(427 days)
Not Found
No
The device description and performance studies focus on the physical components and standard electrical signal conversion of a pressure transducer, with no mention of AI/ML algorithms or data processing beyond basic signal conversion.
No
The device measures and monitors fluid pressure, providing diagnostic information rather than directly treating a disease or condition.
Yes
The device is described as "intended for direct measurement and monitoring of fluid pressure" and converts "changes in pressure into electrical currents that can be input into a compatible pressure monitor," which aligns with the function of a diagnostic device that measures physiological parameters.
No
The device description clearly outlines physical components like a transducer module, luer connector, transducer cable, and stopcock, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for direct measurement and monitoring of fluid pressure." This describes a device used to measure physiological parameters within the body (or directly from a fluid source connected to the body), not a device used to examine specimens outside the body to obtain information about a physiological state, health, or disease.
- Device Description: The description details a transducer that interfaces with a catheter and pressure monitor to convert pressure changes into electrical signals. This is consistent with a device used for in vivo pressure monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the Disposable Blood Pressure Transducer (DBPT) is a medical device used for in vivo pressure monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
Product codes (comma separated list FDA assigned to the subject device)
DRS
Device Description
The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.
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)
The proposed device, Disposable Blood Pressure Transducer (DBPT) has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of biocompatibility, product performance and safety tests, which contains the standards including ASTM F756-13, ISO 10993-5:2009, ISO 10993-10 3Ed:2010, ISO 10993-11:2006, IEC 60601-2-34 3Ed:2011, and ANSI/AAMI BP22:1994 (R) 2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
Zhejiang Haisheng Medical Device Co., Ltd. Jonathan Hu, Technical Manager Medwheat (shanghai) Medical Technology Co.,ltd.. Yangpu Distrist Liaoyuan East Road Shuangyang First Suite No.33 Room 303 Shanghai, 200093 CN
Re: K152472
Trade/Device Name: Disposable Blood Pressure Transducer Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: September 27, 2016 Received: October 7, 2016
Dear Jonathan Hu:
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 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
1
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.
Sincerely,
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152472
Device Name Disposable Blood Pressure Transducer
Indications for Use (Describe)
The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image contains a logo for "HAISHENG MEDICAL". The logo consists of a blue circle with a white "H" in the center. To the right of the circle is the company name in both Chinese and English. The Chinese characters are above the English translation.
Date Prepared: Aug 25th, 2015
510(k) Summary
[As required by 21 CFR 807.92]
1. Submitter's Information
| Name of Sponsor: | ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
|---|---|
| Address: | 305#Tanggong Road, Paojiang Industrial Zone Shaoxing |
| City Zhejiang 312071, P.R.China | |
| Contact Name: | Hu Junbin |
| Telephone No.: | 86-575-88158510 |
| Fax No.: | 86-575-88158559 |
| Email Address: | hujb@hisern.com |
2. Correspondent's Information
| Company Name: | Medwheat Shanghai |
|---|---|
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 0086-021-65181421 |
| Email Address: | Jonathan.hu@medwheat.com |
3. Trade Name, Common Name, Classification
| Trade Name: | Disposable Blood Pressure Transducer |
|---|---|
| Common Name: | Disposable Pressure Transducer |
| Mode Name: | DBPT series |
| Regulation Classification | 870.2850 |
| Product Code: | DRS |
| Classification Panel: | Cardiovascular |
| Device Class: | II |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows: Transpac® Disposable Straight Pressure Transducer (DSPT) as cleared in K061573.
4
Image /page/4/Picture/1 description: The image is a logo for "HAISHENG MEDICAL". The logo consists of a blue circle with a stylized "H" in the center, also in blue. To the right of the circle are the Chinese characters for "HAISHENG MEDICAL", with the English translation "HAISHENG MEDICAL" below the Chinese characters.
5. Description of the Device
The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.
6. Indication for Use
The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
7. Technological Characteristics
As the reason that the working situation and environment of Disposable Blood Pressure Transducer (DBPT) is the same as that of the similar Transpac® Disposable Straight Pressure Transducer (DSPT), the technological characteristics of this product series are designed to make same as that of the equivalence product, including product structure such as stopcock, flush device, etc., and such as the application of materials over different parts of the product series are also be designed to be equal respectively. It applies EO sterilization method, which is also same as that of SE product.
8. Discussion of Non-clinical Testing
The proposed device, Disposable Blood Pressure Transducer (DBPT) has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of biocompatibility, product performance and safety tests, which contains the standards including ASTM F756-13, ISO 10993-5:2009, ISO 10993-10 3Ed:2010, ISO 10993-11:2006, IEC 60601-2-34 3Ed:2011, and ANSI/AAMI BP22:1994 (R) 2011.
9. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, it is concluded, basing on performance testing, indication for use, and technology, the subject device is substantially equivalent to the predicate device K061573.