(23 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/ML algorithms or data processing beyond standard blood pressure measurement.
No.
The blood pressure cuff is used for measurement of blood pressure, not for treatment of a condition. Measurement devices are not considered therapeutic.
No
Explanation:
The device, a blood pressure cuff, is described as an "accessory used in conjunction with non-invasive blood pressure measurement systems." Its role is to wrap around the patient's limb and inflate to facilitate blood pressure measurement. It does not independently analyze or interpret data to diagnose a condition. It merely aids in the collection of a physiological parameter (blood pressure) by a separate measurement system.
No
The device description explicitly details 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 is to be an accessory for non-invasive blood pressure measurement systems. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description details a physical cuff and tubing used to apply pressure to a limb. This is a mechanical device, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, this blood pressure cuff falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. 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.
The subject device is categorized into two types of models according to its reusability. Refer to the master list of models below.
Reusable Blood Pressure Cuff models: PU1883D, PU1883D, PU1882S, PU1882D, PU1881S, PU1881D, PU1885S, PU1885D, PU1880S, PU1880D, PU1886S, PU1869S, PU1869D, PU1889S, PU1889D, PU1884S, PU1884D.
Disposable Blood Pressure Cuff models: PU1710S, PU1720S, PU1730S, PU1740S,
PU1750S, PU1760S, PU1770S, PU1790S, PU1710D, PU1720D, PU1730D, PU1740D,
PU1750D, PU1760D, PU1770D, PU1790D, PU1781S, PU1782S, PU1783S, PU1784S, PU1785S, PU1781D, PU1782D, PU1783D, PU1784D, PU1785D.
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
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 test data:
The subject device meets the following the recognized standards:
- ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
- ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
The proposed device belongs to skin contact, and the contact duration is less than 30 days. Biocompatibility tests have been conducted on the proposed device, including cytotoxicity, sensitization, and skin irritation. The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation.
Clinical test data:
The subject and predicate devices are exactly the same. Since the blood pressure cuffs are identical, no further clinical testing is necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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January 6, 2021
JKH USA, LLC Bill Dai, Manager 14271 Jeffrey Rd. #246 Irvine. California 92620
Re: K203652
Trade/Device Name: Blood Pressure Cuff
Reusable Blood Pressure Cuff models: PU1883D, PU1882S, PU1882D, PU1881S, PU1881D, PU1885S, PU1885D, PU1880S, PU1880D, PU1886S, PU1886D, PU1869D, PU1889S, PU1889D, PU1884S, PU1884D.
Disposable Blood Pressure Cuff models: PU1710S, PU1720S, PU1730S, PU1740S, PU1750S, PU1760S, PU1770S, PU1790S, PU1710D, PU1720D, PU1740D, PU1750D, PU1760D, PU1770D, PU1790D, PU1781S, PU1782S, PU1783S, PU1784S, PU1785S, PU1781D, PU1782D, PU1783D, PU1784D, PU1785D.
Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: December 2, 2020 Received: December 14, 2020
Dear Bill Dai:
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.
1
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 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,
for 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
2
Indications for Use
510(k) Number (if known) K203652
Device Name Blood Pressure Cuff
Indications for Use (Describe)
The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. 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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3
510(k) Summary
| Submitter: | Name: JKH USA, LLC
Mailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620 |
|-----------------------|----------------------------------------------------------------------------------------|
| Contact Person: | Name: Bill Quanqin Dai
Phone Number: 909-929-9896
Email Address: Bill@jkhUSA.com |
| Date Prepared: | 12/02/2020 |
| 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 |
| Predicate Device 1: | |
| 510(k) Number: | K112544 |
| Device Name: | Unimed Blood Pressure Cuff |
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC |
| Predicate Device 2: | |
| 510(k) Number: | K120364 |
| Device Name: | Unimed Disposable Blood Pressure Cuff |
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC |
Description of Devices:
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 reusability. Refer to the master list of models below.
Reusable Blood Pressure Cuff models: PU1883D, PU1883D, PU1882S, PU1882D, PU1881S, PU1881D, PU1885S, PU1885D, PU1880S, PU1880D, PU1886S, PU1869S, PU1869D, PU1889S, PU1889D, PU1884S, PU1884D.
Disposable Blood Pressure Cuff models: PU1710S, PU1720S, PU1730S, PU1740S,
PU1750S, PU1760S, PU1770S, PU1790S, PU1710D, PU1720D, PU1730D, PU1740D,
PU1750D, PU1760D, PU1770D, PU1790D, PU1781S, PU1782S, PU1783S, PU1784S, PU1785S, PU1781D, PU1782D, PU1783D, PU1784D, PU1785D.
Indications for Use:
The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
4
Comparison to predicate device:
The subject and predicate devices are exactly the same, and there is no any difference between them.
| Description | Subject Device | Predicate Device (K112544 and K120364) |
|---|---|---|
| Indications for use | The Blood Pressure Cuff is an | |
| accessory used in conjunction with | ||
| non-invasive blood pressure | ||
| measurement systems. The cuff is | ||
| non-sterile. 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 | ||
| non-invasive blood pressure | ||
| measurement systems. The cuff is | ||
| non-sterile and may be reused. It is | ||
| available in pediatric and adult sizes. | ||
| The cuff is not designed, sold, or | ||
| intended for use except as indicated. | ||
| Prescription/ | ||
| over-the-cou | ||
| nter use | Prescription | Prescription |
| Target | ||
| population | Adults/Pediatrics/neonatal | Adults/Pediatrics/neonatal |
| Application | ||
| site | Arm or leg | Arm or leg |
| Material | Reusable Cuffs: PU Synthetic Leather | |
| Reusable Cuffs: PVC composite | ||
| nonwoven | ||
| Bladder: Transparent Polyurethane | ||
| (TPU Film) | ||
| Tubing: PVC | ||
| Hook: Molded Nylon | ||
| Loop: Nylon | Reusable Cuffs: PU Synthetic Leather | |
| Reusable Cuffs: PVC composite | ||
| nonwoven | ||
| Bladder: Transparent Polyurethane | ||
| (TPU Film) | ||
| Tubing: PVC | ||
| Hook: Molded Nylon | ||
| Loop: Nylon | ||
| Tube | ||
| Configuration | One or two tube | One or two tube |
| Repeated | ||
| inflation | For reusable cuffs: | |
| 10,000 inflations | ||
| 3,000 hook and loop closures | For reusable cuffs: | |
| 10,000 inflations | ||
| 3,000 hook and loop closures | ||
| Pressure | ||
| limits | 0-300mmHg | 0-300mmHg |
| Usage | Reusable and disposable | Reusable and disposable |
| Sterile | Non-sterile | Non-sterile |
| Standards | ||
| met | ISO 81060-1 | |
| ISO 10993-1 | ||
| ISO 10993-5 | ||
| ISO 10993-10 | ISO 81060-1 | |
| ISO 10993-1 | ||
| ISO 10993-5 | ||
| ISO 10993-10 |
| Table 1 Substantial Equivalence Table | |
|---|---|
| --------------------------------------- | -- |
Non-clinical test data:
5
The subject device meets the following the recognized standards:
- ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
- ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
The proposed device belongs to skin contact, and the contact duration is less than 30 days. Biocompatibility tests have been conducted on the proposed device, including cytotoxicity, sensitization, and skin irritation. The test results show that the proposed device has no issue of cytotoxicity, sensitization, or skin irritation.
Clinical test data:
The subject and predicate devices are exactly the same. Since the blood pressure cuffs are identical, no further clinical testing is necessary.
Substantial Equivalence:
The subject and predicate devices are exactly the same. The blood pressure cuffs are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device.