(93 days)
The NavigatorTM 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Navigator™ Delivery System (Navigator DS):
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission is for a minor modification to an already cleared device, the Navigator DS (K120830). The modification involves "modified resistance thresholds." The core approach to acceptance criteria is demonstrating that this minor change does not negatively impact safety or performance and that the device remains substantially equivalent to the predicate.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | Acceptable risk profile after modification. | Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing. |
| Performance | Performance of the Navigator DS is not affected by the modification (modified resistance thresholds). Device provides the same level of performance as the predicate. | All data demonstrated that the safety and performance of the Navigator DS is not affected by the modification. |
| Functional Equivalence | Indication for use, intended use, technological characteristics, principles of operation, and performance are not altered. No new questions of safety or effectiveness. | The Navigator DS, as modified, maintains its indication for use, intended use, technological characteristics, principles of operation, and performance, and does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical study or a distinct, statistically powered performance test with a specific sample size. Instead, it refers to "Performance Data: Testing of the Navigator DS."
- Sample Size for Test Set: Not explicitly stated. The nature of the testing implies engineering/performance testing rather than a patient-based clinical study.
- Data Provenance: Not specified. Given it's a device modification, the testing would likely be internal to the manufacturer (Carticept Medical, Inc.). It is not stated whether this was retrospective or prospective data, but "testing" generally implies prospective data generation. There is no information about the country of origin for the data beyond the manufacturer's location in Alpharetta, GA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided in the context of this submission. The submission is for a minor device modification and relies on engineering performance testing and risk analysis, not on expert-adjudicated ground truth derived from clinical data (e.g., radiologist reviews of images).
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since there's no mention of a human-reviewed test set or clinical study requiring adjudication, this concept does not apply to the provided data.
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 type of study would involve human readers evaluating cases, which is not relevant for this device modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the Navigator DS. The Navigator DS is an "Infusion Pump, External" and not an AI or algorithm-based diagnostic device. The performance data discussed refers to the physical and functional performance of the infusion pump itself (e.g., pressure thresholds, fluid delivery mechanics), not a standalone algorithm's accuracy.
7. The Type of Ground Truth Used
The "ground truth" here is the established performance specifications and safety requirements for an infusion pump, and the demonstrated functional equivalence to its predicate device. This is based on:
- Engineering specifications and test methods: To verify the modified resistance thresholds meet the intended design and function.
- Risk analysis (Safety Case and Hazard Analysis): To ensure the device's operation remains safe within defined parameters.
- Comparison to predicate device performance: The predicate (K120830) itself would have had its performance and safety verified against established standards. This submission states "the system has been demonstrated to provide the same level of performance as the predicate device."
8. The Sample Size for the Training Set
This information is not applicable or not provided. The Navigator DS is a hardware device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided for the same reason as point 8.
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510(k) Summary
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 24, 2012 |
DEVICE INFORMATION
| 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 (K120830) |
| Device Description: | The Navigator Delivery System (Navigator DS) consists of a fluiddelivery module, a daily disposable cassette, a per-patientdisposable handpiece and tubing set, and wired foot pedal.Image integration with qualified ultrasound units occurs byEthernet cable connection, if desired, allowing simultaneousdisplay of Navigator treatment information on the ultrasoundscreen and printing of ultrasound images on the patienttreatment record. |
| Indication for Use: | The NavigatorTM Delivery System (Navigator DS) is intended foruse in the delivery of medication and/or fluids in a controlledmanner. The Navigator DS is indicated for use in theintermittent delivery of medications and other fluids in intra-articular applications. |
| TechnologicalCharacteristics: | All technological and design aspects of the Navigator DS deviceare preserved. |
| Comparison to PredicateDevice: | The Navigator DS intended use and performance characteristicsare not altered by this modification. |
OC
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Performance Data:
Testing of the Navigator DS was carried out, including performance testing. 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 testing.
Rationale for Substantial Equivalence:
This minor 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 modification of resistance thresholds does 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 with modified resistance thresholds is substantially equivalent to the predicate device (Navigator DS K120830).
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2012
Carticept Medical, Incorporated Ms. Tanya Eberle Director, Regulatory Affairs 6120 Windward Parkway, Suite 220 Alpharetta, Georgia 30005
Re: K122215
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: October 1, 2012 Received: October 2, 2012
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. awat
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
K 122215
510(k) No. (if known):
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 (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
Ali (Ch) 10/26/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KI22215 510(k) Number: _
§ 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).