POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
Device Facts
| Record ID | K051991 |
|---|---|
| Device Name | POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE |
| Applicant | C.R. Bard, Inc. |
| Product Code | LJS · General Hospital |
| Decision Date | Oct 20, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5970 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PowerPICC™ catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. The Poly Per-O-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. 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, power injection of contrast media and allow for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Device Story
Polyurethane PICC and CVC catheters; range 3-6 French; 40-60 cm length. Features reverse taper design; depth indicators; barium sulfate for radiopacity; Isoplast polyurethane luer hub. Used for IV therapy, blood sampling, power injection, and CVP monitoring. Operated by clinicians in clinical settings. Catheters provide access to central venous system; CVP monitoring requires 20G or larger lumen. Bench testing confirms performance equivalence to predicates.
Clinical Evidence
Bench testing only. Performance evaluated against recognized standards: IEC 60601-2-34:2000(E) (invasive blood pressure monitoring), AAMI TIR: 1992 (clinical systems for invasive blood pressure), and ANSI/AAMI BP22:1994 (blood pressure transducers). Data demonstrated substantial equivalence to predicate devices.
Technological Characteristics
Polyurethane catheter shaft with barium sulfate; Isoplast polyurethane luer hub; reverse taper design; depth indicators. Sterile, single-use. No electronic components; mechanical device for vascular access.
Indications for Use
Indicated for short or long-term peripheral access to the central venous system for IV therapy, blood sampling, and central venous pressure (CVP) monitoring. For CVP monitoring, use catheter lumen 20 gauge or larger. For blood therapy/sampling, use 4 French or larger catheter. Power injection indicated for specific models (max 5mL/sec, 300 psi).
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Predicate Devices
- Cook Turbo-Flo PICC Catheter (K021557)
- Cook Triple Lumen 9 Fr Triple Lumen (TL) Central Venous Catheter (CVC) (K021557)
Reference Devices
- 5 Fr Single Lumen (SL) Power PICC™ (K033389)
- 6 Fr Dual Lumen (DL) Power PICC™ (K050931)
- 3, 4, 5 Fr Single Lumen (SL) and 4, 5, 6 Fr Dual Lumen (DL) Poly Per-Q-Cath® (K034019)
- 6 Fr Triple Lumen (TL) Poly Per-Q-Cath® (K043502)
- 5 Fr Single Lumen (SL) PowerHohn™ and PowerLine™ (K050185)
- 6 Fr Dual Lumen (DL) PowerHohn™ and PowerLine™ (K051417)
Submission Summary (Full Text)
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Central Venous Pressure Monitoring Traditional 510(k)
ાવવા
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Section 5
## Central Venous Pressure Monitoring
### 510(k) Summary of Safety and Effectiveness 21 CFR 807.92
#### 5.1 General Information
| Submitter Name: | Bard Access Systems, Inc. (BAS)<br>[Wholly owned Subsidiary of C. R. Bard, Inc.] |
|----------------------------------|----------------------------------------------------------------------------------|
| Address: | 5425 West Amelia Earhart Drive<br>Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ext. 7136 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Lynn M. Kirchoff |
| Date of Preparation: | July 21, 2005 |
| Registration Number: | 1720496 |
| Additional Registration Numbers: | C. R. Bard<br>2212754 |
#### 5.2 Device Information
| Device Name: | 5 Fr SL PowerPICCTM Catheter |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| Trade Name: | 5 Fr SL PowerPICCTM Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS)<br>21 CFR 880.5970, Class II<br>Peripherally Inserted Central Catheter |
| Classification Panel: | General Hospital |
| Device Name: | 6 Fr DL PowerPICCTM Catheter |
| Trade Name: | 6 Fr DL PowerPICCTM Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS)<br>21 CFR 880.5970, Class II<br>Peripherally Inserted Central Catheter |
| Classification Panel: | General Hospital |
| Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central<br>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)<br>21 CFR 880.5970, Class II<br>Peripherally Inserted Central Catheter |
| Classification Panel: | General Hospital |
| 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 Name: | Long Term Intravascular Catheter (80 LJS)<br>21 CFR 880.5970, Class II |
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C
| | Peripherally Inserted Central Catheter |
|-----------------------|------------------------------------------------------------------------|
| Classification Panel: | General Hospital |
| Device Name: | 5 Fr SL PowerHohnTM and PowerLineTM (Central Venous<br>Catheter) |
| Trade Name: | PowerHohnTM and PowerLineTM Catheters |
| Common/Usual Name: | Central Venous Catheter |
| Classification Name: | Long Term Intravascular Catheter (80 LJS)<br>21 CFR 880.5970, Class II |
| Classification Panel: | General Hospital |
| Device Name: | 6 Fr DL PowerHohnTM and PowerLineTM (Central Venous<br>Catheter) |
| Trade Name: | PowerHohnTM and PowerLineTM Catheters |
| Common/Usual Name: | Central Venous Catheter |
| Classification Name: | Long Term Intravascular Catheter (80 LJS)<br>21 CFR 880.5970, Class II |
| Classification Panel: | General Hospital |
| Subject/Predicate Device Name | 510(k) | Clearance Date |
|---------------------------------------------------------------------------------|---------|----------------|
| 5 Fr Single Lumen (SL) Power PICCTM | K033389 | 3/19/2004 |
| 6 Fr Dual Lumen (DL) Power PICCTM | K050931 | 6/15/2005 |
| 3, 4, 5 Fr Single Lumen (SL) and 4, 5, 6<br>Fr Dual Lumen (DL) Poly Per-Q-Cath® | K034019 | 1/21/2004 |
| 6 Fr Triple Lumen (TL) Poly Per-Q-<br>Cath® | K043502 | 1/14/2005 |
| 5 Fr Single Lumen (SL) PowerHohnTM<br>and PowerLineTM | K050185 | 5/26/2005 |
| 6 Fr Dual Lumen (DL) PowerHohnTM and<br>PowerLineTM | K051417 | 6/30/2005 |
#### 5.3 Predicate Devices
The predicate devices are:
| Device Name: | Cook Turbo-Flo® PICC Catheter |
|-----------------------|------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Cook Turbo-Flo PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS)<br>21 CFR 880.5970, Class II<br>Peripherally Inserted Central Catheter |
| Classification Panel: | General Hospital |
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K051991 3 of 5
Central Venous Pressure Monit Traditional 510(k)
| Predicate Device Name | 510(k) | Clearance Date |
|---------------------------------------------------------------------------|---------|----------------|
| Cook Turbo-Flo 4 Fr Single Lumen (SL)<br>and 5 Fr Dual Lumen (DL) PICC | K021557 | 5/30/2003 |
| Cook Triple Lumen 9 Fr Triple Lumen<br>(TL) Central Venous Catheter (CVC) | K021557 | 5/30/2003 |
#### 5.4 Device Description
Subject devices:
- Catheters range in French size from 3-5 Fr SL; 4-6 Fr DL and 6 Fr TL .
- Catheter usable length ranges from 40 -60 cm. .
- Catheters are open-ended catheters extruded from polyurethane material containing barium ● sulfate for radiopacity.
- The catheter extension legs are polyurethane extrusions. Extension legs are minimum 2.2 in. . in length to promote easy application of occlusive dressings. Each extension leg has a thumb clamp.
- The luer hub base material is Isoplast polyurethane. .
- The catheter has a reverse taper design .
- The user is informed of the gage size in product labeling and it is printed on the luer hub. .
- The 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 and are packaged with legally marketed kit components that are . preferred by clinicians
#### Intended Use of Device 5.5
The intended use is the same as the predicate devices.
The Indications for Use was expanded to include allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Indications for Use statements are as follows:
## 5 Fr SL and 6 Fr DL PowerPICCTM
The PowerPICC™ catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
### Poly Per-Q-Cath PICC
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
### Poly Per-Q-Cath Triple Lumen PICC
The Poly Per-O-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central
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Kosteqi 4 of 5
Central Venous Pressure Monitorin Traditional 510(k)
venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
## 5 Fr SL and 6 Fr DL PowerHohn™ and PowerLine™
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, power injection of contrast media and allow for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
#### Technological Comparison to Predicate Devices: ર્સ્વ
The technological characteristics of the subject devices are substantially equivalent to the predicate devices in terms of intended use, application, user population, basic design, performance, labeling, packaging, and sterilization method.
#### 510(k) Substantial Equivalence Decision Tree: 5.7
New device compared to Marketed Device?
Yes.
### Does the new device have the same indication statement as the predicates?
Yes, with expansion of indication to include allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Yes. The principles of operation are the same as the predicate devices.
### Could the new characteristics affect safety or effectiveness?
No. There is no change in design that could affect the safety or effectiveness of the device.
#### Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new types of safety and effectiveness questions
### Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Testing was based on recognized and un-recognized standards to evaluate the device's performance:
### Are performance data available to assess effects of new characteristics? Yes. Bench testing was based on the below referenced standards.
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- IEC 60601-2-34:2000(E) Ed.2-Medical electrical equipment- Particular . requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
- AAMI TIR: 1992- Evaluation of Clinical Systems for Invasive Blood Pressure . Monitoring
- ANSI/AAMI BP22:1994-Blood Pressure Transducers .
### Do performance data demonstrate equivalence?
Yes. Performance data demonstrate that the subject devices are substantially equivalent to the predicate devices
#### Conclusion 5.8
Subject devices, except for 21 gauge catheter lumens, met the performance criteria of design verification as specified by applicable standards, test protocols and/or customer inputs. As a result the recommendation of catheter lumen of 20 gauge or larger was added to the indications for use. Based on FDA's decision trees, the subject devices are substantially equivalent to the legally marketed predicate devices, the Cook Turbo-Flo PICC and TL Central Venous Catheter, K021557, cleared 5/30/2003.
| Subject/Predicate Device Name | 510(k) | Clearance Date |
|---------------------------------------------------------------------------------|---------|----------------|
| 5 Fr Single Lumen (SL) Power PICC™ | K033389 | 3/19/2004 |
| 6 Fr Dual Lumen (DL) Power PICC™ | K050931 | 6/15/2005 |
| 3, 4, 5 Fr Single Lumen (SL) and 4, 5, 6<br>Fr Dual Lumen (DL) Poly Per-Q-Cath® | K034019 | 1/21/2004 |
| 6 Fr Triple Lumen (TL) Poly Per-Q-<br>Cath® | K043502 | 1/14/2005 |
| 5 Fr Single Lumen (SL) PowerHohn™<br>and PowerLine™ | K050185 | 5/26/2005 |
| 6 Fr Dual Lumen (DL) PowerHohn™ and<br>PowerLine™ | K051417 | 6/30/2005 |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynn M. Kirchoff Regulatory Affairs Specialist C.R. Bard, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K051991
Trade/Device Name: POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: July 21, 2005 Received: July 22, 2005
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 microlate comments or prices that have been reclassified in accordance with the provisions of / Inchaneliers, or to are , and Cosmetic Act (Act) that do not require approval of a premarket the Federal F 600; Drag, Drag, therefore, market the device, subject to the general approvisions 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 (1 WA), it may of subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earred fourther announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTC issuaires on that your device complies with other requirements Incall that I DAT has mace a actes and regulations administered by other Federal agencies. of the Act of ally I edelar statues and registements, including, but not limited to: registration You must comply with an the Hee Reg (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 067), as times (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality Brovisions (Sections 531-542 of the Act); applicable, the clections product identify ou to begin marketing your device as described 21 CFK 1000-1030. This least will affication. The FDA finding of substantial equivalence III your Section 510(k) promative no or dicate 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), II you desire specific advise for Jour at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Suyate Y.M., Obie Omd.
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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Section 1.2
# Indications for Use
510(k) Number (if known): _________________
Device Name: Single and Dual Poly Per-Q-Cath® PICC
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, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger 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)
Clank le. m
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _ 14 15 1
Image /page/7/Picture/15 description: The image shows the number 6 repeated several times. There is a larger number 6 at the top of the image. Below the number 6, there are five smaller numbers, all of which are also the number 6. The numbers are printed in a slightly distressed font.
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Section 1.2
## Indications for Use
510(k) Number (if known): ___________
5 Fr Single Lumen and 6 Fr Dual Lumen Power PICC™ Device Name:
Indications for Use:
The PowerPICCTM catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger 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)
2
(Civision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K025691
000007
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Central Venous Pressure Monitoring Traditional 510(k)
Section 1.2
# Indications for Use
510(k) Number (if known): _____________
6 Fr Triple Lumen Poly Per-Q-Cath Device Name:
Indications for Use:
The Poly Per-Q-Cath®3 Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger 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)
Cater
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
1545 49 510(k) Number _
Coopera
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Section 1.2
# Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ _ _ 5 Fr Single Lumen Power Hohn™ and Power Line™
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, power injection of contrast media and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger 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)
Chan Un
i Tivision Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________
00000
