(59 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on fluid delivery and image integration without suggesting intelligent processing.
Yes
The device is intended for the delivery of medication and/or fluids to treat a condition.
No
The device is intended for the delivery of medication and fluids, not for the diagnosis of a condition. Its integration with ultrasound units is for displaying treatment information and images, not for diagnostic interpretation.
No
The device description explicitly lists hardware components including a fluid delivery module, disposable cassette, handpiece and tubing set, and a wired foot pedal. It also mentions image integration via Ethernet cable, indicating a physical connection to other hardware (ultrasound units).
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 description details a system for fluid delivery, including a fluid delivery module, cassettes, handpiece, tubing, and foot pedal. While it integrates with ultrasound for guidance, the core function is delivery, not diagnostic testing of a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The integration with ultrasound is for image guidance during the delivery procedure, which is a common feature in many medical devices used for interventions, but it doesn't make the delivery system itself 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
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. Qualified ultrasound imaging units include the SonoSite M-Turbo and SonoSite M-MSK, (configuration part numbers L05323 and L05600, respectively).
Mentions image processing
Yes
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 with image integration capability was carried out, included software validation, electrical testing of the connected devices, and simulated use testing. All data demonstrated that the safety and performance of the Navigator DS is not affected by the added ability to interface with ultrasound accessories. 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)
Navigator™ Delivery System (K101994)
Reference Device(s)
Diagnostic Ultrasound Accessory SonoSite M-Turbo and M-MSK, part of the Maxx Series (K082098)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K112067
=
t
510(k) Summary
SEP 1 6 2011
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: | July 18, 2011 |
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 (K101994) |
| Diagnostic Ultrasound Accessory | |
| SonoSite M-Turbo and M-MSK, part of the Maxx Series | |
| (K082098) | |
| 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. Qualified ultrasound imaging | |
| units include the SonoSite M-Turbo and SonoSite M-MSK, | |
| (configuration part numbers L05323 and L05600, | |
| respectively). | |
| 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. Image integration allows | |
| simultaneous display of Navigator DS treatment images on |
1
| | the ultrasound screen and printing of ultrasound screen
images in the patient treatment record. Independent
functionality of the Navigator DS device and qualified
ultrasound units is preserved. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate
Devices: | The Navigator DS with the added feature of image
integration raises no new questions of safety or
effectiveness. The Navigator DS intended use and
performance characteristics are not changed by this added
feature. |
| Performance Data: | Testing of the Navigator DS with image integration capability
was carried out, included software validation, electrical
testing of the connected devices, and simulated use testing.
All data demonstrated that the safety and performance of the
Navigator DS is not affected by the added ability to interface
with ultrasound accessories. |
| | 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 allowing imaging integration falls
within the FDA regulations for 510(k) review. The Navigator
DS with image integration capability is substantially
equivalent to the predicate device (Navigator DS K101194). |
| 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
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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
SEP 16 2011
Re: K112067
Trade/Device Name: Navigator Delivery System (or Navigator DS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: July 18, 2011 Received: July 19, 2011
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/Safetv/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 vours.
Nh for
Anthony D. Watson, B.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):
[K112067](https://510k.innolitics.com/search/K112067)
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page ___ of
(Part 21 CFR 801 Subpart D)
Rli C. A
9/14/11
(21 CFR 801 Subpart C)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112067