(120 days)
Not Found
No
The summary describes a physical catheter with integrated fiber optics for measuring blood oxygen saturation. There is no mention of AI, ML, or any computational processing beyond basic signal interpretation.
No
Explanation: The device is indicated for monitoring and measurement of physiological parameters (oxyhemoglobin saturation, central venous pressure) and for administration/sampling, not for treating a disease or condition.
Yes
The device is indicated for the "continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status," which involves measuring a physiological parameter to provide information for diagnosis or monitoring.
No
The device description explicitly states it is a "disposable single use central venous catheter with integrated fiber optics," indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for in vivo measurement of oxyhemoglobin saturation in the central venous system (ScvO2), as well as other direct physiological monitoring and access functions (pressure monitoring, drug administration, blood sampling). IVDs are designed to perform tests in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is a catheter with integrated fiber optics for in vivo measurement. It's inserted directly into the central venous system.
- No mention of testing specimens: The description focuses on direct measurement within the body, not on analyzing samples taken from the body.
Therefore, the OPTICATH® Central Venous Oximetry Catheter is a medical device used for direct physiological monitoring and access within the body, not an IVD.
N/A
Intended Use / Indications for Use
The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice.. The OPTICATH® Central Venous Oximetry Catheter is intended for onetime use.
Product codes
DOE
Device Description
The OPTICATH® Central Venous Oximetry Catheter is a disposable single use central venous catheter with integrated fiber optics for measurement of blood oxyhemoglobin levels. It is compatible with existing Oximetrix 3, Q2 or Q2 Plus SO₂ oxylicmographili lovols: 1015 computactured by Philips, GE Medical and Spacelabs. The Central Venous Oximetry – Integrated Catheter is a component within a Hospira Central Venous Catheter (CVC) kit.
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)
The proposed modifications have been evaluated using bench testing as well as in-vivo non-clinical studies of which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness.
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
§ 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
Hospira, Inc
510(k) SUMMARY
| 1. Submitted by: | Hospira, Inc.
D-389 Bldg. H2
275 N. Field Drive
Lake Forest, IL 60045 |
|------------------|--------------------------------------------------------------------------------|
| | Contact: Nicohl R. Wilding
Phone:(224) 212-5270
Fax: (224) 212-5401 |
-
- Date Prepared:
- Name/Classification of Device:
-
- Trade Name of Proposed Device:
-
- Predicate Devices:
-
5 2006
Fax: (224) 212-5401 June 5, 2006
- Fiberoptic Oximetry Catheter, Class II 78 DQE - 21 CFR Parts 870.1230
OPTICATH® Central Venous Oximetry Catheter OPTICATH® Oximetry Catheter (K820674) CVP Polyurethane Catheter (K961552)
PreSep Central Venous Oximetry Catheter (Edwards Lifesciences) (K053609)
6. Manufacturer and Establishment Registration Number:
| Manufacturer Site: | Sterilization Site: |
|---|---|
| ICU Medical (UTAH), Inc. | |
| 4455 Atherton Drive | |
| Salt Lake City, UT 84123 | |
| Establishment Registration #: 1713468 | Isomedix Operations, Inc., Steris Corporation |
| 9120 South 150 East | |
| Sandy, UT 84070 | |
| Establishment Registration #: 1720929 | |
| Isomedix Operations, Inc., Steris Corporation | |
| 7685 St. Andrews Ave. | |
| San Diego, CA 92154 | |
| Establishment Registration #: 2032112 |
7. Performance Standards:
No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act for Pressure Monitoring Devices. Cardiovascular Devices are regulated within 21 CFR 870.1230.
8. Intended Use / Indications for Use:
The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice.. The OPTICATH® Central Venous Oximetry Catheter is intended for onetime use.
The intended use is the same as for the predicate devices.
1
Hospira, Inc
9. Proposed Device Description:
The OPTICATH® Central Venous Oximetry Catheter is a disposable single use central venous catheter with integrated fiber optics for measurement of blood oxyhemoglobin levels. It is compatible with existing Oximetrix 3, Q2 or Q2 Plus SO₂ oxylicmographili lovols: 1015 computactured by Philips, GE Medical and Spacelabs. The Central Venous Oximetry – Integrated Catheter is a component within a Hospira Central Venous Catheter (CVC) kit.
10. Summary of Substantial Equivalence
The OPTICATH® Central Venous Oximetry Catheter is substantially equivalent to the predicate OPTICATH® Oximetry Catheter, K820674 and Central Venous Catheter K961552 with respect to the following characteristics:
Similarities:
-
- The OPTICATH® Central Venous Oximetry Catheter and predicates are intended for measuring central venous oxygen saturation, central venous intenture monitoring, drug and fluid administration, vascular access and venous blood sampling. The device is provided as non-pyrogenic and sterile and is intended for one-time use.
-
- The OPTICATH® Central Venous Oximetry Catheter has 4 lumens and is 8 French where the CVP Polyurethane predicate has 2 or 3 lumens and is 7 French and the Opticath Oximetry Catheter has 5 lumens and is 7.5 or 8 French.
-
- The technology and operating principles are the same.
-
- The catheters are packaged within Central Venous Catheter Kit.
-
- The materials of construction are the same.
-
- The method of sterilization is the same as the OPTICATH® Oximetry Catheter.
Differences:
-
- The OPTICATH® Central Venous Oximetry Catheter is 8 French where as the CVP Polyurethane predicate catheters are 7 French.
-
- The method of sterilization is different from the CVP Polyurethane catheter.
Statement of Safety and Effectiveness 11.
The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications have been evaluated using bench testing as well as in-vivo non-clinical studies of which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness. TTherefore, the OPTICATH® Central Venous Oximetry Catheter is substantially equivalent to the predicate Oximetry Catheter and the Central Venous Pressure Catheters.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.
pg 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2006
Hospira, Inc. c/o Ms. Nicohl R. Wilding Manager Global Device Regulatory Affairs 275 N. Field Drive H2-2 Lake Forest, IL 60045
Re: K061585
Trade Name: OPTICATH® Central Venous Oximetry Catheter Regulation Number: 21 CFR 870.1230 Regulation Name: Fiberoptic oximetry catheter Regulatory Class: Class II (two) Product Code: DOE Dated: August 30, 2006 Received: September 11, 2006
Dear Ms. Wilding:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting 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.
3
Page 2 - Ms. Nicohl Wilding
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K061585 510(k) Number (if known)
Device Name: OPTICATH® Central Venous Oximetry Catheter
Indications for Use:
The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous The OF HOATH® Ochirar Venodo Oximistration, vascular access, venous blood pressure monitoning, drug and liaid administration, resistemoglobin saturation of Sampling and the contral venous system (ScvO₂) for monitoring hemodynamic status during blood in the central venous system (Govern) (Gorog) relaxions of the stime in the melabolic, respiratory, cardiovaoodian, and on current Clinical Standards of Practice.. The in accordance with nospital protesses of Catheter is intended for one-time use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumima
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number