The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying systolic and diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

Device Description

The Cycle BP Monitor and Pulse Oximeter, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system compatible with ergometer stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. The Cycle has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

AI/ML Overview

The provided text describes the SunTech Medical Cycle BP Monitor and Pulse Oximeter, its intended use, and its equivalence to a predicate device. It references several standards and tests, but it does not provide explicit acceptance criteria or detailed study results for device performance against those criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance directly from the given text.

Here's what I can infer and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (from AAMI SP10: 2002, IEC, etc.)	Device Performance
Blood Pressure Measurement Accuracy (Mean Difference)	Not explicitly stated in the document, but typically defined by AAMI SP10. Usually, mean difference ± 5 mmHg and standard deviation ≤ 8 mmHg are acceptance criteria.	Not reported in the document. The document only states "These tests have indicated passing results."
Blood Pressure Measurement Accuracy (Standard Deviation)	Not explicitly stated in the document, but typically defined by AAMI SP10.	Not reported in the document.
Pulse Oximetry Accuracy (SpO2)	Not explicitly stated in the document, but typically defined by ISO 9919. Usually, a root mean square deviation (ARMS) of less than 3% in the range of 70-100% SpO2 is expected.	Not reported in the document. The document only states "These tests have indicated passing results."
Heart Rate Accuracy	Not explicitly stated in the document, but often covered by the same standards as BP.	Not reported in the document.
Safety (Electrical, EMC, etc.)	Compliance with IEC 60601-1, IEC 60601-1-2, etc.	"These tests have indicated passing results."
Functional Specification (SunTech document # 99-0049-XX-FS)	Not detailed in this submission.	"These tests have indicated passing results."

Study that proves the device meets the acceptance criteria:

The document broadly states that "The Cycle BP Monitor has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results." The specific standards listed are:

AAMI SP10: 2002 (American Association for Medical Instrumentation, standard for sphygmomanometers)
IEC 60601-1:1996 (Medical electrical equipment – Part 1: General requirements for safety)
IEC 60601-2-30:1999 (Medical electrical equipment – Part 2-30: Particular requirements for the safety of automatic electronic sphygmomanometers)
ISO 9919:1992 (Pulse oximetry equipment – Particular requirements for safety and essential performance)
IEC 60601-1-2:2001 (Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests)
IEC 60601-1-4:2000 (Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems)
IEC 60601-2-49:2001 (Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment)
Functional Specification, (SunTech document # 99-0049-XX-FS)

The document claims that the device "indicated passing results" for these tests, implying that the studies conducted in accordance with these standards demonstrated compliance with their respective criteria. However, no specific data or methodology details of these studies are provided in this extract.

Missing Information from the provided text:

Due to the nature of this submission (abbreviated 510(k) summary), the detailed information about the studies is not included. The following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not available in the document. For AAMI SP10, there are specific requirements for subject demographics (e.g., age, blood pressure range, gender distribution) and a minimum number of subjects (typically 85 for clinical validation).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the document. For AAMI SP10, ground truth (reference blood pressure) is typically established by at least two trained observers taking simultaneous auscultatory measurements.
Adjudication method for the test set: Not available in the document.
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: Not applicable. This device is a standalone blood pressure and pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself performs the measurements. The "tests have indicated passing results" for standalone performance according to the listed standards.
The type of ground truth used: For Blood Pressure, it's highly likely to be expert auscultation as per AAMI SP10. For SpO2, it would be co-oximetry (invasive blood gas analysis).
The sample size for the training set: Not applicable/Not available. This device (from 2006) would likely use a deterministic algorithm or a simpler calibration model rather than a machine learning model that requires a "training set" in the modern AI sense. Even if it involved some algorithm development, the specifics are not disclosed.
How the ground truth for the training set was established: Not applicable/Not available.

Summary

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K060820

SunTech Medical®

SunTech Medical, Inc. Abbreviated 510(k) Submission Cycle BP Monitor and Pulse Oximeter 510(k) Summary March 22, 2006

JUN - 7 2006

(1) Submitter information

Name:	SunTech Medical, Inc
Address:	507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200
Telephone:FAX:	919.654.2332919.654.2301
Contact person:	David Gallick (Official Correspondent).SunTech Medical507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200Tel: 919-654-2332Fax: 919-654-2301
Date prepared:	March 22, 2006

(2) Name of Device

Trade Name:	Cycle BP Monitor and Pulse Oximeter
Common Name:	NIBP Monitor
Classification name:	Noninvasive blood pressure measurement system.870.1130

(3) Legally-marketed predicate devices

Sun Tech Medical has identified its Tango+, K053209, as the predicate device for the Cycle BP Monitor and Pulse Oximeter.

The Cycle BP Monitor and Pulse Oximeter is substantially equivilent to this device.

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page 2 of 2

Page 53

SunTech Medical Cycle Blood Pressure Monitor and Pulse Oximeter 510(k)

(4) Description

(5) Intended Use

The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

(6) Comparison to Predicate Devices

The Cycle BP Monitor and Pulse Oximeter has the same basic construction as the predicate device. Both devices are microprocessor controlled and the devices utilize similar circuitry. The Cycle is made from the same materials as the Tango+. It uses the same BP cuffs and SpO2 sensors as the Tango+. The Cycle utilizes the same BP measurement range and the same SpO2 range as the Tango+. The Cycle includes Pediatrics in the patient population. The Cycle BP monitor identifies the Korotkoff signals without the use of R-wave gating as used by the Tango+.

(7) Testing and Validations

The Cycle BP Monitor has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results.

AAMI SP10: 2002
. IEC 60601-1:1996
IEC 60601-2-30:1999 .
ISO 9919:1992 .
IEC 60601-1-2:2001 ●
IEC 60601-1-4:2000 .
IEC 60601-2-49:2001 ●
Functional Specification, (SunTech document # 99-0049-XX-FS) ●

(8) Conclusion

The Cycle BP Monitor and Pulse Oximeter is equivalent in safety and efficacy to the legally-marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2006

SunTech Medical, Inc. c/o Mr. David Gallick Vice President, Engineering 507 Airport Blvd., Suite 117 Morrisville, NC 27560-8200

Re: K060820

Trade Name: Cycle BP Monitor and Pulse Oximeter, Model 1060 Regulation Number: 21 CFR 870.1130, and 21 CFR 870.2700 Regulation Name: Noninvasive Blood Pressure Measurement System, and Oximeter Regulatory Class: Class II (two) Product Code: DXN and MUD Dated: May 25, 2006 Received: May 26, 2006

Dear Mr. Gallick:

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. David Gallick

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 (OS) 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), please contact the Office of Compliance at (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Blyminima for

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): K060820

Device Name: Cycle BP Monitor and Pulse Oximeter

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

amminn

Visión Slan-Off) Division of Cardlovascular Devices 510(k) Number

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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).