(89 days)
The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 3ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
The Peripherally Inserted Central Catheter (OmmiPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous central venous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 4 Fr single and 5 Fr dual lumen configurations. These are tested to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec at a maximum power injection setting of 300 psi.
The provided document is a 510(k) premarket notification for the OmniPICC P.I. (Peripherally Inserted Central Catheter). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove safety and effectiveness from scratch. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (like MRMC), and detailed ground truth establishment for AI/algorithm-based devices is not present in this document because it pertains to a different type of device (a physical medical catheter) and regulatory pathway.
The document describes the device, its intended use, and its indications for use, highlighting its capability for power injection. The primary "study" involved is a comparison to a predicate device (Bard PowerPICC™ Catheter) to demonstrate substantial equivalence, rather than a clinical trial assessing performance against specific acceptance criteria in the way an AI diagnostic device would.
However, I can extract the relevant information that is present in the document. The "device performance" in this context refers to its physical capabilities for power injection, which are stated parameters rather than measured outcomes from a clinical study with a test set.
Here's the closest representation of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes the physical capabilities and new features of the OmniPICC P.I. to justify its substantial equivalence to predicate devices, particularly for power injection. The "acceptance criteria" for the device, in this context, are the specified physical performance limits it is designed to meet for safe and effective use during power injection procedures.
| Acceptance Criteria (Stated Device Capability) | Reported Device Performance (as described) |
|---|---|
| Maximum recommended infusion rate for 4 Fr single lumen catheter | 3ml/sec |
| Maximum recommended infusion rate for 5 Fr dual lumen catheter | 5ml/sec |
| Maximum pressure for power injection | 300 psi |
| Catheter material | Radiopaque polyurethane tubing |
| Configuration | 4 French single and 5 French dual lumen |
| Dwell time | Shorter or greater than 30 days |
| Identification of power injectability | "POWER INJECTABLE" printed on extension legs; "300 PSI" and "3ml/sec" (or "5ml/sec") printed on ID inserts. |
Study Details (Based on Substantial Equivalence Justification)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a clinical test set for AI. The "test" for this device involved comparing its physical and material characteristics, intended use, and indications for use against predicate devices. The document does not describe a clinical trial with a "test set" of patients or data.
- Data Provenance: Not applicable. The justification is based on design specifications and material properties, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. Ground truth as typically understood for AI algorithms (e.g., expert consensus on an image) is not relevant for this medical device submission. The "ground truth" for a substantial equivalence determination is the performance and safety profile of the predicate device and the engineering specifications of the new device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication of findings is described.
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:
- Not applicable. This is not an AI/software device, therefore MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of a 510(k) for a physical medical catheter, the "ground truth" is established by a combination of:
- Predicate Device Performance: The safety and effectiveness data and established performance of legally marketed predicate devices (OmniPICC PI™ Catheter, PowerPICC™ Catheter).
- Engineering Specifications and Material Testing: The inherent physical properties, design, and manufacturing standards of the OmniPICC P.I. catheter, including its ability to withstand specified pressures and flow rates for power injection.
- Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.5970).
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is described.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is described.
Summary of the "Study" (510(k) Substantial Equivalence):
The document serves as a premarket notification (510(k)) to the FDA. The "study" described is a demonstration of substantial equivalence to previously cleared predicate devices (K051102 for OmniPICC PITM Catheter and K033389, K050931, K051672, & K051991 for PowerPICCTM Catheter by Bard Access Systems, Inc.).
Key points of this "study" are:
- Intended Use and Fundamental Scientific Technology: The OmniPICC P.I. is stated to be identical to its predicate device (Bard PowerPICC™) in these aspects.
- Configuration, Dimensions, and Materials: The two devices are stated to be substantially similar in these aspects. The 510(k) specifically aims to add new product codes in 4 French single and 5 French dual lumen sizes, which are within the scope of predicate devices' capabilities.
- Performance Claim: The device has been tested (implicitly, through engineering and design validation) to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec (5 Fr dual lumen) at a maximum power injection setting of 300 psi. This is a design specification intended to demonstrate equivalency or improvement upon predicate devices for similar power injection capabilities.
This type of submission does not involve clinical trials with human subjects or a statistical analysis of diagnostic accuracy that would be typical for an AI-powered device. Instead, it relies on a comparison of technical specifications, intended use, and materials to establish that the new device is as safe and effective as a device already on the market.
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2
Pre-market Notification -510(k) RITA Medical Systems, Inc. OmniPICC® PI Power Injectable PICC August 30, 2006
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510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)[
NOV 2 8 2006
Submitter's Name / Contact Person
Manufacturer RITA Medical Systems, Inc. One Horizon Way Manchester, Georgia 31816
Contact David Smith Director of Vascular Products Engineering 706-846-3126
General Information
| Trade Name | OmniPICC P.I. | ||
|---|---|---|---|
| Common Name | Peripherally Inserted Central Catheter (PICC), 4 French single and 5 Frenchdouble lumen | ||
| ClassificationName | Percutaneous, implanted, long-term intravascular catheterClassification Number: 21 CFR §880.5970Classification Panel: General HospitalProduct Code: 80LJS | ||
| Equivalent Device | Product | Manufacturer | 510(k) # |
| OmniPICC PITM Catheter | RITA Medical Systems | K051102 | |
| PowerPICCTM Catheter | Bard Access Systems, Inc | K033389, K050931,K051672, & K051991 |
Device Description: Other OmniPICC P.I product codes were cleared previously under 510(k) K051102.The purpose of this 510(k) is to add new codes in 4 French single and 5 French dual lumen sizes.
The Peripherally Inserted Central Catheter (OmmiPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous central venous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 4 Fr single and 5 Fr dual lumen configurations. These are tested to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec at a maximum power injection setting of 300 psi.
In order to clearly identify the product as power inject able, and the rate to which it is power inject able, the following mechanisms are used:
- . The device has "POWER INJECTABLE" printed on the extension legs.
- The device clamps contain ID inserts that have "300 PSI" printed on one side .
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Image /page/1/Picture/0 description: The image shows the word "RITA" in bold, black letters. To the left of the word is a black square with white diagonal lines running through it. The letters are slightly pixelated, giving them a textured appearance. The overall image has a simple, graphic design.
- The device clamps contain ID inserts that have "3ml/sec" (4 Fr Single) or "5ml/sec" . printed on the opposite side
Intended Use: The OrmiPICC P.I. is intended to be used by medical professionals in patients who require either acute or long-term (chronic) peripheral central venous access for the infusion of medications, nutritional or other parenteral solutions, or blood products, and for the withdrawal of blood samples.
Indications for Use: The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The catheter may be inserted via the basilic, cephalic and medial veins of the upper extremity. The catheter is intended for implantation dwell time of shorter or greater than 30 days. The maximum recommended infusion rate is 3ml/sec to 5ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
Substantial Equivalence Comparison: The OmniPICC P.I. and its predicate, the Bard PowerPICC™, are identical in intended use and fundamental scientific technology. The two devices are substantially similar in configuration, dimensions, and materials.
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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged around the circumference of the circle, with the department's name prominently displayed.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Smith Director of Vascular Products Engineering Rita Medical Systems, Incorporated One Horizon Way Manchester, Georgia 31816
NOV 28 2006
Re: K062579
Trade/Device Name: OmniPICC P.I. Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Il Product Code: LJS Dated: August 30, 2006 Received: September 12, 2006
Dear Ms. Smith:
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 - Ms. Smith
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sue Burns
Chiu Lin, Ph.D.
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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Attachments
Indications for Use
510(k) Number (if known):
Device Name: OmniPICC P.I.
Indications For Use:
തുകളിലും കുട്ടുകുടിയിടെ കേരളം വേണ്ട
The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 3ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
Prescription Use X X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Jon All for ADW fev cse
f Anesthesiology, General Hospital
Control, Dental Devices
§ 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.”