CUF-COVER (TM)

K031195 · Ethox Corp. · DXQ · Oct 10, 2003 · Cardiovascular

Device Facts

• Record ID: K031195
• Device Name: CUF-COVER (TM)
• Applicant: Ethox Corp.
• Product Code: DXQ · Cardiovascular
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

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..

Device Story

The Ethox CUF-COVER is a non-sterile, single-patient-use sleeve designed to cover blood pressure cuffs. It acts as a physical barrier to prevent the transfer of contaminants between the patient and the cuff, reducing the need for frequent cuff cleaning. The device is a sleeve made of non-woven polypropylene with a polyethylene-coated inner layer, secured with a zip-lock closure. It is used in clinical settings where blood pressure monitoring is performed. By providing a barrier, it helps maintain hygiene standards during routine patient care. The device is intended to be replaced if it becomes soiled, torn, or contaminated during a hospital stay.

Clinical Evidence

Clinical testing showed the cover does not significantly affect blood pressure readings. Laboratory testing confirmed the material is an effective microbial and air barrier.

Technological Characteristics

Non-woven polypropylene with polyethylene-coated inner layer; zip-lock closure; translucent material; non-sterile; single-patient use; available in small, medium, and large sizes.

Indications for Use

Indicated for patients undergoing blood pressure measurement procedures to reduce cross-contamination risk. For single-patient use.

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

• CUFF GUARD, BOWEN MEDICAL SERVICES, INC. (K952825)

Submission Summary (Full Text)

{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: [phone] E-mail: [e-mail] Contact: Dodi Kingsfield Quality Systems and Regulatory Affairs Manager 510(k) Summary

- 1. 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.
- 2. Equivalent legally marketed device: CUFF GUARD, BOWEN MEDICAL SERVICES, INC. K952825
- 3. 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<br>Cuff-Guard K952825 | Ethox CUF-COVER™ |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is has the<br>potential to reduce or<br>prevent patient to patient<br>cross contamination<br>which can occur during<br>blood pressure<br>measurement procedures.<br>Covers a blood pressure<br>cuff to provide a barrier<br>between patient and cuff.<br>(reusable (cleanable). | SAME except for single<br>patient use only |
| Materials | White spun plastic and<br>Velcro closure | Thin non-woven<br>polypropylene with a<br>polyethylene coated inner<br>layer. The sheet is folded<br>over and the inner poly<br>layer welded together<br>along each end. Velcro<br>closure. |
| Sizes | Six sizes: Newborn,<br>Infant, Child, Adult,<br>Large Adult, Thigh | Small, Medium, Large |
| Closure | Two sided adhesive tape<br>with removable liner | Zip-Lock |
| Cover material | Opaque | Translucent |

- 5. 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 [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 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 [phone] or [phone] 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