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.

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.

AI/ML Overview

This 510(k) submission (K124053) for the Navigator DS Next Generation Disposables is a Special 510(k) which does not include a traditional study with acceptance criteria and device performance as typically expected for new device submissions or AI/ML-driven devices. Instead, it focuses on demonstrating that a modification to an already cleared device (Navigator DS, K122215) maintains the same safety and performance profile.

Therefore, many of the typical elements of a study with acceptance criteria and a table of performance are not explicitly present in the provided document. The submission argues for substantial equivalence based on the preservation of technological characteristics, intended use, and performance characteristics of the predicate device, rather than new quantitative performance metrics.

Here's an analysis based on the provided text, addressing the requested information where applicable, and noting where information is not available due to the nature of a Special 510(k) for a device modification:

1. A table of acceptance criteria and the reported device performance

Given the nature of this Special 510(k) for a modification (next-generation disposables), specific quantitative performance acceptance criteria and reported device performance in a table format, as one might find for an entirely new device or AI algorithm, are not explicitly provided or required. The acceptance criteria are implicitly that the modified device's performance, safety profile, and intended use are not altered compared to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Technological aspects are preserved.	"All technological aspects of the Navigator DS device are preserved."
Intended use is not altered.	"The Navigator DS intended use and performance characteristics are not altered by this modification." "The indication for use, intended use...have not been altered."
Performance characteristics are not altered.	"The Navigator DS intended use and performance characteristics are not altered by this modification." "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." "The system has been demonstrated to provide the same level of performance as the predicate device."
Safety profile is acceptable and not negatively impacted.	"A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance and human factors testing." "The next-generation disposables do 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 next-generation disposables... do not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale."
No new questions of safety or effectiveness are raised.	"The next-generation disposables do not raise any new questions of safety or effectiveness..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not specify a "test set" in the context of clinical data or algorithm validation with a specific sample size. The performance testing and human factors evaluations mentioned are engineering and usability tests, not a clinical study on a patient cohort. Therefore, information on patient sample size, data provenance, or retrospective/prospective nature is not applicable and not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Since there is no clinical "test set" or diagnostic algorithm requiring ground truth establishment by experts, this detail is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided for the same reasons as #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is typically performed for AI or imaging devices where human interpretation is involved. This device (an infusion pump with disposables) is a mechanical system, not an AI/imaging device requiring human interpretation, nor does it incorporate AI assistance for human readers. Therefore, no MRMC study was performed, and this information is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to the performance of an AI algorithm directly. The Navigator DS is an infusion pump, a hardware device, not an AI algorithm. Therefore, no standalone algorithm performance study was done, and this information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. As noted, there's no clinical "test set" requiring ground truth for a diagnostic purpose. The "ground truth" here is effectively the accepted performance and safety profile of the predicate device, against which the modified device's engineering and human factors performance were compared.

8. The sample size for the training set

This information is not applicable and not provided. The Navigator DS is a mechanical infusion pump, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reasons as #8.

Summary

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Special 510(k) for Navigator DS Next Generation Disposables

K124053

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)

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

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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:

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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

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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

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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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page ___ of ___		Richard C. Chapman2013.03.12 09:40:33-04'00'
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Division Sign-Off
vision of Anesthesiology, General Hospital
fection Control, Dental Devices

510(k) Number:	K124053
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(Part 21 CFR 801 Subpart D)

Regulation Number and Section

§ 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).