(83 days)
Not Found
No
The document describes a simple, reusable blood pressure cuff, an accessory to a blood pressure measurement system. There is no mention of any computational or analytical capabilities, let alone AI or ML. The performance studies focus on basic device specifications and compliance with standards for blood pressure cuffs.
No
The device is described as an "accessory used in conjunction with non-invasive blood pressure measurement systems." Its purpose is to wrap around a limb for measurement, not to treat a medical condition.
No
The device is a reusable blood pressure cuff, which is an accessory used with non-invasive blood pressure measurement systems. It measures blood pressure, which is a vital sign, but it does not diagnose a specific disease or condition on its own. While blood pressure measurements are used in diagnostics, the cuff itself is a measurement tool, not a diagnostic device.
No
The device description explicitly states it is a "Reusable Blood Pressure Cuff," which is a physical hardware component. The summary also details physical characteristics like bladder type, tube, color, joint model, and size, further indicating it is 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 to be an accessory for non-invasive blood pressure measurement systems, wrapping around a patient's limb. This is a physical measurement taken directly from the body.
- Device Description: The description reinforces its function as a physical cuff for blood pressure measurement.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the Reusable Blood Pressure Cuff described is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DXQ
Device Description
The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.
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
adult
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)
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: IEC 80601-2-30: 2018, ISO 81060-1:2007, ISO 10993-5: 2009, ISO 10993-10: 2010. 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 contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2023
Suzhou Minhua Medical Apparatus Supplies Co., LTD % Alex Wang Regulatory Affairs Specialist Suzhou Minhua Medical Apparatus Supplies Co., Ltd. No.789, Wu Fang Road, Friendship Industrial Zone, Song Ling Town, Wu Jiang Suzhou, Jiangsu 215222 China
Re: K233276
Trade/Device Name: Reusable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: August 28, 2023 Received: September 29, 2023
Dear Alex Wang:
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 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,
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
510(k) Number (if known) K233276
Device Name Reusable Blood Pressure Cuff
Indications for Use (Describe)
The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressurement systems. The cuff is non-sterile and reusable. It is available in adult size.
| 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
Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
- Date of Preparation: 08/28/2023 1.
- Sponsor Identification 2.
Suzhou Minhua Medical Apparatus Supplies Co., LTD
You Yi Industrial Park, Songlin Town, Wujiang, 215222, CHINA Establishment Registration Number: 3011529836
Contact Person: Michael Ying Position: Project Manager Tel: +86-0512-63091066 Fax: +86-0512-63091066 Email: yingjiaqing@mhmedical.com.cn
- Designated Submission Correspondent
Mr. Alex Wang Position: Regulatory Affairs Specialist Tel: +86-0512-63091066 Fax: +86-0512-63091066 Email: alex.wang@pedesign.com.cn
5
- Identification of Proposed Device 4.
Trade Name: Reusable Blood Pressure Cuff Common Name: Blood Pressure Cuff
Regulatory Information Classification Name: Blood Pressure Cuff Classification: 2 Product Code: DXQ Regulation Number:870.1120 Review Panel: Cardiovascular
Intended Use Statement:
The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.
Device Description
The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable.
The model difference of the proposed device includes bladder type, tube, color, joint model and size.
న్. Identification of Predicate Device(s)
Predicate Device 1 510(k) Number: K133117 Product Name: Andon Blood Pressure Cuff
Predicate Device 2 510(k) Number: K171889 Product Name: Reusable Blood Pressure Cuff
- Non-Clinical Test Conclusion
6.1 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:
6
-
IEC 80601-2-30: 2018. Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
-
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
-
ISO 10993-5: 2009, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
-
ISO 10993-10: 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- 6.2 Human Factors / Usability Testing
Usability testing is not required per the risk profile of this product.
-
Clinical Test Conclusion 7.
No clinical study is included in this submission. -
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device
Cuff with Internal Bladder | Predicate Device 1
K133117 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device class | 2 | 2 |
| Product code | DXQ | DXQ |
| Regulation
Number | 21 CFR 870.1120 | 21 CFR 870.1120 |
| Intended use | The Reusable Blood Pressure
Cuff is an accessory used in
conjunction with non-invasive
blood pressure measurement
systems. The cuff is non-sterile
and reusable. It is available in
adult size. | Blood Pressure Cuffs are
intended to be wrapped on the
upper arm and used with a non-
invasive blood pressure
monitor system to complete the
measurement of blood
parameters on adults. |
| Patient
populations | adult | adult |
| Tube
configuration | One tube | One tube |
| Bladder | Internal Bladder | Internal Bladder |
Tak1a 1 Campariaan for Creff mith Internal D
7
| Principles of Operation | Bladder is wrapped around the patient's limb and secured by hook and loop closure. Air hose is connected to the noninvasive blood pressure measurement systems. | Bladder is wrapped around the patient's limb and secured by hook and loop closure. Air hose is connected to the noninvasive blood pressure measurement systems. |
|---|---|---|
| Size | Small adult: 17-22cm Small adult long / Adult: 22-30 cm | |
| Large Adult: 30-42 cm | ||
| Large Adult long: 42-48 cm | ||
| Universal: 22-42 cm | KD-525-P34: 15-24cm | |
| KD-525-P31: 20-34 cm | ||
| KD-525-P32: 30-44 cm | ||
| KD-525-P33: 40-48 cm | ||
| Reusable | Yes | Yes |
| Sterile | No | No |
| Pressure range | 0-300mmHg | 0-300mmHg |
| Material | Polyester | Not available |
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | Comply with ISO 10993-5 and ISO 10993-10 |
There are two differences for the proposed cuff and predicate device 1.
For size:
The cuff size range of proposed devices is included in the range of the predicate device 1. And the size is indicated in user manual clearly for selection. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
For material:
The material of proposed device and predicate device 1 may be different, but both of them comply with ISO 10993-5 and ISO 10993-10. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
| Item | Proposed Device
Cuff with Internal Bladder | Predicate Device 2
K171889 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device class | 2 | 2 |
| Product code | DXQ | DXQ |
| Regulation
Number | 21 CFR 870.1120 | 21 CFR 870.1120 |
| | | |
| Intended use | The Reusable Blood Pressure
Cuff is an accessory used in
conjunction with non-invasive
blood pressure measurement
systems. The cuff is non-sterile
and reusable. It is available in
adult size. | The Reusable Blood Pressure
Cuff is an accessory used in
conjunction with noninvasive
blood pressure measurement
systems. The cuff is non-sterile
and reusable. It is available in
infant, pediatric but not
neonatal, and adult sizes. |
| Patient
populations | adult | infant, pediatric but not
neonatal, and adult sizes |
| Tube
configuration | One tube | One or Two tube |
| Bladder | Internal Bladder | Internal Bladder or Integrated
Bladder |
| Principles of
Operation | Bladder is wrapped around the
patient's limb and secured by
hook and loop closure. Air hose
is connected to the noninvasive
blood pressure measurement
systems. | Bladder is wrapped around the
patient's limb and secured by
hook and loop closure. Air hose
is connected to the noninvasive
blood pressure measurement
systems. |
| Size | Small adult: 17-22cm Small
adult long / Adult: 22-30 cm
Large Adult: 30-42 cm
Large Adult long: 42-48 cm
Universal: 22-42 cm | Small adult: 17-22cm Small
adult long / Adult: 22-30 cm
Large Adult: 30-42 cm
Large Adult long: 42-48 cm
Infant / infant long: 9-14.8cm
Child /child long: 13.8-21.5cm
Small adult / small adult long:
20.5-28.5cm
Small adult long / Adult:
27.5-36.5cm
Big adult/big adult long:
35.5-46cm
Thigh: 45-56.5cm |
| Reusable | Yes | Yes |
| Sterile | No | No |
| Pressure range | 0-300mmHg | 0-300mmHg |
| Material | Polyester | Polyester or TPU leather with
nylon |
| Biocompatibility | Comply with ISO 10993-5 and
ISO 10993-10. | Comply with ISO 10993-5 and
ISO 10993-10. |
Table 2 Comparison for Cuff with Internal Bladder
8
There are six differences for the proposed cuff and predicate device 2.
For intended use:
9
The difference of intended use between proposed device and predicate device 2 is the patient population. and the patient populations of proposed devices is included in the range of the predicate device 2. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
For patient populations:
The patient populations of proposed devices is included in the range of the predicate device 2. And the patient populations are indicated in user manual clearly for identification. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
For tube configuration:
The tube configuration range of proposed devices is included in the range of the predicate device 2. And the configuration is indicated in user manual clearly for selection. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
For bladder:
The bladder type of proposed devices is included in the types of the predicate device 2. And the type is indicated in user manual clearly for selection. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
For size:
The cuff size range of proposed devices is included in the range of the predicate device 2. And the size is indicated in user manual clearly for selection. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
For material
The materials of proposed devices is identical to the materials of predicate device 2 with internal bladder type. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.