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

AI/ML Overview

This document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. It declares the device's substantial equivalence to a predicate device. For devices like this, the acceptance criteria and proof of meeting them are primarily based on established regulatory standards and bench testing, rather than studies involving AI algorithms or human reader performance.

Here's a breakdown of the requested information based on the provided text, focusing on how this type of medical device demonstrates compliance:

1. Table of Acceptance Criteria and Reported Device Performance

For an aneroid sphygmomanometer, the primary performance criterion is accuracy.

Acceptance Criterion (Standard)	Reported Device Performance
Pressure Accuracy: +/- 3 mmHg of reading (ISO 81060-1, previously AAMI SP9)	Pressure: +/- 3 mmHg of reading
Environmental Compatibility: 10°C to 40°C (50°F to 104°F) and 15%~85%RH humidity	It can be used from 50°F to 104°F (10°C to 40°C) and 15% ~ 85%RH humidity.
Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10)	Biocompatible as requirements of ISO 10993-1, ISO 10993-5, ISO 10993-10

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission." This indicates that the performance validation was primarily through bench testing and adherence to recognized standards. Therefore, an explicit "test set" in the sense of patient data is not applicable here. The provenance of any internal testing data would be from the manufacturer's own facilities in Wenzhou, Zhejiang, China, and would be prospective testing against the defined standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable as this is not a study involving interpretation of complex data (like medical images) requiring expert consensus for ground truth. Ground truth for a sphygmomanometer's accuracy is established by highly accurate reference pressure devices.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI. This device is a manual measurement tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not contain an AI algorithm. Its performance is inherent to its mechanical and material properties. The accuracy testing ("standalone" in a very literal sense for a mechanical device) would have been performed on the device itself against calibrated reference equipment.

7. The Type of Ground Truth Used

For device accuracy: Comparison against a highly accurate and calibrated reference pressure measurement system.
For biocompatibility: Adherence to ISO standards and material testing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and thus has no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary of Acceptance Criteria and Study for This Device (Aneroid Sphygmomanometer):

The acceptance criteria for this device are primarily based on established international and national standards for blood pressure measuring devices and medical device safety.

Acceptance Criteria:
- Accuracy: Maintain a pressure accuracy of +/- 3 mmHg of reading. This is a critical performance characteristic.
- Environmental Compatibility: Function correctly within specified temperature and humidity ranges.
- Biocompatibility: Materials in contact with the patient's skin must meet ISO 10993 series standards for biological evaluation of medical devices.
- Mechanical and Functional Integrity: The device must inflate, deflate, and hold pressure reliably.
- Design and Materials: Any changes in design or materials (e.g., PVC bulb, Nylon cuff) must be shown not to negatively impact safety or effectiveness.
Study Proving Device Meets Acceptance Criteria:
- Type of Study: The document explicitly states "No clinical study is included in this submission." The "study" here refers to Non-Clinical Testing, specifically bench testing and compliance with recognized standards.
- Methods:
  - Performance Testing (Bench Testing): The device (and its modified components) underwent testing to verify its pressure accuracy against calibrated standards (consistent with ISO 81060-1). This includes tests for pressure measurement accuracy, repeatability, and potentially rapid deflation and overpressure protection.
  - Biocompatibility Testing: Materials used for the device that contact the patient's skin were tested and demonstrated compliance with ISO 10993 standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
  - Comparison to Predicate Device: The submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K043286). Performance specifications, materials, and intended use were compared. Any differences (e.g., optional PVC bulb, various cuff sizes/materials, wider target population including children) were evaluated to ensure they did not introduce new safety or effectiveness concerns, and were supported by the non-clinical testing results.
- Ground Truth: For accuracy, the ground truth is derived from highly accurate and calibrated reference pressure measurement equipment. For material safety, the ground truth is defined by the toxicological and biocompatibility profiles established in the ISO 10993 standards.
- Sample Size: Not explicitly stated for bench testing, but typically involves a statistically relevant sample of manufactured devices tested against the defined criteria.
- Data Provenance: Testing was conducted by the manufacturer (Wenzhou Bokang Instruments Co., Ltd.) in China, likely at their in-house or contracted testing facilities, and would be considered prospective testing.

Summary

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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)

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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510(k) Summary

Company Name:	WENZHOU BOKANG INSTRUMENTS CO., LTD
Company Address:	No. 1500 Haining Rd., Haibin LongwanWenzhou, 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, BK2002-3001MODEL 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

DEVICE DESCRIPTION

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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 ofComparasion
	ANEROIDSPHYGMOMANOMETER,MODEL BK2002,BK2002-3001, BK2015,BK2015-3001	ANEROIDSPHYGMOMANOMETER,MODEL BK2002(K043286)
Applicant	WENZHOU BOKANGINSTRUMENTS CO., LTD	WENZHOU BOKANGINSTRUMENTS CO., LTD	SAME
Classification	Class II	Class II	SAME
Regulation	21CFR 870.1120	21CFR 870.1120	SAME
comparison item	New deviceANEROIDSPHYGMOMANOMETERR, MODEL BK2002,BK2002-3001, BK2015,BK2015-3001	Predicate deviceANEROIDSPHYGMOMANOMETERR, MODEL BK2002(K043286)	Result ofComparison
number
Product code	DXQ, LDE	DXQ, LDE	SAME
Indications foruse	The device is intended to beused by medicalprofessionals or at home forthe measurement of systonicand diastonic pressure bydetecting Korotkoff sounds.	The device is intended to beused by medicalprofessionals or at home forthe measurement of systonicand diastonic pressure onadult by detecting Korotkoffsounds.	Similar
Over-The-Counter Use	Yes	Yes	SAME
Where used	Home, Hospital, heathcarefacility, ambulance etc.	Home, Hospital, heathcarefacility, ambulance etc.	SAME
Target population	Children (greater than 2 to12 years of age)Young Adults (greater than12 to 21 years of age)Adults (greater than 21	Adult (greater than 21 yearsof age)	Different
comparison item	New device	Predicate device	Result ofComparasion
	ANEROIDSPHYGMOMANOMETERR, MODEL BK2002,BK2002-3001, BK2015,BK2015-3001	ANEROIDSPHYGMOMANOMETERR, MODEL BK2002(K043286)
	years of age)
Anatomical sites	Upper Arm (leg for child)	Upper Arm	Different
Measurement	Auscultatory Korotkoff	Auscultatory Korotkoff	SAME
Method	sounds Method	sounds Method
Inflation	Manual by inflation bulb	Manual by inflation bulb	SAME
Deflation	Manual deflation via valve	Manual deflation via valve	SAME
Display	Aneroid Manometer	Aneroid Manometer	SAME
The monitor scale	From 0 to 300 mmHg with aminimum interval of 2mmHg.	From 0 to 300 mmHg with aminimum interval of 2mmHg.	SAME
Design	The device comprisestubing attached to a softinelastic cuff with anintegrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure.(BK2002/2002-3001):The	The device comprisestubing attached to a softinelastic cuff with anintegrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure.The device tubing is	Same as_BK2002/2002-3001DifferentfromBK2015/2015-3001
comparison item	New device	Predicate device	Result of
	ANEROID	ANEROID	Comparasi
	SPHYGMOMANOMETE	SPHYGMOMANOMETE	on
	R, MODEL BK2002,	R, MODEL BK2002
	BK2002-3001, BK2015,	(K043286)
	BK2015-3001
	device tubing is connected	connected to a non-invasive
	to a non-invasive	sphygmomanometer.
	sphygmomanometer.
	(BK2015/2015-3001):The
	bulb and aneroid manometer
	are connected together.
Materials	The manometer: aluminum	The manometer: aluminum	Differernt
	and stainless steel materials.	and stainless steel materials.
	The tubing, inflation bulb:	The tubing, inflation bulb:
	PVC.	nature latex.
	Cuff: Nylon cloth or cotton	Cuff: cotton cloth for
	cloth for outside layer.	outside layer.
	Cuff bladder: PVC or nature	Cuff bladder: nature latex.
	latex.
Accuracy	Pressure:+/- 3 mmHg of	Pressure:+/- 3 mmHg of	SAME
	reading	reading
Compatibility	It can be used from 50°F to	It can be used from 50°F to	SAME
with environment	104°F (10°C to 40°C) and	104°F (10°C to 40°C) and
comparison item	New device	Predicate device	Result ofComparasion
	ANEROIDSPHYGMOMANOMETERR, MODEL BK2002,BK2002-3001, BK2015,BK2015-3001	ANEROIDSPHYGMOMANOMETERR, MODEL BK2002(K043286)
	15% ~ 85%RH humidity.	15% ~ 85%RH humidity.
Cuff Size	20"x 5.5" (510mm140mm)21.7"x 6.3"(550mm160mm)24.4"x 6.9"(620mm175mm)28.3"x 8.3"(720mm210mm)13.4"x 4.15"(340mm105mm)10.2"x 3"(260mm75 mm)	15 9"(l) x 4 9"(w) (480mm x 145 mm)	Different
CuffCircumference	Fits arm circumferences8.7" to 17.3" (220mm to440 mm), The standard cuffshould be available for usein measuring a child's legblood pressure and forchildren with larger arms.	Fits arm circumferences8.7" to 17.3" (220mm to440 mm)	Different
Cuff bladder Size	8.7"x 4.7"(220mm120mm)11.8"x5.9"(300mm150mm)13.4"x	8 8"(l) x 4 8"(w) (225mm x120 mm)	Different
comparison item	New deviceANEROIDSPHYGMOMANOMETERR, MODEL BK2002,BK2002-3001, BK2015,BK2015-3001	Predicate deviceANEROIDSPHYGMOMANOMETERR, MODEL BK2002(K043286)	Result ofComparison
	6.7"(340mm170mm)6.9"x 3.3"(175mm85mm)7.5"x 2"(190mm*50mm)
Cuff Color	Blue, Gray, Red, Green,Yellow, Black	Blue, Gray, Red, Green,Yellow, Black	Same
Contents (withaccessories)	Aneroid gauge, Arm Cuff,Inflation Bulb, Vinyl storagepouch and InstructionManual, Stethoscope(BK2002-3001 andBK2015-3001 only)	Aneroid gauge, Arm Cuff,Inflation Bulb, Vinyl storagepouch and InstructionManual, Stethoscope(option)	Same
Biocompatibility	biocompatible asrequirement of ISO 10993-1ISO 10993-5ISO 10993-10	biocompatible asrequirement of ISO 10993-1ISO 10993-5ISO 10993-10	Same
Performance	compatible as requirementof ISO 81060-1	compatible as requirementof AAMI SP9	Similar

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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/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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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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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.

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).