(177 days)
Not Found
No
The device is a simple physical barrier (a cuff cover) and the description contains no mention of AI, ML, or any computational analysis of data.
No.
The device is a cover for blood pressure cuffs intended to reduce or prevent cross-contamination, not to directly treat or alleviate a medical condition.
No
Explanation: The device is intended to prevent cross-contamination by covering a blood pressure cuff; it does not analyze or interpret patient data for diagnostic purposes.
No
The device description clearly states it is a physical cover made of non-woven polypropylene with a polyethylene coating, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or prevent patient-to-patient cross-contamination during blood pressure measurement. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a physical cover for a blood pressure cuff. It's made of non-woven polypropylene with a polyethylene coating. This describes a physical barrier, not a reagent, instrument, or system intended for in vitro diagnosis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device's function is purely to provide a physical barrier to reduce the transfer of contaminants, which falls under the category of infection control or patient protection devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.
Product codes
DXQ
Device Description
This device is a cover for blood pressure cuffs. It is made non-woven polypropylene with a polyethylene coating. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff cover can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff cover has been designed. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing shows the material is an effective microbial and air barrier. Clinical testing shows the cover does not significantly affect blood pressure readings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
OCT 1 0 2003
EXHIBIT 2
Image /page/0/Picture/3 description: The image shows a logo with the word "Ethox" in bold, stylized letters. Below "Ethox" is the word "CORP." The logo has a geometric design to the left of the word "Ethox", which appears to be a stylized letter E.
251 Seneca Street Buffalo, New York USA 14204-2088 Voice: 716-842-4000 Toll-Free: 1-800-521-1022 Fax: 716-842-4040 E-mail: info@ethoxcorp.com Contact: Dodi Kingsfield Quality Systems and Regulatory Affairs Manager 510(k) Summary
-
- Identification of the Device: Proprietary-Trade Name: Ethox CUF-COVERTM Classification Name: Blood pressure cuff, Product Code: DXQ Common/Usual Name: Blood pressure cuff cover.
-
- Equivalent legally marketed device: CUFF GUARD, BOWEN MEDICAL SERVICES, INC. K952825
-
- Indications for Use (intended use). This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff..
- Description of the Device: This device is a cover for blood pressure cuffs. It is made non-4. woven polypropylene with a polyethylene coating. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff cover can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff cover has been designed. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.
1
| Element of Comparison | Bowen Medical
Cuff-Guard K952825 | Ethox CUF-COVER™ |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is has the
potential to reduce or
prevent patient to patient
cross contamination
which can occur during
blood pressure
measurement procedures.
Covers a blood pressure
cuff to provide a barrier
between patient and cuff.
(reusable (cleanable). | SAME except for single
patient use only |
| Materials | White spun plastic and
Velcro closure | Thin non-woven
polypropylene with a
polyethylene coated inner
layer. The sheet is folded
over and the inner poly
layer welded together
along each end. Velcro
closure. |
| Sizes | Six sizes: Newborn,
Infant, Child, Adult,
Large Adult, Thigh | Small, Medium, Large |
| Closure | Two sided adhesive tape
with removable liner | Zip-Lock |
| Cover material | Opaque | Translucent |
-
- Safety and Effectiveness, comparison to predicate device:
- Conclusion: In all respects, the Ethox CUF-COVERs™ are substantially equivalent to 6. Bowen Medical Cuff-Guard. The covers are made of similar materials. Laboratory testing shows the material is an effective microbial and air barrier. Clinical testing shows the cover does not significantly affect blood pressure readings.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Ethox Corp. c/o Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K031195
Trade Name: Cuf-Cover™ Regulation Number: 21 CFR §870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: September 2, 2003 Received: September 5, 2003
Dear Mr. Kamm:
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.
3
Page 2 -- Mr. Daniel Kamm
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 (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Afelaimap
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number
Device Name: CUF-COVER™
This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X O OR Over the Counter Use (Per 21 CFR 801.109)
lmesl Maya for BDZ
(Division Sign Off)
510:KI Num