The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

Device Description

The NMI PICC III is a Peripherally Inserted Central Catheter (PICC). It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience and demonstrates resistance to blood components (platelet and thrombus) accumulation.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the NMI PICC III device, which is a peripherally inserted central catheter. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study to meet specific acceptance criteria in the context of an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable to this type of regulatory submission.

However, I can extract the information related to the device's technical specifications and the non-clinical tests performed to support its equivalence.

Here's a summary based on the provided text, with "N/A" for sections not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI/ML device. Instead, it lists technical specifications and performance characteristics that the device is stated to meet, largely by demonstrating equivalence to a predicate device through non-clinical testing.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (NMI PICC III)
Intended Use: Short- or long-term peripheral access to central venous system for IV therapy, blood sampling, CVP monitoring, power injection.	Meets intended use.
Configurations: Single and multi-lumen in 4F-6F diameter.	Available in single and multi-lumen, 4F-6F.
Maximum Power Injector Setting: Up to 325 psi.	Rated for up to 325 psi.
Maximum Power Injection Flow Rate (model-dependent).	4F Single Lumen - 55cm: 3.5 mL/sec 5F Single Lumen - 55cm: 5 mL/sec 5F Dual Lumen - 55cm: 4 mL/sec 6F Dual Lumen - 55cm: 5 mL/sec
Resistance to blood components (platelet and thrombus) accumulation.	Demonstrates resistance to blood components accumulation.
Compliance with EN ISO 10555-1:2009.	Compliant with EN ISO 10555-1:2009.
Compliance with EN ISO 10555-3:1997 Corrigendum 1:2002.	Compliant with EN ISO 10555-3:1997 Corrigendum 1:2002.
Compliance with FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995"	Compliant with FDA Guidance.
Gravity Flow Rate characteristics.	Gravity Flow Rate evaluated.
Priming Volume characteristics.	Priming Volume evaluated.

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

N/A. This is a non-clinical testing submission for a physical medical device, not an AI/ML diagnostic system with a "test set" of data in the common AI/ML sense. The testing involved physical device samples (implicitly, as part of standard medical device testing, but specific numbers are not given). The tests were conducted according to international standards and FDA guidance.

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

N/A. Ground truth in this context refers to engineering specifications and performance characteristics tested against established standards, not diagnostic data adjudicated by experts.

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

N/A. Not applicable to engineering tests of a physical device.

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

N/A. This is a 510(k) for a physical medical device, not an AI-assisted diagnostic system.

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

N/A. Not applicable to a physical medical device.

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

The "ground truth" for this device's performance is based on engineering specifications, established international standards (EN ISO 10555-1, EN ISO 10555-3), and FDA guidance documents. Performance attributes like flow rates, pressure ratings, and material resistance are measured against these objective criteria.

8. The sample size for the training set

N/A. There is no AI/ML "training set" for this physical medical device.

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

N/A. Not applicable.

Summary

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K133264

Navilyst Medical, Inc.

Re: NMI PICC III, Special 510(k)

510(K) SUMMARY FOR THE NMI PICC III

Date prepared: 22-October 2013

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact

Brandon M. Brackett Specialist, Global Regulatory Affairs 508-658-7984

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

C. Device Name

Trade Name Common/Usual name: Classification Name:

Classification Panel:

D. Predicate Device

Common/Usual name:

Classification Name

Classification Panel: Premarket Notification

E. Device Description

Intended Use

Maximum Power Injection Flow Rate
Description	Flow Rate
4F Single Lumen - 55cm length	3.5 mL/sec
5F Single Lumen - 55cm length	5 mL/sec
5F Dual Lumen - 55 cm length	4 mL/sec
6F Dual Lumen - 55cm length	5 mL/sec

NOV 20 2013

NMI PICC III

Peripherally Inserted Central Catheter (PICC) Short and Long-Term Intravascular Catheter, (21CFR§880.5970, Class II) General Hospital

Peripherally Inserted Central Catheter (PICC)

Percutaneous, Implanted, Long-Term Intravascular Catheter 21CFR§880.5970, Class II General Hospital K131942 (NMI PICC III and NMI HPICC III)

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

The proposed device incorporates identical materials, design, components and technological characteristics as the predicate intravascular catheters.

In brief, both the proposed and predicate devices are:

. intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, for central venous pressure monitoring and power injection of contrast media;
available in single and multi-lumen configurations in a wide range of sized from 4F to 6F . outside catheter diameter;
. rated for maximum power injector settings up to 325 psi;
rated for maximum power injection flow rate up to 5 ml/second based on model; .
available kitted with a range of procedural accessories for user convenience; and, .
. demonstrate resistance to blood components (platelet and thrombus) accumulation.

G. Performance Data

The NMI PICC III is substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation conducted in accordance with the following FDA guidance documents, international standards, and testing which included:

EN ISO 10555-1:2009, Sterile, Single use intravascular catheters Part 1: General . Requirements
EN ISO 10555-3:1997 Corrigendum 1:2002, Sterile, Single-Use Intravascular Catheters -. Part 3: Central Venous Catheters
. FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995"
Gravity Flow Rate o
Priming Volume .

H. Conclusion

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 20, 2013

Navilyst Medical, Incorporated Mr. Brandon M. Brackett Specialist, Globel Regulatory Affairs 26 Forest Street MARLBOROUGH MA 01752

Re: K133264

Trade/Device Name: NMI PICC III Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 22, 2013 Received: October 23, 2013

Dear Mr. Brackett:

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: CDRFI docs 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 (OS) 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/Resourcesfor You/Industry/default,htm.

Sincerely yours.

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for

Erin Keith M.S. Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133264

Device Name NMI PICC III

Indications for Use (Describe)

The NMI PICC III is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

Maximum Power Injection Flow Rate Description Flow Rate 4F Single Lumen - 55cm length 3.5 mL/sec SF Single Lumen - 55cm length 5 mL/sec 5F Dual Lumen - 55 cm length 4 mL/sec 6F Dual Lumen - 55cm length 5 mL/sec

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

. " " Start Status " " Martin For For USE ONLY - Status" (1992) " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " ్నార్లు ప్రాం Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2013.11.19 15:41:37 -05'00'

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”