(58 days)
Not Found
Not Found
No
The device is a blood pressure cuff, an accessory for non-invasive blood pressure systems, and the description focuses on its physical components and intended use with standard sphygmomanometers. There is no mention of AI or ML in the summary.
No
The device is an accessory for non-invasive blood pressure systems and is used to determine blood pressure parameters; it does not directly treat or prevent a disease or condition.
No
Explanation: The device is an accessory (cuff) for a sphygmomanometer used to determine blood pressure parameters. It does not perform the diagnostic function itself but rather facilitates the measurement.
No
The device description explicitly states it is comprised of physical components: a connector, tubing, an air tight bladder, and an inelastic sleeve. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The All Purpose Cuff is an accessory used with a sphygmomanometer to measure blood pressure. This is a physical measurement taken on the body (in vivo), not a test performed on a sample outside the body (in vitro).
- Intended Use: The intended use clearly states it's for determining blood pressure parameters, which is a physiological measurement.
- Device Description: The description details a physical cuff and tubing, consistent with a device used for external measurement.
Therefore, the All Purpose Cuff falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
The All Purpose Cuff is intended to be used with a manual or automatic non-invasive sphygmomanometer to determine blood pressure parameters on pediatric and adult patients. They are not intended to be used on neonates. They are intended to be used with prescription (clinical grade) blood pressure monitors; they also could be used with prescription (Clinical grade) blood pressure monitors.
Product codes
DXQ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients. They are not intended to be used on neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 ●
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1120 Blood pressure cuff.
(a)
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.(b)
Classification. Class II (performance standards).
0
SunTech Medical
Section B
K 051904
SEP – 9 2005
Section B
510(k) Summary
1
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: 919-654-2332 Fax: 919-654-2301
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
2
(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.
3
(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
4
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.
5
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 (240) 276-0295. 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 (800) 638-2041 or (301) 443-6597 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
6
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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