The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen of 0.021". The SmartPICC system provides real-time catheter tip location information by using the patient's cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.

Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.

Device Description

The Piccolo Medical SmartPICC System is a device used by clinicians for guidance and positioning of commercially available central venous catheters. The reusable SmartPICC System consists of a computer tablet with data processing and display capabilities, a SmartPICC Controller data acquisition module, and a Kit that includes a single use sterile SmartPICC Stylet to enable the use of ivECG confirmation of final PICC tip location by the clinician who is placing the catheter. The SmartPICC System has a supplemental ionic dilution navigation feature to provide qualitative blood flow direction information which requires 5% Dextrose infusion utilizing a mechanical syringe driver, a sterile 20 ml disposable syringe, and tubing with extension set to provide constant flow rate infusion to the SmartPICC Stylet distal tip.

Additional components associated with the reusable system include a USB cable to connect the tablet to the controller and an external ECG (xECG) Trunk Cable to connect the xECG leads to the controller.

Additional accessories in the Stylet Kit include:

Sterile Drape Clip to secure Stylet hub to sterile patient drape
Sterile cover for the tablet
Sterile scissors for opening sterile tubing pouch
xECG Electrodes and Leads
Instructions for Use

AI/ML Overview

The Piccolo Medical SmartPICC System is intended to help position Peripherally Inserted Central Catheters (PICC) in adult patients by providing real-time catheter tip location information using intravascular ECG (ivECG) signals. It also includes a supplemental ionic dilution feature for qualitative blood flow information to assist catheter navigation.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage accuracy or precision target) for the performance of the SmartPICC system. Instead, the "Summary of Human Factors Testing" states that the simulated use testing "adequately reviewed" the device's application to ensure "safe, effective use" and demonstrated "suitability for its intended purpose." This suggests that the acceptance criteria for this study were likely qualitative and focused on the device's ability to facilitate correct PICC tip placement and user comprehension of the device's output.

While no precise performance metrics are given, the overall conclusion is that the device should "perform as intended" and is "substantially equivalent" to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Safe and Effective Use	Demonstrated suitability for intended purpose through simulated use. Non-clinical data supports safety.
Proper PICC Tip Placement	System effectively aids in confirming tip location as an alternative to chest x-ray/fluoroscopy.
User Comprehension	Instructions for Use and hazard analysis considered adequate for safe and effective use.
Substantial Equivalence	Performance is substantially equivalent to the predicate device.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the exact sample size for the "Simulated Use / Human Factors Testing." It only mentions "Human Factors Testing."
Data Provenance: The document does not specify the country of origin of the data nor if it was retrospective or prospective. Given it was "Simulated Use," it was likely prospective, but the location is not mentioned.

3. Number of Experts and Qualifications for Ground Truth in Test Set

The document does not specify the number of experts used to establish ground truth for the human factors/simulated use testing, nor does it detail their qualifications. It only states that the testing was conducted to evaluate the application of the system.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the "Simulated Use / Human Factors Testing."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance versus without. The study described is a "Simulated Use / Human Factors Testing," which focuses on the device's application and user interaction, not a reader study of clinical images.

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop) performance study evaluating the accuracy of the ivECG signal interpretation or ionic dilution feature in isolation. The human factors testing involved the device being used by humans.

7. Type of Ground Truth Used (Test Set)

For the "Simulated Use / Human Factors Testing," the type of ground truth used is not explicitly stated. However, since the test aimed to confirm "PICC tip position," it can be inferred that the ground truth would have been the actual, verified PICC tip position established by a gold standard method during the simulation, although the specific method is not detailed. The comparison to chest x-ray or fluoroscopy confirmation suggests these are the accepted gold standards the device aims to emulate or provide an alternative to.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The text indicates that "Clinical testing was determined to be not applicable for this 510(k) submission. Bench testing was sufficient to demonstrate substantial equivalence of the Smart PICC System to the predicate device." This suggests the device's performance was not primarily established through a machine learning model requiring a large training set, but rather through engineering and human factors validation demonstrating equivalence to a predicate device.

9. How Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing ground truth for a training set is not applicable or provided in this document.

Summary

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January 22, 2021

Piccolo Medical, Inc. % Allison Kumar Principal Consultant Arina Consulting 27 Hilltop Drive San Carlos, California 94070

Re: K200037

Trade/Device Name: Piccolo Medical SmartPICC System Regulation Number: 21 CFR 880.5970880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: January 8, 2021 Received: January 12, 2021

Dear Allison Kumar:

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. 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 located 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.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.

Jessica Paulsen Division Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200037

Device Name Piccolo Medical SmartPICC System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

l. SUBMITTER

	Submission Date:	December 31, 2019
	Submitter Information:
	Company:	Piccolo Medical, Inc.101 Mississippi StreetSuite 500San Francisco, CA 94107
	Official Correspondent:	Alexey SalaminiCEOPiccolo Medical, Inc.617-407-1026asalamini@piccolomedical.com
	Additional Contacts:	Allison KumarArina Consulting, LLCallison@arinaconsulting.com
II.	DEVICE
	Trade Name:	SmartPICC System
	Common Name:	Accessory to Percutaneous, implanted, long-termintravascular catheter
	Device Class:	II
	Regulation Number:	880.5970
	Product Code:	LJS
	Review Panel:	General Hospital

III. PREDICATE DEVICE

Angiodynamics Celerity PICC Tip Positioning Aid (K142889)

Vasonova VPS System (K103255) – Reference Device

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IV. INDICATIONS FOR USE

The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen diameter of 0.021". The SmartPICC system provides real-time catheter tip location information by using the patient's cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.

Note: Use of the intravascular ECG (ivECG) technique to replace xray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-rav or fluoroscopy) is required to confirm catheter tip location.

DEVICE DESCRIPTION V.

The Piccolo Medical SmartPICC System is a device used by clinicians for quidance and positioning of commercially available central venous catheters. The reusable SmartPICC System consists of a computer tablet with data processing and display capabilities, a SmartPICC Controller data acquisition module, and a Kit that includes a single use sterile SmartPICC Stylet to enable the use of ivECG confirmation of final PICC tip location by the clinician who is placing the catheter. The SmartPICC System has a supplemental ionic dilution navigation feature to provide qualitative blood flow direction information which requires 5% Dextrose infusion utilizing a mechanical syringe driver, a sterile 20 ml disposable syringe, and tubing with extension set to provide constant flow rate infusion to the SmartPICC Stylet distal tip.

Additional accessories in the Stylet Kit include:

Sterile Drape Clip to secure Stylet hub to sterile patient drape ●
. Sterile cover for the tablet
Sterile scissors for opening sterile tubing pouch ●
xECG Electrodes and Leads ●
Instructions for Use

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Attribute	SUBJECT:Piccolo MedicalSmartPICC System	PREDICATE:Angiodynamics Celerity PICCTip Positioning Aid	Comparison
510K No	K2000037	K142889
Procode	LJS	LJS
Date	Pending	February 15, 2015
Intended Use	Provides real time tip locationinformation of PICC by usingivECG to position PICC inCAJ.	Provides real time tip locationinformation of PICC by usingivECG to position PICC inCAJ.	SAME
OperatingPrinciple/Technology	ivECG for CAJ identificationand supplemental ionicdilution feature for qualitativeblood flow information	ivECG for CAJ identification	TECHNOLOGICALDIFFERENCE
Alternative toX-ray CAJConfirmation	Yes - HumanFactors/Simulated UseTesting	Yes - HumanFactors/Simulated UseTesting	SAME
TargetPopulation	Adults 18 and over	Adults 18 and over	SAME
UseEnvironment	Hospital, clinic, skillednursing, rehab clinic	Hospital, clinic, skillednursing, rehab clinic	SAME
Clinical Use	Single person operation	Single person operation	SAME

Discussion of Differences: The SmartPICC differs from the predicate in that the SmartPICC has a supplementary feature that uses ionic dilution to provide qualitative blood flow direction information to the user to aid in catheter navigation. This feature was validated with performance testing and its methodology supported by the reference device and does not raise new questions of safety or effectiveness.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation of the SmartPICC was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, "" May 1, 1005, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
Sensitization ●
Irritation ●
Acute system toxicity ●
Hemolysis ●

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Thrombogenicity
. Pvrogenicitv

The SmartPICC device is considered tissue and blood contacting for a duration of less than 24 hours.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the SmartPICC device. The system complied with the IEC 60601-1 Ed. 3.1 2012 standard for operator and patient safety and EMC in the intended use environment.

Software Verification and Validation Testing and Cybersecurity

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator, either directly or indirectly through incorrect or delayed information or through the action of a care provider.

Cybersecurity was assessed and documented according to the FDA Guidance, "Off-the-shelf Software - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software."

Mechanical Testing

lonic dilution component level and system flow testing ●
Leak, Flow, Tensile, Kink, and Torque testing of the stylet 0
Syringe driver infusion rate and pressure testing ●
ECG (xECG and ivECG) verification testing ●
PICC compatibility testing o

Packaging and Shelf Life

Shelf life stability testing ●
Environmental conditioning per ASTM D4332 .
Packaging verification per ASTM F88 (peel) and ASTM F2096 o (bubble leak)

Sterilization Validation:

Validation performed with EBEAM VDMax25 process per ISO .

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11137-1, ISO 11137-2, ISO 11137-3

Summary of Human Factors Testing:

Simulated Use / Human Factors Testing was conducted to evaluate the application of the SmartPICC System when used to confirm PICC tip position as an alternative method to chest x-ray or fluoroscopy confirmation. This is the same methodology used by the reference device. The results from the use related studies have been adequately reviewed in order to ensure the safe, effective use of the device for confirmation of tip location of PICC. Based on the content of the proposed SmartPICC Device Hazard Analysis, and the content of the Instructions for Use, the SmartPICC System has demonstrated its suitability for its intended purpose.

Summary of Clinical Testing:

Clinical testing was determined to be not applicable for this 510(k) submission. Bench testing was sufficient to demonstrate substantial equivalence of the Smart PICC System to the predicate device.

CONCLUSIONS: VIII.

The non-clinical data support the safety of the device and the software verification and validation demonstrate that Piccolo Medical's SmartPICC System should perform as intended in the specified use conditions, and which are substantially equivalent to the predicate device that is currently marketed for the same intended use.

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.”