(190 days)
Not Found
No
The device description explicitly states it is "non-automated" and relies on "manual method for detecting Korotkoff sounds." There is no mention of AI/ML in the description, performance studies, or key metrics.
No
The device is described as measuring blood pressure, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is intended for the "measurement of systolic and diastolic pressure," which provides information used to identify or manage a condition (blood pressure).
No
The device description explicitly lists physical components such as a manometer, cuff, cuff bladder, inflation bulb, and potentially a stethoscope, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The described device is a manual sphygmomanometer used to measure blood pressure directly on the patient's body. It is a non-invasive device that interacts with the patient externally.
- Intended Use: The intended use is to measure systolic and diastolic pressure on patients, not to analyze biological samples.
- Device Description: The components (manometer, cuff, bulb, stethoscope) are all external and used for direct measurement on the body.
- Lack of Specimen Handling: There is no mention of collecting or analyzing any biological specimens.
Therefore, based on the provided information, this device clearly falls under the category of a non-invasive medical device used for physiological measurement, not 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 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 (comma separated list FDA assigned to the subject device)
DXQ, LDE
Device Description
The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device.
The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.
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 and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type [FDA recognition No .: 3-96].
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity[FDA recognition No.: 2-245];
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization[FDA recognition No .: 2-174];
Biocompatibility testing:
The biocompatibility evaluation for the cuff and stethoscope was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process ." September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing items included:
- Cytotoxicity
- Sensitization
- Irritation
Performance testing:
Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007;
No clinical study is included in this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2021
Shanghai Caremate Medical Device Co. Ltd Mark Chu General Manager Building 4, No. 281, Hong An Road, Jinshan District, Shanghai. 201503 China
Re: K211084
Trade/Device Name: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: August 28, 2021 Received: September 16, 2021
Dear Mark Chu:
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.
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
1
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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope
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)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Sponsor Identification and Designated Submission Correspondent
| Company name | Shanghai Caremate Medical Device Co. Ltd |
|---|---|
| Address | Building 4, No. 281, Hong An Road, Zhujing Town, Jinshan |
| District, Shanghai, 201503, China | |
| Establishment Registration Number | 3007699082 |
| Contact name | Mark Chu |
| Contact title | General Manager |
| Phone | +86-21-57341588 |
| Fax | +86-21-37284210 |
| mark@carematemed.com |
Date of Preparation: 9/8/2021
.
| Predicate Device Information | |
|---|---|
| 510(k) Number | K192500 |
| 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 |
| Proposed Device Information | |
|---|---|
| Trade Name | Aneroid sphygmomanometer, |
| Aneroid sphygmomanometer with stethoscope | |
| Classification Name | Blood pressure cuff |
| Regulatory Information | |
| Classification Product code | DXQ |
| Subsequent Product Code | LDE |
| Regulation Number | CFR 870.1120, |
| CFR 870.1875 | |
| ReviewPanel | Cardiovascular |
4
Indications for Use of Propose Device
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.
Device Description of Propose Device
The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device.
The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.
Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type [FDA recognition No .: 3-96].
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity[FDA recognition No.: 2-245];
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization[FDA recognition No .: 2-174];
Biocompatibility testing:
The biocompatibility evaluation for the cuff and stethoscope was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process ." September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing items included:
- · Cytotoxicity
- · Sensitization
- · Irritation
Performance testing:
Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007;
5
Clinical Test Conclusion
No clinical study is included in this submission.
Comparison of Technology Characteristics
| ITEM | Proposed Device
Aneroid Sphygmomanometer | Predicate Device
K192500 | Rema
rk |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product
name | Aneroid sphygmomanometer,
Aneroid sphygmomanometer with
stethoscope | 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 | DXQ, LDE | Same |
| Regulation
No. | 21 CFR 870.1120
21 CFR 870.1875 | 21 CFR 870.1120
21 CFR 870.1875 | Same |
| Class | II | II | Same |
| 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 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. | 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. | Different 1 |
| Over-The
Counter
Use | Yes | Yes | Same |
| Where
used | 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 |
| Anatomical
sites | Upper Arm (leg for child) | Upper Arm (leg for child) | Same |
| Measurement
Method | Auscultatory Korotkoff sounds
Method | Auscultatory Korotkoff sounds
Method | Same |
| Method | | | |
| 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 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. | SE |
| 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 | The manometer: aluminum and
stainless steel materials.
The tubing, inflation bulb and cuff
bladder: PVC or nature latex. | Differ
ent 2 |
| | Cuff: Nylon cloth for outside layer. | Cuff: Nylon cloth for outside layer. | |
| Accuracy | Pressure: +/- 3 mmHg of reading. | Pressure: +/- 3 mmHg of reading. | Same |
| Cuff sizes | 31.49" × 8.66" (800mm220mm)
24.41" × 6.89" (620mm175mm)
20.47" × 5.51" (520mm140mm)
13.4" × 4.33" (340mm110mm)
9.84"×3.15" (250mm80mm)
8.27" × 2.36" (210mm60mm) | 780mm220mm
615mm175mm
540mm145mm
500mm140mm
345mm110mm
255mm75mm
185mm55mm | Differ
ent 3 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Cuff
circumference | 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, young
adult, and adult with larger arms | Fits arm circumferences
100mm-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 | Differ
ent 4 |
| | | | |
| | | | |
| | | | |
| | | | |
| Cuff
bladder
size | 13.39" × 6.69" (340mm170mm)
12.2"×5.51" (310mm140mm)
8.66"×4.72' (220mm120mm)
6.69"×3.15" (170mm80mm)
4.33" × 2.36" (110mm60mm) | 180mm370mm
145mm315mm
120mm220mm
80mm150mm
60mm*120mm | Differ
ent 5 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Configurat
ion | Manometer, cuff, cuff bladder,
inflation bulb and with/without
stethoscope. | Manometer, cuff, cuff bladder,
inflation bulb and with/without
stethoscope. | Same |
| Biocompat
ibility | 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 |
| Performan
ce | compatible as requirement of ISO
81060-1 | compatible as requirement of ISO
81060-1 | Same |
Table 1 Comparison of Technology Characteristics
6
7
Different 1- Indications for use
The indications for use of proposed device include the target population, while the predicate device doesn't include this information. But they have the same target population, therefore, the proposed device and predicate device have the same indications for use.
Different 2- Material
The material of out shell of manometer, material of tubing and inflation bulb of proposed device is different from the predicate device. But these material is not the patient-contact material, therefore the difference on material does not raise new questions on safety and effectiveness of the proposed device.
Different 3 - Cuff sizes
The cuff sizes of proposed device are different from predicate device. However, the cuff size of proposed device is similar to the predicate device and the Cuff Circumference of the two devices is the same. The Velcro on cuff is designed to fit varies arm circumference. This difference doesn't raise new problems on the safety and effectiveness of the proposed device. Therefore, this difference on cuff size does not raise new questions on safety and effectiveness of the proposed device.
Different 4 - Cuff circumference
The arm circumferences for the proposed cuff is 100mm-620mm, and the arm circumferences for the predicate cuff is 100mm-660mm. The range of arm circumferences for proposed device is covered by that of the predicate device, the difference on cuff circumference does not raise new questions on safety and effectiveness of the proposed device.
Different 5 - Cuff bladder size
The cuff bladder size of the proposed device is partly different from predicate device. However, the cuff bladder size of proposed device is similar to the predicate device. It could fit varies requirements of users. This difference doesn't raise new problems on the safety and effectiveness of the proposed device. Therefore, this difference on cuff bladder size does not raise new questions on safety and effectiveness of the proposed device.
Conclusion
Based on the comparison and analysis above, the proposed devices are as safe, as effective, and performs as well as the legally marketed predicate device K192500.