(380 days)
No
The summary describes a system that uses intravascular ECG and ionic dilution for catheter tip positioning. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on established physiological signal processing and fluid dynamics principles.
No
The device aids in the positioning of central catheters, but it does not treat or cure a disease or medical condition. Its function is primarily to guide and confirm placement, rather than to provide therapy.
No
The device is indicated for positioning Peripherally Inserted Central Catheters (PICC) and provides real-time catheter tip location information. While it aids in proper placement and confirms location, it does not diagnose a medical condition or disease.
No
The device description explicitly states that the system consists of hardware components including a computer tablet, a data acquisition module (SmartPICC Controller), a single-use sterile stylet, a mechanical syringe driver, and various cables and accessories. This is not a software-only device.
Based on the provided information, the Piccolo Medical SmartPICC System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is used for positioning a medical device (PICC) within the patient's body. It utilizes physiological signals (intravascular ECG) and a physical process (ionic dilution) to guide the placement of the catheter. It does not analyze biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information about a patient's health status.
- Device Description: The components described are for guiding a medical procedure within the body, not for analyzing samples in a laboratory setting.
- Performance Studies: The performance studies focus on the device's ability to accurately guide the PICC placement, electrical safety, software validation, mechanical integrity, and sterilization. There are no studies related to the analytical or clinical performance of testing biological samples.
- Predicate and Reference Devices: The predicate and reference devices are also systems for guiding catheter placement, not IVD devices.
In summary, the Piccolo Medical SmartPICC System is a medical device used for guiding a surgical/interventional procedure within the body, not for performing diagnostic tests on biological samples.
N/A
Intended Use / 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 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.
Product codes
LJS
Device Description
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults 18 and over
Intended User / Care Setting
Hospital, clinic, skilled nursing, rehab clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
- Thrombogenicity
- Pyrogenicity
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:
- Ionic dilution component level and system flow testing
- Leak, Flow, Tensile, Kink, and Torque testing of the stylet
- Syringe driver infusion rate and pressure testing
- ECG (xECG and ivECG) verification testing
- PICC compatibility testing
Packaging and Shelf Life:
- Shelf life stability testing
- Environmental conditioning per ASTM D4332
- Packaging verification per ASTM F88 (peel) and ASTM F2096 (bubble leak)
Sterilization Validation:
Validation performed with EBEAM VDMax25 process per ISO 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.
Key Metrics
Not Found
Predicate Device(s)
Angiodynamics Celerity PICC Tip Positioning Aid (K142889)
Reference Device(s)
Vasonova VPS System (K103255)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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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.
1
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
2
Indications for Use
510(k) Number (if known) K200037
Device Name Piccolo Medical SmartPICC System
Indications for Use (Describe)
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.
| 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) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
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3
510(k) Summary
l. SUBMITTER
| Submission Date: | December 31, 2019 | |
|---|---|---|
| Submitter Information: | ||
| Company: | Piccolo Medical, Inc. | |
| 101 Mississippi Street | ||
| Suite 500 | ||
| San Francisco, CA 94107 | ||
| Official Correspondent: | Alexey Salamini | |
| CEO | ||
| Piccolo Medical, Inc. | ||
| 617-407-1026 | ||
| asalamini@piccolomedical.com | ||
| Additional Contacts: | Allison Kumar | |
| Arina Consulting, LLC | ||
| allison@arinaconsulting.com | ||
| II. | DEVICE | |
| Trade Name: | SmartPICC System | |
| Common Name: | Accessory to Percutaneous, implanted, long-term | |
| intravascular 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
4
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 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
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Attribute | SUBJECT:
Piccolo Medical
SmartPICC System | PREDICATE:
Angiodynamics Celerity PICC
Tip Positioning Aid | Comparison |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------|
| 510K No | K2000037 | K142889 | |
| Procode | LJS | LJS | |
| Date | Pending | February 15, 2015 | |
| Intended Use | Provides real time tip location
information of PICC by using
ivECG to position PICC in
CAJ. | Provides real time tip location
information of PICC by using
ivECG to position PICC in
CAJ. | SAME |
| Operating
Principle/
Technology | ivECG for CAJ identification
and supplemental ionic
dilution feature for qualitative
blood flow information | ivECG for CAJ identification | TECHNOLOGICAL
DIFFERENCE |
| Alternative to
X-ray CAJ
Confirmation | Yes - Human
Factors/Simulated Use
Testing | Yes - Human
Factors/Simulated Use
Testing | SAME |
| Target
Population | Adults 18 and over | Adults 18 and over | SAME |
| Use
Environment | Hospital, clinic, skilled
nursing, rehab clinic | Hospital, clinic, skilled
nursing, 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 ●
6
- 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 .
7
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.