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.

Device Description

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.

AI/ML Overview

The provided K99 submission for the DeRoyal Sterile Neonatal Blood Pressure Cuff does not include acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

The information provided outlines:

Submitter Information: DeRoyal Industries, Inc.
Device Names: DeRoyal Sterile Neonatal Blood Pressure Cuff
Predicate Devices: Critikon, Ethox, and Lorin Medical blood pressure cuffs.
Device Description: The cuff has an inflatable bladder in an elastic sleeve, mechanisms for inflation/deflation, and is made of commonly used materials (PVC film for the cuff, PVC for the bulb). It's available in neonatal sizes, is disposable, sterile, and has 1 or 2 tubings. It operates within a pressure range of 0-300 mmHg.
Intended Use: To obtain non-invasive physiologic blood pressure from the limbs using an appropriate blood pressure monitor.
Technological Comparison: A table comparing characteristics of the DeRoyal device with "Other Devices" (predicates), highlighting similarities in main cuff material, sizes, disposability, tubing options, and pressure range. It notes that predicate devices come in both sterile and non-sterile versions, while the DeRoyal device is sterile.

Therefore, it is not possible to complete the requested table and detailed study information based on the provided text.

The document's purpose is to satisfy the FDA's 510(k) requirements by demonstrating that the device is "substantially equivalent" to legally marketed predicate devices, implying that its safety and effectiveness are similar. This typically relies on a comparison of design, materials, intended use, and performance characteristics to existing devices, rather than a new clinical or extensive performance study with defined acceptance criteria for a novel device.

Summary

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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: (423) 362-6217 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

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

Seere L. Smurule

Page _

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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).