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 over age 18 at hospitals or at home. The device is for use in OTC.

Device Description

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure monitor that 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 5. Carrying case.

AI/ML Overview

The provided text describes a 510(k) summary for an Aneroid Sphygmomanometer with Stethoscope, Model LD-100. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards for non-automated sphygmomanometers.

Based on the provided text, the following information can be extracted:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Conformance to AAMI/ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers	AAMI/ANSI SP10:2002/A2:2006 "Standard for Manual, Automated, and Semi-automated Sphygmomanometers" was used. The conclusion states "conformance to AAMI/ANSI SP10:2002/A2:2006".
Non-clinical mechanical testing	Non-clinical mechanical testing was performed.

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for any test sets.
- The document does not specify data provenance (e.g., country of origin, retrospective or prospective) for clinical data. The studies mentioned are referred to simply as "studies" and "non-clinical mechanical testing." It's possible the AAMI/ANSI standard itself outlines testing methodologies that were followed, but the specific details of participants/data provenance are not in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies mentioned are non-clinical and based on a standard for manual/automated sphygmomanometers, which typically involves technical performance metrics rather than expert interpretation of results.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document. Given the nature of a non-automated sphygmomanometer and the focus on technical standards, an adjudication method for a test set is unlikely to be relevant in the same way it would be for an AI diagnostic device.
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:
- No, an MRMC comparative effectiveness study was not conducted. This device is a mechanical blood pressure monitor, not an AI diagnostic device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a "non-automated, mechanical blood pressure monitor." It is not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done. The device's performance is inherently "standalone" in the sense that its measurements are direct, although it requires a human operator for proper use and interpretation of Korotkoff sounds via the stethoscope.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies the ground truth for performance is established by the AAMI/ANSI SP10:2002/A2:2006 standard. This standard outlines performance requirements and test methods for accuracy and other characteristics of sphygmomanometers. The ground truth would therefore be derived from reference devices or established measurement protocols defined in the standard.
The sample size for the training set:
- The device is a mechanical blood pressure monitor, not an AI/machine learning algorithm. Therefore, there is no training set in the context of machine learning.
How the ground truth for the training set was established:
- As there is no training set (the device is mechanical), this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image contains handwritten text. The text at the top appears to be "K09245". Below that, the text "P 1/2" is written. The handwriting is somewhat stylized, with the numbers and letters having a distinct, slightly irregular form.

APPENDIX #1

HONSUN(NANTONG)CO.,LTD

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This summary of Shots) Sales) and the first & SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:

OCT 2 8 2009

Submitter's Identification: 1. Company: HONSUN(NANTONG)CO.,LTD

Add: Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA E-mail: david-zhang@lordmed.com

Contact: Mr. David Zheng

Date Summary Prepared: 7TH June 2009

Trade or Proprietary Device Name: 2

Aneroid Sphygmomanometer with Stethoscope, Model LD-100

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, K060871 WENZHOU LONGWAN

MEDICAL INSTRUMENT COMPANY

Device Description: 4.

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure The Anerold Spriygmomanomotor with on pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid

Page 1 of 2

Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA Tel:(00)86-0513-85986718- + 614 Fax:(00)86-0513-85986716

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Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA

Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.

The Aneroid Sphygmomanometer with Stethoscope contains:

Adjustable D-ring Cuff (Adult Size) 1.
Stethoscope (Attaches to the cuff) 2.
Non-stop rotary pin, 300 mmHg gauge 3.
Instruction booklet and record ব
Carrying case ട്.

The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor The Arterold Sphygmomonomoter within the arteries at highest (systolic the procedio on and lowest (diastolic or relaxation) pressure.

To operate, the user places the attached stethoscope on the inner arm above the To operate, the user places the attached the brachial artery. After inflation of the cuff, berid in the elbow, to detect the pace of instethoscope to evaluate systelic and trie user does adultory moniteling was are usually recorded as a ratio of the two measurements: systolic over diastolic.

Intended Use: റ്റ്

The Aneroid Sphygmomanometer with Stethoscope is a non-automated, The Anefold Ophygmomanomettor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by (nor-invasive) and display of archarblood procourer age 18 at hospitals or at home professionals as well as trainounting pressure. The device is for use in OTC.

Statement of Compliance to FDA Recognized Consensus Standards: ે.

The Aneroid Sphygmomanometer with Stethoscope, Model LD-100, has been The Ancroid Ophygmomananesi/AAMI AAMI / ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers.

Conclusion: 7.
HONSUN(NANTONG)CO.,LTD. concludes that the subject Aneroid Sphygmomanometer with Stethoscope, Model LD-100, is as safe and effective as Sphygmomanometer with stomosopperer with Stethoscope, based on the predicate, Ancroid Ophygimsmar: 2006, "Standard for Manual, conformance to AAM17 ANOF OF 10.2002/1212000/ Studis as well as non-clinical mechanical testing performed.

Page 2 of 2

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 8 2009

Honsun (Nantong) Co., Ltd. c/o Mr. David Zhang Official Correspondent No8, Tongxing Road Nantong Economic & Technological Development Area Nantong, Jiangsu 226000 CHINA

K092245 Re:

Trade/Device Name: Aneroid Sphygmomanometer with Stethoscope, Model LD-100 Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: September 15, 2009 Received: October 1, 2009

Dear Mr. Zhang:

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. David Zhang

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 (301) 594-4646. 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,

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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Exhibit B

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510(k) Number (if known):

Device Name: Aneroid Sphygmomanometer with Stethoscope Model LD-100

Indications For Use:

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mechanical blood pressure monitor that is used by mechanical blood pressure monitor object pressure It can be used by (non-invasive) and display of artendr brook users over age 18 at hospitals or at
professionals as well as trained individual users over age in for use in professionals as well as trained individual assist of the device is for use in orc .

Prescription Use
(Per 21 CFR 801 Subpart D)

Over-The Counter Use_x (21 CFR 807 Subpart C)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

KO42245

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).