(59 days)
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.
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).
This document describes the 510(k) submission for the Navigator™ Delivery System (Navigator DS) with added image integration capability. The submission asserts that this modification does not introduce new safety or effectiveness concerns, and thus, a full clinical evaluation was not required. The study focuses on demonstrating that the added image integration feature does not negatively impact the device's original safety and performance.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Validation | All data demonstrated that the safety and performance of the Navigator DS is not affected by the added ability to interface with ultrasound accessories. |
| Electrical Testing of Connected Devices | All data demonstrated that the safety and performance of the Navigator DS is not affected by the added ability to interface with ultrasound accessories. |
| 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. |
| Acceptable Risk Profile (based on design-based risk mitigation) | A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a clinical or retrospective data set for evaluating an algorithm's performance on patient data. Instead, it appears the "test set" refers to the device itself and its interaction with the added feature. Therefore, there is no mention of sample size for patient data or data provenance (e.g., country of origin, retrospective/prospective). The testing described focuses on the device's engineering performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an engineering and functional performance evaluation of a device modification, not an assessment of an AI's diagnostic or predictive capabilities requiring expert-established ground truth on medical data.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a human-in-the-loop diagnostic task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved." This indicates the focus was not on comparing human reader performance with or without AI assistance but rather on the safety and functionality of the device with a new feature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The primary focus of this submission is a device modification. The "image integration capability" described is about displaying treatment information from the Navigator DS on an ultrasound screen and printing ultrasound images on patient treatment records. It does not appear to be an AI algorithm with standalone diagnostic or predictive performance. Therefore, a standalone algorithm performance study as typically understood for AI-driven devices was not conducted. The "software validation" mentioned would cover the functionality of this integration.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context refers to the expected functional performance and safety of the device. This was established through:
- Software Validation: Ensuring the software for image integration works as intended.
- Electrical Testing: Verifying safe electrical operation of connected devices.
- Simulated Use Testing: Confirming the device performs safely and effectively in simulated scenarios.
- Safety Case and Hazard Analysis: Identifying potential risks and ensuring mitigation measures are effective.
These are engineering and safety benchmarks, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The described image integration is a functional modification to a device and does not involve an AI algorithm that would typically require a "training set" of medical data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
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K112067
=
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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 CodeFRN) |
| Predicate Device(s): | Navigator™ Delivery System (K101994) |
| Diagnostic Ultrasound AccessorySonoSite M-Turbo and M-MSK, part of the Maxx Series(K082098) | |
| Device Description: | The Navigator Delivery System (Navigator DS) consists of afluid delivery module, a daily disposable cassette, a per-patient disposable handpiece and tubing set, and wired footpedal. Image integration with qualified ultrasound unitsoccurs by Ethernet cable connection, if desired, allowingsimultaneous display of Navigator treatment information onthe ultrasound screen and printing of ultrasound images onthe patient treatment record. Qualified ultrasound imagingunits 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 intendedfor use in the delivery of medication and/or fluids in acontrolled manner. The Navigator DS is indicated for use inthe intermittent delivery of medications and other fluids inintra-articular applications. |
| TechnologicalCharacteristics: | All technological and design aspects of the Navigator DSdevice are preserved. Image integration allowssimultaneous display of Navigator DS treatment images on |
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| the ultrasound screen and printing of ultrasound screenimages in the patient treatment record. Independentfunctionality of the Navigator DS device and qualifiedultrasound units is preserved. | |
|---|---|
| Comparison to PredicateDevices: | The Navigator DS with the added feature of imageintegration raises no new questions of safety oreffectiveness. The Navigator DS intended use andperformance characteristics are not changed by this addedfeature. |
| Performance Data: | Testing of the Navigator DS with image integration capabilitywas carried out, included software validation, electricaltesting of the connected devices, and simulated use testing.All data demonstrated that the safety and performance of theNavigator DS is not affected by the added ability to interfacewith ultrasound accessories. |
| A Clinical Evaluation was determined not to be required asthe device design, intended use and indication for use arepreserved. | |
| A Safety Case and Hazard Analysis demonstrated anacceptable risk profile based on design-based risk mitigationand satisfactory performance testing. | |
| Rationale for SubstantialEquivalence: | This minor modification allowing imaging integration fallswithin the FDA regulations for 510(k) review. The NavigatorDS with image integration capability is substantiallyequivalent to the predicate device (Navigator DS K101194). |
| Conclusion: | The Navigator DS, as modified by this 510(k), does not raiseany new issues regarding safety or effectiveness, andtherefore is suitable for commercial sale. |
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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.
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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
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Indications for Use Statement
510(k) No.
(if known):
[K112067](https://510k.innolitics.com/device/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
§ 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).