(219 days)
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.
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.
This 510(k) summary describes the Sapiens™ Tip Location System (TLS), intended for guiding and positioning central venous catheters. The study primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and clinical performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the Sapiens™ TLS in the way that specific quantitative thresholds (e.g., sensitivity, specificity, accuracy) are typically defined for AI/CADe devices. Instead, the performance is reported as a success rate for catheter tip placement confirmation.
| Performance Metric | Acceptance Criteria (Not explicitly stated as specific numerical thresholds, implied by predicate device equivalence) | Reported Device Performance (Sapiens™ TLS) |
|---|---|---|
| Catheter tip confirmation at desired location | Implied: Performance comparable to existing methods (chest X-ray/fluoroscopy) and predicate devices. | 97% of cases |
| Safety and efficacy | Implied: No adverse events, good correlation with in-vivo data. | No adverse events or complications occurred |
| ECG waveform accuracy (benchtop and non-clinical) | Implied: Comparable to commercially available ECG monitors and predicate devices. | Demonstrated good correlation and equivalence |
| Electrical impedance testing (benchtop) | Implied: Comparable to predicate devices. | Demonstrated equivalence |
| System usability and validation (non-clinical) | Implied: Acceptable user experience and system functionality. | Performed and showed effectiveness |
Note: The acceptance criteria are inferred from the context of a 510(k) submission, which aims to demonstrate "substantial equivalence" rather than set de novo performance standards. The primary criterion here is that the device performs comparably to the predicate devices and existing methods (chest X-ray/fluoroscopy) for its intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Study: 332 patients (from a prospective, multicenter, non-controlled study).
- Human Factors/Usability Study: 30 patients.
- Total analyzed subsets: 362 patients.
- Data Provenance: Europe (five major hospital centers). The study was described as "prospective" and "multicenter."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document states that the catheter tip placement using Sapiens™ TLS was confirmed with "chest X-ray or fluoroscopy." This implies that the ground truth was established by clinical imaging, interpreted by relevant medical professionals (e.g., radiologists, interventionalists), as standard clinical practice dictates for these imaging modalities. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.
4. Adjudication Method for the Test Set
The adjudication method is implicitly through the standard clinical interpretation of "chest X-ray or fluoroscopy" to confirm catheter tip location. The document does not specify a formal adjudication process like "2+1" or "3+1" for comparing the device's output to the imaging results. It only states that the imaging "confirmed" the placement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not explicitly mentioned. The clinical study was a "prospective, multicenter, non-controlled study" where Sapiens™ TLS was used, and its results were confirmed by X-ray/fluoroscopy. The document does not describe a scenario where different human readers interpreted cases with and without AI assistance to measure an "effect size" of improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Sapiens™ TLS is described as providing "real-time catheter tip location information" using cardiac electrical activity for "guidance and positioning." This implies that the device is providing a standalone measurement or assessment, which is then clinically confirmed by X-ray/fluoroscopy. The reported 97% success rate reflects this standalone performance in guiding placement that was subsequently confirmed. It functions as an alternative method to chest X-ray and fluoroscopy, suggesting a standalone use case that is then verified post-procedure.
7. The Type of Ground Truth Used
The ground truth used for confirming the Sapiens™ TLS's performance was clinical imaging: chest X-ray or fluoroscopy.
8. The Sample Size for the Training Set
The document does not mention a training set or any deep learning/AI model training, as this submission is from 2010 and describes a system based on cardiac electrical activity principles, not explicitly a machine learning algorithm that requires a dedicated training set. The clinical data reported is for performance evaluation, not for training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of an AI/ML model, this question is not applicable based on the provided text. The device's operation is based on real-time cardiac electrical activity rather than a learned model from a dataset.
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510(k) Summary
| Proprietary Name: | Sapiens™ Tip Location System also known as evGuide™ Tip Location System |
|---|---|
| Device Trade name: | Sapiens™ Tip Location System (TLS) |
| ProductClassification: | Class II, 21 CFR §880.5970LJS - Accessory to Percutaneous, Implanted, Long-Term Intravascular CathetersGeneral 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 SystemK032613 - Transvenous Pacemaker Placement Assist DeviceK973371 - Conduction Anesthesia KitK843263 - Arrow-Johans ECG Adaptor |
| Indications for Use: | The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning ofcentral venous catheters such as PICCs. CVCs, implantable ports, and hemodialysiscatheters. The Sapiens™ TLS provides real-time catheter tip location information byusing the patient's cardiac electrical activity. Sapiens™ TLS is indicated for use as analternative method to chest X-ray and fluoroscopy for central venous catheter tipplacement confirmation in adult patients. |
| Limiting but not contraindicated situations for this technique are in patients wherealterations of cardiac rhythm change the presentation of the P wave as in atrialfibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, and in centralvenous catheterization procedures performed through femoral or saphaneous vein accesswhich change the presentation of the P wave. In such patients, who are easily identifiableprior to central venous catheter insertion, the use of an additional method is required toconfirm catheter tip location. | |
| Device Description: | The Sapiens™ TLS consists of the following clements: sterile electrical adaptor, ECGmodule and cable, laptop running Sapiens™ TLS software, label printer (optional), andremote control (optional). A stylet or a guidewire inserted in a central venous catheter canbe connected to the Sapiens™ TLS system via the Sapiens™ TLS Electrical Adaptorestablishing a direct electrical connection to the catheter distal tip for ECG signalmeasurement. A different ECG signal measurement method - the column of salinemethod - 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 catheterand by injecting saline solution into the catheter lumen through the Arrow-JohansAdaptor, thus establishing electrical conductivity to the distal tip of the catheter. Whenthe central venous catheter or its associated stylet or guidewire is connected to Sapiens™TLS, the Sapiens™ TLS laptop screen displays skin ECG signals and endovascularelectrograms acquired at the location of the distal tip of the catheter. The waveformsprovided by Sapiens™ TLS can be used for guiding and positioning of the central venouscatheter. These ECG waveforms can be printed using an optional label printer todocument the catheter tip location for the patient's file. |
| Bench Top Safety &Performance Tests: | Verification and validation tests have been performed in accordance with DesignControls per 21 CFR §820.30. |
| Bench top testing has been performed side-by-side with available predicate deviceswhich has demonstrated substantial equivalence of Sapiens™ TLS to the respectivepredicate devices. The following tests were performed: a) electrical impedance testingand b) ECG waveform accuracy tests. | |
| Summary ofNon-clinical Data: | Non-clinical studies were performed which have demonstrated safety and efficacy ofSapiens™ TLS using Electrical Adaptor, good correlation between bench top and in-vivodata, and substantial equivalence with predicate devices. The following tests wereperformed: a) ECG waveform accuracy comparison with a commercially available ECGmonitor, b) ECG waveform accuracy comparison with the Conduction Anesthesia Kit(K973371) and c) system usability and validation testing. |
| Summary ofClinical Data: | To date, Sapiens™ TLS has been used in Europe for central venous catheterguidance 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 ofusers including nurses and physicians have used Sapiens™ TLS for different clinicalprocedures, e.g., oncology, anesthesia, patient monitoring in the ICU, hemodialysis indifferent 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 ofTechnologicalCharacteristicsCompared toPredicate Devices | The subject Sapiens™ TLS Electrical Adaptor combines design features, materials andtechnological characteristics of marketed predicate devices including the TransvenousPacemaker Placement Assist Device (K032613) and Conduction Anesthesia Kit(K973371) such as: a) a sterile, insulated, electrically conductive wire of very lowelectrical 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 ECGconnection switch. When compared to the Conduction Anesthesia Kit, the Sapiens™ TLSElectrical Adaptor has simplified the design of the device by removing the switch box.When compared to Transvenous Pacemaker Placement Assist Device, the Sapiens™ TLSElectrical Adaptor has simplified the design of the device by removing the connectionbox. 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 |
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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.
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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
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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
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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
§ 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.”