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.

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.

AI/ML Overview

This document describes the FDA's 510(k) clearance for a "Blood Pressure Cuff" by JKH USA, LLC. The key aspect of this clearance is the assertion that the subject device and the predicate devices are exactly the same. Therefore, the "study that proves the device meets the acceptance criteria" is primarily a claim of identity to previously cleared devices, rather than a new performance study.

Given this, I will tailor the response to reflect that the "study" is a comparison and assertion of sameness, rather than a novel clinical trial.

Here's the breakdown of the acceptance criteria and the "study" that supports it:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (as claimed by manufacturer)
Indications for Use Identical to Predicate	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. (Identical to predicate)
Material Composition Identical to Predicate	Reusable Cuffs: PU Synthetic Leather, PVC composite nonwoven; Bladder: Transparent Polyurethane (TPU Film); Tubing: PVC; Hook: Molded Nylon; Loop: Nylon. (Identical to predicate)
Tube Configuration Identical to Predicate	One or two tube. (Identical to predicate)
Repeated Inflation Durability Identical to Predicate	For reusable cuffs: 10,000 inflations; 3,000 hook and loop closures. (Identical to predicate)
Pressure Limits Identical to Predicate	0-300mmHg. (Identical to predicate)
Usage Type Identical to Predicate	Reusable and disposable. (Identical to predicate)
Sterility Status Identical to Predicate	Non-sterile. (Identical to predicate)
Compliance with Recognized Standards (Non-clinical)	The device meets: - 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 (These standards were also presumably met by the predicate devices, and the claim of identicality implies continued adherence.)
Biocompatibility Established	Biocompatibility tests (cytotoxicity, sensitization, skin irritation) were conducted. Test results show no issue of cytotoxicity, sensitization, or skin irritation, given the skin contact duration of less than 30 days.
No Material or Design Modifications from Predicate	"The subject and predicate devices are exactly the same, and there is no any difference between them." "The blood pressure cuffs are identical to the cleared version and are not modified."
No Further Clinical Testing Necessary Due to Identity	"Since the blood pressure cuffs are identical, no further clinical testing is necessary."

Details of the "Study" (Comparison and Assertion of Equivalence):

Sample sizes used for the test set and data provenance:
This 510(k) submission relies on a claim of identicality to previously cleared predicate devices (K112544 and K120364, both "Unimed Blood Pressure Cuff" from UNIMED MEDICAL SUPPLIES INC). Therefore, there is no new clinical test set or patient data presented for this specific submission for the purpose of demonstrating performance. The "sample" is effectively the previously validated predicate device itself. No country of origin for a new test set is provided, and the data provenance is historical, based on the previous clearance of the predicate. This is a retrospective comparison based on design specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable (N/A) to this submission, as no new test set requiring expert ground truth establishment for a novel device performance study was conducted. The ground truth for the predicate devices would have been established at the time of their clearance through their respective validation studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. No new test set requiring adjudication was performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
N/A. This device is a passive blood pressure cuff, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This device is a physical medical accessory, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests (biocompatibility and standard compliance), the ground truth is established by laboratory test results conforming to the specified ISO standards (e.g., in vitro cytotoxicity, irritation, sensitization tests). For the device's overall performance, the "ground truth" for this submission is the established performance and safety of the predicate devices, which presumably met their own ground truth requirements through standard validations (e.g., accuracy against a reference standard for a blood pressure monitoring system, which the cuff is an accessory to, although the cuff itself simply maintains pressure).
The sample size for the training set:
N/A. This is a passive medical device, not a machine learning model. No training set for an algorithm was used.
How the ground truth for the training set was established:
N/A. No training set for an algorithm was used.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K203652

Device Name Blood Pressure Cuff

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Name: JKH USA, LLCMailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620
Contact Person:	Name: Bill Quanqin DaiPhone Number: 909-929-9896Email 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 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:

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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 anaccessory used in conjunction withnon-invasive blood pressuremeasurement systems. The cuff isnon-sterile. It is available inneonatal, pediatric and adult sizes.The cuff is not designed, sold, orintended for use except as indicated.	The Unimed Blood Pressure Cuff is anaccessory used in conjunction withnon-invasive blood pressuremeasurement systems. The cuff isnon-sterile and may be reused. It isavailable in pediatric and adult sizes.The cuff is not designed, sold, orintended for use except as indicated.
Prescription/over-the-counter use	Prescription	Prescription
Targetpopulation	Adults/Pediatrics/neonatal	Adults/Pediatrics/neonatal
Applicationsite	Arm or leg	Arm or leg
Material	Reusable Cuffs: PU Synthetic LeatherReusable Cuffs: PVC compositenonwovenBladder: Transparent Polyurethane(TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon	Reusable Cuffs: PU Synthetic LeatherReusable Cuffs: PVC compositenonwovenBladder: Transparent Polyurethane(TPU Film)Tubing: PVCHook: Molded NylonLoop: Nylon
TubeConfiguration	One or two tube	One or two tube
Repeatedinflation	For reusable cuffs:10,000 inflations3,000 hook and loop closures	For reusable cuffs:10,000 inflations3,000 hook and loop closures
Pressurelimits	0-300mmHg	0-300mmHg
Usage	Reusable and disposable	Reusable and disposable
Sterile	Non-sterile	Non-sterile
Standardsmet	ISO 81060-1ISO 10993-1ISO 10993-5ISO 10993-10	ISO 81060-1ISO 10993-1ISO 10993-5ISO 10993-10

Table 1 Substantial Equivalence Table
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Non-clinical test data:

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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.

Regulation Number and Section

§ 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).