(89 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is for vascular access to administer medications, parenteral nutrition, IV fluids, blood products, or for blood withdrawal, which are supportive functions for medical treatment rather than being a therapeutic treatment itself.
No
The device is a peripherally inserted central catheter used for administering or withdrawing fluids, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter and associated introduction components made of materials like polyurethane tubing and an injection molded hub. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for vascular access to administer or withdraw substances directly from the body. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a catheter and its components for insertion into a vein. This is consistent with a device used for accessing the circulatory system, not for analyzing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide a pathway for substances to enter or leave the body.
N/A
Intended Use / Indications for 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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
80LJS
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 .
- The device clamps contain ID inserts that have "3ml/sec" (4 Fr Single) or "5ml/sec" . printed on the opposite side
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basilic, cephalic and medial veins of the upper extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051102, K033389, K050931, K051672, K051991
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/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 sans-serif and appear to be slightly pixelated, suggesting the image may be a scan or a low-resolution graphic.
2
Pre-market Notification -510(k) RITA Medical Systems, Inc. OmniPICC® PI Power Injectable PICC August 30, 2006
Image /page/0/Picture/2 description: The image shows a series of handwritten numbers and letters. The letters 'Ka' are on the left side of the image, followed by the numbers '625'. To the right of the numbers is the number '79'. The handwriting is in black ink and is somewhat messy.
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 French | ||
| 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) # |
| 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 .
1
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.
004
2
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.
3
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
4
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