ALL PURPOSE CUFF, MODEL 222APC

K051904 · Suntech Medical, Inc. · DXQ · Sep 9, 2005 · Cardiovascular

Device Facts

• Record ID: K051904
• Device Name: ALL PURPOSE CUFF, MODEL 222APC
• Applicant: Suntech Medical, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Sep 9, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The All Purpose Cuff is an accessory that is intended to be used with manual or automated noninvasive sphygmomanometers. It makes no diagnosis. The All Purpose 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

All Purpose Cuff is a non-invasive blood pressure (NIBP) accessory; consists of connector, tubing, air-tight bladder, and inelastic sleeve. Used with manual or automated sphygmomanometers to measure blood pressure in pediatric and adult patients. Operated by clinicians in clinical settings. Device wraps around patient limb; secured via hook and loop fastener. Provides pneumatic interface between patient limb and blood pressure monitor; does not perform diagnosis. Reusable, non-sterile design.

Clinical Evidence

Bench testing only. The device was tested against AAMI SP10:2002, AAMI SP10:1994, AAMI SP9:1994, EN1060-1:1996, EN1060-2:1996, EN1060-3:1997, IEC60601-2-30:1999, and IEC60601-2-50:1999. All tests indicated passing results.

Technological Characteristics

Inelastic sleeve with internal air-tight bladder, tubing, and connector. Available in various sizes marked for limb circumference. Hook and loop fastener. Non-sterile, reusable. Complies with AAMI SP9/SP10, EN1060, and IEC60601-2-30/50 standards.

Indications for Use

Indicated for use with manual or automatic non-invasive sphygmomanometers to determine blood pressure parameters in pediatric and adult patients. Not for use on neonates. Intended for use with prescription (clinical grade) blood pressure monitors.

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

• CRITIKON DURA-CUF® Blood Pressure Cuff
• Cuff accessory for the Oscar 2 Oscillometric Ambulatory BP Recorder (SunTech Medical, Inc.)

Submission Summary (Full Text)

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SunTech Medical

Section B

K 051904

SEP – 9 2005

Section B

510(k) Summary

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SunTech Medical

Page 2 of 4

Section B

KDS 1904

SEP - 9 2005

SunTech Medical, Inc.

SunTech Medical, Inc. Abbreviated 510(k) Submission All Purpose Cuff 510(k) Summary 27 May 2005

#### (1) Submitter information

Name:

Address:

507 Airport Boulevard Suite 117

Morrisville, North Carolina 27560-8200

Telephone: FAX:

David Gallick (Official Correspondent). Contact person:

> SunTech Medical, Inc. 507 Airport Boulevard Suite 117 Morrisville, North Carolina 27560-8200 Tel: [phone] Fax: [phone]

Date prepared:

20 May 2005

919.654.2332

919.654.2301

#### (2) Name of Device

Trade Name: Common Name: Classification name: All Purpose Cuff Blood Pressure Cuff Cuff, Blood Pressure, DXQ, 870.1120

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#### (3) Legally-marketed predicate devices

Sun Tech Medical has identified two predicate devices for the All Purpose Cuff:

CRITIKON DURA-CUF® Blood Pressure Cuff, Critikon company, LLC.

Cuff accessory for the Oscar 2 Oscillometric Ambulatory BP Recorder, SunTech Medical, Inc.

The All Purpose Cuff is substantially equivalent to these devices.

# (4) Description

The All Purpose Cuff is an accessory for noninvasive blood pressure systems. It is comprised of a connector attached to tubing attached to an air tight bladder which is enclosed within an inelastic sleeve. The All Purpose Cuff comes in a range of sizes. Each is marked with the appropriate limb circumference for which the cuff is intended.

# (5) Intended Use

The All Purpose Cuff is an accessory that is intended to be used with manual or automated noninvasive sphygmomanometers. It makes no diagnosis. The All Purpose 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..

### (6) Comparison to Predicate Devices

The All Purpose Cuff has the same basic construction as the predicate devices. All three devices are wrapped around the patients limb and secured by means of a hook and loop type fastener. The All Purpose cuff is made from the same material as the Ocsar2 cuffs. The All Purpose cuff is available in the same size/ranges as the CRITIKON cuff and is intended for the same patient populations.

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# (7) Testing and Validations

The All Purpose Cuff has been tested to the applicable requirements of the The All I urpose Curr has quirements documents. These tests have indicated passing results.

- AAMI SP10: 2002 .
- AAMI SP10:1994 .
- AAMI SP9:1994 .
- EN1060-1: 1996 ●
- EN1060-2:1996 .
- EN1060-3:1997 ●
- IEC60601-2-30:1999 .
- ILC00001-2 50:1999
Marketing Specification, (SunTech document # 97-0037-XX-FS), version 11 ●

#### (8) Conclusion

The All Purpose Cuff is equivalent in safety and efficacy to the legally-marketed predicate devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SunTech Medical, Inc. c/o Mr. David Gallick Vice President - Engineering 507 Airport Blvd., Suite 117 Morrisville, NC 27560-2301

Re: K051904

R051701
Trade Name: All Purpose Cuff, Model 222APC Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: July 12, 2005 Received: July 13, 2005

Dear Mr. Gallick:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is subsets devices marketed in referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1970, the chacmical with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance who as provisions of the Act. The and Cosmetic Act (Act) that do not require approvate species provisions of the Act. The
You may, therefore, market the device, subject to the general registration, listing You may, therefore, market the device, sucject to use grouper misbrandon, listing of
general controls provisions of the Act include required it' ititing against misbranding a general controls provisions of the Act merate requirements misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo cities and regulations affecting your device can
may be subject to such additional controls. Existing major regulations affective may be subject to such additional controlis: Existing major regalato 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Couc of Federal regenance.s, concerning your device in the Federal Register.

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Page 2 - Mr. David Gallick

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backer complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a decertification that your are four and agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, morealing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decloils of Persons of Perior as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket nothication. The PDA miding of basification 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 If you desire specific advice for your ac now on our and one and the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note on Comaci the Office of Compilance at (210) +16 cation" (21CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obta Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsional 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,

Bhimmanfor

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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# Indications for Use

510(k) Number (if known): K051904

Device Name:_All Purpose Cuff; Model 222APC

Indications For Use:

The All Purpose Cuff is intended to be used with a manual or automatic non-invasive
s and adult The All Purpose Cuff is intended to be used with a managers on pediatin and adult
sphygmomanometer to determine blood pressure paremeters on pediating and adult sphygmomanometer to determine blood pressures . They are intended to be used
patients. They are not intended to be used on neonates. They are intended to be used with patients. They are not intended to be used on neonators: They also could be used with
with prescription (clinical grade) blood pressure monitors; they also could be used wi with prescription (Clinical grade) blood pressure monitors.

Prescription Use __ X (Part 21 CFR 801 Subpart D) (AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_

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