(137 days)
The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients.
The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.
The device is for single and short term use.
The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary for a medical device submitted to the FDA. It details a determination of substantial equivalence, not a standalone clinical study report. Therefore, some information typically found in a detailed study report (e.g., highly granular acceptance criteria, specific effect sizes for human improvement with AI) may not be present or directly applicable.
Acceptance Criteria and Device Performance Study
The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) aims to measure blood pressure and/or intra-abdominal pressure. The demonstration of its performance relies on functional performance tests and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Standard / Requirement | Reported Device Performance/Outcome |
|---|---|---|
| Functional Performance | IEC 60601-2-34 (Medical electrical equipment - Part 2-34: Particular requirements for the safety of invasive blood pressure monitoring equipment) | Met the acceptance criteria. The transducer is concluded to be safe and effective for its intended use based on these test results. |
| ANSI/AAMI BP22-1994 (American National Standard for Blood Pressure Transducers) | Met the acceptance criteria. The transducer is concluded to be safe and effective for its intended use based on these test results. | |
| Biocompatibility | ISO 10993-1 Part 1: Evaluation & Testing (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Biocompatible and safe for its intended use based on these test results. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "functional performance tests" and "biocompatibility tests" performed on the Art-Line™ DPT. However, it does not specify the sample size (e.g., number of devices tested, number of patients, number of data points) for these tests.
The data provenance is implicitly from laboratory/bench testing and potentially in-vitro biocompatibility testing, given the standards cited. There is no mention of human clinical data or patient data (retrospective or prospective) being used to assess the functional performance against the cited standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable or not provided in the context of this 510(k) summary. The acceptance criteria are based on established international and national standards for medical devices (IEC 60601-2-34, ANSI/AAMI BP22-1994, ISO 10993-1), which define objective performance benchmarks. These standards themselves are developed by expert committees, but the document does not detail individual expert involvement in establishing ground truth for this specific device's test set.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. Since the performance assessment is against objective standards set for devices (functional and biocompatibility), typical clinical adjudication methods (like 2+1 or 3+1 expert consensus) are not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MrMC study was mentioned or performed. This device is an extravascular blood pressure transducer, a physical measurement device, not an AI/software-based interpretive tool that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is not an algorithm or AI system. Its performance evaluation is based on its physical properties and ability to accurately convert pressure into electrical signals according to established medical device standards.
7. Type of Ground Truth Used:
The ground truth for assessing performance was based on established industry standards and objective measurements prescribed by:
- IEC 60601-2-34: Specifies performance requirements for invasive blood pressure monitoring equipment.
- ANSI/AAMI BP22-1994: Standard for blood pressure transducers.
- ISO 10993-1: Standard for biological evaluation of medical devices.
These standards define the acceptable range of physical and biological characteristics, which serve as the "ground truth" for evaluating the device's compliance.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware component and does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as in point 8.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
Biometrix Ltd. Aviva Touati, Regulatory Affairs Manager Kiryat Mada 4 Jerusalem, 91450 ISRAEL
Re: K151040
Trade/Device Name: Art-line Single Channel Blood Pressure System, Art-line Double Channel Blood Pressure System, Art-line Triple Channel Blood Pressure System, Iap Monitoring Set With Disposable Transducer Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: April 17, 2015 Received: May 7, 2015
Dear Aviva Touati:
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. 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.
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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Sincerelv vours
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151040
Device Name
Art-LineTM Disposable Pressure Transducer set
Indications for Use (Describe)
The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients.
The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.
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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K151040
510(k) Summary
1. Applicant information
- a) Company address: Biometrix Ltd Kiryat Mada 4, 91450 Jerusalem Israel www.biometrixmedical.com
- b) Contact person: Aviva Touati, RA Manager E-mail: Aviva@biometrixmedical.com
- c) Additional Contact person: Zova Lee, RA CO, Degania Silcione Itd. E-mail: Zoya@ds-il.com
2. Device identification
- a) Common name : Disposable Pressure Monitoring System
- b) Trade name : Art-Line™ Disposable Pressure Transducer set
- c) Classification Panel : 21CFR 870.2850
- d) Product code : DRS
3. Predicate Devices
- a) Transpac® III Disposable Straight Pressure, Hospira, Inc, 510(k) K061573
- b) Accutrans Disposable Pressure Monitoring System, Biosensors International, 510(k) K070710
4. Device Description
The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.
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| No | Series Group | Description |
|---|---|---|
| 1 | AA | Art-Line™ Adult Single channel with colored stripe (red or blue)- for blood pressure sensing |
| 2 | AB | Art-Line™ Adult Single channel - for blood pressure sensing |
| 3 | AE | Art-Line™ Adult Double channel - for blood pressure sensing |
| 4 | AC | Art-Line™ Adult Triple channel - for blood pressure sensing |
| 5 | AI | Art-Line™ Single channel, closed system. There are modes foradult and pediatric use - for blood pressure sensing |
| 6 | AF | Art-Line™ Pediatric Single channel - for blood pressure sensing |
| 7 | AP and CA | Art-Line™ Intra-Abdominal Pressure (IAP) transducer set – forIAP sensing via inflated bladder. |
| Table 1. Description of Device modes. | |
|---|---|
| --------------------------------------- | -- |
5. Indication For Use.
The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring and monitoring of the blood and/or intra-abdominal pressure of the critically ill patients.
The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravascular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.
The device is for single and short term use.
Summary of the Technological Characteristics of the Devices in relation to 6. predicate device(s).
The subject Art line models have a similar intended use and design construction with the equivalent components as the predicated models. The safety and effectiveness of the subject device models have been assessed and discussed further in Section 7 below.
7. Assessment of Performance Data used to justify Substantial Equivalence
- a) Functional performance tests were performed on the Art-Line™ DPT to evaluate the performance and the reliability of the transducer in accordance to recommended performance standards, IEC 60601-2-34 and ANSI/AAMI BP22-1994. Based on the test results which meet the acceptance criteria, the transducer is concluded to be safe and effective for its intended use.
- b) Biocompatibility tests were performed in accordance to IS010993-1 Part 1: Evaluation & Testing. Based on the test results, the Biocompatibility tests were performed in accordance to IS010993-1 Part 1: Evaluation &Testing. Based on the test results, the Art-line – Fluid Pressure monitoring set is
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biocompatible and safe for its intended use is biocompatible and safe for its intended use
8. Conclusion
The results of the Functional Performance Tests and Biocompatibility tests have demonstrated that the Art-Line™ Disposable Pressure Transducer Set is substantially equivalent to the predicate devices and is safe and effective for its intended use.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).