(175 days)
Not Found
No
The summary describes a physical medical device (PICC catheter) with antimicrobial properties and pressure injection capabilities. There is no mention of software, algorithms, data analysis, or any other components typically associated with AI/ML. The performance studies are standard bench and in vivo tests for physical device characteristics and antimicrobial efficacy.
No
The device provides access for intravenous therapy and other functions but is explicitly stated not to be for the treatment of existing infections, which would qualify it as therapeutic.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring. Its primary functions are therapeutic delivery and access, not diagnostic interpretation or analysis.
No
The device description clearly details a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware device.
Based on the provided text, the Arrow Antimicrobial Pressure Injectable PICC is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the central venous system for therapeutic purposes (intravenous therapy, infusion, pressure injection of contrast media) and monitoring (central venous pressure). These are all in-vivo procedures, meaning they are performed within the living body.
- Device Description: The description details a catheter designed for insertion into the body.
- Performance Studies: The performance studies focus on the physical and biological properties of the catheter itself (biocompatibility, mechanical strength, antimicrobial efficacy on the device), not on analyzing samples taken from the body to diagnose a condition. While there is mention of "in vitro antimicrobial efficacy," this refers to testing the effectiveness of the antimicrobial coating on the catheter in a lab setting, not using the device to perform a diagnostic test on a patient sample.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the Arrow Antimicrobial Pressure Injectable PICC is a medical device used for therapeutic and monitoring purposes within the body, not an IVD.
N/A
Intended Use / Indications for Use
The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
Product codes
LJS
Device Description
The Arrow Antimicrobial Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based antimicrobial technology. The catheters will be packaged sterile in both nursing and radiology configurations will include components to facilitate insertion.
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)
Bench testing was performed on the Arrow Antimicrobial Pressure Injectable PICC in accordance with ISO 10555-1, 10555-3 and FDA Guidance on Premarket Notification [510(k)] Submission for Short- Term and Long- Term Intravascular Catheters. In vitro and in vivo testing was performed to assess the safety and efficacy of the proposed device. Testing included biocompatibility, in vitro antimicrobial efficacy, and in vivo animal infection study.
Results of verification activities:
- Air Leakage during aspiration: Pass. No air leakage in the form of an air bubble in the syringe connected to the PICC after the first 5 seconds when tested per BS EN ISO 10555-1:1997 Annex D.
- Collapse Resistance: Pass. The catheter shall not collapse during aspiration.
- Liquid Leakage under pressure: Pass. No liquid leakage in the form of a falling drop of water at 300-320 kPa (43.5 -46.4) for 30 sec when tested per BS EN ISO 10555-1:1997 Annex C.
- Force at break - Tensile Testing and Catheter Elongation: Pass. 95% confidence level that 95% of the population meets the specification.
- Radio-Detectability: Pass. The optical density contrast must be at least 0.1.
- Catheter Body Kink: Pass. Does not kink at a radius greater than 0.5 inch when tested per BS EN 13868:2002 Annex A under simulated in vivo conditions.
- Central Venous Pressure Monitoring: Pass. The average amplitude difference between input and output signals shall be less than or equal to 1 mmHg when tested using a 1 Hz sinusoidal input signal.
- Column Strength and Tip Stiffness: Pass. Tip constructed in accordance with requirement 5.1.6 and made of lower durometer material than catheter body. Average force to deflect or compress the tip no greater than that for the catheter body.
- Static Burst Pressure: Pass. The maximum internal static pressure during pressure injection shall not exceed the static burst pressure. (Listed twice in original document)
- Rate Limited Injection Testing: Pass. Each pressure injectable lumen shall withstand at least 5 repeat injections without rupture or visually evident yielding of the catheter when injected at the maximum indicated flow rate using 125 mL of contrast media or equivalent (maximum viscosity of 11.8 ± 0.2 cP) at 37 ± 2 °C.
- Pressure Limited Injection Testing: Pass. The average flow rate of each catheter lumen shall be at least 90% of the maximum indicated flow rate.
- Ink Adhesion Testing: Pass. The catheter shall remain legible when examined without magnification with exposure to ChloroPrep and Iodine for 1 minute each, then application and removal of semi-permeable adhesive dressing and Biopatch after 7 days.
- Step Stress Testing: Pass. The catheters shall pass the first 10 injections at the maximum flow rate without visually evident yielding or rupture.
- Trim Tool: Pass. After trimming, the indwelling catheter shall terminate at the distal end with a square tip that has no points and produces a clean, smooth surface (sample size n=60, zero failures).
- Luer Hub Slip: Pass. The hub shall meet the Luer slip requirements with 95% confidence and a LTPD of 10% when tested per BS EN 20594-1:1994, ISO 594-1:1986 Clauses 5.1 through 5.5.
- Luer Hub Lock: Pass. The hub shall meet the Luer lock requirements with 95% confidence and a LTPD of 10% when tested per BS EN 1707:1997 Clauses 5.2 through 5.8.
- Catheter Securement: Pass. The catheter includes a feature that enables it to be secured to the patient's skin, demonstrating 95% confidence level and LTPD=5% with zero failures for suture holes and retainer wings.
- First Article Inspection: Pass. Distance markings (if present) indicate distance from the distal end, lumen identification is apparent, French size and manufacturer name/tradename are printed in visible locations.
- Clamp Closure Efficacy: Pass. When clamps are in the fully constrained position, there shall be no flow through the lumen being tested.
- Flow restriction after clamping: Pass. Extension lines not permanently deformed to decrease gravity flow below 90 mL/hr.
- In vitro efficacy testing - external antimicrobial treatment: Pass. Antimicrobial agent release rate sufficiently slow to provide efficacy against gram (+), gram (-) and fungi for a minimum of 7 days (minimum 4 log reduction of adherent biomass).
- In vitro efficacy testing - internal antimicrobial treatment: Pass. Antimicrobial agent release rate sufficiently slow to provide efficacy against gram (+), gram (-) and fungi for a minimum of 7 days (minimum 4 log reduction of adherent biomass).
- In vivo animal infection study: Pass. Product to exhibit efficacy against Staphylococcus aureus at minimum 7 days for in-vivo studies (minimum 4 log reduction of adherent biomass).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
KIDQ635
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS FOR ARROW ANTIMICROBIAL PRESSURE INJECTABLE PICC
AUG 27 2010
1. Submitter Information
| Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 | |
| Telephone Number: | (610) 378-0131 |
| Contact Person: | Tracy Maddock |
| Regulatory Affairs Specialist | |
| Telephone Number: | (610) 378-0131 Extension 3384 |
| Fax Number: | (610) 374-5360 |
| Email: | tracy.maddock@teleflexmedical.com |
| Date Prepared: | June 4, 2010 |
2. Device Name
| Device Trade Name: | Arrow Antimicrobial Pressure Injectable Peripherally
Inserted Central Catheter (PICC) |
|----------------------|------------------------------------------------------------------------------------------|
| Common Name: | Peripherally Inserted Central Catheter |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter |
3. Predicate Devices
| Predicate 1: | Pressure Injectable PICC (K061289) |
|---|---|
| Predicate 2: | 6 French Triple Lumen Pressure Injectable PICC (K080604) |
| Predicate 3: | ARROWg+ard Blue PLUS® Multi-Lumen CVC (K993691) |
4. Device Description
The Arrow Antimicrobial Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based antimicrobial technology.
The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .
1
5. Indications for Use
The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
6. Summary Comparing Technological Modifications
Modifications to existing Arrow products include:
- Inclusion of 4.5 Fr. single lumen and 5.5 Fr double lumen catheters to ● those ARROW PICCs already marketed. The increase in OD of the catheters allow for the subject devices to achieve 5 mL/sec pressure injection and to accommodate external / internal treatment.
- The catheter body material for the subject devices consist of a blending of . two durometers of polyurethane resin. A blue colorant was added to the catheter body resins to differentiate from non-antimicrobial PIC catheters.
- A blue colorant was added to the juncture hub material of the subject . devices to further differentiate the antimicrobial catheters.
- The catheter tip material of the subject devices includes a different . radiopacifier for enhanced radiopacity.
- Antimicrobial treatment has been applied to the external catheter body ● surface and the entire fluid path of the device.
- The antimicrobial treatment present on the external catheter body of the . subject devices consist of chlorhexidine only as opposed to chlorhexidine and silver sulfadiazine present on currently marketed Arrowgard Blue Plus central venous catheters.
7. Nonclinical Testing
Bench testing was performed on the Arrow Antimicrobial Pressure Injectable PICC in accordance with ISO 10555-1, 10555-3 and FDA Guidance on Premarket Notification [510(k)] Submission for Short- Term and Long- Term Intravascular Catheters. In vitro and in vivo testing was performed to assess the safety and efficacy of the proposed device. Testing included biocompatibility, in vitro antimicrobial efficacy, and in vivo animal infection study.
2
8. Summary of Verification Activities
| Test | Acceptance Criteria | Results | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Air Leakage | ||||||||||||||
| during | ||||||||||||||
| aspiration | There shall be no air leakage in the form of an air bubble in the | |||||||||||||
| syringe connected to the PICC after the first 5 seconds when | ||||||||||||||
| tested per BS EN ISO 10555-1:1997 Annex D. |
All catheters must pass to achieve a 5% LTPD with 95%
confidence | Pass | | | | | | | | | | | | |
| Collapse
Resistance | The catheter shall not collapse during aspiration as evidenced by
water being able to be pulled out of the catheter when vacuum is
applied by a minimum of a 10 cc syringe. The extension line
clamps, if present, shall be in the fully constrained position.
All catheters must pass to achieve a 5% LTPD with 95%
confidence | Pass | | | | | | | | | | | | |
| Liquid
Leakage under
pressure | There shall be no liquid leakage in the form of a falling drop of
water at 300-320 kPa (43.5 -46.4) for 30 sec when tested per BS
EN ISO 10555-1:1997 Annex C.
All catheters must pass to achieve a 5% LTPD with 95%
confidence | Pass | | | | | | | | | | | | |
| Force at break
-Tensile
Testing and
Catheter
Elongation | There must be a 95% confidence level that 95% of the population
meets the specification. | Pass | | | | | | | | | | | | |
| | Tensile attribute | | | | | | | | | | | | | |
| | Requirement per BS EN ISO 10555-1 and 10555-3 Catheter Body Force at Break ≥ 10N Blue Flex Tip to Catheter Body Force at Break ≥ 4N Catheter Body to Juncture Hub Force at Break ≥ 10N Extension Line to Juncture Hub Force at Break ≥ 15N Extension Line to Luer Hub Force at Break ≥ 15N Catheter Body Elongation > 100% | | | | | | | | | | | | | |
| | Radio-
Detectability | | The optical density contrast must be at least 0.1. | Pass | | | | | | | | | | |
| | Catheter Body
Kink | | Does not kink at a radius greater than 0.5 inch when tested per BS
EN 13868:2002 Annex A under simulated in vivo conditions. This
requirement shall be met with 95% assurance. | Pass | | | | | | | | | | |
:
.
.
3
| Test | Acceptance Criteria | Results |
|---|---|---|
| Central | ||
| Venous | ||
| Pressure | ||
| Monitoring | The average amplitude difference between input and output | |
| signals shall be less than or equal to 1 mmHg when tested using a | ||
| 1 Hz sinusoidal input signal. This requirement shall be met with | ||
| 95% assurance. | Pass | |
| Column | ||
| Strength and | ||
| Tip Stiffness | For catheters having a tip of different construction to the catheter | |
| body, the tip shall be constructed in accordance with the | ||
| requirement 5.1.6 and shall be made of lower durometer material | ||
| than that of the catheter body. |
Design of tip shall ensure that the average force required to
deflect or compress the tip is no greater than the average force
required to deflect or compress the catheter body.
NOTE: Requirement 5.1.6 referenced above is taken from an
internal Arrow requirements document. Requirement 5.1.6 is
identical to the requirement found in ISO 10555-3 Section 4.3. | Pass |
| Static Burst
Pressure | The maximum internal static pressure during pressure injection
shall not exceed the static burst pressure. | Pass |
| Static Burst
Pressure | The maximum internal static pressure during pressure injection
shall not exceed the static burst pressure. | Pass |
| Rate Limited
Injection
Testing | Each pressure injectable lumen shall withstand at least 5 repeat
injections without rupture or visually evident yielding of the
catheter when injected at the maximum indicated flow rate using
125 mL of contrast media or equivalent (maximum viscosity of
$11.8 \pm 0.2$ cP) at $37 \pm 2$ °C. | Pass |
| Pressure
Limited
Injection
Testing | The average flow rate of each catheter lumen shall be at least 90%
of the maximum indicated flow rate. | Pass |
| Ink Adhesion
Testing | The catheter shall remain legible when examined without
magnification with exposure to ChloroPrep and Iodine for 1
minute each, then application and removal of semi-permeable
adhesive dressing and Biopatch after 7 days. The acceptance
criteria for meeting this requirement will be a legible marking. | Pass |
| Step Stress
Testing | The catheters shall pass the first 10 injections at the maximum
flow rate without visually evident yielding or rupture. | Pass |
| Trim Tool | After trimming with the provided trimming tool and visualized
under 2.5X magnification, the indwelling catheter shall terminate
at the distal end with a square tip that:
Has no pointsProduces a clean, smooth surfaceWith a sample size of n=60, zero failures are required to show a | Pass |
| Test | Acceptance Criteria | Result |
| Luer Hub Slip | Luer Hub Slip
The hub shall meet the following Luer slip requirements with 95% confidence and a LTPD of 10% when tested per BS EN 20594-1:1994, ISO 594-1:1986 Clauses 5.1 through 5.5:
Gauging: The plane of the maximum diameter at the opening of the female conical fitting shall lie between the two limit planes of the gauge. Rocking shall not be evident between the gauge and the fitting made of rigid material undergoing test.
Liquid Leakage: No liquid leakage shall occur in the form of one or more falling drops of water.
Air Leakage: There shall be no signs of continued formation of air bubbles.
Separation force: The Luer hub shall remain attached to the reference fitting.
Stress cracking: There shall be no evidence of stress cracking of the fitting. | Pass |
| Luer Hub Lock | Luer Hub Lock
The hub shall meet the following Luer lock requirements with 95% confidence and a LTPD of 10% when tested per BS EN 1707:1997 Clauses 5.2 through 5.8:
Gauging: When tested with the appropriate gauge, the conical part of the lock fitting shall have the plane of the maximum diameter at the opening of the female conical fitting shall lie between the two limit planes of the gauge. Rocking shall not be evident between the gauge and the fitting made of rigid material undergoing test.
Liquid Leakage: No liquid leakage shall occur in the form of one or more falling drops of water.
Air Leakage: There shall be no signs of continued formation of air bubbles.
Separation force: The Luer hub shall remain attached to the reference fitting.
Unscrewing torque: The Luer hub shall remain attached to the reference fitting.
Ease of Assembly to Male Fitting: No resistance shall be observed until the taper of the fitting under test and the reference fitting fit together securely.
Resistance to Overriding Male to Female Luer Connection: The reference fitting shall not override the threads or lugs of the fitting under test.
Stress cracking: There shall be no evidence of stress cracking of the fitting | Pass |
| Catheter Securement | The catheter shall include a feature that enables the catheter to be secured to the patient's skin.
Demonstrate a 95% confidence level and LTPD=5% by having the suture holes for all catheters fit over the Securement posts with zero failures and the retainer wings from all catheters lock | Pass |
| Test | Acceptance Criteria | Results |
| First Article
Inspection | If the catheter is provided with distance markings, the marking
system shall indicate distance from the distal end. From the first
mark, the distance between marks shall not exceed 5cm. (BS EN ISO
10555-3: 1997 Section 4.4 and JIS T 3218:2005, Section 5.7)
For multilumen catheters, identification of each lumen shall be
apparent to the user (BS EN ISO 10555-3:1997, Item 4.5 and JIS T
3218:2005, Item 5.8)
The French size of the catheter shall be printed on the integral
juncture hub or in a location that can be seen after the catheter has
been inserted.
The tradename and/or name of the manufacturer of the catheter shall
be printed on the integral juncture hub or in a location that can be
seen after the catheter has been inserted. | Pass |
| Clamp
Closure
Efficacy | The clamp closure capability shall be such that when the clamps
are in the fully constrained position, there shall be no flow
through the lumen being tested when tested in accordance with
BS EN ISO 10555-3 Annex A or JIS T 3218 Annex C. | Pass |
| Flow
restriction
after clamping | The extension lines shall not be permanently deformed from the
use of extension line clamps during the maximum expected clamp
duration of the catheter to the point where a restriction in the
extension line decreases the gravity flow through the catheter
below the minimum gravity flow rate requirement (i.e. 90 mL/hr) | Pass |
| In vitro
efficacy testing
- external
antimicrobial
treatment | The antimicrobial agent release rate will be sufficiently slow to
provide efficacy against gram (+), gram (-) and fungi for a
minimum of 7 days.
Note: Efficacy will be based upon a minimum 4 log reduction of
adherent biomass (microbial colonization) when compared to the
initial inoculum concentration. | Pass |
| In vitro
efficacy testing - internal
antimicrobial
treatment | The antimicrobial agent release rate will be sufficiently slow to
provide efficacy against gram (+), gram (-) and fungi for a
minimum of 7 days.
Note: Efficacy will be based upon a minimum 4 log reduction of
adherent biomass (microbial colonization) when compared to the
initial inoculum concentration. | Pass |
| In vivo animal
infection study | The product shall exhibit efficacy against Staphylococcus aureus
at minimum 7 days for in-vivo studies. Efficacy will be based
upon a minimum 4 log reduction of adherent biomass (microbial
colonization) when compared to the initial inoculum
concentration. | Pass |
,
.
and the comments of the comments of the comments of
and the comments of the comments of the comments of
4
and the comments of the comments of
5
9. Conclusions
The Arrow Antimicrobial Pressure Injectable PICCs are substantially equivalent to the Arrow Pressure Injectable PICCs (K061289) and the Arrow 6 French Triple to the Pressure Injectable PICCs (K080604). The subject devices have the same intended use, principles of operation and technological characteristics as the predicates. The indications for use, for the proposed catheters, are the same as the
6
Arrow PICC predicate device K080604 with the addition of the proposed catheter's effectiveness in reducing microbial colonization.
The antimicrobial agent for the proposed device is a similar Chlorhexidine-based solution used for the ARROWg ard Blue PLUS® Multi-Lumen CVC (K993691). The process of application of the antimicrobial agent is also similar to that of the predicate device.
The results of the testing performed have demonstrated that the Arrow Antimicrobial Pressure Injectable PICC devices are safe and perform as intended. The differences, between subject devices and predicate devices, do not raise any new issues of safety and effectiveness. Thus, the Arrow Antimicrobial Pressure Injectable PICCs are substantially equivalent to the predicate devices.
7
Image /page/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of a human figure, with three lines forming the body and head. The figure is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tracy Maddock Regulatory Affairs Specialist Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605
AUG 2 7 2010
Re: K100635
Trade/Device Name: Arrow Antimicrobial Pressure Injectable Peripherally Inserted Central Catheter (PICC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 23, 2010 Received: August 24, 2010
Dear Ms. Maddock:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
8
Page 2- Ms. Maddock
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sisa Tuone
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Arrow Antimicrobial Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Indications for Use:
The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
Prescription Use (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)
(Division Sign-Off)
Division of Anesthesiology, General HospitalPage _ of _
Infection Control, Dental Devices
510(k) Number: K100635