Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states the device uses a manual method for detecting Korotkoff sounds and does not mention any AI/ML terms or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML.

Therapeutic

No
Explanation: The device is a blood pressure cuff and sphygmomanometer, which is a diagnostic device used for measurement, not for treatment or therapy.

Diagnostic

Yes
The device is described as a non-invasive sphygmomanometer intended for the measurement of systolic and diastolic pressure, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it comprises physical components like tubing, a sleeve, an inflatable bladder, and a sphygmomanometer, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the measurement of systolic and diastolic pressure on adults using a manual method for detecting Korotkoff sounds. This is a physiological measurement taken directly from the patient's body.
Device Description: The device is a sphygmomanometer cuff and tubing, used externally on the patient's limb.
Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any such specimens.

The device described is a non-invasive blood pressure measurement device, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXQ

Device Description

The device comprises tubing attached to a soft inelastic 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 sphygmomanometer.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults

Intended User / Care Setting

medical professionals or in the home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench and laboratory testing was conducted to demonstrate Performance performance (safety and effectiveness) of the Model HT-110 cuff. Biocompatibility same as predicate devices. Repeated inflations and testing to ANSI/AAMI SP-9.

Key Metrics

Not Found

Predicate Device(s)

K974080, K940214

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

510(k) Summary

JUL 2 0 2001

012194 p/2 K#

Date:
Contact	I. Ishll
Nihon Seimitsu Sokki Co., Ltd.
2508-13 Nakago Komochi
Kitagunma Gunma
377-0293
Japan

Classification Name	21 CFR Section	Product Code	Class	Tier
Blood Pressure cuff	870.1120	DXQ	II	2
Stethoscope
(Optional)	870.1875		I
(exempt)

| Predicate Devices | The Nissei Blood Pressure Monitor, Model HT-110 is substantially
equivalent to following: |

-------------------	----------------------------------------------------------------------------------------------

	Device	Manufacturer	510(k) K#
	Critikon	Johnson & Johnson	K974080
	SoftCheck Cuff	Statcorp, Inc.	K940214

| Device Description | The device comprises tubing attached to a soft inelastic 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 sphygmomanometer. |

--------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Submission Page #

27

370-03-01-014

1

KO12194 p2/2

Device is intended to be used by medical professionals or in the home Indications 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. Technological The Model HT-110 cuff is virtually the same as the Critikon adult Characteristics devices. All of these devices are configured for use with a wide variety of manual and automated sphygmomanometers. Bench and laboratory testing was conducted to demonstrate Performance performance (safety and effectiveness) of the Model HT-110 cuff. Biocompatibility same as predicate devices. Repeated inflations and testing to ANSI/AAMI SP-9. In accordance with the Federal Food, Drug and Cosmetic Act and 21 Conclusions CFR Part 807, and based on the information provided in this premarket notification, Nihon Seimitsu Sokki Co., Ltd., concludes that the Model HT-110 Blood Pressure Cuff, is safe and effective and substantially equivalent to the predicate devices as described herein. Nihon Seimitsu Sokki Co., Ltd., will update and include in this summary Other any other information deemed reasonably necessary by the FDA.
28

2

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2001

Nihon Seimitsu Sokki Co., Ltd. c/o Mr. Mark Job TüV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K012194

KorzzyTrade Name: Blood Pressure Monitor (Sphygmomanometer), Model HT-110 Regulation Number: 21 CFR 870.1120 Regulatory Class: Class II (two) Product Code: DXQ Dated: July 12, 2001. Received: July 13, 2001

Dear Mr. Job:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave leviewed your becally in the device is substantially equivalent (for the indications for use above and we nave determined the avedicate devices marketed in interstate commerce stated in the enerosary to regary masses of the Medical Device Amendments, or to devices that prior to may 20, 1970, are chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may) , merceive, is more of the Act include requirements for annual provisions of the rea. " rea" res. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 icharter Approval), it may of success of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections; the Food and Dation may result in regulatory action. In addition, FDA may publish

3

Page 2 - Mr. Mark Job

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premarker notheaters stations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematic notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The FDA miding of backansa of the super 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 and IT you desire specific acrite for your as to received the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (301) 594-4040. Addinonally, for questions of are processes onte the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please of Chicago entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsionnies and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ken Tellh

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) Number K 012194

Device Name: Blood Pressure Monitor Model Ht-110

Indications for use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012194

Prescription Use _

OR

Over-The-Counter Use Yes

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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