(143 days)
The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kits device description is as follows:
• 6 French outside diameter, reversed tapered shaft design
• Catheter usable length is 55 cm
• Shaft inner lumen is a triple lumen design
• Catheter shaft tubing is marked with depth indicators
• The catheter has one power injectable lumen
• The product labeling warns against power injection procedures through the two small lumens, which are clearly identified as non CT.
• Three extension legs to facilitate injection through each lumen of the catheter shaft.
The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is a medical device. The provided text describes the device, its intended use, and the verification activities undertaken to demonstrate its safety and effectiveness, primarily through comparison to predicate devices.
Here's the detailed breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Proposed Device Acceptance Criteria | Proposed 6F Triple Catheter (K093406) T=0 (Initial) | Proposed 6F Triple Catheter (K093406) T=1 (After Accelerated Aging/Sterilization) |
|---|---|---|---|
| Tip Whip | Tip "whipping" must be less than or equal to predicate devices | Pass | Pass |
| Tip Displacement | Tip displacement must be less than or equal to predicate devices | Pass | Pass |
| CT Injection - Catheter Flow Rate | Flow Rate = 5mL/sec ± 0.5mL/sec with 95% confidence that 95% of the population meets specification | (Value not explicitly stated, but assumed to pass as no failure indicated) | (Value not explicitly stated, but assumed to pass as no failure indicated) |
| CT Injection - CT Lumen Integrity | CT Lumen must withstand a minimum of 10 injections at a minimum flow rate of 5mL/sec with a 95% confidence that 80% of the population meets specification | Pass | Pass |
| Aspiration | Minimum aspiration rate to be 3cc/min using a 10cc syringe without total collapse (all three catheter lumens) with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Gravity Flow Rate | Minimum gravity flow rate to be 750 ml/hr for CT lumen and 182 ml/hr for non-CT lumens with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Stylet Withdrawal Testing | Stylet withdrawal force must be less than 2 lbs with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Wire Withdrawal Testing | Guidewire withdrawal force must be less than 2 lbs with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Static Burst | Catheter burst pressure must be greater than 150 psi with 95% confidence that 95% of the population meets the specification | Pass | Pass |
| Dynamic Burst | Catheter dynamic burst pressure must be greater than 300 psi with 95% confidence that 95% of the population meets specification | Pass | Pass |
| Extension Leg to Natural Color Hub - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Non-CT Extension Leg to Trifurcate - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| CT Extension Leg to Trifurcate - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Shaft to Trifurcate - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Catheter Shaft (at nominal OD) - Tensile Testing | Tensile strength must be greater than 5 lbs with 95% confidence that 99% of the population meets the specification | Pass | Pass |
| Pressure Monitoring | No difference observed between SVS and catheter in mean pressure, systolic pressure and diastolic pressure as compared to predicate devices | Pass | Pass |
| Natural Frequency | The natural frequency must be equal to or greater than the predicate device | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of devices (sample size) used for each individual test. Instead, acceptance criteria are generally expressed with statistical confidence levels (e.g., "95% confidence that 95% of the population meets specification" or "95% confidence that 80% of the population meets specification"), implying that a sufficient sample size was used to achieve these statistical guarantees.
The data provenance is not specified regarding country of origin or specific details of test conditions beyond the type of tests. The studies are described as "verification/validation activities completed on the proposed device," which are typically laboratory-based engineering and performance tests rather than clinical trials with patient data. Thus, the data would be prospective in the sense that the tests were specifically designed and executed for this device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the studies described. The "ground truth" for these tests (e.g., a catheter's flow rate, tensile strength, or burst pressure) is determined by objective measurements and engineering standards, not by expert consensus or interpretation of clinical findings.
4. Adjudication Method for the Test Set
This is not applicable. The tests are objective measurements against defined acceptance criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the engineering and performance characteristics of the device, primarily comparing it to predicate devices based on objective technical specifications. It's a physical medical device, not an AI or imaging diagnostic tool that would typically involve MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This is not applicable. The device is a physical medical catheter, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on engineering specifications and objective measurements of the device's physical and functional properties, and comparison to the performance of legally marketed predicate devices. This includes:
- Physical durability (tensile strength, burst pressure)
- Flow rates (CT injection, gravity flow, aspiration)
- Mechanical behavior (tip whipping, tip displacement, stylet/wire withdrawal force)
- Biocompatibility (tested per ISO 10993)
8. The Sample Size for the Training Set
This is not applicable. The studies described are performance and safety verification tests for a physical medical device, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for a physical medical device.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
MAR 2 5 2010
| GeneralProvisions | Trade Name: AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit | ||
|---|---|---|---|
| Classification Name: Percutaneous, Implanted, Long-Term, Intravascular Catheters 80 LJS | |||
| Name ofPredicateDevices | The following predicate devices have been identified for the 6F Triple Lumen Morpheus®SMART PICC CT and Procedure Kits: | ||
| Device Name | 510(k) Number | Concurrence Date | |
| AngioDynamics Morpheus® CT PICCand Procedure Kits | K070615K060887K041420K040446K031626K030415 | May 04, 2007April 24, 2006July 26, 2004March 05, 2004June 19, 2003April 30, 2003 | |
| Bard Access Systems, Inc. 6 Fr TLPowerPICC® Catheter | K053501 | January 13, 2006 | |
| Contact Name | Jodi Lynn FrasierSenior Regulatory Affairs ProfessionalAccess Business UnitAngioDynamics, Inc603 Queensbury, NY 12804(518) 798-1215 ext 1676 | ||
| Date SummaryPrepared | March 01, 2010 | ||
| Classification | Class II | ||
| PerformanceStandards | No performance standards have been established under Section 514 of the Food, Drug andCosmetic Act for Percutaneous, Implanted, Long-Term, Intravascular Catheters. |
Continued on next page
Page 3 of 14
.
.
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| Intended Useand DeviceDescription | Biocompatibility | SummaryComparingTechnologicalModifications |
|---|---|---|
| The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit isintended for short or long term peripheral access to the central venous system for intravenoustherapy, power injections of contrast media, and allows for central venous pressuremonitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. Forcentral venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge orlarger be used. The device is available as a procedural kit with either a Stylet or a NitinolWire. | The 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit have been tested forbiocompatibility per ISO 10993. All data demonstrate this device is biocompatible for itsintended use. | The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kitsdevice description is as follows:• 6 French outside diameter, reversed tapered shaft design• Catheter usable length is 55 cm• Shaft inner lumen is a triple lumen design• Catheter shaft tubing is marked with depth indicators• The catheter has one power injectable lumen• The product labeling warns against power injection procedures through the two smalllumens, which are clearly identified as non CT.• Three extension legs to facilitate injection through each lumen of the catheter shaft. |
510(k) Summary of Safety and Effectiveness, Continued
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{2}------------------------------------------------
510(k) Summary of Safety and Effectiveness. Continued
Summary Comparing Technological Modifications (continued)
The only modifications that were made are as follows:
- . Expand the existing product line to provide a 6F triple lumen catheter shaft. The existing Morpheus® product line currently provides a 6F and 7F Dual lumen catheter design, while
- The catheter shaft is a single durometer material vs. the dual durometer design of the . existing product portfolio. The material is the same base material as the distal end of the currently marketed Morpheus® PICC CT and Procedure Kits, with the exception of the barium loading. The 6F triple device will have a 20% Barium loading which is the same as the proximal end of the currently marketed Morpheus® PICC CT and Procedure Kits.
- An additional extension leg has been added to facilitate injection through the third . lumen of the catheter shaft. The extension leg materials are identical to those of the currently marketed dual lumen Morpheus® PICC CT and Procedure Kits.
- A natural colored luer will be utilized for the third lumen of the catheter. This luer . has identical specifications as those used on the existing Morpheus® PICC CT and Procedure kits and is of the same material. The only difference is the omission of a colorant (red or blue) so that each lumen has a distinctly colored luer for identification purposes.
- Use of a silicone processing aid, for which leave trace amounts may remain on the ● finished device.
{3}------------------------------------------------
510(k) Summary of Safety and Effectiveness, Continued
Summary of Verification Activities
The table immediately following outlines the verification/validation activities completed on the proposed device and compares that to the predicate device.
| Test | Proposed DeviceAcceptanceCriteria | Proposed 6FTripleCatheter(K093406)T=0 | Proposed 6FTriple Catheter(K093406) T=1 | PredicateDeviceAcceptanceCriteria | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=0 | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=1 |
|---|---|---|---|---|---|---|
| Tip Whip | Tip “whipping” isdefined as the tipmoving from left toright during aninjection. Tipwhipping must beless than or equal topredicate devices | Pass | Pass | Tip“whipping” isdefined as thetip movingfrom left toright duringan injection.Tip whippingmust be lessthan or equalto predicatedevices | Pass | Pass |
| TipDisplacement | Tip displacement isdefined as the tipbacking-up duringan injection. Tipdisplacement mustbe less than orequal to predicatedevices | Pass | Pass | Tipdisplacementis defined asthe tipbacking-upduring aninjection. Tipdisplacementmust be lessthan or equalto predicatedevices | Pass | Pass |
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. .
Summary of Verification Activities (continued)
| Test | Proposed Device Acceptance Criteria | Proposed 6F Triple Catheter (K093406) T=0 | Proposed 6F Triple Catheter (K093406) T=1 | Predicate Device Acceptance Criteria | AngioDynamics Morpheus® CT PICC and Procedure Kits (K070615, K060887, K041420, K040446, K031626, K030415) T=0 | AngioDynamics Morpheus® CT PICC and Procedure Kits (K070615, K060887, K041420, K040446, K031626, K030415) T=1 |
|---|---|---|---|---|---|---|
| CT Injection - Catheter Flow Rate | Flow Rate = 5mL/sec ± 0.5mL/sec with 95% confidence that 95% of the population meets specification | Flow Rate = 3 to 8mL/sec ± 0.5mL/sec (depending on catheter configuration) with 95% confidence that 95% of the population meets specification | ||||
| CT Injection - CT Lumen Integrity | CT Lumen must withstand a minimum of 10 injections at a minimum flow rate of 5mL/sec with a 95% confidence that 80% of the population meets specification | Pass | Pass | CT Lumen must withstand a minimum of 10 injections at a minimum flow rate of 3 to 8mL/sec (depending on catheter configuration) with a 95% confidence that 80% of the population meets specification | Pass | Pass |
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| TestAspiration | Proposed DeviceAcceptanceCriteria | Proposed 6F.TripleCatheter(K093406)T=0 | Proposed 6FTriple Catheter,(K093406) T=1 | PredicateDeviceAcceptanceCriteria | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=0 | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=1 |
|---|---|---|---|---|---|---|
| Minimumaspiration rate to be3cc/min using a10cc syringewithout totalcollapse (all threecatheter lumens)with 95%confidence that95% of thepopulation meetsspecification | Pass | Pass | Minimumaspiration rateto be 3cc/minusing a 10ccsyringewithout totalcollapse (allthree catheterlumens) with95%confidencethat 95% ofthepopulationmeetsspecification | Pass | Pass | |
| Gravity FlowRate | Minimum gravityflow rate to be 750ml/hr for CT lumenand 182 ml/hr fornon-CT lumenswith 95%confidence that95% of thepopulation meetsspecification | Pass | Pass | Minimumgravity flowrate to be 750ml/hr for CTlumen and182 ml/hr fornon-CTlumens with95%confidencethat 95% ofthepopulationmeetsspecification | Pass | Pass |
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ﺑ
Summary of Verification Activities (continued)
| Test | Proposed DeviceAcceptanceCriteria | Proposed 6FTripleCatheter(K093406) T=0 | Proposed 6FTriple Catheter(K093406) T=1 | PredicateDeviceAcceptanceCriteria | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=0 | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=1 |
|---|---|---|---|---|---|---|
| StyletWithdrawalTesting | Stylet withdrawalforce must be lessthan 2 lbs with 95%confidence that95% of thepopulation meetsspecification | Styletwithdrawalforce must beless than 2 lbswith 95%confidencethat 95% ofthepopulationmeetsspecification | ||||
| Pass | Pass | Pass | Pass | |||
| WireWithdrawalTesting | Guidewirewithdrawal forcemust be less than 2lbs with 95%confidence that95% of thepopulation meetsspecification | Guidewirewithdrawalforce must beless than 2 lbswith 95%confidencethat 95% ofthepopulationmeetsspecification | ||||
| Pass | Pass | Pass | Pass | |||
| Static Burst | Catheter burstpressure must begreater than 150 psiwith 95%confidence that95% of thepopulation meetsthe specification | Catheter burstpressure mustbe greaterthan 150 psiwith 95%confidencethat 95% ofthepopulationmeets thespecification | ||||
| Pass | Pass | Pass | Pass | |||
| Test | Proposed DeviceAcceptanceCriteria | Proposed 6FTripleCatheter(K093406)T=0 | Proposed 6FTriple Catheter(K093406) T=1 | PredicateDeviceAcceptanceCriteria | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=0 | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=1 |
| Dynamic Burst | Catheter dynamicburst pressure mustbe greater than 300psi with 95%confidence that95% of thepopulation meetsspecification | Catheterdynamic burstpressure mustbe greaterthan 300 psiwith 95%confidencethat 95% ofthepopulationmeetsspecification | ||||
| Pass | Pass | Pass | Pass | |||
| Tensile Testing | ||||||
| Extension Leg toNatural ColorHub | Tensile strengthmust be greaterthan 5 lbs with 95%confidence that99% of thepopulation meetsthe specification | Tensilestrength mustbe greaterthan 5 lbswith 95%confidencethat 99% ofthe populationmeets thespecification | ||||
| Pass | Pass | Pass | Pass | |||
| Non- CTExtension Leg toTrifurcate | Tensile strengthmust be greaterthan 5 lbs with 95%confidence that99% of thepopulation meetsthe specification | Tensilestrength mustbe greaterthan 5 lbswith 95%confidencethat 99% ofthe populationmeets thespecification | ||||
| Pass | Pass | Pass | Pass | |||
| AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=0 | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=1 | |||||
| Test | Proposed DeviceAcceptanceCriteria | Proposed 6FTripleCatheter(K093406)T=0 | Proposed 6FTriple Catheter(K093406) T=1 | PredicateDeviceAcceptanceCriteria | ||
| CT ExtensionLeg to Trifurcate | Tensile strengthmust be greaterthan 5 lbs with 95%confidence that99% of thepopulation meetsthe specification | Pass | Pass | Tensilestrength mustbe greaterthan 5 lbswith 95%confidencethat 99% ofthepopulationmeets thespecification | Pass | Pass |
| Shaft toTrifurcate | Tensile strengthmust be greaterthan 5 lbs with 95%confidence that99% of thepopulation meetsthe specification | Pass | Pass | Tensilestrength mustbe greaterthan 5 lbswith 95%confidencethat 99% ofthepopulationmeets thespecification | Pass | Pass |
| Catheter Shaft(at nominal OD) | Tensile strengthmust be greaterthan 5 lbs with 95%confidence that99% of thepopulation meetsthe specification | Pass | Pass | Tensilestrength mustbe greaterthan 5 lbswith 95%confidencethat 99% ofthepopulationmeets thespecification | Pass | Pass |
:
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.
.
{9}------------------------------------------------
| Test | Proposed DeviceAcceptanceCriteria | Proposed 6FTripleCatheter(K093406)T=0 | Proposed 6FTriple Catheter(K093406) T=1 | PredicateDeviceAcceptanceCriteria | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=0 | AngioDynamicsMorpheus® CTPICC andProcedure Kits(K070615,K060887,K041420,K040446,K031626,K030415) T=1 |
|---|---|---|---|---|---|---|
| PressureMonitoring | No differenceobserved betweenSVS and catheter inmean pressure,systolic pressureand diastolicpressure ascompared topredicate devices | Pass | Pass | No difference observedbetween SVS and catheterin mean pressure, systolicpressure and diastolicpressure as compared topredicate devices | Pass | Pass |
| NaturalFrequency | The naturalfrequency must beequal to or greaterthan the predicatedevice | Pass | Pass | The natural frequencymust be equal to or greaterthan the predicate device | Pass | Pass |
Summary of Substantial Equivalence
The 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit have been tested and compared to the predicate device. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised.
{10}------------------------------------------------
Additional Information
Material In addition to the previously submitted information, AngioDynamics would like to identify Change an additional change for the device submitted for the pending 510(k) K093406. A suicone material is used as a processing aid which may leave trace amounts on the device. As a result, this MDX silicone should be identified as a material present and included in the 510(k). All testing previously conducted were on units built with this processing ad and as a result representative of the finished device for which we seek marketing clearance. This was an omission in the original submission.
Biocompatibility MDX Silicone, manufactured by Dow is a commonly used medical grade material. Data Extensive biocompatibility testing has previously been conducted. The following page provides written authorization to allow the Food & Drug Administration to access these data for purpose of this submission review.
Page 13 of 14
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MAR 2 5 2010
AngioDynamics, Incorporated Ms. Jodi Lynn Frasier Senior Regulatory Affairs Professional Access Business Unit 603 Queensbury Avenue Queensbury, New York 12804
Re: K093406
Trade/Device Name: Morpheus® SMART PICC CT and Procedure Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 1, 2010 Received: March 2, 2010
Dear Ms. Frasier:
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 1 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.
{12}------------------------------------------------
Page 2- Ms. Frasier
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/ucm 115809.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 yours.
the for
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
{13}------------------------------------------------
Section 6
Statement of Indications For Use
INDICATIONS FOR USE
510(k) Application: Special 510K Application
AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit Device Name:
Indications for Use:
The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use --------
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurre
Division Sign-Off)
Jivision of Anesthesiology, General Hospital ifection Control, Dental Devices
10(k) Number: K093406
Page 20 of 48
§ 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.”