(207 days)
Not Found
No
The device description and intended use clearly state it is a manual aneroid sphygmomanometer that relies on manual inflation and detection of Korotkoff sounds. There is no mention of any automated or computational processes that would indicate AI/ML.
No.
The device is described as a manual non-invasive aneroid sphygmomanometer used for measurement of systolic and diastolic pressure, which is a diagnostic function, not a therapeutic one.
Yes
The device measures systolic and diastolic pressure, which are vital signs used by medical professionals to assess a patient's health and aid in diagnosing various conditions.
No
The device description clearly outlines physical components like an inflation cuff, manual inflation bulb, manometer (aneroid gauge), and potentially a stethoscope, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a manual non-invasive aneroid sphygmomanometer used to measure systolic and diastolic blood pressure. It works by physically interacting with the patient's arm and detecting Korotkoff sounds.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient.
Therefore, since the device operates by directly interacting with the patient's body to measure a physiological parameter (blood pressure) rather than analyzing a specimen taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. 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 (comma separated list FDA assigned to the subject device)
DXQ, LDE
Device Description
Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.
The device comprised tubing attached to a cuff with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure.
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 born, Infants, children, young adults, adults
Intended User / Care Setting
medical professional or at home / Hospital, home, office, and ambulance, etc.
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)
Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO 10993 and ISO 81060-1, were included. Results of testing were acceptable.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure : ±3mmHg of reading
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
§ 870.1120 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.
April 6, 2020
Honsun (Nantong) Co., Ltd Iris Du RA manager No.8, Tongxing Road, Nantong Economic & Technology Development Area Nantong, 226009 CHINA
Re: K192500
Trade/Device Name: Aneroid Sphygmomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C, HS-50B, HS-50D Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: March 6, 2020 Received: March 11, 2020
Dear Iris Du:
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. 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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
LT 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
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Indications for Use
510(k) Number (if known) K192500
Device Name
Aneroid Sphygmomanometer Model HS-20A, HS-20D, HS-201Y, HS-201Y, HS-201C1, HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C, HS-50B, HS-50D
Indications for Use (Describe)
The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. 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)
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Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
Chapter 6. 510(K) Summary
1.submitter
- Company name: HONSUN(NANTONG)Co.,Ltd
- Address:No.8, Tongxing Road, Nantong Economic & Technological development Area,Jiangsu, 226009, China
- Postal Code:226010
- TEL:86-0513-80580127
- Contact person: Xinhua Pan (General Manager)
Iris Du(RA Manager)
- E-mail:dulh@lordmed.com
2.Subject Device Information
- Model HS-20A,HS-20D, HS-50C, HS-50B, HS-50D, HS-201Q3,HS-201C1,HS-201Y, HS-201W
- Common name: Blood Pressure Kit(Blood Pressure Cuff)
- Trade name: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B,HS-50D
- Product Code: DXQ,LDE
- Regulation name: 21CFR 870.1120/21CFR 870.1875
- Regulation class: II
- Review Panel: Cardiovascular
3.Predicate device
- RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope.MODEL
4
Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
Max0201,Max0202,Max0203,(K190902)
4.Intended use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. 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
Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.
The subject devices are same as the predicate device(K190902) in terms of PVC or latex inflation bulb and the PVC or latex bladder. Besides, the material of added the optional various size of cuff (nylon or cotton cuff for this application)and the aluminum manometer are identical to the predicate device (K190902).
6. Substantial equivalence comparison
It is substantially equivalence to the predicate device (K190902) RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope MODEL Max0201,Max0202,Max0203 with respect to indication for use, device description, and technical description.
All comparison table for applied device are as following, and the substantial equivalence determination is based on the 510(K) Substantial Equivalence
5
Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
Decision-Making Process Flowchart which includes the comparison and discussion of indication for use, technology, and performance specifications.
The new device column includes the following device: Aneroid sphymomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3/ Aneroid sphymomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D.
| Comparison item | Subject device: | Predicate device : | Result of comparison |
|---|---|---|---|
| Applicant | HONSUN(NANTONG)Co.,Ltd | Wenzhou Renhua Instruments Co.,Ltd | |
| 510(K) number | Applying | K190902 | - |
| Regulation number | 21 CFR 870.1120 | 21 CFR 870.1120 | Same |
| Product code | DXQ.LDE | DXQ.LDE | Same |
| Classification | Class II | Class II | Same |
| Intended use | The device is intended to be used by medical professional or at home for the measurement of systolic and diastolic pressure by detecting korotkoff sounds. | The device is intended to be used by medical professional or at home for the measurement of systolic and diastolic pressure by detecting korotkoff sounds. | Same |
| Aneroid sphymomanometer | |||
| Model HS-20A, | |||
| HS-20D,HS-201W, HS-201Y, | |||
| HS-201C1, HS-201Q3/ | |||
| Aneroid sphymomanometer | |||
| with stethoscope, Model | |||
| HS-50C, HS-50B, HS-50D | RH non-Automated Blood | ||
| pressure meter Model Max | |||
| 02,RH non-Automated | |||
| Blood pressure meter | |||
| with stethoscope, Max0201, | |||
| Max0202,Max0203 |
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Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3
Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
| Over-the-co
| unter use | Yes | Yes | Same |
|---|---|---|---|
| Target | |||
| population | New born, Infants, children, | ||
| young adults, adults | New born, Infant, children, | ||
| young adults, adults | Same | ||
| Where used | Hospital, home, office, | ||
| and ambulance, etc. | Hospital, home, office, | ||
| and ambulance, etc. | Same | ||
| Anatomical | |||
| sites | Upper arm(leg for child) | Upper arm(leg for child) | Same |
| Measureme | |||
| nt Method | Ausculatory Korotkoff | ||
| sounds method | Ausculatory 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 |
| The monitor | |||
| scale | From 0 to 300mmHg with a | ||
| minimum interval of 2 | |||
| mmHg | From 0 to 300mmHg with a | ||
| minimum interval of 2 | |||
| mmHg | Same |
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Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-201W, HS-201Y,HS-201C1,HS-201Q3
Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
| Design | The device comprised
tubing attached to a cuff
with an integrated
inflatable bladder that is
wrapped around the
patient's limb and secured
by hook and loop closure. | The device comprised
tubing attached to a 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
Rappaport | Three types option:
Single head
Dual head
Rappaport | Same |
| Materials | The manometer
:aluminum and stainless
steel materials.
The tubing ,inflation
bulb:PVC or latex.
Cuff:Nylon cloth or cotton
cloth for outside layer.
Cuff bladder:PVC or nature
latex | The manometer
:aluminum and stainless
steel materials.
The tubing ,inflation
bulb:PVC or latex.
Cuff:Nylon cloth or cotton
cloth for outside layer.
Cuff bladder:PVC or nature
latex | Same |
| Accuracy | Pressure : ±3mmHg of
reading | Pressure : ±3mmHg of
reading | Same |
| Compatibility
with
environment | It can be used from 50°F to
104°F (10°C to 40°C) and
15%~85% RH humidity. | It can be used from 50°F to
104°F (10°C to 40°C) and
15%~85% RH humidity. | Same |
8
Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-201W, HS-201Y,HS-201C1,HS-201Q3
Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
| Cuff size | 185mm55mm
255mm75mm
345mm110mm
500mm140mm
540mm145mm
615mm175mm
780mm220mm | 20"×5.5"(510mm140mm)
21.7"×6.3"(550mm160mm)
24.4"×6.9"(620mm175mm)
28.3"×8.3"(720mm210mm)
13.4"×4.15"(340mm105mm)
10.2"×3"(260mm75mm) | Similar |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Cuff
circumference | Fits arm circumferences
100mm-660mm,the
standard cuff should be
available for use in
measuring a child's leg
blood pressure and for
children with larger arms. | Fits arm circumferences
8.7" to 17.3"
(220mm-440cm),the
standard cuff should be
available for use in
measuring a child's leg
blood pressure and for
children with larger arms. | Similar |
| Cuff bladder
Size | 40mm80mm
60mm120mm
80mm150mm
120mm220mm
145mm315mm
180mm370mm | 8.7"×4.7"(220mm120mm)
11.8"×5.9"(300mm150mm)
13.4"×6.7"(340mm170mm)
6.9"×3.3"(175mm85mm)
7.5"×2"(190mm50mm) | Similar |
| Contents(with
accessories) | Aneroid gauge,Arm cuff,
inflation bulb, and
instruction manual,
stethoscope(option) | Aneroid gauge,Arm cuff,
inflation bulb, and
instruction manual,
stethoscope(option) | Same |
| Biocompatibility | Biocompatible as requirement of
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Biocompatible as requirement of
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
| performance | Compatible as requirement of ISO 81060-1 | Compatible as requirement of ISO 81060-1 | Same |
9
Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
Discussion:
Same in details:
- Compared with the predicate device(K190902) RH non-Automated Blood pressure meter Model Max 02,RH non-Automated Blood pressure meter with stethoscope, Max0201, Max0202, Max0203, the subject device Aneroid sphymomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3/ Aneroid sphymomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D are same as the predicate device(K190902) in terms of material s of the inflation bulb,tubing, cuff and manometer.
- Predicate device (K190902) and subject device HS-20A, HS-20D, HS-50C, HS-50B, HS-50D, HS-201Q3, HS-201C1, HS-201Y, HS-201W have same classification,indication for use, target population, measurement method, product physical design and operation, performance parameter ranges,mechanical safety, anatomical sites, operation principles and etc. The structure of the predicate device (K190902) are same as the subject device ,which all have manometer, bulb, tube, various size of cuff and stethoscope(optional).The predicate device and subject device all have dual head stethoscope, single head stethoscope and rappaport stethoscope.
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10
Sponsor:HONSUN(NANTONG)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1,HS-201Q3 Aneroid sphygmomanometer with stethoscope Model HS-50C,HS-50D
Difference in details:
- The different sizes of the cuffs and bladders,cuff circumstance are provided in order to accommodate target population. All performance have been tested in this submission and do not raised any safety or effectiveness issue.All performance specification was verified to comply with the ISO 81060-1 standard.
7. Non-clinical testing
Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO 10993 and ISO 81060-1, were included. Results of testing were acceptable.
8. Clinical testing
No clinical study is included in this submission.
Conclusion
RH non-automated blood pressure meter Model Max 02, non-automated blood pressure meter with stethoscope Model Max0201, Max 0202,Max0203(K190902) and subject device have the same intended use and similar technological characteristics. Moreover, information contained in this submission supplied demonstrates that any difference in their characteristic do not raise any new questions of safety or effectiveness. Thus, aneroid sphygmomanometer Model HS-20A, HS-20D, HS-201W, HS-201Y, HS-201C1, HS-201Q3/ aneroid sphygmomanometer with stethoscope, Model HS-50C, HS-50B, HS-50D are equivalent to the predicate device(K190902)..
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