(58 days)
No
The device description and intended use are for a standard blood pressure cuff, which is a mechanical accessory. There is no mention of AI, ML, or any computational processing beyond basic measurement.
No
The device is described as an "accessory used in conjunction with noninvasive blood pressure measurement systems" and facilitates measurement rather than directly providing a therapeutic effect.
No
Explanation: The device is a blood pressure cuff, an accessory used with noninvasive blood pressure measurement systems. Its stated function is to be wrapped around a patient's limb for blood pressure measurement, not to directly diagnose a condition.
No
The device description explicitly states it comprises physical components like tubing, an inelastic sleeve, an inflatable bladder, and hook and loop closure, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a blood pressure cuff used in conjunction with noninvasive blood pressure measurement systems. It is applied externally to the patient's limb to facilitate the measurement of blood pressure.
- No Sample Analysis: The device does not involve the collection or analysis of any biological samples from the patient.
Therefore, since the device does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is a medical device used for a physiological measurement.
N/A
Intended Use / Indications for Use
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate size. The cuff is not designed, sold, or intended for use except as indicated.
Product codes
DXQ
Device Description
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.
The subject device is categorized into two types of models according to its usage.
Reusable blood pressure cuff: C6711, C6921, C6911, C6921, C6811, C6821, C6611, C6621, C6521, C6311, C6321
Disposable blood pressure cuff: C0101, C0102, C0103, C0104, C0105
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm or leg
Indicated Patient Age Range
Adults/Pediatrics/neonatal (for reusable cuff)
neonate (for disposable cuff)
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 devices 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, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2024
Shenzhen Medke Technology Co., Ltd. % Jie Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue Nanshan District Shenzhen, Guangdong 518067 China
Re: K242623
Trade/Device Name: Disposable Blood Pressure cuff: Reusable Blood Pressure cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: August 30, 2024 Received: September 3, 2024
Dear Jie Yang:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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-regulatory
2
assistance/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
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
ndications for Use (Describe)
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate size. The cuff is not designed, sold, or intended for use except as indicated.
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)
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: 2024/10/29
1. Submission sponsor
Name: Shenzhen Medke Technology Co., Ltd. Address: 401, 503, Bldg. A1, Anle Ind. Zone No. 172, Hangcheng RD., Sanwei Community, Hangcheng Street Baoan District 518126 Shenzhen PEOPLE'S REPUBLIC OF CHINA Contact person: Li Wei Tao Title: CEO E-mail: tate@medke.com Tel: 0755-23463462
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie E-mail: yangjie(@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Reusable NIBP Cuff, Disposable NIBP Cuff |
|---|---|
| Model | Reusable blood pressure cuff: C6711, C6721, C6911, C6921, C6811, C6821, |
| C6611, C6621, C6511, C6521, C6311, C6321 | |
| Disposable blood pressure cuff: C0101, C0102, C0103, C0104, C0105 | |
| Common Name | Non-invasive Blood Pressure Cuff |
| Regulatory Class | Class II |
| Classification | 21CFR 870.1120 / Blood pressure cuff / DXQ |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
| Predicate device | Blood Pressure Cuff | K232772 | Shenzhen Plinma
Technology Co. Ltd. |
|------------------|----------------------------|---------|----------------------------------------|
| Reference device | Unimed Blood Pressure Cuff | K112544 | UNIMED MEDICAL
SUPPLIES INC. |
5
5. Device Description
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.
The subject device is categorized into two types of models according to its usage.
Reusable blood pressure cuff: C6711, C6921, C6911, C6921, C6811, C6821, C6611, C6621, C6521, C6311, C6321
Disposable blood pressure cuff: C0101, C0102, C0103, C0104, C0105
Intended use & Indication for use 6.
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate size. The cuff is not designed, sold, or intended for use except as indicated.
7. Comparison to the Predicate Device
The following tabulation indicates the detailed differences between the subject devices and the predicate device.
| Features | Predicate Device
Blood Pressure Cuff | Subject Device
NIBP CUFFs | Remark |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| K# | K232772 | K242623 | / |
| Classification
Regulation | 21CRF 870.1120 | 21CRF 870.1120 | Same |
| Classification and
Code | Class II,
DXQ | Class II,
DXQ | Same |
| Common
name | Non-invasive Blood Pressure
Cuff | Non-invasive Blood
Pressure
Cuff | Same |
| Reusable blood pressure cuff Comparison | | | |
| Intended Use&
Indications for
use | The reusable blood pressure cuff
is an accessory used in
conjunction with noninvasive
blood pressure measurement
systems. The cuff is non-sterile
and may be reused. It is | The reusable blood
pressure cuff is an
accessory used in
conjunction with
noninvasive blood | Same |
| Features | Predicate Device
Blood Pressure Cuff | Subject Device
NIBP CUFFS | Remark |
| | available in neonatal, pediatric
and adult sizes. The cuff is not
designed, sold, or intended for
use except as indicated. | pressure measurement
systems. The cuff is non-
sterile and may be reused.
It is available in neonate,
infant, child and adult
sizes. The cuff is not
designed, sold, or
intended for use except as
indicated. | |
| Prescription/over-
the counter-use | Prescription | Prescription | Same |
| Target
population | Adults/Pediatrics/neonatal | Adults/Pediatrics/neonatal | Same |
| Application
site | Arm or leg | Arm or leg | Same |
| Limb Circumference
(Range in cm) | For Bladder
Neonate 5 (6-11)
Infant (10-19)
Child (15.8-21.3)
Small Adult (20-28)
Adult (25-35)
Adult Long (25-35)
Large Adult (33-47)
Large Adult Long (33-47)
Thigh (44-56) | For Bladder
Neonate 5 (6-11)
Infant (10-19)
Pediatric (18-26)
Adult (25-35)
Large Adult (33-47)
Adult Thigh(46-66) | Similar |
| Repeated
inflation | 10,000 inflations
3,000 hook and loop closures | 10,000 inflations
3,000 hook and loop
closures | Same |
| Tube
Configuration | One | One or two tube | Similar,
note 2. Same as
K112544
reference
device. |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Material | Sleeve of reusable cuff : PU,
Synthetic Leather | Sleeve of reusable cuff :
PU | Similar, |
| Features | Predicate Device
Blood Pressure Cuff | Subject Device
NIBP CUFFS | Remark |
| | Bladder: Transparent
Polyurethane(TPU Film) | Bladder: TPU | |
| | Tubing: PVC | Tubing: PVC | |
| | Hook: Molded Nylon | Hook: Nylon | |
| | Loop: Nylon | Loop: Nylon | |
| | Disposable blood pressure cuff Comparison | | |
| Intended Use&
Indications for
use | The disposable blood pressure
cuff is an accessory used in
conjunction with noninvasive
blood pressure measurement
systems. The cuff is non-sterile
and for single-patient use. It is
available in neonatal, pediatric
and adult sizes. The cuff is not
designed, sold, or intended for
use except as indicated. | The disposable blood
pressure cuff is an
accessory used in
conjunction with
noninvasive blood
pressure measurement
systems. The cuff is non-
sterile and for single-
patient use. It is available
in neonate size. The cuff
is not designed, sold, or
intended for use except as
indicated. | Same. The
neonate use of
the subject
device is
covered by the
predicate
device. |
| Prescription/over-
the counter-use | Prescription | Prescription | Same |
| Target population | Adults/Pediatrics/neonatal | neonatal | Same. The
neonate use of
the subject
device is
covered by the
predicate
device. |
| Application
site | Arm or leg | Arm or leg | Same |
| Limb Circumference
(Range in cm) | Neonate 1 (3-6)
Neonate 2 (4-8)
Neonate 3 (6-11)
Neonate 4 (7-13)
Neonate 5 (8-15)
Infant (12.3-16.8)
Child (15.8-21.3) | Neonate 1 (3-6)
Neonate 2 (4-8)
Neonate 3 (6-11)
Neonate 4 (7-13)
Neonate 5 (8-15) | Same. The
neonate use of
the subject
device is
covered by the
predicate
device. |
| Features | Predicate Device
Blood Pressure Cuff | Subject Device
NIBP CUFFS | Remark |
| | Adult (27.5-36.5) | | |
| | Adult Long (27.5-36.5) | | |
| | Large Adult (35.5-46) | | |
| | Large Adult Long (35.5-46) | | |
| | Thigh (44-56) | | |
| Tube Configuration | One | One | Same |
| Pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Material | Sleeve of disposable cuff: PVC,
composite nonwoven | Sleeve of disposable cuff:
Nylon | Similar |
| | Tubing: PVC | Tubing: PVC | |
| | Hook: Molded Nylon | Hook: Nylon | |
| | Loop: Nylon | Loop: Nylon | |
6
7
8
8. Non-clinical data
The following non-clinical data were provided in support of the substantial equivalence determination. Biocompatibility
The subject device is in contact with intact skin only AND all the component materials are included in Attachment G, Section B of the FDA Biocompatibility Guidance, 2023 (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process").
Performance testing
Non-clinical tests were conducted to verify that the proposed devices 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, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
9. Clinical study
No clinical study is included in this submission
10. Conclusion
Substantial equivalence comparisons, performance testing and compliance with voluntary standards demonstrate that the subject device is substantially equivalent to the predicate device.