(208 days)
The OmniPICC 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.
The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administrations, 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 5ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 5ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
The Peripherally Inserted Central Catheter (OmniPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous 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 5 Fr lumen configuration. These are tested to withstand power injection of 5 cc/sec at a maximum power injection setting of 300 psi.
The provided text is a 510(k) summary for the OmniPICC P.I. (Peripherally Inserted Central Catheter). It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through an AI/Machine Learning lens.
Therefore, I cannot fulfill your request for information regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study, including effect size.
- Standalone algorithm performance.
- Type of ground truth used (beyond general clinical indications).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission for a medical device (a catheter), not an AI/ML product. The "acceptance criteria" discussed in such a document would typically refer to engineering specifications, biocompatibility, sterilization, and mechanical testing, not the performance metrics of an AI model against a ground truth.
If you have a document describing the validation of an AI/ML medical device, I would be happy to analyze it against your specified criteria.
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emarket Notification 510(k) TTA Medical Systems, Inc. omniPICC P.I. - March 25th, 2005
K05//02
page lot of 1
510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]
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), single and double lumen | ||
| Classification Name | Percutaneous, implanted, long-term intravascular catheter | ||
| Classification Number: | 21 CFR §880.5970 | ||
| Classification Panel: | General Hospital | ||
| Product Code: | 80LJS | ||
| Equivalent Device | Product | Manufacturer | 510(k) # |
| PowerPICCTM Catheter | Bard Access Systems, Inc | K033389 |
Device Description: The Peripherally Inserted Central Catheter (OmniPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous 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 5 Fr lumen configuration. These are tested to withstand power injection of 5 cc/sec at a maximum power injection setting of 300 psi.
Intended Use: The OmniPICC 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 administrations, 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 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
NOV 2 3 2005
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
Re: K051102
Trade/Device Name: OmniPICC P.I. Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 11, 2005 Received: October 12, 2005
Dear Mr. 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 - Mr. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
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Indications For Use
510(k) Number (if known): K051102
Device Name: OmniPICC P.I.
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 OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 5ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
Prescription Use 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)
Inthong V.m
BO-Unis City ാമ of Anesthesiology, General Hospital, Clion Control. Dental Devices
: 10(is) Number:______________________________________________________________________________________________________________________________________________________________
§ 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.”