(98 days)
No
The description focuses on a standard pressure transducer converting physical pressure to electrical signals, with no mention of AI/ML terms or functionalities.
No
The device is a diagnostic tool that measures and monitors various pressure types; it does not explicitly state that it treats or cures a condition.
Yes
Explanation: The device is intended for "direct measurement and monitoring" of various pressures, which are used to assess physiological states and aid in diagnosis. While it converts pressure changes to electrical signals, the core function is to provide data for diagnostic purposes.
No
The device description explicitly states it consists of hardware components such as a transducer, luer connector, transducer cable, and stopcock.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure." These are measurements taken in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The description details how the device interfaces with an "intravascular catheter" and converts pressure changes into electrical currents for a "compatible patient monitor." This further reinforces its use for direct physiological monitoring within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the device described is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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., Ltd |
| Building 11, Lishan Industrial Park, Xinghai Ave | |
| Nanshan District, Shenzhen, Guangdong, 518052, China | |
| Correspondent: | Ms. Diana Hong / Mr. Lee Fu |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Suite 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 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. | |
| Testing Conclusion: | 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. | |
| SE Conclusion: | The proposed device, Disposable Pressure Transducer (DPT) is claimed to be |
| substantially equivalent to the predicate device, Transpac® Disposable Straight | |
| Pressure Transducer (DSPT) as cleared in K061573. |
111-1
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
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.
2
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
3
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:
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.
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
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