BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110

K012194 · Nihon Seimitsu Sokki Co., Ltd. · DXQ · Jul 20, 2001 · Cardiovascular

Device Facts

• Record ID: K012194
• Device Name: BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
• Applicant: Nihon Seimitsu Sokki Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

The device is a blood pressure cuff consisting of an inflatable bladder within a soft, inelastic sleeve with hook-and-loop closure. It connects via tubing to a non-invasive sphygmomanometer. Used by medical professionals or patients in home settings, the cuff is manually wrapped around the patient's limb and manually inflated. The device facilitates the manual detection of Korotkoff sounds to determine systolic and diastolic blood pressure. It functions as a passive component in the blood pressure measurement process, compatible with various manual and automated sphygmomanometers.

Clinical Evidence

Bench testing only. Testing included repeated inflation cycles and performance evaluation in accordance with ANSI/AAMI SP-9 standards. Biocompatibility is stated to be the same as the predicate devices.

Technological Characteristics

Soft inelastic sleeve with integrated inflatable bladder; hook and loop closure; tubing for connection to sphygmomanometer. Complies with ANSI/AAMI SP-9 for repeated inflation testing. Non-electronic, mechanical device.

Indications for Use

Indicated for the measurement of systolic and diastolic blood pressure in adult patients. Intended for use by medical professionals or in home settings.

Regulatory Classification

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.

Predicate Devices

• Critikon (K974080)
• SoftCheck Cuff (K940214)

Submission Summary (Full Text)

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# 510(k) Summary

JUL 2 0 2001

012194 p/2 K#

| Date: | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | I. Ishll<br>Nihon Seimitsu Sokki Co., Ltd.<br>2508-13 Nakago Komochi<br>Kitagunma Gunma<br>377-0293<br>Japan<br> |
| Telephone: | 81-279-20-2311 |
| Telefax: | 81-279-20-2411 |
| Submission<br>Correspondent | J. Harvey Knauss<br>Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 77071-3404 |
| Telephone | 713-723-4080 |
| E-fax | 208-694-6953 |
| | [e-mail] |
| Device Name | Blood Pressure Monitor Model HT-110 |
| Common Name | Blood Pressure Cuff |
| Classification | The classification name, 21 CFR Part and Paragraph number, product<br>code and classification of the Nissei Blood Pressure Monitor Model HT-<br>110 follow. The tier categorization is also included. |

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

| Predicate Devices | The Nissei Blood Pressure Monitor, Model HT-110 is substantially<br>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<br>integrated inflatable bladder that is wrapped around the patient's limb<br>and secured by hook and loop closure. The device tubing is connected<br>to a non-invasive sphygmomanometer. |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

510(k) Submission Page #

27

370-03-01-014

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## 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

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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

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#### 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, [phone]. Addinonally, for questions of are processes onte the regulation
please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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

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#### 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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