(58 days)
Not Found
No
The device description explicitly states it is a manual blood pressure monitor that relies on manual inflation and manual detection of Korotkoff sounds. There is no mention of automated analysis or algorithms that would suggest AI/ML.
No.
The device is used for measurement (diagnosis) of blood pressure, not for treating any medical condition.
Yes
The device is intended for the "measurement of systolic and diastolic pressure," which involves assessing a physiological state to provide objective data for diagnosis.
No
The device description explicitly lists multiple hardware components (cuff, inflation bulb, pressure gauge, air valve, stethoscope) and describes their physical materials and functions. It is a manual blood pressure monitor with physical components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- This Device's Function: The device described is an Aneroid Sphygmomanometer, which is a manual blood pressure monitor. It measures blood pressure by applying pressure to the upper arm and listening for Korotkoff sounds. This process involves direct interaction with the patient's body and does not involve the analysis of biological specimens.
The description clearly indicates that the device is used to measure a physiological parameter (blood pressure) directly on the patient, not by analyzing a sample taken from the patient.
N/A
Intended Use / Indications for Use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Product codes
DXO, LDE
Device Description
The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional).
Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.
Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.
Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS.
Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.
Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Arm (leg for child)
Indicated Patient Age Range
new borns, infants, children, young adults
Intended User / Care Setting
medical professionals or in the home
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
Non-clinical data
Safety and performance
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Biocompatibility
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation
Key Metrics
Accuracy: ± 3 mmHg
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2024
Wenzhou Longwan Medical Device Factory Bernard Zeng, Manager Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District Wenzhou. Zhejiang 325026 China
Re: K240165
Trade/Device Name: Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO, LDE Dated: January 15, 2024 Received: January 22, 2024
Dear Bernard Zeng:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE; ANEROID SPHYGMOMANOMETER
Indications for Use (Describe)
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X 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."
4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: Dec. 11,2023
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | WENZHOU LONGWAN MEDICAL DEVICE FACTORY |
|---|---|
| Address: | Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial |
| Cluster District, Wenzhou, Zhejiang, 325026 China | |
| Contact person: | Bernard Zeng |
| Title: | Manager |
| E-mail: | bernard@taiyumed.com |
| Tel: | 86-13957715667 |
2. Device Identification
| 510(K) number: | TBD |
|---|---|
| Trade/Device Name: | ANEROID SPHYGMOMANOMETER, |
| ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE | |
| Common name: | Blood Pressure Cuff |
| Regulation Number: | 870.1120 |
| Regulation Name: | Blood Pressure Cuff |
| Regulation Class: | Class 2 |
| Panel: | Cardiovascular |
| Product Code: | DXQ,LDE |
3. Predicate Device
| 510(K) number: | K211084 |
|---|---|
| Trade/Device Name: | Aneroid sphygmomanometer, |
| Aneroid sphygmomanometer with stethoscope | |
| Common name: | Blood Pressure Cuff |
| Regulation Number: | 870.1120 |
| Regulation Name: | Blood Pressure Cuff |
| Regulation Class: | Class 2 |
| Panel: | Cardiovascular |
| Product Code: | DXQ,LDE |
5
Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER
4. Indication for Use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
5. Device Description
The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional).
Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.
Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.
Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS.
Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.
Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.
6. Compared to Predicate Device
Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table
| SE
Comparisons | Subject Device | Predicate Device | Similarities/
Differences |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(K) number | TBD | K211084 | / |
| Name | ANEROID
SPHYGMOMANOMETER,
ANEROID
SPHYGMOMANOMETER
WITH STETHOSCOPE | Aneroid sphygmomanometer,
Aneroid sphygmomanometer
with stethoscope | Same |
| Indication for
Use | The device is intended to be
used by medical professionals | The device is intended to be
used by medical professionals | Same |
| | or in the home for the
measurement of systolic and
diastolic pressure on new
borns, infants, children, young
adults and adults. The device
is intended to be manually
attached to a patient and
manually inflated along with a | or in the home for the
measurement of systolic and
diastolic pressure on new borns,
infants, children, young adults
and adults. The device is
intended to be manually
attached to a patient and
manually inflated along with a | |
| | manual method for detecting
Korotkoff sounds. | manual method for detecting
Korotkoff sounds. | |
| Product code | DXQ,LDE | DXQ,LDE | Same |
| Class | II | II | Same |
| Regulation
Number | 21 CFR 870.1120 | 21 CFR 870.1120 | Same |
| Common name | Blood Pressure Cuff | Blood Pressure Cuff | Same |
| Type of Use | Over the Counter | Over the Counter | Same |
| Environment of
Use | Home, Hospital, healthcare
facility,ambulance etc. | Home, Hospital, healthcare
facility, ambulance etc. | Same |
| Target
population | New borns, infants, children,
young adults and adults | New borns, infants, children,
young adults and adults | Same |
| Site | Upper Arm (leg for child) | Upper Arm (leg for child) | Same |
| Measurement
Method | Auscultatory Korotkoff sounds
Method | Auscultatory Korotkoff sounds
Method | Same |
| Inflation | Manual by inflation bulb | Manual by inflation bulb | Same |
| Deflation | Manual deflation via valve | Manual deflation via valve | Same |
| Display | Aneroid Manometer | Aneroid Manometer | Same |
| Monitor scale | From 0 to 300 mmHg with a
minimum interval of 2 mmHg. | From 0 to 300 mmHg with a
minimum interval of 2 mmHg. | Same |
| Design of the
device | The device comprises tubing
attached to a soft inelastic cuff
with an integrated inflatable
bladder that is wrapped around
the patient's limb and secured
by hook and loop closure. | The device comprises tubing
attached to a soft inelastic cuff
with an integrated inflatable
bladder that is wrapped around
the patient's limb and secured
by hook and loop closure. | Same |
| Design of
Stethoscope | Three types option:
Single head
Dual head
Sprague Rappaport | Three types option:
Single head
Dual head
Sprague Rappaport | Same |
| Materials | The manometer: aluminum or
ABS
The tubing, inflation bulb and
cuff bladder: Neoprene or
Silicon rubber or Nature latex
or PVC
Cuff: Nylon cloth for outside
layer | The manometer: aluminum or
ABS
The tubing, inflation bulb and
cuff bladder: Neoprene or
Silicon rubber or Nature latex or
PVC
Cuff: Nylon cloth for outside
layer | Same |
| Accuracy | ± 3 mmHg | ± 3 mmHg | Same |
| Cuff sizes | 500 ×140mm
350 ×100mm
600 ×170mm
780 × 220mm
260 × 80mm
200 × 60mm
255 × 75mm
380 × 110mm
560 × 150mm
660 × 170mm
760 × 210mm | 800mm × 220mm
620mm × 175mm
520mm × 140mm
340mm × 110mm
250mm × 80mm
210mm × 60mm | Different,
See Note 1 |
| Cuff
circumference | Fits arm circumferences
60mm-660mm, the standard
cuff should be available for use
in measuring a New born,
infant, child's leg blood
pressure and for child, young
adult, and adult with larger
arms | Fits arm circumferences
100mm-620mm, the standard
cuff should be available for use
in measuring a New born, infant,
child's leg blood pressure and
for child, younq adult, and adult
with larger arms | Different,
See Note 1 |
| Cuff bladder
size | 220 × 120mm
175 × 85mm
315 × 145mm
375 × 185mm
110 × 60mm
80 × 40mm
115 × 55mm
175 × 80mm
215 × 120mm
310 × 140mm
340 × 170mm | 340mm × 170mm
310mm × 140mm
220mm × 120mm
170mm × 80mm
110mm × 60mm
80mm × 40mm | Different.
See Note 1 |
| Biocompatibility | ISO 10993-5:2009,
ISO 10993-10:2021,
ISO 10993-23:2021 | ISO 10993-5:2009,
ISO 10993-10:2010 | Different,
See Note 2 |
| Performance | ISO 81060-1:2007 | ISO 81060-1:2007 | Same |
6
Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER
7
Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER
Note 1: All of the cuff were tested alongside aneroid sphygmomanometer according to ISO 81060-1:2007, these differences do not affect safety and effectiveness.
Note 2: The skin irritation testing and skin sensitization testing were conducted in accordance with ISO 10993-23:2021 and ISO 10993-10:2021 due to the version update of the standard, this difference does not affect safety and effectiveness.
The subject device and predicate device are substantially equivalent in the areas of technological characteristics such as basic design, features, method of operation, general function,
8
Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER
application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
8. Performance Testing Summary
The subject device comply with:
Clinical test:
Clinical testing is not required.
Non-clinical data
Safety and performance
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Biocompatibility
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject devices ANEROID SPHYGMOMANOMETER,ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are as safe, as effective, and performs as well as the legally marketed predicated devices Aneroid sphygmomanometer,Aneroid sphygmomanometer with stethoscope(K211084).