Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a manual aneroid sphygmomanometer using a manual inflation bulb and manual detection of Korotkoff sounds. There is no mention of any computational or algorithmic components that would suggest AI/ML.

Therapeutic

No

Explanation: The device is an aneroid sphygmomanometer used for measuring blood pressure, which is a diagnostic function rather than a therapeutic one. It does not actively treat or alleviate a medical condition.

Diagnostic

Yes

Explanation: The device is intended for the measurement of systolic and diastolic pressure, which are used to assess a patient's health and diagnose conditions like hypertension.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like an inflation cuff, manual inflation bulb, manometer (Aneroid gauge), and potentially a stethoscope, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states the device is a manual non-invasive aneroid sphygmomanometer used for measuring blood pressure by wrapping a cuff around the upper arm and detecting Korotkoff sounds. This is a physical measurement taken directly from the patient's body, not an analysis of a specimen.
Intended Use: The intended use is for measuring systolic and diastolic pressure, which is a physiological measurement, not a diagnostic test performed on a sample.

Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Product codes (comma separated list FDA assigned to the subject device)

DXO, LDE, DXQ

Device Description

Aneroid Sphgmomanometer, Models BK2002, BK2002-3001, BK2002a, BK2002a-3001, BK2015, BK2015-3001, are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL BK2002-3001, BK2015, BK2015-3001 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model BK2002-3001 and BK2015-3001 include additional stethoscope. It is conjunction with Stethoscope when use.

This is modified device differs from the original one (K043286) in terms of added the optional PVC inflation bulb (original bulb is made of nature latex) and in terms of added the optional various size of cuffs which cuffs outside layer is made of Nylon Cloth and inside bladder is made of PVC or nature latex (original bulb is made of nature latex and cuff outside layer is made of Cotton Cloth).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm (leg for child)

Indicated Patient Age Range

Children (greater than 2 to 12 years of age)

Young Adults (greater than 12 to 21 years of age)

Adults (greater than 21 years of age)

Intended User / Care Setting

Medical professionals or in the home; Home, Hospital, heathcare facility, ambulance etc.

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 testing included biocompatibility and bench testing. The tests listed in the ISO10993 and ISO81060-1, were included. Results of testing were acceptable. No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: +/- 3 mmHg of reading

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.

K043286

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.

K111141

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

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).

Summary

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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, 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.

May 30, 2018

Wenzhou Bokang Instruments Co., Ltd Youhua Xiang General Manager No. 1500 Haining Road, Haibin Longwan Wenzhou, 325024 Zhejiang, China

Re: K173246

Trade/Device Name: Aneroid Sphygmomanometer, M BK2002-3001. BK2002a, BK2002a-3001, BK2015, BK2015-3001 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO, LDE Dated: September 28, 2017 Received: October 6, 2017

Dear Youhua Xiang:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Youhua Xiang

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Wilhelm

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173246

Device Name

Aneroid Sphygmomanometer, Models BK2002, BK2002-3001, BK2002a-3001, BK2015, BK2015-3001

Indications for Use (Describe)

The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

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)

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Image /page/3/Picture/0 description: The image shows the logo for BOKANG. The logo is in red and features the word "BOKANG" in a bold, sans-serif font. There is a square-like shape with a line through it to the left of the word "BOKANG". There is a line underneath the word "BOKANG", and a registered trademark symbol is in the upper right corner of the logo.

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510(k) Summary

Company Name:	WENZHOU BOKANG INSTRUMENTS CO., LTD
Company Address:	No. 1500 Haining Rd., Haibin Longwan
Wenzhou, 325024 Zhejiang, China
Telephone:	+86-577-86876969
Fax:	+86-577-86880123
Contact Person:	Youhua Xiang
Summary Preparation Date:	2017.9.28
Device Trade Name:	Aneroid Sphygmomanometer, Models BK2002, BK2002-3001
MODEL BK2002a, BK2002a-3001, BK2015, BK2015-3001
Classification Name:	Blood pressure cuff, Stethoscope, manual
Regulation Number:	21 CFR 870.1120/ 21 CFR 870.1875
Product Code:	DXQ; LDE
Device Class:	Class 2
Panel:	Cardiovascular

PREDICATE DEVICE:

ANEROID SPHYGMOMANOMETER, MODEL BK2002 (K043286)

INDICATIONS FOR USE

The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

DEVICE DESCRIPTION

Aneroid Sphgmomanometer, Models BK2002, BK2002-3001, BK2002a, BK2002a-3001, BK2015, BK2015-3001, are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL BK2002-3001, BK2015, BK2015-3001 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl

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Image /page/4/Picture/0 description: The image shows the red-colored logo for "BOKANG". The logo features a stylized "K" enclosed in a square, followed by the letters "BOKANG" in a bold, sans-serif font. A line underlines the letters "OKANG", and a registered trademark symbol is present in the upper right corner of the logo.

bag. Model BK2002-3001 and BK2015-3001 include additional stethoscope. It is conjunction with Stethoscope when use.

This is modified device differs from the original one (K043286) in terms of added the optional PVC inflation bulb (original bulb is made of nature latex) and in terms of added the optional various size of cuffs which cuffs outside layer is made of Nylon Cloth and inside bladder is made of PVC or nature latex (original bulb is made of nature latex and cuff outside layer is made of Cotton Cloth).

Substantial Equivalence Comparison

It is substantially equivalent to the predicate device (K043286), Aneroid Sphgmomanometer MODEL BK2002, BK2002-3001, MODEL BK2002a, BK2002a-3001, BK2015, BK2015-3001 MODEL with respect to indications for use, device description, and technical characteristics.

All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.

The new device column includes the following devices: MODEL BK2002, BK2002-3001, MODEL BK2002a, BK2002a-3001, BK2015, BK2015-3001 MODEL

| comparison item | New device | Predicate device | Result of
Comparasi
on |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| | ANEROID
SPHYGMOMANOMETER,
MODEL BK2002,
BK2002-3001, BK2015,
BK2015-3001 | ANEROID
SPHYGMOMANOMETER,
MODEL BK2002
(K043286) | |
| Applicant | WENZHOU BOKANG
INSTRUMENTS CO., LTD | WENZHOU BOKANG
INSTRUMENTS CO., LTD | SAME |
| Classification | Class II | Class II | SAME |
| Regulation | 21CFR 870.1120 | 21CFR 870.1120 | SAME |
| comparison item | New device
ANEROID
SPHYGMOMANOMETER
R, MODEL BK2002,
BK2002-3001, BK2015,
BK2015-3001 | Predicate device
ANEROID
SPHYGMOMANOMETER
R, MODEL BK2002
(K043286) | Result of
Comparison |
| number | | | |
| Product code | DXQ, LDE | DXQ, LDE | SAME |
| Indications for
use | The device is intended to be
used by medical
professionals or at home for
the measurement of systonic
and diastonic pressure by
detecting Korotkoff sounds. | The device is intended to be
used by medical
professionals or at home for
the measurement of systonic
and diastonic pressure on
adult by detecting Korotkoff
sounds. | Similar |
| Over-The-
Counter Use | Yes | Yes | SAME |
| Where used | Home, Hospital, heathcare
facility, ambulance etc. | Home, Hospital, heathcare
facility, ambulance etc. | SAME |
| Target population | Children (greater than 2 to
12 years of age)

Young Adults (greater than
12 to 21 years of age)

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Image /page/5/Picture/0 description: The image shows the logo for BOKANG. The logo is red and features a stylized letter "K" inside a square on the left. The word "BOKANG" is written in capital letters, with a stylized "A" that resembles a triangle. A horizontal line underlines the word, and a circled "R" trademark symbol is located in the upper right corner.

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Image /page/6/Picture/0 description: The image shows the logo for BOKANG. The logo is red and features the word "BOKANG" in a bold, sans-serif font. There is a symbol to the left of the word "BOKANG" that looks like a stylized letter "K" inside of a square. Above the right side of the word "BOKANG" is a registered trademark symbol.

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Image /page/7/Picture/0 description: The image shows the logo for BOKANG. The logo is red and features the word "BOKANG" in a bold, sans-serif font. There is a symbol to the left of the word "BOKANG" that looks like a stylized "K" inside of a square. The "A" in "BOKANG" is shaped like a triangle, and there is a line underneath the word "BOKANG". There is a registered trademark symbol to the right of the word "BOKANG".

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Image /page/8/Picture/0 description: The image shows a logo for a company called "BOKANG". The logo is red and features a stylized letter "B" inside a square on the left. The rest of the word "BOKANG" is written in a bold, sans-serif font, with a triangle shape above the "A". There is a registered trademark symbol in the upper right corner.

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Image /page/9/Picture/0 description: The image shows the logo for BOKANG. The logo is red and features the word "BOKANG" in a bold, sans-serif font. The "A" in "BOKANG" is stylized to resemble a triangle. There is a line underneath the word "BOKANG" and a registered trademark symbol to the right of the "G".

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Discussion

Comparing with the predicate device, ANEROID SPHYGMOMANOMETER Model BK2002 (K043286), modified ANEROID SPHYGMOMANOMETER Model BK2002, BK2001-3001, BK2015 and BK2015-3001 have same product name, classification and product code, product physical design and operation, same Aneroid gauge, packaging

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Image /page/10/Picture/0 description: The image shows the logo for "BOKANG" in red font. The "B" is inside of a square, and there is a triangle above the "A". There is also a registered trademark symbol to the right of the "G".

materials, performance parameter ranges, physical properties, mechanical properties, biocompatibility. The differences between those two devices are as following.

. The AAMI SP9 standard which predicate device complied with is invalid to FDA recognized standard, and current recognized standard is ISO 81060-1:2010. All verification and validation activities, such as comparison test between modified device and original one was performed and the results demonstrated that predetermined acceptance criteria were met the requirement of standards.
The Nylon cuff, PVC bulb and PVC bladder have been used with another predicate device (K111141, Bokang Digital Blood Pressure Monitor, Model BK6001 which use same bulb and cuff bladder). All the materials which contacts with body skin are no changed as predicate device, and meet the FDA requirement of Biocompatibility.
The extended sizes of the cuffs are provided optionally in order to accommodate target population besides adults, such as infants, children and young adults. Based on the performance testing in this submission, the slight difference between these blood pressure cuffs does not raise any safety or effectiveness issue. All performance specification was verified to comply with the ISO81060-1 standard. (Please see section 18 of this submission)

Non-Clinical Testing

Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO10993 and ISO81060-1, were included. Results of testing were acceptable.

Clinical Study

No clinical study is included in this submission.

CONCLUSION

ANEROID SPHYGMOMANOMETER. MODEL BK2002 have the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, ANEROID SPHYGMOMANOMETER, MODEL BK2002, BK2002-3001, MODEL BK2002a, BK2002a-3001, BK2015, BK2015-3001 MODEL are substantially equivalent to the predicate devices.