The Navigator™ AE is an infiltration pump used with the Cellfina handpiece to cause a flow of dilute Lidocaine from a bag for subcutaneous delivery of anesthetic in a manner controlled manually by a healthcare professional. The Navigator is not intended for use as an IV infusion pump.

Device Description

The Navigator AE is an optional fluid delivery mechanism for use with the Cellfina Aesthetic handpiece. The device is comprised of the following major components: (1) a fluid delivery module (pump drive unit); (2) a disposable cassette that is designed for single use; and, (3) a wired USB foot pedal. The Navigator AE components interface with a commercially available single-use handpiece and tubing set that is discarded following use on a specific patient.

AI/ML Overview

The provided text describes the acceptance criteria and performance testing of the Navigator Aesthetic Delivery System (Navigator AE), an infiltration pump.

Here's the breakdown of the information requested:

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

The document doesn't present a direct table of acceptance criteria with corresponding performance metrics in a concise format. Instead, it describes various performance tests and the overall conclusion that the device "functions as designed and can be operated by the user as intended," and that "The performance data demonstrates that the Navigator Aesthetic Delivery System is substantially equivalent to the named predicates."

However, we can infer the acceptance criteria from the "Performance Testing Summary" and list the reported performance implicitly:

Acceptance Criteria (Inferred from Performance Testing Summary)	Reported Device Performance (Implicit)
Functionality
Characterization of system functionality over expected conditions of use (fluidic properties, environmental characteristics)	Testing confirmed system functionality.
Flow rate characterization, accuracy of volumes dispensed, flow profiles, flow rate accuracy	Testing confirmed flow rate characterization, accuracy of volumes dispensed, flow profiles, and flow rate accuracy.
Occlusion testing	Occlusion testing was performed.
Integrity of fluid pathway components	Integrity of fluid pathway components was confirmed.
Reliability assessment	Reliability assessment was performed.
Shipping studies per ISTA 2a	Shipping studies per ISTA 2a were performed.
Software
Development in accordance with EN 62304:2006	Software was developed in accordance with EN 62304:2006 and evaluated.
Documentation for Major Level of Concern software provided	Documentation for Major Level of Concern software was provided.
Software verification and validation (including static analysis)	Software verification and validation testing, including software static analysis, was performed.
Zero unresolved software anomalies	Zero unresolved software anomalies were reported.
Electrical Safety and Electromagnetic Compatibility
Verification through testing in accordance with UL60601-1, IEC 60601-2-24, IEC 60601-1-2	Electrical safety and electromagnetic compatibility were verified through testing in accordance with these standards.
Biological and Drug Compatibility
Biocompatibility per ISO 10993-1 (Cytotoxicity, Sensitization, Hemolysis, Irritation, Acute Systemic Toxicity)	Biocompatibility testing was performed per ISO 10993-1, covering Cytotoxicity, Sensitization, Hemolysis, Irritation, and Acute Systemic Toxicity.
Extractables/leachables testing per ISO 10993-18	Extractables/leachables testing was performed per ISO 10993-18.
Drug compatibility and particulate analysis per USP <788>	Drug compatibility and particulate analysis were performed per USP <788>.
Sterility and Shelf Life
Sterilization validation methodology in accordance with ISO 11135	Sterilization validation methodology in accordance with ISO 11135 was described.
Ethylene oxide residuals for ethylene oxide and ethylene chlorohydrin specification limits per ISO 10993-7	Ethylene oxide residuals specification limits were established per ISO 10993-7.
Sterility Assurance Level of 10^-6	Sterility Assurance Level is 10^-6.
Non-pyrogenic claims verified through Kinetic Chromogenic LAL and Material-Mediated Rabbit Pyrogen testing per ISO 10993-11	Non-pyrogenic claims were verified through specified testing.
Shelf Life of 6 months established with accelerated aging data per ASTM F1980	A Shelf Life of 6 months was established with accelerated aging data.
Package integrity and functional attributes remain within specifications	Testing verified package integrity and functional attributes remained within established specifications.
Human Factors
Simulated use/human factors studies	A simulated use study of human factors was conducted with intended users in the intended use environment.
Evaluation of device performance, possible use error, user perception of difficulties, and critical tasks/use scenarios	The study assessed these aspects and demonstrated that the Navigator AE functions as designed and can be operated by the user as intended.

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

The document does not explicitly state the sample sizes for the "test set" for most of the performance criteria. The testing discussed seems to involve engineering, laboratory, and simulated use studies rather than clinical data with a traditional "test set" of patient cases.

Functionality: Number of units or test conditions are not specified.
Software: "Zero unresolved software anomalies were reported," but the exact scope or sample size of testing is not detailed.
Electrical Safety and EMC: Not specified.
Biological and Drug Compatibility: Not specified (e.g., number of samples for each test).
Sterility and Shelf Life: Not specified for sterilization validation, but a "Shelf Life of 6 months" was established.
Human Factors: A "simulated use study" was conducted with "intended users," but the number of users or sessions is not specified.

Data Provenance: The studies appear to be laboratory-based and simulated use studies, rather than retrospective or prospective human clinical data from specific countries.

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 provided in the document. The studies described are primarily engineering, software, and laboratory tests, and a simulated human factors study. There is no mention of experts establishing a "ground truth" for a test set in the context of clinical evaluation or image interpretation. A "Clinical Evaluation was determined not to be required for the Navigator AE."

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

This information is not applicable/not provided. The performance tests are technical validations (e.g., flow rate accuracy, electrical safety, software V&V) and a simulated human factors study, not clinical studies requiring adjudication of outcomes or diagnoses.

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

There is no mention of an MRMC study or AI assistance in the document. The Navigator AE is an infusion pump, a hardware device, and not an AI-powered diagnostic or assistive tool for human readers.

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

This concept is not applicable as the device is an infusion pump. However, much of the performance testing (functionality, software, electrical safety, biological compatibility, sterility) can be considered "standalone" in the sense that it evaluates the device's inherent technical performance without a human operator performing clinical tasks. The human factors study involved human interaction, but its purpose was to evaluate usability and potential use errors.

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

The "ground truth" for the Navigator AE's performance is established by engineering specifications, recognized national and international standards (e.g., ISO, IEC, UL, ASTM, USP), and documented design requirements. For example:

Fluid flow accuracy tested against defined flow rate and volume specifications.
Software performance verified against design requirements and EN 62304.
Electrical safety tested against UL60601-1, IEC 60601-2-24, and IEC 60601-1-2.
Biocompatibility against ISO 10993-1.
Sterility against ISO 11135 and a specified Sterility Assurance Level.

For the human factors study, the "ground truth" would be the expected safe and effective operation of the device by intended users according to its design and instructions, with deviations representing potential use errors.

8. The sample size for the training set

This information is not provided and is largely not applicable in the context of device performance testing for an infusion pump. The device does not appear to involve machine learning or AI models that require a "training set." The development process follows engineering and software development methodologies (e.g., V&V per EN 62304), not AI model training.

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

As there is no mention of a training set for machine learning/AI, this question is not applicable. The "ground truth" for the device's design and operation is established by engineering principles, regulatory requirements, and international standards, as described in point 7.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, arranged in a row. The faces are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 30, 2015

Carticept Medical, Inc. c/o Ms. Rachel Kennedy Regulatory and Clinical Research Institute 5353 Wayzata Blvd. Suite 505 Minneapolis, MN 55416

Re: K151255

Trade/Device Name: Navigator Aesthetic Delivery System (Navigator AE) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 30, 2105 Received: December 1, 2015

Dear Ms. Kennedy:

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. Iisting 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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151255

Device Name

Navigator Aesthetic Delivery System (Navigator AE)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional 510(k) Summary

Submitted by:	Carticept, Inc.
Contact Person:	Carribeth RameyVice President, EngineeringCarticept Medical, Inc.Email: cramey@carticept.com
Date of Summary:	December 30, 2015
Device Trade Name:	Navigator Aesthetic Delivery System (Navigator AE)
Model Number:	NAV-013 (FDM), NAV-014 (Foot Pedal Control), NAV-037(Cassette), Software version 5.1.1.0
Product Code:	FRN
Common or Usual Name:	Infusion Pump, External
Classification Name:	Infusion pump (21 CFR 880.5725)
Predicate Device(s):	Carticept's Navigator DS (K124053)HK Surgical's KleinTouch Pump (K123822)
Reference Predicate:	The Cellfinal Aesthetic handpiece was cleared by FDA on April14, 2014 as part of the Cabochon Aesthetics, CabochonSystem, K134010.
Device Description:	The Navigator AE is an optional fluid delivery mechanism foruse with the Cellfina Aesthetic handpiece. The device iscomprised of the following major components: (1) a fluiddelivery module (pump drive unit); (2) a disposable cassette thatis designed for single use; and, (3) a wired USB foot pedal. TheNavigator AE components interface with a commerciallyavailable single-use handpiece and tubing set that is discardedfollowing use on a specific patient.

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Indication for Use:	The Navigator™ AE is an infiltration pump used with the Cellfina handpiece to cause a flow of dilute Lidocaine from a bag for subcutaneous delivery of anesthetic into a patient in a manner controlled manually by a healthcare professional. The Navigator is not intended for use as an IV infusion pump.
	Predicate Indication for Use:
	The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch Pump is not intended to be used as an IV infusion pump.
	The indications for the Navigator AE describe the intended application of the device, in contrast to the very general terms used in the predicate indication statement. These differences do not reflect an actual difference in the manner in which these devices are used, based on a review of labeling. For this reason, the differences do not impact safety and effectiveness of the device when used as labeled.
Rationale for SubstantialEquivalence:	The Navigator AE is substantially equivalent to the HK Surgical KleinTouch Pump (K123822). The Navigator AE raises no new questions of safety or effectiveness as compared to the KleinTouch Pump. The Navigator AE has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Navigator AE and its predicate devices raise no new issues of safety or effectiveness.
TechnologicalCharacteristics:	The Navigator AE fluid delivery module is a software-driven, microprocessor controlled electromechanical system that pulls fluids from an IV bag and pushes them through the cassette to a commercially available handpiece assembly for delivery to the patient. Delivery volumes and rates are programmed by the operator on an LCD touch screen display.
	All aspects of the fluid delivery module are contained within a plastic housing that receives the system-dedicated, sterile, disposable cassette. Once installed, the cassette is the point of attachment for the commercially available per-patient tubing and handpiece set. The wired foot pedal control interfaces with the fluid pump via USB for wired control of fluid delivery. The system operates with user-provided disposable supplies, such as off-the-shelf IV bag(s) and tubing sets. (All technological aspects of the Navigator DS device are preserved with the exception of ultrasound imaging and over-pressure alarm features.)
Performance TestingSummary:	The following performance data was the basis for the a substantial equivalence determination:
	An assurance case was provided for the Navigator Aesthetic Delivery System, per the FDA guidance

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document, Infusion Pumps Total Product Life Cycle.

The stated goal of the assurance case is to document that the design of the Navigator AE System is adequately safe for its intended use.

The assurance case defined the device system, including the indications for use, system specifications, use environments, and user population. The supporting assurance arquments covered the following attributes:

Mitigation of device hazards, including infusion o delivery errors, incorrect therapy, biological/chemical hazards, and traumatic injuries.
Mitigation of hazardous situations о
Adequacy of risk management O
Device reliability o
System performance specifications are acceptable O for the intended use
Device is accurate under expected conditions of use O

The following specific evidence was included within the assurance case:

Functionality

Testing to characterize the system functionality over ● expected conditions of use, including fluidic properties and environmental characteristics.
. Flow rate characterization, accuracy of volumes dispensed, flow profiles and flow rate accuracy.
. Occlusion testing,
Integrity of fluid pathway components. ●
Reliability assessment
. Shipping studies per ISTA 2a

Software

Device Software Version 5.1.1.0/5.1.1.0 was developed ● in accordance with EN 62304:2006 and evaluated as part of this 510(k) Submission.
. Documentation for Major Level of Concern software was provided, as recommended by the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
. Software verification and validation testing, including software static analysis.
. Zero unresolved software anomalies were reported.

Electrical Safety and Electromagnetic Compatibility

Electrical safety and electromagnetic compatibility were ● verified through testing in accordance with UL60601-1. IEC 60601-2-24 and IEC 60601-1-2.

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Biological and Druq Compatibility

Biocompatibility per ISO 10993-1
- o Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10 O
- Hemolysis per ISO 10993-4 O
- O Irritation per ISO 10993-10
- Acute Systemic Toxicity per ISO 10993-11 O
Extractables/leachables testing per ISO 10993-18, . Biological evaluation of medical devices - Part 18: Chemical characterization of materials
. Drug compatibility and particulate analysis per USP <788> Particulate Matter in Injections

Sterility and Shelf Life

The Navigator AE Cassettes are sterilized with Ethylene . Oxide gas.
Sterilization validation methodology in accordance with ISO 11135 was described.
. Ethylene oxide residuals for ethylene oxide and ethylene chlorohydrin specification limits were established per ISO 10993-7.
Sterility Assurance Level is 10°6 .
. Non-pyrogenic claims for the Navigator AE Cassettes were verified through Kinetic Chromogenic LAL and Material-Mediated Rabbit Pyrogen testing per ISO 10993 Biological evaluation of medical device - Part 11: Tests for systemic toxicity.
. A Shelf Life of 6 months was established with accelerated aging data per ASTM F1980. Testing verified package integrity (ASTM F88/F1929) and functional attributes of the Navigator AE Cassette remained within established specifications. A protocol for real-time aging was evaluated to assure ongoing stability.

Human Factors

Simulated use/human factors studies A Clinical Evaluation was determined not to be required for the Navigator AE. A simulated use study of human factors was conducted with intended users in the intended use environment that evaluated device performance, possible use error and user perception of difficulties with pump use. The study assessed the critical tasks or use scenarios where use related errors are most likely to occur.
The assurance case and referenced evidence demonstrate that the Navigator AE functions as designed and can be operated by the user as intended through the user interface and instructions provided.

Summary of Substantial

The performance data demonstrates that the Navigator

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Equivalence

Aesthetic Delivery System is substantially equivalent to the named predicates.

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).