(219 days)
No
The description focuses on using the patient's cardiac electrical activity (ECG signals and endovascular electrograms) to guide catheter placement. There is no mention of AI, ML, or any learning algorithms used for analysis or interpretation of these signals. The system appears to be based on direct measurement and display of physiological signals.
No
The device is used for guidance and positioning of central venous catheters and confirmation of their tip placement, acting as an alternative to imaging methods. It does not directly treat a disease or condition.
No
The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters and for confirming tip placement, not for diagnosing a medical condition or disease.
No
The device description explicitly lists hardware components such as a sterile electrical adaptor, ECG module and cable, and a laptop running the software. While software is a key part of the system, it is not the sole component.
Based on the provided information, the Sapiens™ Tip Location System (TLS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Sapiens™ TLS Function: The Sapiens™ TLS works by measuring the patient's cardiac electrical activity in real-time to guide and position a catheter within the body. It does not analyze specimens taken from the body.
- Mechanism of Action: The system relies on the electrical signals generated by the heart and detected through the catheter tip or a saline column within the catheter. This is an in vivo measurement, not an in vitro analysis of a biological sample.
Therefore, the Sapiens™ TLS falls under the category of a medical device used for guiding a procedure within the body, rather than an IVD device used for analyzing biological specimens.
N/A
Intended Use / Indications for Use
The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs. CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients.
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, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. 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.
Product codes
LJS
Device Description
The Sapiens™ TLS consists of the following clements: sterile electrical adaptor, ECG module and cable, laptop running Sapiens™ TLS software, label printer (optional), and remote control (optional). A stylet or a guidewire inserted in a central venous catheter can be connected to the Sapiens™ TLS system via the Sapiens™ TLS Electrical Adaptor establishing a direct electrical connection to the catheter distal tip for ECG signal measurement. A different ECG signal measurement method - the column of saline method - can be used by connecting the Sapiens™ TLS Electrical Adaptor to the Arrow-Johans Adaptor, by connecting the Arrow-Johans Adaptor to any central venous catheter and by injecting saline solution into the catheter lumen through the Arrow-Johans Adaptor, thus establishing electrical conductivity to the distal tip of the catheter. When the central venous catheter or its associated stylet or guidewire is connected to Sapiens™, TLS, the Sapiens™ TLS laptop screen displays skin ECG signals and endovascular electrograms acquired at the location of the distal tip of the catheter. The waveforms provided by Sapiens™ TLS can be used for guiding and positioning of the central venous catheter. These ECG waveforms can be printed using an optional label printer to document the catheter tip location for the patient's file.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous
Indicated Patient Age Range
adult patients (ages 19-96)
Intended User / Care Setting
users including nurses and physicians have used Sapiens™ TLS for different clinical procedures, e.g., oncology, anesthesia, patient monitoring in the ICU, hemodialysis in different clinical settings: in the operating room, in outpatient clinics and at the 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)
To date, Sapiens™ TLS has been used in Europe for central venous catheter guidance and positioning in five major hospital centers on more than 350 adult patients (ages 19-96) of both genders for placing several types of central venous catheters: PICCs, CVCs, implantable ports, hemodialysis catheters, and tunneled catheters. Several types of users including nurses and physicians have used Sapiens™ TLS for different clinical procedures, e.g., oncology, anesthesia, patient monitoring in the ICU, hemodialysis in different clinical settings: in the operating room, in outpatient clinics and at the bedside. Side-by-side comparisons with available predicate devices were performed which demonstrated substantial equivalence of Sapiens™ TLS to the respective predicate devices. In the two analyzed subsets of 362 patients (332 patients from a prospective, multicenter, non-controlled study and 30 patients form a human factors/ usability study), the catheter tip placement using Sapiens™ TLS at the desired location was confirmed with chest X-ray or fluoroscopy in 97% of the cases. No adverse events or complications have occurred.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091324, K032613, K973371, K843263
Reference Device(s)
Not Found
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
.
510(k) Summary
| Proprietary Name: | Sapiens™ Tip Location System also known as evGuide™ Tip Location System |
|---|---|
| Device Trade name: | Sapiens™ Tip Location System (TLS) |
| Product | |
| Classification: | Class II, 21 CFR §880.5970 |
| LJS - Accessory to Percutaneous, Implanted, Long-Term Intravascular Catheters | |
| General Hospital | |
| Applicant name: | Romedex International Srl 58 Aleea Arubium, Bucharest, 022944 Romania, |
| +1.650.209.4838, info@romedex.com, www.romedex.com | |
| Contact person: | Sorin Grunwald Ph.D., MBA, 175 Colorado Ave, Palo Alto, CA 94303, |
| sorin@romedex.com, Tel: +1.650.209.4838, Fax: +1.650.887.0348 | |
| Preparation Date: | June 4, 2010 |
| Predicate Devices: | K091324 - Sherlock 3CG Tip Positioning System |
| K032613 - Transvenous Pacemaker Placement Assist Device | |
| K973371 - Conduction Anesthesia Kit | |
| K843263 - Arrow-Johans ECG Adaptor | |
| Indications for Use: | The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of |
| central venous catheters such as PICCs. CVCs, implantable ports, and hemodialysis | |
| catheters. The Sapiens™ TLS provides real-time catheter tip location information by | |
| using the patient's cardiac electrical activity. Sapiens™ TLS is indicated for use as an | |
| alternative method to chest X-ray and fluoroscopy for central venous catheter tip | |
| placement confirmation in adult patients. | |
| 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, and in central | |
| venous catheterization procedures performed through femoral or saphaneous vein access | |
| which change the presentation of the P wave. 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 Sapiens™ TLS consists of the following clements: sterile electrical adaptor, ECG |
| module and cable, laptop running Sapiens™ TLS software, label printer (optional), and | |
| remote control (optional). A stylet or a guidewire inserted in a central venous catheter can | |
| be connected to the Sapiens™ TLS system via the Sapiens™ TLS Electrical Adaptor | |
| establishing a direct electrical connection to the catheter distal tip for ECG signal | |
| measurement. A different ECG signal measurement method - the column of saline | |
| method - can be used by connecting the Sapiens™ TLS Electrical Adaptor to the Arrow- | |
| Johans Adaptor, by connecting the Arrow-Johans Adaptor to any central venous catheter | |
| and by injecting saline solution into the catheter lumen through the Arrow-Johans | |
| Adaptor, thus establishing electrical conductivity to the distal tip of the catheter. When | |
| the central venous catheter or its associated stylet or guidewire is connected to Sapiens™ | |
| TLS, the Sapiens™ TLS laptop screen displays skin ECG signals and endovascular | |
| electrograms acquired at the location of the distal tip of the catheter. The waveforms | |
| provided by Sapiens™ TLS can be used for guiding and positioning of the central venous | |
| catheter. These ECG waveforms can be printed using an optional label printer to | |
| document the catheter tip location for the patient's file. | |
| Bench Top Safety & | |
| Performance Tests: | Verification and validation tests have been performed in accordance with Design |
| Controls per 21 CFR §820.30. | |
| Bench top testing has been performed side-by-side with available predicate devices | |
| which has demonstrated substantial equivalence of Sapiens™ TLS to the respective | |
| predicate devices. The following tests were performed: a) electrical impedance testing | |
| and b) ECG waveform accuracy tests. | |
| Summary of | |
| Non-clinical Data: | Non-clinical studies were performed which have demonstrated safety and efficacy of |
| Sapiens™ TLS using Electrical Adaptor, good correlation between bench top and in-vivo | |
| data, and substantial equivalence with predicate devices. The following tests were | |
| performed: a) ECG waveform accuracy comparison with a commercially available ECG | |
| monitor, b) ECG waveform accuracy comparison with the Conduction Anesthesia Kit | |
| (K973371) and c) system usability and validation testing. | |
| Summary of | |
| Clinical Data: | To date, Sapiens™ TLS has been used in Europe for central venous catheter |
| guidance and positioning in five major hospital centers on more than 350 adult patients | |
| (ages 19-96) of both genders for placing several types of central venous catheters: PICCs, | |
| CVCs, implantable ports, hemodialysis catheters, and tunneled catheters. Several types of | |
| users including nurses and physicians have used Sapiens™ TLS for different clinical | |
| procedures, e.g., oncology, anesthesia, patient monitoring in the ICU, hemodialysis in | |
| different clinical settings: in the operating room, in outpatient clinics and at the bedside. Side-by-side comparisons with available predicate devices were performed which demonstrated substantial equivalence of Sapiens™ TLS to the respective predicate devices. In the two analyzed subsets of 362 patients (332 patients from a prospective, multicenter, non-controlled study and 30 patients form a human factors/ usability study), the catheter tip placement using Sapiens™ TLS at the desired location was confirmed with chest X-ray or fluoroscopy in 97% of the cases. No adverse events or complications have occurred. | |
| Summary of | |
| Technological | |
| Characteristics | |
| Compared to | |
| Predicate Devices | The subject Sapiens™ TLS Electrical Adaptor combines design features, materials and |
| technological characteristics of marketed predicate devices including the Transvenous | |
| Pacemaker Placement Assist Device (K032613) and Conduction Anesthesia Kit | |
| (K973371) such as: a) a sterile, insulated, electrically conductive wire of very low | |
| electrical resistance; b) a distal end alligator clip to connect to stylets and guidewires; | |
| c) a proximal end connector which can be connected to an ECG cable or to an ECG | |
| connection switch. When compared to the Conduction Anesthesia Kit, the Sapiens™ TLS | |
| Electrical Adaptor has simplified the design of the device by removing the switch box. | |
| When compared to Transvenous Pacemaker Placement Assist Device, the Sapiens™ TLS | |
| Electrical Adaptor has simplified the design of the device by removing the connection | |
| box. The Sapiens™ TLS Electrical Adaptor may be connected to the ECG pin of the predicate Arrow-Johans Adaptor (K843263) using an ECG cable which allows for the saline conduction method of ECG measurement. Use of the Sapiens™ TLS Electrical Adaptor with the Arrow-Johans Adaptor does not require any modifications of design features, materials, or technological characteristics of the marketed predicate device. Additionally, the subject Sapiens™ TLS System combines design features, components and technological characteristics of the predicate device Sherlock 3CG Tip Positioning System (K091324) but uses only cardiac electrical signal detection to provide real-time catheter tip location information. The subject Sapiens™ System does not use a passive |
4
1
.
2
Any differences between technological features of the subject and predicate devices do not raise new questions of safety or efficacy of the subject Sapiens™ TLS device.
Summary of Substantial Equivalence: The Sapiens™ TLS has the same intended use and similar indications for use as the commercially available Sherlock 3CG Tip Positioning System (K091324), Transvenous Pacemaker Placement Assist Device (K032613). Conduction Anesthesia Kit (K973371), and Arrow-Johans ECG Adaptor (K843263). Additionally. clinical and non-clinical performance testing has demonstrated that any differences in technological characteristics do not raise new issues of safety or effectiveness when compared to the aforementioned predicate devices. Therefore, the Sapiens™ TLS meets the requirements for substantial equivalence to the referenced predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUL 28 2010
Dr. Sorin Grunwald, Ph.D. US FDA Agent for Romedex International, Srl 175 Colorado Avenue Palo Alto, California 94303
Re: K093775
Trade/Device Name: Sapiens™ TLS Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 5, 2010 Received: June 7, 2010
Dear Dr. Grunwald:
This letter corrects our substantially equivalent letter of July 15, 2010.
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 (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.
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.
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
4
Page - Dr. Grunwald
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 (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K093775
Not known at this time
Sapiens TM TLS Device Name: _
Indications for Use:
The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens TM TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity. Sapiens TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients.
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, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page of (Posted November 13, 2003)
RUC. Ch 7/20/10
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093775