The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure.

Device Description

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid sphygmomanometer to measure pressure, and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: 1. Adjustable D-ring Cuff (Adult Size) 2. Stethoscope (Attaches to the cuff) 3. Non-stop rotary pin, 300 mmHg gauge 4. Instruction booklet and record 4. Carrying case The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pulse of the brachial artery. After inflation of the cuff, the user does auditory monitoring with the stethoscope to evaluate systolic and diastolic pressure. The two values are usually recorded as a ratio of the two measurements: systolic over diastolic.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AS101 Blood Pressure Cuff:

It's important to note that this 510(k) summary is for an Aneroid Sphygmomanometer, a non-automated, mechanical device. Therefore, the questions related to AI, algorithms, and multi-reader multi-case studies are not applicable.

Acceptance Criteria and Device Performance Study for K060871

1. A table of acceptance criteria and the reported device performance

The submission states that testing was performed in accordance with AAMI/ANSI SP10: 2002 & AAMI/ANSI SP10: 2002/A1: 2003 and that the device conforms to this standard. The AAMI/ANSI SP10 standard for non-automated sphygmomanometers defines the acceptance criteria for accuracy.

Acceptance Criteria (from AAMI/ANSI SP10 Standard)	Reported Device Performance
Accuracy (Mean difference): Device measurements shall not differ by more than ±3 mmHg from the reference standard.	Conforms to AAMI/ANSI SP10: 2003
Accuracy (Standard Deviation): The standard deviation of the difference between device measurements and the reference standard shall not exceed 8 mmHg.	Conforms to AAMI/ANSI SP10: 2003

Note: The specific numerical values (e.g., mean difference, standard deviation) are not provided in the summary but are implicitly met by the statement of conformity to the standard.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set. For AAMI/ANSI SP10, typically, a minimum of 85 participants (with specific blood pressure ranges covered) are required for clinical validation studies to assess performance against reference measurements.

The data provenance is not explicitly mentioned but implies a clinical study was conducted as per the AAMI/ANSI SP10 standard. The country of origin of the data is not specified. It is a prospective study, as the device performance is being validated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For an aneroid sphygmomanometer, the "ground truth" during validation according to AAMI/ANSI SP10 is established by trained observers (typically healthcare professionals) taking simultaneous measurements using a reference standard (e.g., a mercury sphygmomanometer) alongside the device under test. The standard specifies detailed training and qualification for these observers. The exact number of experts and their specific qualifications are not provided in this summary, but would adhere to the requirements of the AAMI/ANSI SP10 standard.

4. Adjudication method for the test set

The AAMI/ANSI SP10 standard outlines specific protocols for comparing the device under test to a reference standard, often involving multiple readings by trained observers to minimize measurement error. This acts as an "adjudication" in a sense by creating a robust reference. The text doesn't explicitly detail a separate adjudication method beyond adherence to the standard's methodology for comparing readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not applicable nor performed for this device. This type of study is relevant for AI-powered diagnostic imaging devices where human readers interpret medical images. The AS101 is a mechanical blood pressure cuff.

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

No, a standalone (algorithm-only) performance study was not applicable nor performed. This device is a non-automated mechanical device that requires a human operator to inflate the cuff, listen for Korotkoff sounds with a stethoscope, and read the pressure gauge. There is no "algorithm" in the modern sense.

7. The type of ground truth used

The ground truth used for this type of device (Aneroid Sphygmomanometer) is simultaneous reference measurements, typically obtained using a calibrated reference sphygmomanometer (historically mercury sphygmomanometer) by trained observers. This is essentially an expert measurement standard.

8. The sample size for the training set

Not Applicable. This device is a mechanical device and does not involve machine learning or an "algorithm" that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for a mechanical device.

Summary

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K060871

510(k) Submission

510(k) Summary

JUN - 9 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: February 18, 2006

Company and Correspondent making the submission:

Name - Wenzhou Longwan Medical Instrument Company Address - 8 Jinjiang Road, Longwan Fuping Development Area, Longwan section, Wenzhou, Zhejiang, P. R. China Telephone/Fax - (86-577) 88868068 Contact - Mr. Birrell Xiang / Manager Email - wetd(@mail.wzptt.zi.cn

Device:

Proprietary Name - AS101 Common Name - Blood Pressure Cuff Classification Name - Aneroid Sphygmomanometer

1. Validation of Performance:
  Testing was performed in accordance with AAMI/ANSI SP10: 2002 & AAMI/ANSI SP10: 2002/A1: 2003.

Labeling: Labeling of the AS101 Aneroid Sphygmomanometer complies with AA MI/ANSI SP10, Section 4.

Device Description:

The Aneroid Sphygmomanometer with Stethoscope contains:

1. Adjustable D-ring Cuff (Adult Size)
1. Stethoscope (Attaches to the cuff)

Wenzhou Longwan Medical Instrument Company

Page 1 of 2

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1. Non-stop rotary pin, 300 mmHg gauge
1. Instruction booklet and record
1. Carrying case

The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pulse of the brachial artery. After inflation of the cuff, the user does auditory monitoring with the stethoscope to evaluate systolic and diastolic pressure. The two values are usually recorded as a ratio of the two measurements: systolic over diastolic.

5. Intended Use:

The Aneroid Sphygmomanometer with Stethoscope is a non-automated. mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure.

6. Statement of Compliance to FDA Recognized Consensus Standards:

The Aneroid Sphygmomanometer with Stethoscope, Model AS101, has been tested to and conforms to ANSI/AAMI SP-10: 2003 Standard for Non-automated Sphygmomanometers.

7. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, based on the information provided in this premarket notification Wenzhou Longwan Medical Instrument Company concludes that the AS101 Aneroid Sphygmomanometer is safe and effective and complies to the testing validations defined in AAMI/ANSI SP10 standard.

Wenzhou Longwan Medical Instrument Company will update and include in this 8. summary any other information deemed necessary by the FDA.
END

Wenzhou Longwan Medical Instrument Company

page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2006

Wenzhou Longwan Medical Instrument Company c/o Charlie Mack President International Regulatory Consultants 340 Shady Grove Road Flintville, TN 37335

Re: K060871

Trade Name: AS101 Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: May 21, 2006 Received: May 30, 2006

Dear Mr. Mack:

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. Charlie Mack

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

B.J. Zimmerman Jr.

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):

Device Name: Aneroid Sphygmomanometer

Indications for Use:

K060871

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

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Bhiminuma

initials sign on

Division Sign-Off) Division of Cardlovascular Devices 610kg Number 11.05

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Wenzhou Longwan Medical Instrument Company

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).