The pressure isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device may be used in procedures lasting up to 6 hours in duration.

Device Description

The Terumo Pressure Isolator is a single use, disposable device that is intended to act as an interface between the extracorporeal circuit and a pressure gauge in order to prevent fluids from coming into contact with gauges while transducing pressure during cardiopulmonary bypass procedures. The device is geometrically similar to the IBC Isolator device, which is the predicate device for purposes of this application. Furthermore, the operating principles and product technology of the two devices are identical. The Terumo Pressure Isolator has a housing that is made of rigid polyvinylchloride and includes a flexible polyvinylchloride diaphragm inside the housing chamber.

AI/ML Overview

This response is based on the provided text, which refers to a 510(k) submission for a medical device called the "Terumo Pressure Isolator." The document focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance in the same way a new, novel device might.

Here's an analysis based on the provided information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative format. Instead, it describes performance through comparative studies, aiming to show "functional equivalence" or "no difference" compared to the predicate device.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Tubing Connection Strength	Functionally equivalent to the predicate device (IBC Isolator).	"No difference" in strength of connection between circuit tubing and the device, both with and without solvent bonding, compared to the predicate device.
Pressure Transduction Accuracy	Capable of accurately and consistently transferring circuit pressures to gauges, functionally equivalent to the predicate device.	Noted to be "functionally equivalent to the predicate device" in accurately and consistently transferring circuit pressures to gauges at a distal point in the pressure monitoring circuit.
Mechanical Integrity (Leak Test)	No evidence of breach under negative and positive pressures, equivalent to the predicate device.	"The Terumo device and the predicate device were found to be equivalent" in the leak test, where both negative and positive pressures were applied, and devices were examined for evidence of breach.
Sterility Assurance Level (SAL)	SAL of 10⁻⁴.	"Sterilization conditions for the Terumo Pressure Isolator are validated to provide a Sterility Assurance Level (SAL) of 10⁻⁴."
Ethylene Oxide Residues	Not to exceed stated or implied maximum residue limits.	"Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution."
Biocompatibility	Meet recommendations in FDA General Program Memorandum #G95-1 (ISO 10993).	Blood contacting materials were "found to be biocompatible" as recommended in FDA General Program Memorandum #G95-1 (ISO 10993 - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing; External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration).

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the tests (tubing connection, pressure transduction, mechanical integrity). It also does not specify the country of origin of the data or whether the studies were prospective or retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the type of device and testing described. The "ground truth" for this device's performance would be objective measurements from laboratory testing (e.g., pressure readings, force measurements, leak detection), not expert opinion or interpretation of data in the way radiologists or pathologists might establish ground truth for an imaging AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to the type of testing performed. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert interpretation are resolved, which is not relevant for the objective physical performance tests described for the Terumo Pressure Isolator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done, as this is neither an imaging device nor an AI device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the Terumo Pressure Isolator is a physical medical device, not an algorithm or AI. The testing described focuses on the physical performance of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests described (tubing strength, pressure transduction, mechanical integrity) would be objective, quantifiable measurements from the physical tests themselves. For example:

Tubing connection strength: Force required to disconnect or break the connection.
Pressure transduction: Output pressure readings vs. input pressure, indicating accuracy.
Mechanical integrity: Observation of leaks (or lack thereof) under specified pressure conditions.
Sterility: Laboratory testing results confirming SAL.
Biocompatibility: Results from standardized biological tests.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for a device of this type.

Summary

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O TERUMO

K092644

: Dr DEC-1 0 2009

Section 5 -510(k) Summary (for FDA Website Presentation)

	Page
Submitter Information	18
Device Names / Classification	18
Identification of Predicate Device	18
Summary	18
Conclusion for 510(k) Summary	19

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TERUMO

Submitter Information:

This submission was prepared in August 2009 by:

Garry A. Courtney, MBA, RAC Regulatory Affairs & Compliance Manager Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420 Fax: 410-398-6079

This submission was prepared for:

Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841

Device Names/Classifications: Proprietary Name

Classification Name

Common Name

Terumo Pressure Isolator

Transducer, Blood Pressure, Extravascular (Code: DRS )

Transducer Isolator

Predicate Device(s):

Terumo Cardiovascular Systems has identified the IBC Isolator (Model 2000N) as an appropriate predicate device for which comparisons of the new Terumo device shall be demonstrated. The IBC Isolator is manufactured by International Biophysics Corporation and is legally marketed under 510(k) application K841959. The 510(k) application was originally sponsored by Sterile Design, Incorporated in Oldsmar, Florida with an FDA decision date of October 19, 1984.

Summary:

The primary differences between the Terumo Pressure Isolator and the predicate IBC Isolator are herein identified as material differences, specific dimensions of the components and the type of diaphragm material that is encapsulated within the device housing.

The Terumo Pressure Isolator has a housing that is made of rigid polyvinylchloride and the predicate IBC Isolator is comprised of polycarbonate. Both of these materials permit a clear view of the fluids that enter the isolator, although the polycarbonate housing is clearer than the polyvinylchloride housing. This difference would not be problematic in an operating arena and neither device offers a therapeutic and/or functional advantage as a result of materials used and or housing clarity.

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From the perspective of product geometry, the Terumo Pressure Isolator is designed with a more rounded housing as compared to the IBC Isolator, which is characterized by more distinct edges at the opposing ends of the housing chamber. It is expected that the rounded design featured by the Terumo Pressure Isolator will facilitate enhanced fluid flow and would be less susceptible to fluid becoming stagnated within the chamber.

Finally, the Terumo Pressure Isolator includes a flexible polyvinylchloride diaphragm inside the housing chamber, whereas the predicate IBC Isolator includes a polyurethane diaphragm. This difference in materials does not create any functional advantages for either device as both materials are capable of transducing circuit pressures to gauges that would be at the distal end of the pressure circuit.

With respect to product performance, Terumo conducted head-to-head studies to assess the relative functional capabilities of the Terumo Pressure Isolator to the predicate IBC device. The studies included a tubing connection test (pre-connection with solvent as well as testing without a solvent bond) whereby the strength of the connection between circuit tubing and the device was measured - and the resulting conclusion is that there is no difference.

Testing also included a pressure transduction assessment if the Terumo Pressure Isolator was capable of accurately and consistently transferring circuit pressures to gauges at a distal point in the pressure monitoring circuit. Again, the Terumo device was noted to be functionally equivalent to the predicate device.

Terumo Cardiovascular also conducted a mechanical integrity assessment in the form of Jeak test where both negative and positive pressures were applied to the isolator and the devices were examined for evidence of breach. The Terumo device and the predicate device were found to be equivalent.

Additional Safety Information:

· Sterilization conditions for the Terumo Pressure Isolator are validated to provide a Sterility Assurance Level (SAL) of 104. Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.
Terumo maintains biocompatibility studies as recommended in the FDA General Program . Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993. "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.

Conclusion:

Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Terumo Pressure Isolator is substantially equivalent to the predicate IBC Isolator device. It is further concluded that any recognized differences noted during the assessments do not raise any new issues of patient/user safety or product effectiveness.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

EC 1 0 2009

Terumo Cardiovascular Systems Corp. c/o Mr. Garry A. Courtney Regulatory Affairs 125 Blue Ball Rd. Elkton, MD 21921

Re: K092644

Trade Name: Terumo Pressure Isolator Regulation Number: 21 CFR 870.2850 Regulation Class: Class II (two) Product Code: DRS Dated: October 15, 2009 Received: October 16, 2009

Dear Mr. Courtney:

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 reguirements 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

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Page 2 - Mr. Garry A. Courtney

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

pura R. h. hmer

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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T TERUMO

Section 4

Indications for Use

510(k) Number (if known): Unknown at time of submission ko92644

Device Name: Terumo Pressure Isolator

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) OROver-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vihinen

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K092644

Regulation Number and Section

§ 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).