UNIMED DISPOSABLE BLOOD PRESSURE CUFF

K120364 · Unimed Medical Supplies, Inc. · DXQ · May 4, 2012 · Cardiovascular

Device Facts

• Record ID: K120364
• Device Name: UNIMED DISPOSABLE BLOOD PRESSURE CUFF
• Applicant: Unimed Medical Supplies, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: May 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Unimed disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Story

Device consists of inelastic sleeve with integrated inflatable bladder and tubing; wraps around patient limb; secured via hook and loop fastener. Connects to non-invasive blood pressure measurement system. Used in clinical settings to facilitate indirect blood pressure monitoring. Healthcare provider wraps cuff around limb; system inflates/deflates bladder to measure pressure. Output used by clinician for patient hemodynamic assessment. Benefits include disposable design to reduce cross-contamination risk.

Clinical Evidence

Bench testing only. Device tested for performance per ANSI/AAMI SP10 (2002+A1:2003+A2:2006+(R)2008). Biocompatibility testing performed per ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/hypersensitivity). No clinical data presented.

Technological Characteristics

Inelastic sleeve with integrated inflatable bladder; hook and loop closure. Available in neonatal, pediatric, and adult sizes. Pressure range 0-300mmHg. Materials conform to ISO 10993. Non-sterile. Connectivity via one or two tubes to external non-invasive blood pressure measurement system.

Indications for Use

Indicated for non-invasive blood pressure measurement in neonatal, pediatric, and adult patient populations. For single-patient use.

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

• Soft-Cuff (K974080)

Submission Summary (Full Text)

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K120364 MAY - 4 2012

No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

Image /page/0/Picture/3 description: The image shows the logo for Unimed medical supplies. The logo consists of the word "Unimed" in a bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a circular graphic with the letters "UM" inside. The logo is simple and modern, and it is likely used to identify the company and its products.

Section 3

510(K) Summary

Summary prepared Date: January 12, 2012

## Submitter Information:

Unimed Medical supplies Inc.

No.37, Yanshan Road, Shekou, Shenzhen, China 518067

## Contact Person:

Xinmei Tan, QA manager No.37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Email: [e-mail]; [e-mail]

## Device Name

Trade Name: Unimed Disposable Blood Pressure Cuff Common Name: Non-invasive Blood pressure cuff Product Code/Classification: DXQ/21 CFR870.1120 Review Panel: Cardiovascular

### Predicate Device

Soft-Cuff (K974080) JOHNSON & JOHNSON MEDICAL, INC. (GE Healthcare)

### Intended Use

The Unimed disposable blood pressure cuff is an accessory used in conjunction with

Confidential

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No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

Image /page/1/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The logo consists of the word "Unimed" in a bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a stylized oval shape containing the letters "UM".

noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

# Device Description

The device comprises tubing attached to an 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 blood pressure measurement system.

| Features | Unimed Medical | JOHNSON & JOHNSON<br>MEDICAL (GE Healthcare) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Indirect measurement of<br>blood pressure | Indirect measurement of<br>blood pressure |
| Patient Populations | Adults/Pediatrics | Adults/Pediatrics |
| Tube Configuration | One or two tube | One or two tube |
| Size<br>(Range in cm) | Conform to AHA bladder sizes<br>recommendations<br>Neonate 1 (3-6)<br>Neonate 2 (4-8)<br>Neonate 3 (6-11)<br>Neonate 4 (7-13)<br>Neonate 5 (8-15)<br>Infant (9-14.8)<br>Child (13.8-21.5)<br>Small Adult (20.5-28.5)<br>Adult (27.5-36.5)<br>Adult Long(27.5-36.5)<br>Large Adult (35.5-46cm)<br>Large Adult Long(35.5-46cm)<br>Thigh (45-56cm) | Conform to AHA bladder sizes<br>recommendations<br>Neonatal 1 (3-6)<br>Neonatal 2 (4-8)<br>Neonatal 3 (6-11)<br>Neonatal 4 (7-13)<br>Neonatal 5 (8-15)<br>Infant (8-13)<br>Child (12-19)<br>Small Adult (17-25)<br>Adult (23-33)<br>Large Adult (31-40)<br>Thigh (38-50) |

# Comparison to the Predicate Device

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No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

Image /page/2/Picture/2 description: The image shows the logo for Unimed Medical Supplies. The logo consists of the word "UNIMED" in bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "UNIMED" is a circular graphic with the letters "UM" inside.

| Sterility | Not supplied sterile | Not supplied sterile |
|------------------|------------------------------------------------------|------------------------------------------------------|
| Pressure limits | 0-300mmHg | 0-300mmHg |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993<br>biocompatibility evaluation | Comply with ISO 10993<br>biocompatibility evaluation |

The Unimed Disposable Blood Pressure Cuff has the same Intended Use, basic construction, and technology specification as the predicated devices are wrapped the patient's arm or leg and secured by a hook and loop fastener commonly called Velcro. Both devices are available in the same size and range and are intended for the same patient populations. The materials of both devices are all conformed to ISO 10993. We extend the length of the cuffs in order to accommodate special groups, such as overweight subjects. Based on the performance testing in this submission, the slight difference on the range of these blood pressure cuffs does not raise any safety or effectiveness issue.

# Performance Summary

The Unimed Blood Pressure Cuff has been tested according to the following standards:

- � ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and � testing within a risk management process, 2009
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for � irritation and delayed-type hypersensitivity, 2002+A1:2006

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No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

## Conclusion

The subject device Unimed Blood Pressure Cuff has all features of the predicate

device. The few differences do not affect the safety and effectiveness of the

subject devices.

Thus, the subject device is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a circle of text around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The caduceus is depicted with a single snake winding around a staff, and the overall design is simple and clean.

#### Public Health Service

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

MAY - 4 2012

Unimed Medical Supplies, Inc. Xinmei Tan Quality Assurance Manager No.37, Yanshan Road, Shekou, Shenshen 518067 China

K120364 Re:

> Trade/Device Name: Unimed Blood Pressure Cuffs: U1710S, U1720S, U1730S, U1740S, U1750S, U1760S, U1770S, U1790S, U1710D, U1720D, U1730D, U1740D, U1750D, U1760D, U1770D, U1790D, U1781S, U1782S, U1783S, U1784S, U1785S, U1781D, U1782D, U1783D, U1784D, U1785D Regulation Number: 21 CFR 870.1120

Regulation Name: Blood Pressure Cuff

Regulatory Class: Class II (two)

Product Code: DXO

Dated: February 2, 2012

Received: February 6, 2012

### Dear Mr. Tan:

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. Xinmei Tan

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Unimed Medical Supplies Inc. No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] Website: www.unimed.cn Email: [e-mail]

Image /page/6/Picture/1 description: The image shows the logo for Unimed Medical Supplies. The word "Unimed" is in bold, sans-serif font, with the words "medical supplies" in a smaller font underneath. To the right of the word "Unimed" is a black circle with a white "UM" inside.

#### Section 4 Indications for use Statement

510(k) Number: _

Device Name: Unimed Disposable Blood Pressure Cuff

## Indications for Use

The Unimed disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Prescription Use __ X_ (Part 21 CFR 801 Sub part D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------|
| (Division Sign-Off) Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | K120364 |