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 Nonautomated Sphygmomanometer uses an occluding cuff, an aneroid sphygmomanometer to measure pressure, and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: Adjustable D-ring Cuff (Adult Size), Stethoscope (Attaches to the cuff), Non-stop rotary pin. 300 mmHg gauge, Instruction booklet and record, Carrying case.

AI/ML Overview

This document is a 510(k) summary for the Aneroid Sphygmomanometer with Stethoscope, Model HS-50A. It does not describe a study to prove a device meets acceptance criteria. Instead, it demonstrates substantial equivalence to a predicate device through conformance to a recognized consensus standard.

Therefore, many of the requested data points (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable or extractable from this type of document, as they pertain to clinical or performance studies rather than compliance with a standard.

However, I can extract the following information relevant to demonstrating conformance to a standard:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Conformance to ANSI/AAMI SP-9-1994 (Standard for Non-automated Sphygmomanometers)	"The Aneroid Sphygmomanometer with Stethoscope, Model HS-50A, has been tested to and conforms with ANSI/AAMI SP-9-1994 Standard for Non-automated Sphygmomanometers."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document. Conformance to a standard typically involves specific testing protocols, but the number of devices or measurements isn't detailed in this summary.
Data Provenance: Not specified. The testing likely occurred in China, where the manufacturer is located, but this is not explicitly stated for the test data itself. The document does not indicate if it was retrospective or prospective.

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

Not applicable as this is a conformance to a standard for a non-automated medical device, not a performance study requiring human expert ground truth. The "ground truth" here is the adherence to the technical specifications and accuracy requirements outlined in the ANSI/AAMI SP-9-1994 standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for conformance to a standard.

5. 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

Not applicable. This device is an aneroid sphygmomanometer (manual blood pressure cuff), not an AI-powered diagnostic device involving human readers or AI assistance.

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

The device itself is a standalone, non-automated mechanical device. Its performance is inherent to its design and manufacturing, tested against the standard. There is no "algorithm only" component as it's not a software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the technical specifications and accuracy requirements defined by the ANSI/AAMI SP-9-1994 Standard for Non-automated Sphygmomanometers. Performance is measured against these established engineering and clinical specifications.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Shanghai Lord International Trade Co., Ltd. The logo includes the word "LORD" in a stylized font, followed by the Chinese characters for the company name. Below the Chinese characters is the English translation of the company name: "SHANGHAI LORD INTERNATIONAL TRADE CO.,LTD." To the right of the company name is the letter "K".

JUN 20 2005

EXHIBIT #1

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is ._______________________________________________________________________________________________________________________________________________

Submitter's Identification: ﮩ

Shanghai Lord International Trade Co., Ltd. Rm.C., Floor 22, Zhi Yuan Bldg. No.768 Xie Tu Road Shanghai, China 200023 TEL: 0086-021-63056696

Contact: Mr. David Zheng

Date Summary Prepared: April 21, 2005

Trade or Proprietary Device Name: 2.

Aneroid Sphygmomanometer with Stethoscope, Model HS-50A

Common or Usual Name:

Blood Pressure Kit (Blood Pressure Cuff)

Classification Name:

Cuff, Blood Pressure

Panel: Cardiovascular

Legally Marketed Predicate Device: 3.

Aneroid Sphygmomanometer with Stethoscope, Wang & Li, Inc., K003415

4. Device Description:

R m. C. Floor 22, ZhiYuan Bldg. . No. 768 XieTu Rd., Shanghai. China P.C. 200023 TEL:0086-21-63056696,63059200,63012811,63022122 FAX:0086-21-63036162

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Shanghai Lord International Trade Co., Ltd. The logo consists of the word "LORD" in a stylized, bold font, followed by the Chinese characters for "Shanghai Lord International Trade Co., Ltd." The English translation of the company name, "SHANGHAI LORD INTERNATIONAL TRADE CO.,LTD.," is printed below the Chinese characters in a smaller font.

sphygmomanometer to measure pressure, and a stethoscope for detecting Korotkoff sounds.

The Aneroid Sphygmomanometer with Stethoscope contains:

Adjustable D-ring Cuff (Adult Size) 1.
1. Stethoscope (Attaches to the cuff)
1. Non-stop rotary pin. 300 mmHg gauge
Instruction booklet and record র্ব
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.

ર. Intended Use:

6. Statement of Compliance to FDA Recognized Consensus Standards:

The Aneroid Sphygmomanometer with Stethoscope, Model HS-50A, has been tested to and conforms with ANSI/AAMI SP-9-1994 Standard for Non-automated Sphygmomanometers.

7. Conclusion:

Shanghai Lord International Trade Co., Ltd. concludes that the subject Aneroid Sphygmomanometer with Stethoscope, Model HS-50A, is as safe and effective as the predicate. Aneroid Sphygmomanometer with Stethoscope, based on conformance to ANSI/AAMI SP9-1994 test results as well as non-clinical mechanical testing performed.

Page 2 of 2

R m . C , F loor 2 2 , Z h i Y u a n B l d g , N o . 7 6 8 X i e T u R d , S h a n g h a i , S h a n g h a i , S h a n g h a i , S h a n g h a i , S h a n g h a TEL:0086-21-63056896,63059200,63012811,63022122 FAX:0086-21-63036162 P.C. 200023

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol.

JUN 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Lord International Trade Co., Ltd. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K051021

Trade Name: Model HS-50A Aneroid Sphygmomanometer with Stethoscope Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: April 21, 2005 Received: April 22, 2005

Dear Ms. Goldstein-Falk:

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.

{3}------------------------------------------------

Page 2 - Ms. Susan D. Goldstein-Falk

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 or any I 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 Of It Far 607); and mig (2 (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) 276-0295. 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/industry/support/index.html.

Sincerely yours,

Afummer for

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

Enclosure

{4}------------------------------------------------

Exhibit B

1 Page __ 1 of

510(k) Number (if known): پیک کارک )

Device Name: Aneroid Sphygmomanometer with Stethoscope Model HS-50A

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use_ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenmer

Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 05 No

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).