(99 days)
Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only.
Indications for the Disposable Integrated Pressure Transducer (DIPT) include:
Direct arterial blood pressure monitoring - central and peripheral
Pulmonary artery monitoring
Venous pressure monitoring
Left atrial monitoring when used with an air eliminator
Cardiac catheterization
The disposable Transducer in an extravascular blood pressure transducer that convert mechanical changes in pressure into electrical current that can be input into a pressure monitor. The disposable Transducer consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. One of the major components that the transducer include is an integral flush valve and Luer connector that can connect a flashing fluid source to the intravascular catheter.
The provided text is for a 510(k) summary for a medical device that does not involve AI/ML technology or image processing. The device is an "Elcam Disposable Integrated Pressure Transducer (DIPT)" used for direct measurement and monitoring of blood pressure.
Therefore, the requested information about acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.
The document states:
- Rationale for Substantial Equivalency: "Elcam is the manufacturer of the Disposable integrated pressure transducer substantially equivalent to the predicate device and also the manufacture of the predicate device. Both products are the same products. The claim for substantial equivalence is supported by the information provided in the 510(k) submission" (Page 1)
- Safety & Effectiveness: "The proposed and predicate devices are similar in design, materials of construction, components, intended use and labeling. Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above. Elcam Medical believes that the proposed device safe & effectiveness is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues." (Page 1)
This indicates that the device's approval is based on its substantial equivalence to a predicate device (K052828), which is also manufactured by Elcam, meaning they are essentially the same product. The "performance results" mentioned are likely standard engineering and bench testing for pressure transducers, not AI/ML performance metrics.
To answer your specific questions, based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML. The 510(k) relies on substantial equivalence to an existing device, implying it meets the same performance standards of that predicate.
- Sample sized used for the test set and the data provenance: Not applicable/not provided for AI/ML. Any "test results and clinical data" mentioned are for the physical transducer.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided for AI/ML.
- Adjudication method: Not applicable/not provided for AI/ML.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
- The type of ground truth used: Not applicable/not provided for AI/ML. For a physical device like this, performance would be validated against established physical standards and measurements.
- The sample size for the training set: Not applicable/not provided for AI/ML.
- How the ground truth for the training set was established: Not applicable/not provided for AI/ML.
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Image /page/0/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of a stylized symbol to the left of the text "Elcam MEDICAL". Below the text is the tagline "Where everything connects" in a smaller font. The logo appears to be in black and white.
JUN - 8 2012
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92
Submitter Information
Elcam Medical A.C.A.L. Kibbuts BarAm, M.P. Merom HaGalil, 13860, Israel Tel: (972) 4 6988120/1/2, Fax: (972) 4 6980777
Submission contact person:
Aharon Cohen Kibuz Bar Am 30889. Israel TEL: 972-4-6988324
Device Classification
| Proprietary Device Name: | Elcam Disposable integrated pressure transducer (DIPT) |
|---|---|
| Common name: | Disposable integrated pressure transducer (DIPT) |
| Product Code: | DRS |
| Classification Name: | Extravascular blood pressure transducer |
| Classification Regulation: | 21 CFR § 870.2850 |
| Regulatory Class: | II |
Identification of Legally Marketed Predicate Devices
Hospira Disposable integrated pressure transducer - K052828
Device Description
The disposable Transducer in an extravascular blood pressure transducer that convert mechanical changes in pressure into electrical current that can be input into a pressure monitor. The disposable Transducer consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. One of the major components that the transducer include is an integral flush valve and Luer connector that can connect a flashing fluid source to the intravascular catheter.
Intended Use of Device
The disposable Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for one time use.
Indications for the Disposable Integrated Pressure Transducer (DIPT) include:
- Direct arterial blood pressure monitoring central and peripheral -
- Pulmonary artery monitoring -
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- Venous pressure monitoring -
- Left atrial monitoring when used with an air eliminator
- Cardiac catheterization
Safety & Effectiveness
The proposed and predicate devices are similar in design, materials of construction, components, intended use and labeling.
Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above. Elcam Medical believes that the proposed device safe & effectiveness is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.
Rational for Substantial Equivalency
Elcam is the manufacturer of the Disposable integrated pressure transducer substantially equivalent to the predicate device and also the manufacture of the predicate device. Both products are the same products.
The claim for substantial equivalence is supported by the information provided in the 510(k) submission
Substantial Equivalence Statement
Based on the above, it is Elcam Medical's opinion that the proposed Elcam Disposable integrated pressure transducer is substantially equivalent in terms design principles, performance features and of safety & effectiveness to the legally cleared predicate device (K052828) referred to in chapter 4 of this 510(K) submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 8 2012
Elcam Medical A.C.A.L. c/o Mr. Aharon Cohen Regulation Affairs Manager M.P. Merom HaGalil Kibbuts BarAm, 13860 Israel
Re: K120624
Trade/Device Name: Elcam Disposable Integrated Pressure Transqucer Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular blood pressure transducer Regulatory Class: Class II (two) Product Code: DRS Dated: May 30, 2012 Received: June 4, 2012
Dear Mr. Cohen:
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.
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Page 2 - Mr. Aharon Cohen
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 (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/Resourcesfor You/Industry/default.htm.
fri
Sincerely yours,
Bram D. Euekerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K120.624
Indications for Use
510(k) Number (if known): K !20.624..
Device Name: Elcam Disposable Integrated Pressure Transducer
Indications for Use:
Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only.
Indications for the Disposable Integrated Pressure Transducer (DIPT) include:
Direct arterial blood pressure monitoring - central and peripheral 1
- Pulmonary artery monitoring
- Venous pressure monitoring
- Left atrial monitoring when used with an air eliminator
- Cardiac catheterization
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)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Cardiovascular Devices
| 510(k) Number | K120624 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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).