(48 days)
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
The device comproses tubing attached to a soft ineastic 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 sphygmomaniometer.
Here's an analysis of the provided 510(k) summary regarding the Aneroid Sphygmomanometer BK2002, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI standard SP-9, "Non-automated sphygmomanometer" | "The Aneroid Sphygmomanometer BK2002 has been tested to conform to the ANSI/AAMI standard SP-9, Non-automated sphygmomanometer." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the device "has been tested to conform to the ANSI/AAMI standard SP-9." To fully understand the rigor of the testing, one would need to refer to the full test report for the ANSI/AAMI SP-9 standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The ANSI/AAMI SP-9 standard outlines specific requirements for clinical validation, including the number of subjects and, by extension, the number of reference measurements from qualified observers. However, the summary itself does not detail these aspects.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a medical instrument (sphygmomanometer), not an AI-powered diagnostic tool that typically involves human readers interpreting outputs.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable to the device described. The Aneroid Sphygmomanometer BK2002 is a manual device, and its function involves human operation for inflation and detection of Korotkoff sounds. There is no "algorithm only" component in the traditional sense of AI/software-as-a-medical-device studies.
7. Type of Ground Truth Used
The ground truth for evaluating an aneroid sphygmomanometer against ANSI/AAMI SP-9 typically involves comparison against a highly accurate reference method (e.g., a mercury sphygmomanometer) during a clinical study, with measurements taken by trained observers. The summary states the device is compliant with the standard, implying this type of ground truth was established during the testing required by the standard.
8. Sample Size for the Training Set
This is not applicable as the Aneroid Sphygmomanometer BK2002 is a mechanical device and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
Summary of Device Performance and Compliance
The 510(k) summary declares that the Aneroid Sphygmomanometer BK2002 has been tested and found to conform to the ANSI/AAMI standard SP-9 for non-automated sphygmomanometers. This standard sets the performance requirements for accuracy and other aspects of manual blood pressure devices. The submission indicates substantial equivalence to a predicate device (Nihon Seimitsu Sokki Co.,Ltd's model HT-110, K012194) based on similar technological characteristics and compliance with this recognized standard. The intended use specifies manual operation and detection of Korotkoff sounds.
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JAN 1 3 2005
510(K) submission,Aneroid Sphygmomanometer Wenzhou Bokang Instrument Co.,Ltd P.R.China
510(K) Summary
| Contact | Zhen HuiZhejiang ML Medical Device Consultant Co.,Ltd23#,Huanchengdong Road,Hangzhou,310009P.R.ChinaTel:+86-571-87044795Fax:+86-571-87046982 |
|---|---|
| Submitter | Xiang YouwangWenzhou Bokang Instrument Co.,Ltd72#,Haibin Ningchen Hengjie,Wenzhou,325024P.R.ChinaTel:+86-577-86873588Fax:+86-577-86880123 |
| Proprietary Name | Aneroid Sphygmomanometer BK2002 |
| Common Name | Aneroid Sphygmomanometer BK2002 |
| Classification Name | Blood Pressure, Cuff |
| Panel | Cardiovascular |
| Classification | The classification Name 21 CFR Part and Paragraph num |
ne,21 CFR Part and Paragraph number,Product code and classification of Aneroid Sphygmomanometer BK2002 and stethoscope are as follows.The tier categorization is also included.
| classification name | 21 CFRsection | Productcode | Class | Tier |
|---|---|---|---|---|
| Blood Pressure,Cuff | 870.1120 | DXQ | II | 2 |
| Stethoscope | 870.1875(optional) | I.DE | I(exempt) | 1 |
Predicate Device The Bokang's Aneroid Sphygmomanometer BK2002 is substantially equivalent to Nihon Seimitsu Sokki Co.,Ltd's model HT-110 which 510(K) number is K012194
Device Description The device comproses tubing attached to a soft ineastic 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 sphygmomaniometer.
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| Indication For Use The device is intended to be used by medical professionals or in thehome for the measurement of systonic and diastonic pressure onadults. The device is intended to be manually attached to a patient andmanually inflated along with a manual method for detectingKorotkoff sounds. | |
|---|---|
| TechnologicalCharacteristics | The Bokang's Aneroid Sphygmomanometer BK2002 is virtually thesame as Nihon Seimitsu Sokki Co.,Ltd's model HT-110 |
| Performance | The Aneroid Sphygmomanometer BK2002 has been tested toconform to the ANSI/AAMI standard SP-9,Non-automatedsphygmomanometer. |
| Conclusion | In accordance with the Federal Food,Drug and Cosmetic Act,21CFRPart 807 and based on the information provided in this premarketnotification,Wenzhou Bokang Instrument Co.,Ltd concludes that theAneroid Sphygmomanometer BK2002 is safe and effective,andsubstantially equivalent to the predicate device described herein. |
| Others | Wenzhou Bokang Instrument Co.,Ltd will update and include in thissummary any other informations needed by FDA. |
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JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wenzhou Bokang Instrument Co. Ltd. c/o Mr. Tzu-Wei Li Manager Center for Measurement Standards/Industrial Technology Research Institute Bldg. 16, 321 Kuang Fu Rd. Sec. 2 Hsinchu, Taiwan 30042 R.O.C.
Re: K043286
Trade Name: Aneroid Sphygmomanometer BK2002 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: December 29, 2004 Received: January 05, 2005
Dear Mr. Li:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Tzu-Wei Li
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bzumma 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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RE: Review of BK2002 - OMDE 930705 BY: Sandy Liu DA: 01/03/05
Page Page _of
(043286)
510(k) Number (if known): __ K043286
Device Name: Aneroid Sphygmomanometer BK2002
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 on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use V (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BÉLOW THIS LINE-CONTINUE ON NOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K04/3286
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
§ 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).