DEVON ACCUBP CUFF

K090664 · Devon Medical, Inc. · DXQ · Mar 23, 2009 · Cardiovascular

Device Facts

• Record ID: K090664
• Device Name: DEVON ACCUBP CUFF
• Applicant: Devon Medical, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant and adult sizes.

Device Story

AccuBP Cuff is a non-sterile, disposable blood pressure cuff used with non-invasive blood pressure monitoring systems. Device consists of an inflatable bladder within an inelastic sleeve, secured to a patient's limb via hook and loop closure. Tubing connects the bladder to an external blood pressure monitor. Available in various sizes (neonatal through large adult) and configurations (single or double tube). Operated by healthcare professionals in clinical settings. The cuff facilitates the measurement of blood pressure by enabling controlled inflation and deflation around the limb, allowing the monitoring system to detect pressure oscillations. Benefits include reliable, single-patient use blood pressure monitoring across a wide patient population.

Clinical Evidence

Bench testing only. Performance was validated against ANSI/AAMI SP-10 standards, confirming functional parameters including compression, pressure control, and leakage when connected to inflation and measurement equipment.

Technological Characteristics

Materials: Latex-free, PVC tubing, inelastic sleeve. Sensing: Pneumatic inflation/deflation for oscillometric or auscultatory blood pressure measurement. Form factor: Neonatal to large adult sizes, single or double tube configurations. Connectivity: Connects to standard non-invasive blood pressure monitoring systems via integrated tubing/connectors. Sterilization: Non-sterile. Standards: ANSI/AAMI SP-10.

Indications for Use

Indicated for use in conjunction with non-invasive blood pressure monitoring systems to determine blood pressure in patients ranging from neonates to adults.

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

• Medline Single Patient Use Blood Pressure Cuff (K071244)

Submission Summary (Full Text)

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K090664

# Section 1: 510(k) Summary

MAR 2 3 2009

Submitter:

Devon Medical Inc. 1100 15t Ave, Suite 100 King of Prussia, PA 19406

### Contact Person:

Ruth Wu, COO (Official Correspondent) Address: 1100 First Avenue, Suite 100 · King of Prussia, PA 19406, USA 800.571.3135 Phone: [phone] Fax:

Common Classification & Proprietary Names:

| Common Names: | Blood Pressure Cuff |
|-------------------|---------------------|
| Proprietary Name: | AccuBP Cuff |

Date Prepared:

February 18th 2009

### Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the AccuBP Cuff.

| Classification Name | 21 CFR Section | Product Code | Class |
|---------------------|----------------|--------------|-------|
| Blood Pressure Cuff | 870.1120 | DXQ | II |

### Predicate Devices

The AccuBP Cuff is substantially equivalent to the following:

| Predicate Device | Manufacturer | 510(k)# |
|------------------------------------------------|--------------------------|---------|
| Medline Single Patient Use Blood Pressure Cuff | Medline Industries, Inc. | K071244 |

The AccuBP Cuff has the same intended use and general construction as the predicate devices and is available in the same sizes of Statcorp Disposable Blood Pressure Cuff and has the same functional performance with Statcorp Disposable Blood Pressure Cuff.

### Device Description

Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Devon AccuBP Cuffs are Latex Free.

The Devon AccuBP Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure

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measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.

Attached to the end of each PVC tube are a variety of connectors for use with most monitoring systems.

The AccuBP Cuffs are available in the following configurations:

Five sizes for Neonatal (Neonatal #1-#5) and eight sizes for (Infant, Child, Small Adult, Adult, Adult Long, Large Adult, Large Adult Long, and Thigh)

Both Single Tube and Double Tube configuration are available for all size.

### Intended Use

The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant and adult sizes.

## Technological Characteristics

The Devon AccuBP Cuff are identical to the Medline Single Patient Use Blood Pressure Cuff in design, mode of operation, and performance characteristics, all of these cuffs are configured for use with a wide variety of manual and automated sphygmomanometers.

# Performance

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Devon AccuBP Cuff. Tests showed that the functional and operational performance characteristics including compression, pressure control, leakage, and both safety and operational parameters used when connected to inflation and measurement equipment meet standard ANSI/AAMI SP-10.

# Statement of Substantial Equivalence

The AccuBP Cuff is substantially equivalent in technology, function, operating parameters, and intended use to Blood Pressure Cuffs that are currently commercially available and in distribution. The original devices are marked for "single-patient use only".

# Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Inc, concludes that the AccuBP Cuff, is safe and effective and substantially equivalent to the predicate devices as described herein.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

MAR 2 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Devon Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K090664

Devon AccuBP Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXO Dated: March 11, 2009 Received: March 13, 2009

#### Dear Mr. Job:

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.

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#### Page 2 - Mr. Mark Job

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 elcctronic 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/industry/support/index.html.

Sincerely yours,

ina R. bahnes

Image /page/3/Picture/5 description: The image shows a symbol that appears to be a stylized or abstract design. It features curved lines and loops, creating a flowing and somewhat calligraphic appearance. The symbol is simple and lacks any shading or color variations, suggesting it may be a logo, icon, or signature.

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

Enclosure

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510(k) Number (if known):

K070664

Device Name: The Devon AccuBP Cuff

Indications for Use:

The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, through adult sizes.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sime D. Vochme

(Division, S Division . I ardiovascula

2090664 5 Tu(K) Numbe

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