(80 days)
The PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, and blood sampling.
The CT rated PICC is also indicated for the power injection of contrast media.
The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec.
The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The PICC (CT Rated and Non-Rated) is a family of peripherally inserted central venous catheters designed to perform infusion. intravenous therapy, and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each PICC has a kink resistant, reverse tapered catheter design. The PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The PICC (CT Rated and Non-Rated) is indicated for dwell times shorter or greater than 30 days.
The PICC (CT Rated and Non-Rated) product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
The CT rated PICC is also indicated for the power injection of contrast media studies. The CT rated PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. All PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PFM Medical PICC (CT Rated and Non-Rated) device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Intended Use & Performance Data) | Reported Device Performance |
|---|---|
| General PICC Performance: | |
| - Reliable design and performance for infusion, IV therapy, blood sampling. | Demonstrated through "in vitro testing... to assure reliable design and performance in accordance with established standards and specifications." Specifically, testing included: tensile strength, dynamic flow, dynamic failure, static burst. |
| - Biocompatibility for permanent contact device (based on ISO 10993). | "Biocompatibility testing on the PICC (CT Rated and Non-Rated) demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device." |
| CT Rated PICC Specific Performance: | |
| - Withstand power injection of worst-case viscosity injection media at 5 ml/sec. | "The CT rated PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec." This is corroborated by the "power injection performance" testing mentioned. |
| - Withstand maximum power injector pressure of 300 psi. | "The CT rated PICC catheter assemblies have been tested to withstand... a maximum power injector pressure of 300 psi." This is corroborated by the "power injection performance" testing mentioned. |
| - Maximum recommended infusion rating of 5 ml/sec (for all PICC products, including CT rated). | "All PICC products have a maximum recommended infusion rating of 5 ml/sec." and "The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec." This was likely verified through "dynamic flow" and "power injection performance" testing. |
| - Withstand life cycle power injection (for CT Rated PICC, implied by testing section). | "life cycle power injection" testing was performed. |
| Overall Conclusion (met acceptance criteria for performance and design verification): | "The PICC (CT Rated and Non-Rated) met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the PICC (CT Rated and Non-Rated) is safe and effective for its intended use, and is substantially equivalent to the following predicate devices: V-Cath Power PICC (HDC Corp, SE-K071875) and PFM PICC (PFM Medical, SE-072391)" |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for the "in vitro testing." It mentions "testing includes tensile strength, dynamic flow, dynamic failure, static burst, power injection performance and life cycle power injection."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The studies were in vitro (laboratory-based) testing. There is no information about the country of origin, but it's implied to be conducted by or for PFM Medical, Inc. The studies are prospective in the sense that they were conducted for the purpose of demonstrating the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" for this device relied on engineering specifications, material standards (ISO 10993), and performance metrics derived from physical testing, rather than expert interpretation of medical images or patient outcomes. No experts were used in the traditional sense of clinical review for establishing ground truth as there were no clinical studies.
4. Adjudication Method for the Test Set
This is not applicable. Since the testing was in vitro and based on measurable physical and mechanical properties, there was no need for human adjudication of results in the way it's done for clinical or imaging studies. Results would be determined by whether the measured values met pre-defined acceptance thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device." Therefore, there is no information about the effect size of human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical catheter, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
The "ground truth" for this device was established based on:
- Engineering Specifications and Performance Metrics: Acceptable force, flow rates, pressure resistance, burst strength, and life cycle durability as defined by engineering principles and industry standards (e.g., ability to withstand 300 psi at 5 ml/sec).
- Biocompatibility Standards: Compliance with ISO 10993 for permanent contact devices.
- Predicate Device Performance: Implicitly, the performance of the legally marketed predicate devices serves as a benchmark for what constitutes an acceptable "safe and effective" device.
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering, materials science, and physical prototypes, not statistical training on data sets.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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MAR 1 9 2009
510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
| Name: | PFM Medical, Inc |
|---|---|
| Address: | 2605 Temple Heights Drive |
| Suite A | |
| Oceanside, CA 92056 | |
| Contact Person: | SALVADORE F. PALOMARES, RAC |
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: Trade Name: PICC (CT Rated and Non-Rated) Common Name: Catheter, Intravascular, Therapeutic, Long Term Classification: 115
| Equivalent Devices: | |
|---|---|
| Manufacturer: | PFM Medical |
| Name: | PFM PICC |
| 510(k) #: | K072391 |
| Manufacturer: | HDC Corporation |
Name: V-Cath Power PICC 510(k) #: K071875
Device Description:
The PICC (CT Rated and Non-Rated) is a family of peripherally inserted central venous catheters designed to perform infusion. intravenous therapy, and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each PICC has a kink resistant, reverse tapered catheter design. The PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The PICC (CT Rated and Non-Rated) is indicated for dwell times shorter or greater than 30 days.
The PICC (CT Rated and Non-Rated) product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
The CT rated PICC is also indicated for the power injection of contrast media studies. The CT rated PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. All PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
Intended Use:
The PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, and blood sampling.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The CT rated PICC is also indicated for the power injection of contrast media.
The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec.
The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
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Performance Data:
In vitro testing was performed on the PICC (CT Rated and Non-Rated) to assure reliable design and performance in accordance with established standards and specifications. Testing includes tensile strength, dynamic flow, dynamic failure, static burst, power injection performance and life cycle power injection.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Biocompatibility:
Biocompatibility testing on the PICC (CT Rated and Non-Rated) demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
CONCLUSION
The PICC (CT Rated and Non-Rated) met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the PICC (CT Rated and Non-Rated) is safe and effective for its intended use, and is substantially equivalent to the following predicate devices: V-Cath Power PICC (HDC Corp, SE-K071875) and PFM PICC (PFM Medical, SE-072391)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAR 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Salvadore Palomares, RAC Director of Regulatory Affairs PFM Medical, Incorporated 2605 Temple Heights drive Suite A Oceanside, California 92056
Re: K083873
Trade/Device Name: PICC (CT Rated and Non-Rated) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: П Product Code: LJS Dated: December 23, 2008 Received: December 29, 2008
Dear Mr. Palomares:
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. Palomares
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 (OS) 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ginette Y. Michaud, M.D. Acting 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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510(k):
Device Name:
Indications for Use:
PICC (CT Rated and Non-Rated)
The PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, and blood sampling.
The CT rated PICC is also indicated for the power injection of contrast media.
The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec.
The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over the Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Kia Cel
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K (83873
§ 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.”