(25 days)
Not Found
No
The summary describes a standard medical catheter and explicitly states there are no new operating principles and no mentions of AI, DNN, or ML.
No.
Explanation: The device is a PICC (Peripherally Inserted Central Catheter) and is indicated for "peripheral access to the central venous system for intravenous therapy and blood sampling." It serves as a conduit for fluids and blood, rather than directly diagnosing, treating, or preventing a disease or condition itself.
No
The device, a PICC catheter, is described as a conduit for fluids and blood for intravenous therapy and blood sampling. It does not perform any diagnostic function.
No
The device description clearly states it is a catheter, which is a physical medical device, not software.
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 reinforces its function as a "conduit for fluids and blood into and out of the central venous system." This is a physical device for accessing the circulatory system.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any analysis or testing of specimens outside the body.
Therefore, the Poly Per-Q-Cath® Triple Lumen PICC is a medical device used for accessing the central venous system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Triple Lumen PICC is intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The Poly Per-Q-Cath® Triple Lumen 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
There are no new operating principles. The modified 6 Fr Poly Per-Q-Cath® TL PICC catheter relies on the same basic, fundamental scientific technology as the predicate 6 Fr DL Poly Per-Q Cath PICC. The devices serve as conduit for fluids and blood into. and out of the centry venous system.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 inhouse protocols.
Performance data gathered in design verification and validation testing demonstrated that the 6 Fr Poly Per-Q-Cath® TL PICC is substantially equivalent to the predicate 6 Fr DL Poly Per-Q-Cath PICC, and the risks associated with use of the new device were found acceptable when evaluated by FMFA.
The 6 Fr Poly Per-Q-Cath** TI. PICC meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalement the predicate device 6 Fr DL Poly Per-Q-Cath PICC, K034019, cleared January quivalen
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.
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
6 Fr Poly Per-
Section 6
510(k) Summary
6 Fr Poly Per-Q-Cath 83 Triple Lumen PICC
510(k) Summary of Safety and Effectiveness Information 21CFR 807.92
6.1 Submitter Information
| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|---|---|
| [Subsidiary of C.R. Bard, Inc.] | |
| Address: | 5425 W. Amelia Earhart Drive |
| Salt Lake City, UT 84116 | |
| Telephone Number: | (801) 595-0700, Ext. 7136 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | I... M. Kimhoff |
| Date of Preparation: | 16 December, 2004 |
6.2 Device Name
| Device Name: | Poly Per-Q-Cath®3 Triple Lumen PICC Catheter |
|---|---|
| Trade Name: | Poly Per-Q-Cath®3 Triple Lumen PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Panel: | General Hospital |
| Classification Name: | 80LJS - Long Term Intravascular Catheter |
| 21 CFR 880.5970, Class II | |
| Peripherally Inserted Central Catheter (PICC) |
6.3 Predicate Device Name
| Device Name: | Poly Per-Q-Cath® PICC Catheter |
|---|---|
| Trade Name: | Poly Per-Q-Cath® PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K034019, concurrence date -- January 21, 2004 |
6.4 Device Description
Principle of Operation
There are no new operating principles. The modified 6 Fr Poly Per-Q-Cath® TL PICC catheter relies on the same basic, fundamental scientific technology as the predicate 6 Fr DL Poly Per-Q Cath PICC. The devices serve as conduit for fluids and blood into. and out of the centry venous system.
6.5 Intended Use
The Triple Lumen PICC is intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The intended use has not changed.
Indications for Use 6.6
1
The indications for use have not changed from the predicate Poly Per-Q-Cath PICC (K034019).
The Poly Per-Q-Cath® Triple Lumen 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.
6.7 Summary of Technological Characteristics in Relation to the Predicate Device
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Not in all regards. The 6 Fr Poly Per-Q-Cath® TL PICC has some minor differences from the predicate 6 Fr DI. Poly Per-Q-Cath PICC. However, the basic fundamental scientific technology of the catheter has not changed.
Could the new characteristics affect safety or effectiveness?
ires. The new characteristics could affect safety or effectiveness of the davice,
Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new types of issues of safety and effectiveness.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The following FDA guidance documents and international standards were used to evaluate the device's performance:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements .
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, . Amendment |
- . ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
- AAMI/ANSI/ISO 11135:1994, Medical Devices -- Validation and Routine Control of Ethylene . Oxide Sterilization
Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-J : Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the subject device were previously cleared for similar applications by Bard Access Systems.
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 inhouse protocols.
Do performance data demonstrate equivalence?
Yes. Performance data gathered in design verification and validation testing demonstrated that the 6 Fr Poly Per-Q-Cath® TL PICC is substantially equivalent to the predicate 6 Fr DL Poly Per-Q-
Image /page/1/Picture/23 description: The image shows the number 000034. The number is written in a bold, sans-serif font. The numbers are all the same size and are evenly spaced. The background of the image is white.
2
KC4 3562
6 Fr Poly Per-Q-Cath 53 TL PIC Special 510(k)
Cath PICC, and the risks associated with use of the new device were found acceptable when evaluated by FMFA.
Conclusion 6.8
The 6 Fr Poly Per-Q-Cath** TI. PICC meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalement the predicate device 6 Fr DL Poly Per-Q-Cath PICC, K034019, cleared January quivalen
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, represented by three stylized lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2005
Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K043502
Trade/Device Name: 6 Fr Poly Per-Q-Cath®3 Triple Lumen PICC Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 17, 2004 Received: December 20, 2004
Dear Ms. Kirchoff:
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.
4
Page 2 - Ms. Kirchoff
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvisod that I DIT of issuaires on that your device complies with other requirements Incall that I DX mas made a astes and regulations administered by other Federal agencies. of the Act of ally I oderal base species and systements, including, but not limited to: registration 1 ou mast comply with and the rise ling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quarty is a 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) Fins letter will anow Jourse of Substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific advice to: Joan ee at (301) 594-0115. 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 may obtain 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,
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
5
K04350d
..............................................................................................................................................................................
Indications for Use
510(k) Number (if known):
Device Name: __ 6 Fr Poly Per-Q-Cath®3-Triple Lumen PICC_
Indications for Use:
The Poly Per-Q-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the centra venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony V. nutz
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number __ kg 4 35 42