injectable Peripherally Inserted Central Catheter (21 CFR 880.5970, Product Code LJS)
PICC Device common name:
Device classification name: Catheter, intravascular, therapeutic, long-term greater than 30 days
Arrow International's Peripherally Inserted Central Legally marketed devices Catheter (K073451) and Bard Access Systems, 6 Fr Triple Lumen which the device is PowerPICC® (K053501) and Central Venous Pressure substantially equivalent: Monitoring (K051991).
Description of the device:
The Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics:
- Radiopaque polyurethane catheters ●
- 6 Fr Triple Lumen BlueFlex® Tip t
- Usable length of catheters are 40 cm to 55 cm
- Catheters are provided in sterile kit configurations �
- The 6 Fr BlueFlex® Tip catheter is labeled for "6 ml/sec, � pressure injectable" on the Luer hub to facilitate the proper use of the device
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.
{1}------------------------------------------------
Performance tests:
The following tests were performed to demonstrate substantial equivalence:
1080604
- Liquid Leakage Under Pressure .
- Air Leakage During Aspiration .
- Air Leakage Under Pressure ●
- Catheter and Blue Flex Tip Stiffness .
- Catheter Collapse .
- . Tensile Testing
- Catheter Radiopacity
- Non-Pressure Injectable Lumen Static Burst Pressure .
- Repeat Pressure Injection ●
- Static Burst Pressure under power injection .
- Central Venous Pressure Monitoring .
The Arrow International Pressure Injectable PICC met 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 Pressure Injectable PICC (K073451) and Bard Access Systems, 6 Fr Triple Lumen PowerPICC® (K053501) and Central Venous Pressure Monitoring (K051991).
Arrow International's 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC) has the same intended use as the predicate device, Arrow International's PICC. 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 devices.
Assessment of non-clinical performance data:
Summary:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Ms. Juie Lawson Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K080604
Trade/Device Name: Pressure Injectable PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutancous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 5, 2008 Received: June 9, 2008
Dear Ms. Lawson:
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.
{3}------------------------------------------------
Page 2 -- Ms. Lawson
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.
Cers
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
{4}------------------------------------------------
Indications for Use Statement
510(k) Number: K 08()(004
Device Name: 6 French Triple Lumen Pressure Injectable PICC
Indications For Use:
The 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use (21CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
fo for APN
(Divisible Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K680604
§ 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.”