(201 days)
Not Found
No
The description focuses on processing and displaying ECG waveforms using intravascular ECG (ivECG) and does not mention any AI or ML techniques for analysis or interpretation.
No
The device is used for confirming catheter tip placement, not for treating a disease or condition. It is a diagnostic/positioning tool.
No
This device is used for confirming the precise placement of a catheter, not for diagnosing a medical condition. While it utilizes the patient's cardiac electrical activity, it primarily serves a procedural guidance and confirmation function rather than identifying a disease or pathological state.
No
The device description and performance studies clearly indicate the presence of hardware components (ECGuide™ Connector, PM2 system) and associated hardware verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Piccolo Medical PM2™ System with ECGuide™ Connector works by using the patient's cardiac electrical activity (intravascular ECG) to determine the position of a catheter tip within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for positioning and confirming the location of a central venous catheter tip, not for diagnosing a disease or condition based on analysis of a biological sample.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Piccolo Medical PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated. for patients where cardiac rhythms may change presentation of the P-wave; including
-Atrial fibrillation
-Atrial flutter
-Severe tachycardia
-Pacemaker-driven rhythm
-Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
Product codes (comma separated list FDA assigned to the subject device)
LJS, DRX, DSA
Device Description
The PM2™ System and ECGuide™ Connector is a device used by clinicians for bedside tip location confirmation of central venous catheters. The PM2™ System and ECGuide™ Connector provide real-time catherer tip location information by using intravascular ECG (ivECG). The ECGuide™ Connected to the distal lumen hub of a CVC and primed with saline to create an ivECG electrode at the distal tip of the catheter and allow for ECG catheter tip confirmation. The EGuide™ Connector is used only during CVC installation, and removed once the CVC tip position is confirmed to be at the target location. The ECGuide™ Connected to the PM2 system which processes, displays, and stores the ECG waveforms.
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
adult patients
Intended User / Care Setting
clinicians / bedside
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence was based on an assessment of non-clinical performance testing performed on the PM2 System and ECGuide Connector verified all device performance requirements including electrical safety, EMC, software verification and validation, tensile insertion force, corrosion resistance, catheter compatibility, leak testing, electrical hardware verification, sterile barrier packaging testing, biocompatbility, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2024
Piccolo Medical, Inc. Augustus Shanahan CEO 218 Mississippi St San Francisco, California 94107
Re: K240486
Trade/Device Name: PM2 System and ECGuide Connector Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS, DRX, DSA Dated: August 9, 2024 Received: August 9, 2024
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.
1
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" (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 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-reportingcombination-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-device-advicecomprehensive-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-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-regulatory
2
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,
MARCO CANNELLA -S
for
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
3
Indications for Use
Submission Number (if known)
Device Name
PM2 System and ECGuide Connector
Indications for Use (Describe)
The Piccolo Medical PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated. for patients where cardiac rhythms may change presentation of the P-wave; including
-Atrial fibrillation
-Atrial flutter
-Severe tachycardia
-Pacemaker-driven rhythm
| -Chronic obstructive pulmonary disease (COPD) |
|---|
| ----------------------------------------------- |
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary 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)
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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."
4
| 510(k) #: | K240486 | 510(k) Summary | Prepared on: 2024-08-09 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
| 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 ECGuide Connector |
|---|---|
| Common Name | Tip Location System |
| Classification Name | Percutaneous, implanted, long-term intravascular catheter |
| Regulation Number | 21 CFR 880.5870 |
| Product Code(s) | LJS |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K160925 | VPS Rhythm Device with TipTracker Technology | LJS |
| K200037 | SmartPICC System | LJS |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The PM2
TM System and ECGuideTM Connector is a device used by clinicians for bedside tip location confirmation of central venousThe PM2™ System and ECGuide™ Connector is a device used by clinicians for bedside tip location confirmation of central venous catheters. The PM2™ System and ECGuide™ Connector provide real-time catherer tip location information by using intravascular ECG (ivECG). The ECGuide™ Connected to the distal lumen hub of a CVC and primed with saline to create an ivECG electrode at the distal tip of the catheter and allow for ECG catheter tip confirmation. The EGuide™ Connector is used only during CVC installation, and removed once the CVC tip position is confirmed to be at the target location. The ECGuide™ Connected to the PM2 system which processes, displays, and stores the ECG waveforms.
Intended Use/Indications for Use
The Piccolo Medical PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PCCs. It provides catheter tip location by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.
21 CFR 807.92(a)(5)
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including -Atrial fibrillation -Atrial flutter -Severe tachycardia -Pacemaker-driven rhythm
5
-Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
Indications for Use Comparison
The indications for use for the predicate device and the same with the exception that the predicate device indications includes the use of an optional accessory which is not relevant to the subject device (optional Tip Tracker Technology). The intended use of the predicate and subject device is the same.
Technological Comparison
The subject and predicate devices have technological characteristics for providing intravascular ECG to the end user to facilitate catheter tip confirmation. Both devices utilize a luer-lock style connect to a CVC and a saline column within the lumen of the CVC to conduct the intravascular ECG signal to the tip.
The VPS Rhythm device (K103255) also includes an optional Tip Tracker Accessory and disposable stylet for PCC navigation which is not relevant to the subject device.
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 testing performed on the PM2 System and ECGuide Connector verified all device performance requirements including electrical safety, EMC, software verification and validation, tensile insertion force, corrosion resistance, catheter compatibility, leak testing, electrical hardware verification, sterile barrier packaging testing, biocompatbility, 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 subject PM2 System and ECGuide Connector to the stated predicate device as hardware utilized in the PM2 System. The same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate devices to which it was compared. The results of the testing included in this premarket notification support a determination of substantial equivalence.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)