(167 days)
No
The summary describes a physical catheter with fiber optics for oxygen saturation measurement and standard features for venous access. There is no mention of AI, ML, or any software component that would process data using these technologies. The performance studies focus on physical and biocompatibility testing.
No
The device is primarily designed for diagnosis and monitoring (continuous ScvO2 measurement, pressure monitoring, blood sampling) and facilitating therapy delivery (intravenous therapy, pressure injection), rather than directly providing therapy itself.
Yes
The device is indicated for "continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2)" and allows for "continuous measurement of central venous oxygen saturation (ScvO2)". This functionality indicates that it collects and provides data on a physiological parameter (blood oxygen saturation) which can be used to inform a diagnosis or monitor a patient's condition.
No
The device description clearly details a physical catheter with multiple lumens, fiber optics, and radiopaque material, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The PICCOx catheter is a device inserted into the central venous system (inside the body). Its primary functions are:
- Access to the central venous system.
- Continuous in vivo (within the living body) measurement of oxyhemoglobin saturation (ScvO2).
- Intravenous therapy.
- Blood sampling (though the analysis of the blood sample would be an IVD process, the catheter itself is not).
- Pressure injection of contrast media.
- Central venous pressure monitoring.
While the device facilitates the collection of blood samples which could be used for in vitro diagnostic testing, the device itself performs its primary functions within the patient's body. The continuous ScvO2 measurement is also an in vivo measurement.
Therefore, the PICCOx catheter is a medical device used for therapeutic and monitoring purposes within the body, not for examining specimens outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
DQE
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.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous system, superior vena cava
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)
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.
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 24 hours and
§ 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).
0
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
800.824.7890
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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® Central
Venous Oximetry
Catheter | ArrowADVANTAGE™ |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K NUMBER | TBD | K061585 | K113277 |
| GENERAL CHARACTERISTICS | | | |
| Product Code | DQE | Same | LIS |
| Sterility | Supplied within a sterile
package with non-pyrogenic
fluid path. | Same | Same |
| Sterilization
Method | Catheter is gamma irradiated. | Same | EO (Arrow Pressure Injectable PICC
Promotional 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® Central
Venous Oximetry
Catheter | ArrowADVANTAGETM |
| Luer | PCTG | Same | Not known |
| Clamps | ABS | Same | Not known |
| Technology | | | |
| Operating
Principles | Multilumen catheters are
capable of continuous
measurement of central venous
oxygen saturation (ScvO₂) in
the superior vena cava. The
catheter includes fiber optics
for light transmission, multiple
lumens with access hubs and
shutoff clamps. Catheters are
radiopaque enabling the use of
fluoroscopy or X-ray to guide
insertion and verify position.
The distal end of the catheter is
constructed of polyurethane
that is radiopaque providing
greater deflection when coming
into contact with vessels,
minimizing trauma to the
vessels during use. | Same | The Arrow® Pressure Injectable
PICC is a peripherally inserted
central venous catheter (PICC)
manufactured with medical grade,
flexible polyurethane. The Arrow®
PICC has a non-tapered catheter
body with either a blunt tip or a
Blue FlexTip® that is softer than a
cut tip with a contour design to
enhance maneuverability. The Blue
FlexTip® also provides visual
confirmation of an intact catheter
upon removal. The kit components
assist the clinician in maintaining
maximal sterile barrier
precautions. (Arrow Pressure
Injectable PICC Promotional
Materials) |
| Principle of
Operation | Reflection Spectrophotometry | Same | N/A |
| Pressure
Injection | Pressure injection of contrast
media may not exceed 300 psi | N/A | Same (K113277) |
| Number of
Pressure
Injection | Ten | N/A | Same (Arrow Pressure Injectable
PICC Promotional Materials) |
| Pressure
Injectable
Lumen Flow | Maximum flow rate of 5
mL/sec. | N/A | Same (K113277) |
| Manufacturing
Process | Trained personnel using
documented and validated
procedures within a Quality | Same | Not known |
Table 1: Summary Comparison of Technological Characteristics Table
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human connections
| 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 Fr | ||
| 40-55 cm | |||
| Single and multilumen | 8 Fr | ||
| 20 cm | |||
| Multilumen | 4, 5, & 6 Fr | ||
| 40-55 cm | |||
| Single 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® Central
Venous Oximetry
Catheter | 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
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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 24 hours and 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-
">
7
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
8
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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