(28 days)
Not Found
No
The document describes a fluid delivery system with optional ultrasound image integration for display and printing, but there is no mention of AI or ML being used for analysis, processing, or control.
Yes
Explanation: The device is intended for the "delivery of medication and/or fluids," which directly relates to therapeutic intervention.
No
The device is described as a delivery system for medication and fluids, not for diagnosis. Although it can integrate with ultrasound units for display and record-keeping, its primary function, as stated in "Intended Use / Indications for Use" and "Device Description", is to deliver substances in a controlled manner.
No
The device description explicitly lists hardware components such as a fluid delivery module, disposable cassette, handpiece and tubing set, and a wired foot pedal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of medication and/or fluids in a controlled manner" and "intermittent delivery of medications and other fluids in intra-articular applications." This describes a therapeutic or procedural device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The components listed (fluid delivery module, cassette, handpiece, tubing set, foot pedal) are all consistent with a system designed for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
The mention of image integration with ultrasound is for displaying treatment information and printing images, which supports the procedural nature of the device, not an IVD function.
N/A
Intended Use / Indications for Use
The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a daily disposable cassette, a per-patient disposable handpiece and tubing set, and wired foot pedal. Image integration with qualified ultrasound units occurs by Ethernet cable connection, if desired, allowing simultaneous display of Navigator treatment information on the ultrasound screen and printing of ultrasound images on the patient treatment record.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
intra-articular
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)
Testing of the Navigator DS was carried out, including performance testing. All data demonstrated that the safety and performance of the Navigator DS is not affected by the alarm modification. A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved. A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
.
APR 1 6 2012
:
510(k) Summary
SUBMITTER'S INFORMATION
| Owner: | Carticept Medical, Inc. |
|---|---|
| Address: | 6120 Windward Parkway, Suite 220, Alpharetta, GA 30005 |
| Phone: | 770-754-3800 |
| Fax Numbers: | 770-754-3808 |
| Contact Person: | Tanya Eberle, Director, Regulatory Affairs |
| Date Summary Prepared: | March 16, 2012 |
DEVICE INFORMATION
| Name of Device: | Navigator™ Delivery System (Navigator DS) |
|---|---|
| Common/Usual Name: | Infusion Pump, External |
| Classification Name: | Infusion Pump, Class II, 21 CFR 880.5725 (Product Code |
| FRN) | |
| Predicate Device(s): | Navigator™ Delivery System (K112067) |
| Device Description: | The Navigator Delivery System (Navigator DS) consists of a |
| fluid delivery module, a daily disposable cassette, a per- | |
| patient disposable handpiece and tubing set, and wired foot | |
| pedal. Image integration with qualified ultrasound units | |
| occurs by Ethernet cable connection, if desired, allowing | |
| simultaneous display of Navigator treatment information on | |
| the ultrasound screen and printing of ultrasound images on | |
| the patient treatment record. | |
| Indication for Use: | The Navigator™ Delivery System (Navigator DS) is intended |
| for use in the delivery of medication and/or fluids in a | |
| controlled manner. The Navigator DS is indicated for use in | |
| the intermittent delivery of medications and other fluids in | |
| intra-articular applications. | |
| Technological | |
| Characteristics: | All technological and design aspects of the Navigator DS |
| device are preserved. | |
| Comparison to Predicate | |
| Device: | The Navigator DS intended use and performance |
| characteristics are not altered by this modification. |
1
Performance Data:
Testing of the Navigator DS was carried out, including performance testing. All data demonstrated that the safety and performance of the Navigator DS is not affected by the alarm modification.
A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved.
A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing.
Rationale for Substantial Equivalence:
This minor modification falls within the FDA regulations for 510(k) review. The indication for use, intended use, technological characteristics, principles of operation, and performance have not been altered. The removal of this feature does not raise any new questions of safety or effectiveness and the system has been demonstrated to provide the same level of performance as the predicate device. The Navigator DS with aligned alarm settings is substantially equivalent to the predicate device (Navigator DS K112067).
Conclusion:
The Navigator DS, as modified by this 510(k), does not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale.
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 consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tanya Eberle Director. Regulatory Affairs Carticept Medical, Incorporated 6120 Windward Parkway, Suite 220 Alpharetta, Georgia 30005
APR 1 6 2012
Re: K120830
Trade/Device Name: Navigator Delivery System (Navigator DS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN Dated: March 16, 2012 Received: March 19, 2012
Dear Ms. Eberle:
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.
3
Page 2- Ms. Eberle
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 yours,
Anthony D. Watson, B.S., M.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
4
Indications for Use Statement
510(k) No. (if known): K120830
Device Name:
Navigator™ Delivery System (Navigator DS)
Indications for Use:
The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Lijl Uli for RZC Apr 13, 2012
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KJ20830