ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS

K040286 · Ethox Corp. · DXQ · Mar 15, 2004 · Cardiovascular

Device Facts

• Record ID: K040286
• Device Name: ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
• Applicant: Ethox Corp.
• Product Code: DXQ · Cardiovascular
• Decision Date: Mar 15, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This device is intended for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.

Device Story

Ethox SURGI-CUF Adult Disposable Blood Pressure Cuffs are inflatable bladders with tubing used for non-invasive blood pressure monitoring. The device consists of a polyester-reinforced vinyl cuff, a hook-and-loop fastening system, and PVC tubing with various connectors (female luer, quick-disconnect, or multi-purpose screw). The device is used in clinical settings by healthcare professionals in conjunction with external blood pressure monitoring systems. The cuff is wrapped around the patient's limb; the monitoring system inflates the bladder to occlude blood flow and measures pressure oscillations to determine systolic and diastolic blood pressure. The disposable nature of the cuff helps reduce cross-contamination risks. The device is latex-free and available in multiple sizes to accommodate different patient limb circumferences.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per FDA blue book memorandum #G95-1 for prolonged skin contact. Mechanical performance testing confirmed conformance to American Heart Association recommendations and EN1060-1, 2, & 3 standards for specific series.

Technological Characteristics

Materials: Polyester-reinforced vinyl cuff, Velcro/YKK PVC hook-and-loop fastener, PVC tubing, Nylon/PVC connectors. Sensing: Pneumatic inflation/occlusion. Connectivity: Mechanical interface to external monitoring systems via luer, quick-disconnect, or screw connectors. Dimensions: 6 sizes (15-50 cm range). Sterilization: Non-sterile. Standards: USP Class VI (tubing/connectors), AHA recommendations, EN1060-1, 2, & 3.

Indications for Use

Indicated for use as a non-sterile disposable inflatable bladder and tube set for blood pressure determination in adults, compatible with various monitoring systems. Patient population includes adults requiring blood pressure monitoring with limb circumferences ranging from 15.0 cm to 50.0 cm.

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

• Ethox Corp. SURGI-CUFF (K883977)

Submission Summary (Full Text)

{0}------------------------------------------------

# Attachment III

### 510(k) Summary

January 15, 2004 Ethox Corporation 251 Seneca Street Buffalo, New York USA 14204-2088 Voice: 716-842-4000, Toll-Free: 1-800-521-1022, Fax: [phone] Regulatory Contact: Eon Verrall; VP of Quality and Regulatory Affairs E-mail: verrall(@ethoxcorp.com

- 1. Identification of the Device:
Proprietary-Trade Name: Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs Classification Name: Blood Pressure Cuff, 21CFR870.1120 Product Code: DXO Common/Usual Name: Blood Pressure Cuff

- Equivalent legally marketed device Blood-Pressure Cuff: Ethox Corp. SURGI-2. CUF® Adult Blood Pressure Cuffs, K883977
- 3. Indications for use (Intended Use): This device is intended for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.
- 4. Description of the Device: The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs consists of a cuff bladder manufactured from polyester reinforced vinyl. The cuff is closed with a hook and loop fastening system (Velcro Loop with vinyl backing and YKK PVC hook). The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are disposable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC or Nylon) for use with most monitoring systems. Refer to Attachment VII for product engineering drawings for each model family.

#### Product Family Description*

| Family | Number of Tubes | Connector Type |
|--------|-----------------|------------------------------|
| 510X | 1 | Female Luer Lock |
| 520X | 2 | Multipurpose Screw Connector |
| 540X | 1 | Quick-disconnect Connector |

* Each product family comes in 6 sizes: 15-22 cm, 17-25 cm, 24-32 cm, 28-32 cm, and 42-50 cm

- 5. Safety and Effectiveness, comparison to predicate device:
See Table on Next Page

Image /page/0/Picture/15 description: The image shows the logo for Ethox Corp. The logo consists of a stylized letter "E" made up of triangles on the left, followed by the word "ethox" in a bold, sans-serif font. The letters are connected to each other. Below the word "ethox" is the word "CORP." in a smaller font size.

251 Seneca Str Buffato, New York 14204-2088 716-842-4000 FAX [phone]

E-Mail: [e-mail] Web Site: www.ethoxcorp.com

{1}------------------------------------------------

| 0<br>CORP. |
|------------|
|------------|

251 Seneca Street
- Buffalo, New York
14204-2088
14204-2088
716-842-4000 FAX [phone] E-Mail:
[e-mail] Web Site:
www.ethoxcorp.com

| Element of<br>comparison | Originally cleared device<br>(K883977) | Current Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For Monitoring Blood pressure.<br>Single patient use only. Sterile &<br>non-sterile. | For Monitoring Blood pressure. Disposable.<br>Non-sterile versions only. |
| Materials | | |
| Cuff material | PVC | Vinyl with polyester reinforcement |
| Connectors | Cycolac (ABS) | Nylon or PVC (See Summary under<br>biocompatibility) |
| Tube | PVC | Maclin PVC VE-2855 |
| Fastener | Velcro hook & loop | Velcro Loop with vinyl backing, YKK PVC hook |
| Stub | PVC | PVC |
| Marking | Not specified in original 510(k). | Green hot-stamp (Currently in the process of<br>switching) |
| Bonding agent | Cylcohexanone | Cylcohexanone |
| Biocompatability | (Refer to Attachment VIII For Supporting Data) | |
| Primary Cuff Material | (PVC) USP Class III.<br>Printing on Cuff not specified | (Vinyl with polyester reinforcement) with<br>printing currently being tested to FDA blue book<br>memorandum #G95-1 requirements for prolonged<br>skin contact. Refer to Attachment VIII Item 1.<br>Product will only be released upon completion of<br>this testing with acceptable results. |
| Stub | PVC USP Class III | PVC Non-patient contact item (Performed MEM<br>Elution Cytotoxicity testing found to be non-<br>toxic. Performed Physico-Chemical Tests - C19<br>Found to meet USP Limits). Refer to Attachment<br>VIII Item 2. |
| Connectors | Cycolac (ABS) USP Class III | Various -- See below (All non-patient contact<br>items. |
| Female Luer | NA | Nylon: USP Class II and Cytotoxicity MEM<br>Elution. Refer to Attachment VIII Item 3. |
| Quick Disconnect<br>Connector | NA | Nylon: USP Class II and Cytotoxicity MEM<br>Elution. Refer to Attachment VIII Item 3. |
| Multi-purpose screw<br>connector | NA | PVC USP Class VI. Refer to Attachment VIII<br>Item 4. |
| Tube | PVC USP Class III | Virgin PVC (Constituent materials USP Class VI<br>) Refer to Attachment VIII Item 5. |
| General Cuff Design | Refer to Attachment 9 for product<br>drawings of predicate device. | Refer to Attachment VI for product photographs<br>and Attachment VI for product drawings |
| Connectors | 1 option:<br>Tapered connector to fit with<br>most standard luer connectors. | 3 Options:<br>1. Female Luer Connector: 510X Series<br>2. Quick Disconnect Connector: 540X Series<br>3. Multi-purpose Screw Connector (2 Tubes /<br>2 connectors): 520X Series |
| Cuff | No changes to general cuff design aside from material changes referenced above. | |
| Sizes | 7<br>Min. 17.0 cm Max. 25.0 cm<br>8<br>Min. 25.0 cm Max. 35.0 cm<br>9<br>Min. 32.0 cm Max. 42.0 cm<br>10<br>Min. 42.0 cm Max. 50.0 cm | 6 Min. 15.0 cm Max. 22.0 com<br>7 Min. 17.0 cm Max. 25.0 cm<br>8 Min. 25.0 cm Max. 35.0 cm<br>8P Min. 28.0 cm Max. 37.0 cm<br>9 Min. 32.0 cm Max. 42.0 cm<br>10 Min. 42.0 cm Max. 50.0 cm |
| Performance | Conforms to American Heart<br>Association recommendations | Conforms to American Heart Association<br>recommendations. The 540X and 520X series<br>conform to EN1060-1,2, & 3 |
| Target Population | Sizes from 17.0 cm to 50.0 cm | Sizes from 15.0 cm to 50.0 cm |
| Features | Compatible with most monitors | Compatible with most monitors. Latex Free. |
| Labeling | Predicate Device labeling provided in<br>Attachment IX | Current labeling provided in Attachment IV |

{2}------------------------------------------------

In all respects, the Ethox "SURGI-CUF Adult Disposable Blood Pressure Cuffs are substantially equivalent to the originally cleared devices (Ethox Corp. SURGI-CUFF The intended use, product function and design are substantially K883977). equivalent to the predicate device. All material changes to patient contact components are with materials that have been tested to equivalent, or more stringent, biocompatibility standards than the predicate device. In addition, changes in features/general design relate to size and adapter types which are improvements over the predicate device, allowing the product line to service a larger patient population and work with a wider range of ancillary monitoring equipment.

Image /page/2/Picture/1 description: The image shows the logo for Ethox Corp. The logo is black and white and features a stylized letter "E" followed by the word "thox" in a bold, sans-serif font. Below the word "thox" is the word "CORP." in a smaller font size. The logo also includes a registered trademark symbol.

251 Seneca Street Buffalo, New York 14204-2088 716-842-4000

FAX [phone]

E-Mail: [e-mail] Web Site: www.ethoxcorp.com

{3}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR | 5 2004

Ethox Corporation c/o Mr. Ned Devine Responsible Official Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K040286

Trade Name: Ethox SURGI-CUF Adult Disposable Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: March 4, 2004 Received: March 5, 2004

Dear Mr. Devine:

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.

{4}------------------------------------------------

Page 2 - Mr. Ned Devine

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]. 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 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 yours,

Duna R. Lachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Attachment II

#### Statement of Indications for Use

510(k) Number: k640286

Device Name: Ethox SURGI-CUF Adult Disposable Blood Pressure Cuffs

Indications for Use: A non-sterile disposable inflatable bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.

V Prescription Use (Part 21 CFR 801 Subpart D)

_______ ... ... ...

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dorna R. Lochner

(Division Sir -Off) Division of Catalovascular Devices

510(k) Number_k 040286