(79 days)
Not Found
No
The device description and performance studies focus on the physical components and biocompatibility of a blood pressure cuff, with no mention of AI or ML technology.
No.
The device is described as an accessory for noninvasive blood pressure measurement systems; its intended use is for obtaining measurements, not for providing therapy or treatment.
No
The device is a blood pressure cuff, which is an accessory used with blood pressure measurement systems to take readings. It does not independently diagnose conditions.
No
The device description clearly outlines physical components like tubing, an inelastic sleeve, an inflatable bladder, and hook and loop closure, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "accessory used in conjunction with noninvasive blood pressure measurement systems." It is applied to the patient's limb to facilitate the measurement of blood pressure.
- Device Description: The description details a physical device (cuff, tubing, bladder) that interacts with the patient's body externally.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility and testing according to standards for non-invasive sphygmomanometers, which are devices used for direct measurement on the body, not for analyzing samples.
Therefore, this blood pressure cuff is a medical device used for direct physiological measurement on a patient, not an in vitro diagnostic device.
N/A
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 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 neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXO, 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. The subject device is categorized into two types of models according to its usage: Reusable Blood Pressure Cuff and Disposable Blood Pressure Cuff.
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
neonatal, pediatric and adult sizes.
Intended User / Care Setting
Prescription Use
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)
Performance data provided in support of substantial equivalence include:
Biocompatibility evaluation conducted in accordance with FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The tests included Cytotoxicity, Sensitization, and Irritation. The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation.
The subject device has been tested according to ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
Clinical data: The subject and predicate devices are exactly the same. No further clinical testing is necessary.
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). 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.
November 29, 2023
Shenzhen Plinma Technology Co. Ltd. Zhang Mongdi QA Manager 401, Xinheng Building No.22, Row 3, Shiling Road Jinsha Community, Kengzi Street, Pingshan District Shenzhen, Guangdong 518122 China
Re: K232772
Trade/Device Name: Blood Pressure Cuff (1201D1, 12L2D1, 1202D1, 12L3D1, 1203D1, 1204D1, 1205D1, 1206D1, 1207D1-1#, 1207D1-2#, 1207D1-3#, 1207D1-4#, 1207D1-5#, 1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1, 1207B1-1#, 1207B1-2#, 1207B1-3#, 1207B1-4#, 1207B1-5#, 1201W2, 12L2W2, 1202W2, 12L3W2, 1203W2, 1204W2, 1205W2, 1206W2 and 1207W2) Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: September 9, 2023 Received: September 11, 2023
Dear Zhang Mongdi:
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 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-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
Submission Number (if known) K232772
Device Name
Blood Pressure Cuff
(1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D 1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,1203B1,1204B1,1205B1,1206B1,120 7B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1203W2,1203W2 1204W2,1205W2,1206W2 and 1207W2)
Indications for Use (Describe)
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 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 neonatal, pediatric and adult sizes. 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)
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4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| Prepared Date | November 1, 2023 |
|---|---|
| Sponsor | Name: Shenzhen Plinma Technology Co.,Ltd |
| Address: 401, Xinheng Building, No.22, Row 3, Shiling Road, Jinsh | |
| a Community, Kengzi Street, Pingshan District, Shenzhen, Guangdong,China | |
| Contact person | Sandra Zhai |
| E-mail: Master@plinma.com | |
| Tel: +86-755- 28097345 | |
| Device Trade Name | Blood pressure cuff |
| Device Common Name | Blood pressure cuff |
| Classification Names | Blood pressure cuff |
| Regulation Number | 21 CFR 870.1120 |
| Product Code | DXQ |
| Regulatory Class | Class II |
| Predicate Device 1 | UNIMED MEDICAL SUPPLIES INC. Unimed Blood Pressure Cuff |
| under K112544 | |
| Predicate Device 2 | UNIMED MEDICAL SUPPLIES INC. Unimed Disposable Blood |
| Pressure Cuff under K120364 |
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.
The subject device is categorized into two types of models according to its usage.
Reusable Blood Pressure Cuff models:
1201B1,12L2B1,1202B1,12L3B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,1207B1-
3#,1207B1-4#,1207B15#,1201W2,12L2W2,1202W2,12L3W2,1203W2,
1204W2,1205W2,1206W2 and 1207W2
Disposable Blood Pressure Cuff models:
1201D1,12L2D1,1202D1,12L3D1,1204D1,1205D1,1204D1,1207D1-1#,1207D1-2#,1207D1-
3#,1207D1-4#,1207D1-5#
Connector models: PLINMA-03-127-003, PLINMA-03-T, PLINMA-03-Z3
Intended use & Indication 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.
5
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 neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
| Features | Subject device-Disposable | Predicate device
(K120364) | Comment |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 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 Unimed 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. | Same |
| 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
(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)
Small Adult (20.5-28.5)
Adult (27.5-36.5)
Adult Long (27.5-36.5)
Large Adult (35.5-46) | Neonate 1 (3-6)
Neonate 2 (4-8)
Neonate 3 (6-11)
Neonate 4 (7-13)
Neonate 5 (8-15)
Infant (9-14.8)
Child (13.8-21.5)
Small Adult (20.5-28.5)
Adult (27.5-36.5)
Adult Long(27.5-36.5)
Large Adult (35.5-46) | Difference 1 |
| Features | Subject device-Disposable | Predicate device
(K120364) | Comment |
| | Thigh (44-56) | Thigh (45-56) | |
| Material | Sleeve of disposable cuff: PVC | Sleeve of disposable cuff: PVC | Same |
| | composite nonwoven | composite nonwoven | |
| | Tubing: PVC | Tubing: PVC | |
| | Hook: Molded Nylon | Hook: Molded Nylon | |
| | Loop: Nylon | Loop: Nylon | |
| Tube
Configuration | One | One or two tube | Difference 2 |
| Pressure limits | 0-300mmHg | 0-300mmHg | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Standards met | ISO 81060-1 | ISO 81060-1 | Same |
| | ISO 10993-1 | ISO 10993-1 | |
| | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | |
Comparison to the Predicate Device Disposable
6
Reusable
| Features | Subject device-Reusable | Predicate device
(K112544) | Comment | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------|
| 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 neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | The Unimed 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 neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. | Same | |
| 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
(cm) | For Bladder
Neonate (6-11)
Infant (10-19)
Child (15.8-21.3) cm | Bladder
Neonatal (6-11cm)
Infant (10-19cm)
Pediatric (18-26cm) | Difference 3 | |
| Features | Subject device-Reusable | Predicate device
(K112544) | Comment | |
| | Small Adult (20-28) | Small Adult (20-28cm) | | |
| | Adult (25-35) | Adult (25-35cm) | | |
| | Adult Long (25-35) | Adult Long (25-35cm) | | |
| | Large Adult (33-47) | Large Adult (33-47cm) | | |
| | Large Adult Long (33-47) | Large Adult Long (33-47cm) | | |
| | Thigh (44-56) | Adult Thigh (46-66cm) | | |
| | For bladderless | | | |
| | 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) | | | |
| | Small Adult (20.5-28.5) | | | |
| | 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) | | | |
| Repeated
inflation | 10,000 inflations
3,000 hook and loop closures | 10,000 inflations
3,000 hook and loop closure | Same | |
| Material | Sleeve of reusable cuff : PU
Synthetic Leather
Bladder: Transparent
Polyurethane
(TPU Film)
Tubing: PVC
Hook: Molded Nylon
Loop: Nylon | Cuff: PU Synthetic Leather
Bladder: Transparent
Polyurethane (TPU Film)
Tubing: PVC
Hook: Molded Nylon
Loop: Nylon | Same | |
| | Tube
Configuration | One | One or two tube | Difference 4 |
| | Pressure limits | 0-300mmHg | 0-300mmHg | Same |
| | Sterile | Non-sterile | Non-sterile | Same |
| Standards met | ISO 81060-1 | ISO 81060-1 | Same | |
| | ISO 10993-1 | ISO 10993-1 | | |
| | ISO 10993-5 | ISO 10993-5 | | |
| Features | Subject device-Reusable | Predicate device
(K112544) | Comment | |
| | ISO 10993-10 | ISO 10993-10 | | |
7
8
Different 1&3: Both devices have slightly different limb circumference range, the size of limb circumference of subject device met the requirements of ISO 81060-1, and the limb circumference was marked in the labeling. Thus, this difference does not raise any safety or effectiveness issue.
Different 2&4: The subject device with one tube differs from that of predicate device. The subject device met the requirements of ISO 81060-1. Thus, this difference does not raise any safety or effectiveness issue.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity
- . Sensitization
- Irritation ●
The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation.
The subject device has been tested according to ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
Clinical data
The subject and predicate devices are exactly the same. Since the blood pressure cuffs are identical, no further clinical testing is necessary.
Conclusion
The sponsor has demonstrated through performance testing and features comparison, that the subject device is substantially equivalent to the predicate device.