(219 days)
Not Found
No
The device description explicitly states it is a manual aneroid sphygmomanometer that uses manual inflation and a manual method for detecting Korotkoff sounds. There is no mention of any automated or computational processes that would involve AI or ML.
No.
The device is an aneroid sphygmomanometer used for measuring blood pressure, not for treating any medical condition.
Yes
Explanation: The device is an aneroid sphygmomanometer used for the "measurement of systolic and diastolic pressure." The measurement of blood pressure is a common diagnostic parameter used to assess a patient's health status and aid in the diagnosis and monitoring of various conditions.
No
The device description explicitly details physical components like an inflation cuff, manual inflation bulb, manometer (Aneroid gauge), and potentially a stethoscope, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure systolic and diastolic blood pressure in a patient. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is a manual non-invasive aneroid sphygmomanometer. It involves a cuff, inflation bulb, manometer, and potentially a stethoscope. These are all external components used to interact with the patient's body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not process or analyze any biological specimens.
The device described is a standard medical device used for a non-invasive physiological measurement.
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 NT-20, NT-201/ Aneroid sphygmomanometer stethoscope, Model NT-50 are a manual non-invasive aneroid with 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 NT-50 also includes a stethoscope. It is conjunction with stethoscope when use.
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 professionals or in the 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.
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
§ 870.1120 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
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July 2, 2020
Little Doctor Electronic (Nantong) Co.,Ltd % Iris Du RA manager Little Doctor Electronic (Nantong)Co.,Ltd No.14, Zhenxingxilu Road, Chongchuan Area Nantong, 226000 CHINA
Re: K193259
Trade/Device Name: Aneroid Sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope, Model NT-50 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: May 27, 2020 Received: June 1, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193259
Device Name
Aneroid Sphygmomanometer Model NT-20, NT-201 Aneroid Sphygmomanometer with Stethoscope, Model NT-50
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:Little Doctor Electronic(Nantong)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
Chapter 6. 510(K) Summary
1.submitter
- Company name: Little Doctor Electronic(Nantong)Co.,Ltd
- Address:No.14, Zhenxingxilu Road, Chongchuan Area, Nantong, Jiangsu, 226000, China
- Postal Code:226000
- TEL:86-0513-80580127
- Contact person: Xinhua Pan (General Manager)
Iris Du(RA Manager)
- E-mail:dulh@lordmed.com
2.Subject Device Information
- Model: NT-20, NT-201, NT-50
- Common name: Blood Pressure Kit(Blood Pressure Cuff)
- Trade name: Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid
sphygmomanometer with stethoscope, Model NT-50
- Product Code: DXQ,LDE
- Regulation name: 21CFR 870.1120 (Blood pressure cuff)/21CFR 870.1875(Stethoscope)
- 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 Max0201,Max0202,Max0203,(K190902)
4
Sponsor:Little Doctor Electronic(Nantonq)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
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 NT-20, NT-201/ Aneroid sphygmomanometer stethoscope, Model NT-50 are a manual non-invasive aneroid with 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 NT-50 also includes a stethoscope. It is conjunction with stethoscope when use.
This is subject device 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 Decision-Making Process Flowchart which includes the comparison and discussion of indication for use, technology, and performance specifications.
5
Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
The new device column includes the following device: Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50
| Comparison
item | Subject device:
Aneroid
sphygmomanometer Mode
NT-20, NT-201/ Aneroid
sphygmomanometer with
stethoscope, Model NT-50 | Predicate device :
RH non-Automated Blood
pressure meter Model Max
02,RH non-Automated
Blood pressure meter
with stethoscope,
Max0201,Max0202,Max02
03 | Result of
comparison |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Applicant | Little Doctor Electronic
(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 |
| Classificatio
n | 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 |
| Over-the-co
unter use | Yes | Yes | Same |
| Target | New born, Infants, children, | New born,Infants,children , | Same |
| population | young adults,adults | young adults,adults | |
| 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 |
| 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 | One type option:
Single head | Three types option:
Single head
Dual head
Rappaport | Similar |
| 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 |
| Cuff size | 185mm55mm
255mm75mm
345mm110mm
500mm140mm
540mm145mm
615mm175mm
780mm220mm | 20"×5.5"(510mm140mm)
21.7"×6.3"(550mm160m
m)
24.4"×6.9"(620mm175m
m)
28.3"×8.3"(720mm210m
m)
13.4"×4.15"(340mm105m
m)
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"(300mm150m
m)
13.4"×6.7"(340mm170m
m)
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 |
| Biocompatibili
ty | 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 |
6
Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
7
Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
8
Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
9
Sponsor:Little Doctor Electronic(Nantonq)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
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, Max02 01, Max0202, Max0203, the subject device Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50 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 NT-20, NT-201, NT-50 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 single head stethoscope.
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.
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Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd
Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201
Aneroid sphygmomanometer with stethoscope Model NT-50
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 sphymomanometer Model NT-20, NT-201/ aneroid sphymomanometer with stethoscope, Model NT-50 are equivalent to the predicate device(K190902).