DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF

K991525 · Deroyal Industries, Inc. · DXQ · Jul 20, 1999 · Cardiovascular

Device Facts

• Record ID: K991525
• Device Name: DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
• Applicant: Deroyal Industries, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jul 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DeRoyal Sterile Neonatal Blood Pressure Cuff is indicated for use whenever non-invasive physiologic blood pressure needs to be obtained from the limbs (extremities) using the appropriate blood pressure monitor designed to operate together with the cuff.

Device Story

DeRoyal Sterile Neonatal Blood Pressure Cuff; inflatable bladder within elastic sleeve; used with external blood pressure monitor to measure neonatal blood pressure; manual or automated inflation/deflation mechanism; disposable; sterile; used in clinical settings; provides pressure data to monitor for clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: PVC film (cuff), PVC (bulb). Pressure range: 0-300 mmHg. Configuration: 1 or 2 tubing ports. Disposable. Sterile. Mechanical inflation/deflation principle.

Indications for Use

Indicated for non-invasive blood pressure measurement in neonates via limb extremities using compatible blood pressure monitors.

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
• Ethox
• Lorin Medical

Submission Summary (Full Text)

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K99 15 25

# JUL 20 1999

#### DeRoyal Industries, Inc.

# STERILE NEONATAL BLOOD PRESSURE CUFF

#### 510(k) Summary

## Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based

#### SUBMITTER INFORMATION

DeRoyal Industries, Inc. NAME: ADDRESS: 200 DeBusk Lane Powell, TN 37849

TELEPHONE: CONTACT: DATE OF PREPARATION: [phone] Lois Marsh April 29, 1999

#### DEVICE NAMES

NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Sterile Neonatal Blood Pressure Cuff Blood Pressure Cuff Cuff, Blood Pressure (74DXQ)

# PREDICATE OR LEGALLY MARKETED DEVICES

Critikon, Ethox, and Lorin Medical

#### DEVICE DESRIPTION

The DeRoyal Sterile Neonatal Blood Pressure Cuff functions in the same manner as predicate devices in that it is intended to be used in conjunction with another device to determine a subject's blood pressure.

Device Design/ Materials Used/Physical Properties: The DeRoyal Sterile Neonatal Blood Pressure Cuff is made of materials commonly used for their purpose. The concept of use is that the device has an inflatable bladder in an elastic cuff (sleeve) with a mechanism for inflating and deflating the bladder. Both components, together, are used to determine a patient's blood pressure.

#### DEVICE INTENDED USE

The DeRoyal Sterile Neonatal Blood Pressure Cuff is indicated for use whenever non-invasive physiologic blood pressure needs to be obtained from the limbs (extremities) using the appropriate blood pressure monitor designed to operate together with the cuff.

| Characteristic | DeRoyal Device | Other Devices |
|--------------------|----------------|-------------------------|
| Main Cuff Material | PVC Film | PVC Film |
| Sizes | Neonate | Neonate |
| Disposable | Yes | Yes |
| Sterility | Sterile | Sterile and Non-Sterile |
| Number of Tubings | 1 and 2 | 1 and 2 |
| Pressure Range | 0-300 mmHg | 0-300 mmHg |
| Bulb Material | PVC | PVC |

### TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLYMARKETED DEVICE/SY

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Ms. Lois Marsh Requlatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849

Re: K991525 DeRoyal Sterile Neonatal Blood Pressure Cuff Regulatory Class: II (Two) Product Code: DXO Dated: April 29, 1999 Received: May 3, 1999

Dear Ms. Marsh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish 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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lois Marsh

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

1991525

Device Name:

DeRoyal Sterile Neonatal Blood Pressure Cuff

Indications for Use:

The DeRoyal Sterile Neonatal Blood Pressure Cuff is indicated for use whenever non-invasive physiologic blood pressure need be obtained from the limbs (extremities) using the appropriate blood pressure monitor designed to operate together with the cuff.

Seere L. Smurule

of

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Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices \$10(k) Number _ 1 991525

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Prescription Use (Per 21 CFR §801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________