(88 days)
CRITIKON's DURA-CUF®
Not Found
No
The device description and performance studies focus on the mechanical aspects and standard testing of a blood pressure cuff, with no mention of AI or ML.
No.
The device is a blood pressure cuff used for monitoring blood pressure, not for treating a disease or condition.
No
This device is a blood pressure cuff, which is an accessory used with non-invasive blood pressure monitoring systems. It does not independently perform a diagnostic function but rather facilitates the measurement of blood pressure. The diagnostic function is performed by the monitoring system it connects to, not the cuff itself.
No
The device description clearly outlines a physical blood pressure cuff with fabric, an inflatable bladder, tubing, and connectors. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The CLEEN-ABLE™ blood pressure cuff is used externally on a patient's limb to measure blood pressure. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's used in conjunction with non-invasive blood pressure monitoring systems. This is an external, non-invasive measurement.
The device description and intended use clearly indicate it's a device for external physiological measurement, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi-use device and is available in infant through adult sizes.
Product codes
DXQ
Device Description
The device is comprised of one er two tubes attached to a soft fabric with an integral inflatable bladder that is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes will include infant through adult. Each unit is packaged in a polyfilm bag. Connectors, adapters and pump bulb /valve assemblies are available for use with a variety of manual and automatic sphygmomanometers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's limb
Indicated Patient Age Range
infant through adult
Intended User / Care Setting
personnel properly trained in the use of manual and automatic sphygmomanometers.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate performance (safety and effectiveness) of the CLEEN-ABLE™ blood pressure cuff. The key performance requirements and the test methodologies were selected from the ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder. This standard is referred to in the FDA Guidance for Industry document titled "Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1. The cuff performance testing included but was not limited to Cuff Closure/construction, Pressure Capacity and Repeated Inflation testing, and systems leak testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CRITIKON's DURA-CUF®
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
FEB 2 5 2000
K 994044
Section 2 Page 2 - 1
510(k) SUMMARY
| Submitter's Name: | Vital Signs, Inc
20 Campus Road
Totowa, New Jersey |
|----------------------------|-------------------------------------------------------------------|
| Official Contact: | Anthony P. Martino
VP Quality Assurance and Regulatory Affairs |
| Telephone Number: | (973) 790-1330
ext. 356 |
| Fax Number: | (973) 790-4150 |
| Date: | November 24, 1999 |
| Proprietary or Trade Name: | CLEEN-ABLE™ |
| Common/Usual Name: | Blood Pressure Cuff |
| Classification Name: | Cuff, Blood Pressure
(Per CFR 870.1120) |
| Predicate Device: | CRITIKON's DURA-CUF® |
Device Description:
The device is comprised of one er two tubes attached to a soft fabric with an integral inflatable bladder that is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes will include infant through adult. Each unit is packaged in a polyfilm bag. Connectors, adapters and pump bulb /valve assemblies are available for use with a variety of manual and automatic sphygmomanometers.
Intended Use:
.
The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi- patient rewable device and is available in infant through adult sizes.
1
| Item | CLEEN-ABLE™ | DURA-CUF® |
|---|---|---|
| Intended Use | Indirect measurement of blood pressure | Indirect measurement of blood pressure |
| Prescription Device | Yes | Yes |
| Intended Population | Infant - Adult | Infant - Adult |
| Labeling | Multi-patient use | Multi -patient use |
| Materials | Nylon fabric/PVC | Nylon fabric/PVC or polyurethane |
| Number of tubes | 1 and 2 | 1 and 2 |
| Cleaning Instructions | Provided, same as DURA-CUF® | Provided |
Technology Comparison to Predicate Device:
Summary of Non-Clinical Performance Testing:
Bench testing was conducted to demonstrate performance (safety and effectiveness) of the CLEEN-ABLE™ blood pressure cuff. The key performance requirements and the test methodologies were selected from the ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder. This standard is referred to in the FDA Guidance for Industry document titled "Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1. The cuff performance testing included but was not limited to Cuff Closure/construction, Pressure Capacity and Repeated Inflation testing, and systems leak testing.
Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Section 807, and based on the information provided in this premarket notification, Vital Signs, Inc. concludes that the CLEEN-ABLE™ Blood Pressure Cuff is safe, effective and substantially equivalent to the predicate device as described herein and meets the appropriate requirements of ANSI/AAMI SP-9.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2000
Mr. Anthony P. Martino VP of Quality Assurance and Regulatory Affairs Vital Signs, Inc. 20 Campus Road Totowa, NJ 07512
Re: K994044 Cleen-Able™ Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: November 24, 1999 Received: November 29, 1999
Dear Mr. Martino:
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 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, Druq, 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, 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 affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 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.
3
Page 2 - Mr. Anthony P. Martino
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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number:
Kg94044
Device Name:
CLEEN-ABLE™
Indications for Use:
1
રજુન
The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi-use device and is available in infant through adult sizes.
Division Sign-Off
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_k 99 4(2)44
Concurrence of CDRH, Office of Device Evaluation (ODE)
134