SENSA-CUFF, MODELS INFANT, CHILD, ADULT

K022482 · Ge Medical Systems Information Technologies · DXQ · Aug 13, 2002 · Cardiovascular

Device Facts

• Record ID: K022482
• Device Name: SENSA-CUFF, MODELS INFANT, CHILD, ADULT
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DXQ · Cardiovascular
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Story

Sensa-Cuff is a reusable, non-sterile blood pressure cuff accessory; consists of inelastic sleeve with integrated inflatable bladder, tubing, and hook-and-loop closure. Device wraps around patient limb; connects to non-invasive blood pressure measurement system. Used in clinical settings to facilitate indirect blood pressure monitoring. Benefits include reliable, repeated use for patient vital sign assessment.

Clinical Evidence

Bench testing only. Device tested for performance and safety per SP-9 (Nonautomated Sphygmomanometer), BS EN 1060 (Non-Invasive Sphygmomanometers), and ISO 10993 (Biological Evaluation).

Technological Characteristics

Materials: Woven nylon cuff, EVA bladder film, PVC tubing, textured polyester ribbon, molded nylon hook/loop. Energy: Pneumatic (inflatable). Form factor: Inelastic sleeve with 1 or 2 tube configuration. Sizes: Infant to thigh (8-50 cm range). Standards: SP-9, BS EN 1060, ISO 10993.

Indications for Use

Indicated for indirect blood pressure measurement in pediatric and adult patient populations when used with noninvasive blood pressure measurement systems.

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

• DURA-CUF (Critikon Company, LLC)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The letters are black, and the circle is also black with white accents around the edges.

# AUG 1 3 2002

GE Medical Systems Information Technologies

General Electric Company 4502 Woodland Corporate Blvd., Tampa, FL 33614 813 887-2000

#### SUMMARY OF SAFETY AND EFFECTIVENESS June 24, 2002

#### Sensa-Cuff

#### A. Submitter

GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614

### B. Company Contact

Primary: Melissa Robinson, Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

#### Secondary:

Tom English, Global QA/RA Phone: [phone] Fax: [phone]

#### C. Device Name

Trade Name: Common Name: Classification/Product Code: Sensa-Cuff Blood Pressure Cuff DXQ-870.1120

### D. Predicate/Legally Marketed Devices

DURA-CUF®-Preamendment Critikon Company, LLC

#### E. Device Description

The device comprises tubing attached to an 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 a non-invasive blood pressure measurement system.

#### F. Intended Use

The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

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- G. Testing
The Sensa-Cuff Blood Pressure Cuffs were tested according to the applicable sections of the following standards:

- •SP-9 Nonautomated Sphygmomanometer
- •BS EN 1060 Non-Invasive Sphygmomanometers
- •ISO 10993 Biological Evaluation of Medical Devices

## H. Comparison to the Predicate Device

| COMPARISON OF THE Critikon Sensa-Cuff to the Critikon DURA-CUF® | | |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | DURA-CUF® | Sensa-CUFF |
| Intended Use | Indirect measurement of blood pressure | Indirect measurement of blood pressure |
| Patient Populations | Adults/pediatrics | Adults/pediatrics |
| Material | Cuff Substrate: Polyurethane<br>coated nylon woven cloth<br>Tubing: SE-BS Thermoplastic<br>elastomer<br>Hook: Molded Nylon<br>Loop: Nylon | Cuff material: Woven nylon<br>Film (bladder): Ethylene vinyl<br>acetate copolymer (EVA)<br>Tubing: PVC<br>Ribbon: Textured polyester<br>Hook: Molded Nylon<br>Loop: nylon |
| Tube Configuration | 1 and 2 tube | 1 and 2 tube |
| Sizes<br>(Ranges in cm) | Conform to AHA bladder size<br>recommendations<br>• Infant (8-13)<br>• Child (12-19)<br>• Small Adult (17-25)<br>• Adult (23-33)<br>• Large Adult (31-40)<br>• Thigh (38-50) | Conform to AHA bladder size<br>recommendations<br>• Infant (8-13)<br>• Child (12-19)<br>• Small Adult (17-25)<br>• Adult (23-33)<br>• Large Adult (31-40)<br>• Thigh (38-50) |
| Repeated Inflations | 10,000 inflations<br>3,000 hook and loop closures | 10,000 inflations<br>3,000 hook and loop closures |

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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 & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

GE Medical Systems Information Technologies c/o Mr. Jeff D. Rongero Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K022482

Trade Name: Sensa-Cuff Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: July 26, 2002 Received: July 29, 2002

Dear Mr. Rongero:

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. Jeff D. Rongero

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours.

Elisa Diaz for

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

Enclosure

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June 24, 2002

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510(K) Number (if known): _ K 022482

Device Name: Sensa-Cuff Blood Pressure Cuff

Indications for Use:

The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

(Per 21 CFR 801.109)

or

Over-The Counter Use

Olish for Bru Zuchn
(Division Sign-Off)
Division of Cardiovascular
8/14/02

nd Respiratory De

510(k) Number

(Optional Format 1-2-96)