When used with a power injectable needle, the NMI Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Device Description

The NMI Ports are subcutaneous implantable venous access devices with one reservoir and are designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing, silicone septum covering the reservoir.

NMI Ports are available in plastic or titanium single lumen and valved or non-valved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue: whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories.

AI/ML Overview

The provided text is a 510(k) summary for the NMI Port, an implanted infusion port. As such, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's diagnostic performance or comparative effectiveness against human readers.

Therefore, the information requested in your prompt regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance, and AI-related metrics is not available in the provided document. The device in question is a medical hardware component, not an AI-powered diagnostic tool.

However, I can extract the information related to the performance data and "acceptance criteria" (in this context, meaning successful completion of specified tests for product safety and functionality) as described in the 510(k) submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test/Standard)	Reported Device Performance
Internal Product Specification Requirements	Successfully passed relevant testing
Power Injection	Successfully passed relevant testing
Valve Integrity	Successfully passed relevant testing
Port Septum Testing	Successfully passed relevant testing
Chemical/Vesicant Compatibility	Successfully passed relevant testing
Biocompatibility (per ISO 10993-1)	Successfully passed relevant testing
EN ISO 10555-1:2009 (Sterile, Single Use Intravascular Catheters - Part 1: General Requirements)	Successfully passed relevant testing
EN ISO 10555-3:1997 COR 2002 (Sterile, Single Use Intravascular Catheters Part 3: Central Venous Catheters)	Successfully passed relevant testing
FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990"	Successfully passed relevant testing (compliance with guidance)
FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995"	Successfully passed relevant testing (compliance with guidance)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document refers to "relevant testing" without detailing the number of units tested for each criterion.
Data Provenance: The tests were conducted according to FDA guidance documents and international standards. The document doesn't specify countries of origin for test data, but typically such testing is performed in accredited labs, often within the manufacturer's region (Marlborough, MA, USA for the sponsor). The nature of these tests (e.g., power injection, valve integrity) suggests laboratory-based, prospective testing of manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the study involves physical device testing against engineering and biocompatibility standards, not the establishment of ground truth from expert clinical interpretation.

4. Adjudication method for the test set:

This is not applicable for the type of performance testing described. Adjudication methods are typically relevant for human interpretation of medical images or clinical data.

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:

No. This is an implanted medical device, not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance refers to the device's operational characteristics as tested (e.g., flow rates, septum integrity).

7. The type of ground truth used:

The "ground truth" for this type of device testing consists of established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance limits defined by the guidance documents mentioned (e.g., maximum infusion rates, pressure limits). The device either met these predefined, objective criteria or it did not.

8. The sample size for the training set:

Not applicable. There is no AI model or algorithm being trained described in this document.

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

Not applicable, as there is no training set for an AI model.

Summary

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K122767

APR 3 0 2013

510(k) Summary for the NMI Port

Date prepared: 07 -Sep -2012

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact

Lorraine M. Hanley Vice President, Global Regulatory Affairs 508-494-1129

Or

Wanda M. Carpinella Director, Global Regulatory Affairs 508-658-7929

C. Device Name

Trade Name: Common/Usual name: Classification Name:

Classification Panel:

D. Predicate Device(s)

Common/Usual name:

Classification Name:

Classification Panel: Premarket Notification(s):

NMI Port

Implanted Port Catheter, Subcutaneous, Implanted, Intravascular Infusion Port and Catheter

21CFR§880.5965, Class II General Hospital

Peripherally Inserted Central Catheter (PICC)

Short and Long-Term Intravascular Catheter

21CFR§880.5965, Class II K030083, K031844, K032008, K032375, K032600, K071993, K072481 and K073210

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E. Device Description

F. Intended Use

The NMI Ports with and without PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

G. Summary of Similarities and Differences in Technological Characteristics and Performance

The proposed device has similar materials, design and components and technological characteristics as predicate port catheters. Both the NMI Ports and predicate devices are, in brieff, intended for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, available in single lumen configurations, plastic or titanium port body and 6 or 8 F outside catheter diameter, rated for maximum power injector settings up to 300 psi with maximum power injection flow rate up to 5 ml/second based on model, and available kitted with a range of procedural accessories.

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H. Performance Data

The performance evaluation of the NMI Port included testing conducting in accordance with the following FDA guidance documents and international standards:

. FDA 's "Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990.
. EN ISO 10555-1:2009, Sterile, Single Use Intravascular Catheters - Part 1: General Requirements
EN ISO 10555-3:1997 COR 2002, Sterile, Single Use Intravascular Catheters Part 3: · • Central Venous Catheters
. FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995.
Biocompatibility per ISO 10993-1 .

The proposed NMI Port successfully passed relevant testing per the above Guidance and standards including:

. Internal Product Specification Requirements
. Power Injection
Valve Integrity
Port Septum Testing .
Chemical/Vesicant Compatibility .

I. Conclusion

Based on successful results of testing and on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

April 30, 2013

Ms. Lorraine M. Hanley Vice President Global Regulatory Affairs Navilyst Medical, Incorporated 26 Forest Street MARLBOROUGH MA 01752

Re: K122767

Trade/Device Name: NMI Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: March 22, 2013 Received: March 25, 2013

Dear Ms. Hanley:

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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Page 2 - Ms. Hanley

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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.

Vor

Seth
urohitus.

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

510(k) Number (if Known):

Device Name: NMI Port

Indications for Use:

Prescription Use (21 CFR 801 Subpart D) ಸ And/Or

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)		Richard C. Chapman2013.04.29 15:22:45-04'00'
	(Division Sign-Off)Division of Anesthesiology General HospitalInfection Control, Dental Devices
510(k) Number:	K122767

4-2

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.