(72 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, ML, or any form of image analysis or processing beyond simple display and printing.
Yes
The device is described as a delivery system for medication and/or fluids in a controlled manner for intra-articular applications, indicating a direct therapeutic purpose.
No
The device is described as a delivery system for medication and fluids, not for diagnosis. While it can integrate with ultrasound units, this integration is for displaying treatment information and printing images, not for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (fluid delivery module, disposable cassette, reusable cassette housing, disposable vial clamps, handpiece and tubing, wired foot pedal).
Based on the provided information, the Navigator™ Delivery System 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 to provide information for diagnosis, monitoring, or screening.
- Device Description: The components listed (fluid delivery module, cassette, housing, clamps, handpiece, tubing, foot pedal) are all related to the physical delivery of substances into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
The mention of ultrasound integration is for visualizing the anatomical site during the procedure, not for analyzing the ultrasound images themselves for diagnostic purposes in the context of an IVD.
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 disposable cassette, a reusable cassette housing, disposable vial clamps, per-patient disposable handpiece and tubing, 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
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 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 and human factors evaluations. All data demonstrated that the safety and performance of the Navigator DS is not affected by the 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 and human factors 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.
NavigatorTM Delivery System (K122215)
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
Special 510(k) for Navigator DS Next Generation Disposables
510(k) Summary
MAR 1 3 2013
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: | December 28, 2012 |
DEVICE INFORMATION
Device Description:
Indication for Use:
Technological
Device:
Characteristics:
Comparison to Predicate
| Name of Device: | NavigatorTM 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): | NavigatorTM Delivery System (K122215) |
The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a disposable cassette, a reusable cassette housing, disposable vial clamps, per-patient disposable handpiece and tubing, 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.
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 intraarticular applications.
All technological aspects of the Navigator DS device are preserved.
The Navigator DS intended use and performance characteristics are not altered by this modification.
December 2012
1
Performance Data:
Testing of the Navigator DS was carried out, including performance testing and human factors evaluations. All data demonstrated that the safety and performance of the Navigator DS is not affected by the 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 and human factors testing.
This 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 next-generation disposables do not raise
Rationale for Substantial Equivalence:
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 next-generation disposables is substantially equivalent to the predicate device (Navigator DS K122215).
The Navigator DS next-generation disposables, as modified by this 510(k), do not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale.
Conclusion:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure, with flowing lines suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
March 13, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Tanya Eberle Director, Regulatory Affairs Carticept Medical, Incorporated 6120 Windward Pkwy Suite 220 ALPHARETTA GA 30005
Re: K124053
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: February 8, 2013 Received: February 21, 2013
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.
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
3
Page 2 - Ms. Eberle
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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital. Respiratory, 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): | K124053 | |||
|---|---|---|---|---|
| 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: | X | AND/OR | Over-the-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
.
(21 CFR 801 Subpart C)
ﺔ ﺍﻟﻌ
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Page ___ of ___ | | Richard C. Chapman
2013.03.12 09:40:33
-04'00' |
| ----------------- | ------------------------------------------------------- | ------------------------------------------------------ |
|---|
| Division Sign-Off |
|---|
| vision of Anesthesiology, General Hospital |
| fection Control, Dental Devices |
| 510(k) Number: | K124053 |
|---|---|
| ---------------- | --------- |
(Part 21 CFR 801 Subpart D)