The disposable pressure transducer (DPT) is intended for direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure.

Device Description

The proposed device, disposable pressure transducer (DPT), is an extravascular pressure transducer interfaces between an intravascular catheter and monitor by converting changes in pressure into electrical currents that can be impute into a compatible patient monitor. It is for single use; DPT mainly consists of a transducer which converting the pressure changes to electrical currents, a luer connector which can be connected to an intravascular catheter, a transducer cable that can connect to a compatible patient monitor and a stopcock for altering direction fluid flow.

AI/ML Overview

This document describes a 510(k) submission for a Disposable Pressure Transducer (DPT). The submission aims to establish substantial equivalence to a predicate device, the Transpac® Disposable Straight Pressure Transducer (DSPT) (K061573).

Here's the breakdown of the information requested, based on the provided text:

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

The provided text only states that "Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications and was substantially equivalent to the predicate device." It does not specify the actual acceptance criteria (e.g., specific accuracy ranges, drift limits, etc.) or the detailed reported performance results against those criteria. The focus of this 510(k) summary is on the conclusion of equivalence, not the granular performance data.

Acceptance Criteria	Reported Device Performance
Met all design specifications (details not provided in the text)	Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications.
Substantial equivalence to predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT), K061573)	Performance testing was conducted to validate and verify that the proposed device... was substantially equivalent to the predicate device.

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

The document does not provide details on the sample size used for performance testing or the data provenance.

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 information is not applicable and not provided. The device in question is a physical measurement transducer, not one requiring expert interpretation of data to establish ground truth for testing. Performance testing for such devices typically involves comparison against calibrated reference standards, not human expert consensus.

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

This information is not applicable and not provided, as the testing does not involve human interpretation or adjudication.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for a disposable pressure transducer.

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

This concept is not directly applicable to a disposable pressure transducer. The performance tests would have evaluated the device's ability to accurately convert pressure into electrical signals, without human intervention in the primary measurement process itself. The "standalone" performance here refers to the device's intrinsic accuracy and reliability. The text indicates "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," which implies standalone performance evaluation.

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

The ground truth for evaluating the performance of a pressure transducer would be established using calibrated reference pressure sources and possibly traceable measurement standards. For example, a precise pressure calibrator would be used to apply known pressures, and the DPT's output would be compared against these known values. This is not explicitly stated but is the standard practice for such devices.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided. This device is not an AI/ML algorithm.

Summary

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AUG 1 8 2009

Section III 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date of Submission:	May 11, 2009
Sponsor:	Shenzhen ANT Hi-Tech Industrial Co., LtdBuilding 11, Lishan Industrial Park, Xinghai AveNanshan District, Shenzhen, Guangdong, 518052, China
Correspondent:	Ms. Diana Hong / Mr. Lee FuShanghai Mid-Link Business Consulting Co., LtdSuite 8D, No.19, Lane 999,Zhongshan Road (S-2),Shanghai, 200030, China
Proposed Device	Disposable Pressure Transducer
Classification:	Class II, DRS, 870.2850
Predicate Device:	Transpac® Disposable Straight Pressure Transducer (DSPT) as cleared in K061573
Intended Use:	The disposable pressure transducer (DPT) is intended for direct measurement andmonitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure,compartmental (intramuscular) pressure and intracranial pressure.
Device Description:	The proposed device, disposable pressure transducer (DPT), is an extravascularpressure transducer interfaces between an intravascular catheter and monitor byconverting changes in pressure into electrical currents that can be impute into acompatible patient monitor. It is for single use; DPT mainly consists of a transducerwhich converting the pressure changes to electrical currents, a luer connector which canbe connected to an intravascular catheter, a transducer cable that can connect to acompatible patient monitor and a stopcock for altering direction fluid flow.
Testing Conclusion:	Performance testing was conducted to validate and verify that the proposed device,Disposable Pressure Transducer (DPT) met all design specifications and wassubstantially equivalent to the predicate device.
SE Conclusion:	The proposed device, Disposable Pressure Transducer (DPT) is claimed to besubstantially equivalent to the predicate device, Transpac® Disposable StraightPressure Transducer (DSPT) as cleared in K061573.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 1 8 2009

Shenzhen Ant Hi-Tech Industrial Co., Ltd. c/o Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd. Suite 8D, No. 19 Lane 999 Zhongshan Road (S-2) Shanghai, 200030 CHINA

Re: K091408

Trade/Device Name: Disposable Pressure Transducer Regulatory Number: 21 CFR 870.2550 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (two) Product Code: DRS Dated: August 3, 2009 Received: August 5, 2009

Dear Mr. Fu:

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. ·

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lee Fu

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

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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091408

Premarket Notification Section 510{k} Submission Disposable Pressure Transducer Section II Indication for Use Ref No.: A2009-002-033

Section II Indication for Use

510(k) Number:

Device Name: Disposable Pressure Transducer

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subparl 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

Page 1_ of

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).