(167 days)
The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.
The Peripherally Inserted, Pressure Injectable Central Venous Oximetry Catheter (PICCOx) is a single or multi-lumen catheter capable of intravenous infusion including pressure infusion up to 300psig, central venous pressure monitoring, venous blood sampling, and allows for continuous measurement of central venous oxygen saturation (ScvO2) in the superior vena cava. The device includes fiber optics in a dedicated lumen for light transmission and single or multiple fluid lumens. Constructed of barium sulfate filled polyurethane, these catheters are radiopaque enabling the use of fluoroscopy or X-ray, to guide insertion and verify position. The maximum recommended infusion rate for the pressure injectable lumen is 5 mL/sec. Distance markings on the catheters provide a visual indication of insertion depth. Every 5cm the insertion depth is printed with an actual number and in between the numbers are black dots which are printed every 1cm. The catheter is non-trimmable, and offered in usable lengths of 40cm, 45cm, 50cm, and 55cm. Individual lumen hubs are ISO standard female luers which are adaptable to NeedleFree Connectors, syringes or IV tubing compliant with the ISO standard. The fiber optic lumen which is terminated in a housing, can be plugged into a compatible Optical Module. PICCOx is intended to be used with a user defined convenience kit. These "kits" are cleared under 510(k) K052865. All kits are terminally sterilized. The contents of the kit are sterile, medical devices intended for single patient use only with fluid path and invasive surfaces non-pyrogenic (or as indicated on the labeling of internal component packaging.)
This is a medical device 510(k) premarket notification summary for the PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, and the provided text focuses on the device's technical characteristics and non-clinical performance data. There is no information in the provided text that describes a study comparing the device's performance against acceptance criteria using patient data or expert assessments. The information primarily covers device description, intended use, and a comparison of features with predicate devices.
Therefore, the following information is not available in the provided text:
- Acceptance criteria table and reported device performance based on a study of that nature.
- Sample size used for the test set and data provenance specific to such a study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for a performance study.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text focuses on non-clinical performance testing and biocompatibility, as stated:
"The successful results of the key tests involving dynamic response, fiber optics, flow rates, leakage, force at break, lead tubing, markings, priming volumes, radiopacity, needlefree connector compatibility, and catheter to introducer fitment demonstrate that the proposed PICCOx Peripherally Inserted Central Venous Oximetry Catheter has met the pre-determined acceptance criteria applicable to the safe use of the devices."
This indicates that internal performance specifications were met through non-clinical bench testing, but these acceptance criteria and results are not detailed in a way that allows for filling out the requested table. The summary confirms that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, the device "has been tested in accordance with its performance specification which accommodates known functional requirements."
Without further details on these specific "performance specifications" and their corresponding results, the requested table and other study-related information cannot be generated from the given text.
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JUL 0 2 2014
Section 5 510(k) Summary
human connections
icur
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Company Name: | ICU Medical, Inc |
|---|---|
| 4455 Atherton Drive | |
| Address: | Salt Lake City, UT 84123 |
| Contact Person: | Kristin Casper |
| Regulatory Affairs Specialist | |
| ICU Medical, Inc. | |
| Phone: (801)264-1313 | |
| Fax: (801)264 1755 | |
| Preparation Date: | January 15, 2013 |
| Device (Trade Name): | PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter |
| Common/Usual Name: | Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter |
| Classification Names: | 21 CFR 870.1230. Fiberoptic Oximeter Catheter. Product Code: DQE |
| Predicate Device: | K061585 ICU Medical, Inc. Opticath Central Venous Oximetry Catheter (also known as TriOx ScvO₂ Central Venous Catheter} |
| K113277 Teleflex ArrowADVANTAGE™ Pressure Injectable PICC | |
| Device Description: | The Peripherally Inserted, Pressure Injectable Central Venous Oximetry Catheter (PICCOx) is a single or multi-lumen catheter capable of intravenous infusion including pressure infusion up to 300psig, central venous pressure monitoring, venous blood sampling, and allows for continuous measurement of central venous oxygen saturation (ScvO2) in the superior vena cava. The device includes fiber optics in a dedicated lumen for light transmission and single or multiple fluid lumens. Constructed of barium sulfate filled polyurethane, these catheters are radiopaque enabling the use of fluoroscopy or X-ray, to guide insertion and verify position. The maximum recommended infusion rate for the pressure injectable lumen is 5 mL/sec. |
| Distance markings on the catheters provide a visual indication of insertion depth. Every 5cm the insertion depth is printed with an actual number and in between the numbers are black dots which are printed every 1cm. The catheter is non-trimmable, and offered in usable lengths of 40cm, 45cm, 50cm, and 55cm. | |
| Individual lumen hubs are ISO standard female luers which are adaptable to NeedleFree Connectors, syringes or IV tubing compliant with the ISO standard. The fiber optic lumen which is terminated in a housing, can be plugged into a compatible Optical Module. | |
| PICCOx is intended to be used with a user defined convenience kit. These "kits" are cleared under 510(k) K052865. All kits are terminally sterilized. The contents of the kit are sterile, medical devices intended for single patient use only with fluid path and invasive surfaces non-pyrogenic (or as indicated on the labeling of internal component packaging.) | |
| Intended Use: | The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for |
949.366.2183 л
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continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.
- Technology: The PICCOx Peripherally-Inserted, Pressure-Injectable, Central Venous Oximetry Catheter employs the same fundamental scientific technology as its predicate devices. Technological characteristics of the subject PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter are equivalent to those of the predicate ICU Medical, Inc. Opticath Central Venous Oximetry Catheter with respect to the basic catheter design and functionality including continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, and central venous pressure monitoring. Technical characteristics based on the subject device's peripheral insertion and power injection capabilities are comparable to the predicate Teleflex ArrowADVANTAGE™ Pressure Injectable PICC. Differences do not raise any new questions regarding safety and effectiveness. Please see Table 1 for more information.
| Feature | PICCOX | Opticath® CentralVenous OximetryCatheter | ArrowADVANTAGE™ |
|---|---|---|---|
| 510K NUMBER | TBD | K061585 | K113277 |
| GENERAL CHARACTERISTICS | |||
| Product Code | DQE | Same | LIS |
| Sterility | Supplied within a sterilepackage with non-pyrogenicfluid path. | Same | Same |
| SterilizationMethod | Catheter is gamma irradiated. | Same | EO (Arrow Pressure Injectable PICCPromotional Materials) |
| Materials of Composition | |||
| Shaft | Yellow polyurethane compound | Same | Polyurethane (K113277) |
| Junction | Yellow polyurethane resin | Same | Not known |
| Fiber Optics | Black coated fibers | Same | N/A |
| Optical | Polyurethane | Same | N/A |
| Coupler | Black ABS | Same | N/A |
| Lead Tubing | Polyurethane | Same | Not known |
| Feature | PICCOX | Opticath® CentralVenous OximetryCatheter | ArrowADVANTAGETM |
| Luer | PCTG | Same | Not known |
| Clamps | ABS | Same | Not known |
| Technology | |||
| OperatingPrinciples | Multilumen catheters arecapable of continuousmeasurement of central venousoxygen saturation (ScvO₂) inthe superior vena cava. Thecatheter includes fiber opticsfor light transmission, multiplelumens with access hubs andshutoff clamps. Catheters areradiopaque enabling the use offluoroscopy or X-ray to guideinsertion and verify position.The distal end of the catheter isconstructed of polyurethanethat is radiopaque providinggreater deflection when cominginto contact with vessels,minimizing trauma to thevessels during use. | Same | The Arrow® Pressure InjectablePICC is a peripherally insertedcentral venous catheter (PICC)manufactured with medical grade,flexible polyurethane. The Arrow®PICC has a non-tapered catheterbody with either a blunt tip or aBlue FlexTip® that is softer than acut tip with a contour design toenhance maneuverability. The BlueFlexTip® also provides visualconfirmation of an intact catheterupon removal. The kit componentsassist the clinician in maintainingmaximal sterile barrierprecautions. (Arrow PressureInjectable PICC PromotionalMaterials) |
| Principle ofOperation | Reflection Spectrophotometry | Same | N/A |
| PressureInjection | Pressure injection of contrastmedia may not exceed 300 psi | N/A | Same (K113277) |
| Number ofPressureInjection | Ten | N/A | Same (Arrow Pressure InjectablePICC Promotional Materials) |
| PressureInjectableLumen Flow | Maximum flow rate of 5mL/sec. | N/A | Same (K113277) |
| ManufacturingProcess | Trained personnel usingdocumented and validatedprocedures within a Quality | Same | Not known |
Table 1: Summary Comparison of Technological Characteristics Table
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| Feature | PICCOX | Opticath® Central Venous Oximetry Catheter | ArrowADVANTAGE™ |
|---|---|---|---|
| Wavelengths | Three Wavelengths | Same | N/A |
| Calibration | In vitro using included calibration block or | Same | N/A |
| Preferred Insertion | Seldinger Technique | Same | Same (Arrow Pressure Injectable PICC Promotional Materials) |
| Central Venous System Access | Peripheral Access | Not indicated for peripheral placement. | Same (K113277) |
| Optical Module | 2 Optic Fiber Mechanical Coupler | Same | N/A |
| Size | 5 Fr40-55 cmSingle and multilumen | 8 Fr20 cmMultilumen | 4, 5, & 6 Fr40-55 cmSingle and multilumen (K113277) |
| Needlefree Connector | MicroClave | Same | Same (Arrow Pressure Injectable PICC Promotional Materials) |
| Packaging | Tray and Pouch | Same | Not known |
| Distinct Labeling | Pressure injection capabilities are marked on the extension line offering a clear | N/A | Same |
| Connection to External Equipment | -Connected to the monitoring computer by inserting the optical connector into the optical module when measuring central venous oxygen saturation.-Administration sets are connected to the PICCOx catheter when delivering I.V. therapy to the patient.-Syringes are connected when obtaining blood samples or delivering drugs.-A manometer or an electronic pressure transducer with any | Same EXCEPT for pressure injector equipment. | Same EXCEPT for connected to the monitoring computer and optical module when measuring central venous oxygen saturation. |
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.
| Feature | PICCOX | Opticath® CentralVenous OximetryCatheter | ArrowADVANTAGE™ |
|---|---|---|---|
| Duration | Short-term | Same | Short-term or long-term |
| Single Use | Yes | Same | Same |
951 Calle Amanecer, San Clemente, CA 92673
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949.366.2183
800.824.7890
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Determination of Substantial
Non Clinical Performance Data
Equivalence:
Summary
The demonstration of substantial equivalence is based on a comparison of features to the predicate devices and an assessment of non-clinical performance data. Information is included with this 510(k) submission that supports this determination. The PICCOx, Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter has the same indications for use, principles of operation and technological characteristics making it substantially equivalent to the predicate devices. No new issues of safety and efficacy have been raised.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. The PICCOx, Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter has been tested in accordance with its performance specification which accommodates known functional requirements.
The PICCOx has been tested and passed the required testing for biocompatibility for external communicating devices, circulating blood, with prolonged exposure of > 24 hours and < 30 days and the Clear MicroClave has been tested and passed the required testing for biocompatibility for external communicating devices, blood path, indirect, prolonged contact > 24 hours and < 30 days according to the requirements of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing. The successful results of the key tests involving dynamic response, fiber optics, flow rates, leakage, force at break, lead tubing, markings, priming volumes, radiopacity, needlefree connector compatibility, and catheter to introducer fitment demonstrate that the proposed PICCOx Peripherally Inserted Central Venous Oximetry Catheter has met the pre-determined acceptance criteria applicable to the safe use of the devices.
Conclusion:
Performance testing included within this 510(k) demonstrates that the Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx) is safe, effective and performs in an equivalent manner to the predicate devices and in accordance with its intended use.
951 Calle Amanecer, San Clemente, CA 92673
949.366.2183
800.824.7890
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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July 2, 2014
Icu Medical, Inc. Kristin Casper Regulatory Affairs Specialist 4455 Atherton Drive Salt Lake City, UT 84123
Re: K140129
Trade/Device Name: PICCOx peripherally inserted, pressure injectable, central venous oximetry catheter Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: Class II Product Code: DQE Dated: June 5, 2014 Received: June 6, 2014
Dear Ms. Casper,
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.
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-
">
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Page 2 - Ms. Kristin Casper
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
ﺎ ﻣﻌﻤﺪ ﺳ
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140129
Device Name
PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter
Indications for Use (Describe)
The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
e: 2014.07.02 14:45:15
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§ 870.1230 Fiberoptic oximeter catheter.
(a)
Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.(b)
Classification. Class II (performance standards).