(26 days)
Not Found
No
The summary describes a physical catheter and its features, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for intravenous therapy, which is a therapeutic intervention.
No
This device is a peripherally inserted central catheter (PICC) used for intravenous therapy and blood sampling, which are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly describes a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "peripheral access to the central venous system for intravenous therapy and blood sampling." This describes a device used in vivo (within the body) for delivering substances and collecting blood directly from the bloodstream.
- Device Description: The description details a catheter, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, assays, or instruments that analyze biological samples like blood, urine, or tissue.
Therefore, the Poly Per-Q-Cath PICC is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
The Poly RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
Product codes
LJS
Device Description
- The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethane catheters .
- . Catheter sizes are 3, 4, 5 Fr SL and 4, 5, 6 Fr DL. All are 60 cm usable length
- The catheter has a reverse taper design.
- . The catheter extension legs provide for improved durability and resistance to alcohol and have a thumb clamp.
- . Catheter tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point.
- . Catheters are provided sterile in basic, intermediate and RadPICC configurations ..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Verification and validation testing was performed according to protocols based on the above-referenced guidance document recommendations and standards, as well as in accordance with in-house protocols. The modified devices met the acceptance criteria for the tests performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K03//29
Poly Per-Q-Cath PICC 510(k)
Modifications
Section 6
510(k) Summary Poly Per-Q-Cath PICC Catheters
510(k) Summary of Safety and Effectiveness Information 21 CFR 807.92
| 1. | Submitter Information: | |
|---|---|---|
| Submitter Name: | Bard Access Systems, Inc. | |
| [Subsidiary of C. R. Bard, Inc.] | ||
| Address: | 5425 W. Amelia Earhart Drive | |
| Salt Lake City, UT 84116 | ||
| Telephone Number: | (801) 595-0700, Ext. 4903 | |
| Fax Number: | (801) 595 5425 | |
| Contact Person: | Peggy Keiffer | |
| Date of Preparation: | April 4, 2003 | |
| 2. | Device Name: | |
| Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central Venous | |
| Catheter) | ||
| Trade Name: | Poly Per-Q-Cath PICC Catheter | |
| Poly RadPICC | ||
| Common/Usual Name: | Poly Per-Q-Cath PICC | |
| Classification Name: | Long Term Intravascular Catheter (80LJS) | |
| 3. | Predicate Device: | |
| Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central Venous | |
| Catheter) | ||
| Trade Name: | Poly Per-Q-Cath PICC Catheter | |
| Common/Usual Name: | Poly Per-Q-Cath PICC | |
| Classification Name: | Long Term Intravascular Catheter (80LJS) | |
| Premarket Notification: | K012902, cleared for marketing on September 10, 2001 | |
| 4. | Device Description |
- The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethane catheters .
- . Catheter sizes are 3, 4, 5 Fr SL and 4, 5, 6 Fr DL. All are 60 cm usable length
- The catheter has a reverse taper design.
- . The catheter extension legs provide for improved durability and resistance to alcohol and have a thumb clamp.
- . Catheter tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point.
- . Catheters are provided sterile in basic, intermediate and RadPICC configurations ..
- ડ. Intended Use
The modified Poly Per-Q-Cath PICC catheters are intended for short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Summary of Technological Characteristics in relation to Predicate Device: 6.
Does the new device have the same indication statement?
Yes.
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1
KC3il29
Poly Per-O-Cath PICC 510(k) Modifications
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Yes, except the durometer of the extension leg material was changed for improved durability and resistance to alcohol
Could the new characteristics affect safety or effectiveness?
Yes. The durometer of the extension leg material could affect safety and effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new issues of safety and effectiveness.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.
The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, and relevant ISO 10555 Standards were used to determine the appropriate methods for evaluating the modified device's performance.
Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, and the FDA-Modified ISO 10993 Test Profile for externally communicating, blood-contacting, long-term devices, were met.
Are performance data available to assess effects of new characteristics?
Yes. Verification and validation testing was performed according to protocols based on the above-referenced guidance document recommendations and standards, as well as in accordance with in-house protocols. The modified devices met the acceptance criteria for the tests performed.
Do performance data demonstrate equivalence?
Yes. Performance data demonstrated that the modified Poly Per-Q-Cath PICCs are substantially equivalent to the predicate devices and/ or met pre-determined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
7. Conclusion
The modified Poly Per-Q-Cath PICCs met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate Poly Per-Q-Cath PICC catheters, cleared under K012902.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
MAY - 5 2903
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Peggy Keiffer Senior Regulatory Affairs Manager C. R. Bard, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K031129
Trade/Device Name: Poly Per-Q-Cath PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJS Dated: April 4, 2003 Received: April 9, 2003
Dear Ms. Keiffer:
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. Keiffer
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Rhodes
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 1.2
INDICATION(S) FOR USE STATEMENT*
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
The Poly RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
Signature of 510(k) Submitter:
Printed Name of Submitter:
Buzzy Kriff
Peggy Keiffer Sr. Regulatory Affairs Manager
Date:
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801,4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
510(k) Number
Division Sign-Off Office of Device Evaluation
Prescription Use
OR Over-The-Counter Use
Patricio Cussiante
siology. General Hospital,
2
00000