(29 days)
Not Found
No
The summary describes a physical catheter device and its intended use, with no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is intended for administering therapies such as IV fluids, blood products, drugs, and parenteral nutrition, which are therapeutic interventions.
No
Explanation: The device is a catheter designed for delivering fluids, products, and solutions, as well as for blood withdrawal. It is used for access to the central venous system, not for diagnosing medical conditions.
No
The device description explicitly details physical components like catheters made of polyurethane, with specific sizes, lengths, and markings. It also mentions sterile packaging and colorants, all indicative of 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 clearly states that the catheters are for "short or long term 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 withdrawing blood directly from the patient.
- Device Description: The description details a physical catheter designed for insertion into the central venous system. This is consistent with an in vivo medical device.
- 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, analyzers, or other components used to test blood, urine, tissue, or other biological samples.
Therefore, the PowerHohn and PowerLine Catheters are medical devices used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PowerHohn" and PowerLine™ Catheters are intended for short or long term access to the central venous system for intravenous therapy and blood sampling.
PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.
Product codes
LJS
Device Description
- The PowerHohn" and PowerLine™ Catheters are open-ended radiopaque polyurethane catheters.
- Catheter size is 6 Fr DL with 50 cm (PowerLine) or 40 cm (PowerHohn) usable length.
- The catheter has a reverse taper design.
- Catheter shaft 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 radiology configurations.
- Purple colorants were added to the catheter materials to provide the catheter appearance that allows the end user to differentiate the PowerHohn" and PowerLine from other CVC catheters.
- The catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as PowerHohn" and PowerLine" and to include information to facilitate proper use of the device.
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 inhouse protocols. Performance data gathered in design verification testing demonstrated that the 6 Fr DL PowerHohn" and PowerLine" catheter is substantially equivalent to the predicate 5 Fr SL PowerHohn"" and PowerLine"" catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
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.”
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JUN 3 0 2005
6 Fr DL PowerH Special 510(k)
page 1 of 3
00012
-31 એ
Section 6
510(k) Summary
6 Fr DL PowerHohn" and PowerLine" Catheter
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. 4903 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Peggy Keiffer |
| Date of Preparation: | May 26, 2005 |
6.2 Device Name
| Device Name: | 6 Fr DL PowerHohn™ and PowerLine™ Catheter |
|---|---|
| Trade Name: | 6 Fr DL PowerHohn™ and PowerLine™ Catheter |
| Common/Usual Name: | Central Venous Catheter (CVC) |
| Classification Panel: | General Hospital |
| Classification Name: | 80LJS - Long Term Intravascular Catheter |
| 21 CFR 880.5970, Class II | |
| Central Venous Catheter (CVC) |
6.3 Predicate Device Name(s)
| Device Name: | PowerHohnTM and PowerLineTM Catheter |
|---|---|
| Trade Name: | PowerHohnTM and PowerLineTM Catheter |
| Common/Usual Name: | Central Catheter (CVC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K050185, concurrence date -May 26, 2005. |
| 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, 2005 |
6.4 Device Description
- The PowerHohn" and PowerLine™ Catheters are open-ended radiopaque polyurethane � catheters.
- Catheter size is 6 Fr DL with 50 cm (PowerLine) or 40 cm (PowerHohn) usable length. .
- . The catheter has a reverse taper design.
- . Catheter shaft 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 radiology configurations.
1
6 Fr DL PowerHo
3
- . Purple colorants were added to the catheter materials to provide the cath appearance that allows the end user to differentiate the PowerHohn" and PowerLine other CVC catheters.
- . The catheter extension leg. junction and clamp ID tag were printed with markings to identify the catheter as PowerHohn" and PowerLine" and to include information to facilitate proper use of the device.
6.5 Intended Use
The PowerHohn" and PowerLine™ Catheters are intended for short or long term access to the central venous system for intravenous therapy and blood sampling.
The intended use has not changed.
6.6 Indications for Use
The indications for use have not changed from the predicate PowerHohn" and PowerLine"" catheter (K050185).
PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.
Summary of Technological Characteristics in Relation to the Predicate Device 6.7
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Not in all regards. The 6 Fr DL PowerHohn™ and PowerLine™ catheter has some minor differences from the predicate 5 Fr SL PowerHohn" and PowerLine" catheter. However, the basic fundamental scientific technology of the catheter has not changed.
Could the new characteristics affect safety or effectiveness?
Yes. The new characteristics could affect safety or effectivencss of the device.
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 I
- 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
2
No new design validation was required. The design validation for the predicate device issues pertaining to the subject device
6 Fr DL PowerHohn
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. 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 testing demonstrated that the 6 Fr DL PowerHohn" and PowerLine" catheter is substantially equivalent to the predicate 5 Fr SL PowerHohn"" and PowerLine"" catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
6.8 Conclusion
The 6 Fr DL PowerHohn" and PowerLine " catheter meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA 's decision tree, is substantially equivalent to the predicate device 5 Fr SL PowerHohn" and PowerLine" catheter, K050185, cleared May 26, 2005. and the Poly Per-Q-Cath PICC Catheters. cleared under K034019.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Public Health Service
JUN 3 0 2005
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: K051417
Trade/Device Name: 6 Fr DL PowerHohn™ and PowerLine™ Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Long Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 31, 2005 Received: June 1, 2005
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.
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Page 2 - Mr. 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 (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,
Sulette y. Michael Oms.
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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6 Fr DL Po and PowerLine
Section 1.2
Special 510(k)
- Page 1 of 1
Indications for Use Statement
510(k) Number (if known):
Device Name: 6 Fr DL PowerHohn" and PowerLine™ Catheter
Indications For Use:
PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Auu Suliom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, D 510(k) Number