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 Use X (Part 21 CFR 801 Subpart D) (AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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.

AI/ML Overview

The provided text describes a 510(k) summary for the SunTech Medical All Purpose Cuff. However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document states that the device has been "tested to the applicable requirements" of various AAMI, EN, and IEC standards, and "These tests have indicated passing results." It also mentions a "Marketing Specification, (SunTech document # 97-0037-XX-FS), version 11," but the content of this specification is not provided.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

Here's a breakdown of what could be provided based on the very limited information, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text.	"These tests have indicated passing results." (Specific values not provided)

Missing Information: The document states testing was done according to AAMI SP10, EN1060, and IEC60601-2-30. These standards would contain specific performance criteria (e.g., accuracy, pressure stability, leak rates) for blood pressure cuffs, but the document does not enumerate them or report the specific numerical performance of the device against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information: The document does not specify any sample sizes for testing or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "These tests."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Missing Information: There is no mention of experts, ground truth establishment, or any human-based evaluation in the provided text. The testing appears to be primarily related to engineering and performance standards for the physical cuff itself.

4. Adjudication Method for the Test Set

Missing Information: Not applicable, as no expert evaluation or ground truth establishment process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Missing Information: This device (All Purpose Cuff) is a physical blood pressure cuff, not an AI-powered diagnostic tool interpreting medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Missing Information: This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable. The device's "standalone" performance would be its inherent physical performance characteristics as a cuff. The document states "These tests have indicated passing results" for various standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Missing Information: The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus for image interpretation) is not explicitly discussed for this device. The "ground truth" for a blood pressure cuff's performance would be derived from physical measurements against calibrated references and adherence to engineering standards. The specific methods are not detailed beyond referencing AAMI, EN, and IEC standards.

8. The Sample Size for the Training Set

Missing Information: This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

Missing Information: Not applicable, as there is no "training set" for this physical device.

Summary

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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: 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

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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

(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 (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

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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_

Page 1 of

Regulation Number and Section

§ 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).