(78 days)
Not Found
No
The summary describes a simple blood pressure cuff, a mechanical device, with no mention of AI/ML or any software processing.
No.
The device is a blood pressure cuff used for diagnostic purposes (measuring blood pressure), not for treating a condition or disease.
Yes
Explanation: The device is used to obtain non-invasive physiologic blood pressure, which is a measurement used for diagnostic purposes.
No
The device description explicitly states it is a physical cuff with an inflatable bladder and elastic sleeve, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DeRoyal Sterile Neonatal Blood Pressure Cuff is used to measure blood pressure non-invasively on the limbs of a patient. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for obtaining non-invasive physiologic blood pressure from the limbs.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
DXO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs (extremities)
Indicated Patient Age Range
Neonate
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Critikon, Ethox, and Lorin Medical
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
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.
2
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
3
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
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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________