The PM2+ System and SmartPICC Stylet is indicated for guidance and positioning of commercially available central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording for catheter guiding and positioning, and intravascular ionic dilution for supplemental catheter navigation. The SmartPICC Stylet, when used with the PM2+ System, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When relying on the patient's ECG signal, the PM2+ System and SmartPICC Stylet is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. The SmartPICC Stylet is indicated for use with PICC lines having a minimum lumen diameter of 0.021".

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion the use of an additional method is required to confirm catheter tip location.

Device Description

The PM2+ System and SmartPICC Stylet is a device used by clinicians for bedside navigation and tip location confirmation of central venous catheters including PICCs. The PM2+ System and SmartPICC Stylet provide real-time catheter tip location information by using intravascular ECG (ivECG). The SmartPICC Stylet provides intravascular ECG for catheter tip location confirmation as well as an optional, ionic dilution navigation feature. The SmartPICC Stylet is used only during PICC installation, and removed once the PICC tip position is confirmed to be at the target location. The SmartPICC Stylet is electrically connected to the PM2+ system which processes, displays, and stores the ECG waveforms as well as the ionic dilution data. The PM2+ System is also compatible with the commercially available ECGuide Connector.

AI/ML Overview

The provided FDA 510(k) clearance letter for the PM2+ System and SmartPICC Stylet does not include acceptance criteria or a detailed study that proves the device meets specific acceptance criteria related to its primary function (catheter tip placement confirmation using ECG).

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics derived from a clinical trial.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

This information is not provided in the document. The clearance letter states that "Performance testing performed on the PM2+ System and SmartPICC Stylet verified that device performance requirements including tensile strength, insertion force, corrosion resistance, catheter compatibility, leak testing, infusion rate testing, ionic dilution performance testing, algorithm verification, electrical hardware verification, sterile barrier packaging testing, biocompatibility, electrical safety, EMC, software verification and validation, design validation and human factors validation. All tests were successfully completed." However, the specific acceptance criteria (e.g., "tensile strength must be >X Newtons") and the measured performance values for these non-clinical tests are not disclosed.

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

This information is not provided for demonstrating the core performance of the device (catheter tip placement confirmation). The document explicitly states: "No human clinical data was provided to support substantial equivalence." This implies that there was no clinical test set for this specific submission to demonstrate the accuracy of the ECG-based tip localization. The performance testing mentioned in point 1 refers to non-clinical (engineering and benchtop) tests.

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. As "No human clinical data was provided," there was no clinical ground truth established for a test set in this submission.

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

This information is not provided. As "No human clinical data was provided," there was no clinical test set requiring an adjudication method.

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

This information is not provided. The device is a "Tip Location System" and "Stylet," which assists in the placement of central venous catheters. It's not described as an AI system that improves human readers of medical images. The primary use case is direct guidance during placement, not interpretation of images post-placement. The clearance relies on substantial equivalence to predicate devices, where the ECG-based tip confirmation method is already established.

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

A standalone performance evaluation of the algorithm's accuracy in determining catheter tip location is not explicitly detailed with specific metrics. While "algorithm verification" is listed as a completed test, the specific methodology, dataset, and performance criteria for this verification are not disclosed. The device description explicitly states it provides "real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information," which implies it has an embedded algorithm, but its standalone performance against a ground truth is not specified in this document.

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

For the non-clinical tests (tensile strength, etc.), the ground truth would be established by objective physical measurements. However, for the crucial function of accurate catheter tip placement confirmation using ECG, the document does not specify the type of ground truth used for algorithm verification, nor does it provide a clinical study where a ground truth (e.g., fluoroscopy, chest X-ray interpreted by experts, or MRI) would be established for comparison. The clearance implies that the underlying technology (ivECG for tip location) is already validated from the predicate devices.

8. The sample size for the training set

This information is not provided. Given "No human clinical data was provided" for the current submission, and the reliance on substantial equivalence, details about a training set for a new algorithm performance claim are absent. If the "algorithm verification" refers to the core ECG-based localization, the training would have been part of the predicate device development.

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

This information is not provided. (See explanation for point 8).

In summary, the FDA 510(k) clearance for the PM2+ System and SmartPICC Stylet does not contain the detailed acceptance criteria and study data you requested for its primary function (ECG-based catheter tip localization). The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices (K200037 Piccolo Medical SmartPICC System and K240486 PM2 System and ECGuide Connector) which already use similar technology, and on successful completion of various non-clinical engineering and benchtop performance tests. The document explicitly states that "No human clinical data was provided to support substantial equivalence" for this specific submission.

Summary

FDA 510(k) Clearance Letter - PM2+ System and SmartPICC Stylet

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 29, 2025

Piccolo Medical, Inc.
Augustus Shanahan
CEO
218 Mississippi St
San Francisco, California 94107

Re: K243484
Trade/Device Name: PM2+ System and SmartPICC Stylet
Regulation Number: 21 CFR 880.5970
Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter
Regulatory Class: Class II
Product Code: LJS, DRX, DSA
Dated: April 30, 2025
Received: April 30, 2025

Dear Augustus Shanahan:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K243484 - Augustus Shanahan Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K243484 - Augustus Shanahan Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K243484

Device Name
PM2+ System and SmartPICC Stylet

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
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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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510(k)#: K243484 510(k) Summary Prepared on: 2025-04-29

Contact Details 21 CFR 807.92(a)(1)

Applicant Name	Piccolo Medical, Inc.
Applicant Address	218 Mississippi St San Francisco CA 94107 United States
Applicant Contact Telephone	6178424168
Applicant Contact	Mr. Augustus Shanahan
Applicant Contact Email	ashanahan@piccolomedical.com

Device Name 21 CFR 807.92(a)(2)

Device Trade Name	PM2+ System and SmartPICC Stylet
Common Name	Tip Location System
Classification Name	Percutaneous, implanted, long-term intravascular catheter
Regulation Number	21 CFR 880.5870
Product Code(s)	LJS, DRX, DSA

Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K200037	Piccolo Medical SmartPICC System	LJS
K240486	PM2 System and ECGuide Connector	LJS
K201286	0.9% Sodium Chloride I.V. Flush Syringe	NGT

Device Description Summary 21 CFR 807.92(a)(4)

The PM2+ System and SmartPICC Stylet is a device used by clinicians for bedside navigation and tip location confirmation of central venous catheters including PICCs. The PM2+ System and SmartPICC Stylet provide real-time catheter tip location information by using intravascular electrocardiogram (ivECG). The SmartPICC Stylet provides intravascular ECG for catheter tip location confirmation as well as an, optional, ionic dilution navigation feature. The SmartPICC Stylet is used only during PICC installation, and removed once the PICC tip position is confirmed to be at the target location. The SmartPICC Stylet is electrically connected to the PM2+ system which processes, displays, and stores the ECG waveforms as well as the ionic dilution data. The PM2+ System is also compatible with the commercially available ECGuide Connector.

Intended Use/Indications for Use 21 CFR 807.92(a)(5)

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Indications for Use Comparison 21 CFR 807.92(a)(5)

The indications for use for the predicate device and the subject device are the same.

Technological Comparison 21 CFR 807.92(a)(6)

The subject device is identical to the predicate K200037 SmartPICC System in its use of intravascular ECG for central venous catheter tip location confirmation as well as its optional ionic dilution navigation feature. In addition, the interaction with the PICC is identical between the two devices. There are minor differences between the packaging configuration, accessories, software system and user interface; however these minor differences do not raise different questions of safety and effectiveness.

The subject device is also equivalent to the additional predicate device (PM2 System with ECGuide Connector). There is a minor change in software between the subject PM2+ and predicate PM2 System and both are used with the same ECGuide Connector disposable component.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The determination of substantial equivalence was based on an assessment of non-clinical performance data. Performance testing performed on the PM2+ System and SmartPICC Stylet verified that device performance requirements including tensile strength, insertion force, corrosion resistance, catheter compatibility, leak testing, infusion rate testing, ionic dilution performance testing, algorithm verification, electrical hardware verification, sterile barrier packaging testing, biocompatibility, electrical safety, EMC, software verification and validation, design validation and human factors validation. All tests were successfully completed. The passing results supported the determination of substantial equivalence with the predicate device.

No human clinical data was provided to support substantial equivalence.

The information included in this premarket notification supports the substantial equivalence of the subject PM2+ System and SmartPICC Stylet to the stated predicate device. The listed reference device also provides substantial equivalence support for the electrical hardware utilized in the PM2+ System. The subject device has the same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate device and the reference devices to which it was compared. The results of the testing included in this premarket notification support a determination of substantial equivalence.

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.”