The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

Device Description

The 247 BP, Temperature and Pulse Oximeter device, a microprocessor based noninvasive blood pressure, predictive temperature and oxygen saturation measurement system, uses oscillometric signals to determine blood pressure, oral, rectal or auxiliary probes to determine temperature and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff. Deflation of the cuff is controlled by two valves. Implementation of Pulse Oximetry and temperature is achieved through the incorporation of OEM devices from companies with currently marketed products and accessories.

AI/ML Overview

The provided text is a 510(k) summary for the SunTech Medical 247 NIBP, Temperature, and Pulse Oximeter device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with specific acceptance criteria and detailed performance metrics as would be found in a multi-reader, multi-case (MRMC) study for an AI-powered diagnostic device.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC study effect size, standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the device's validation against relevant standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device has been tested to applicable requirements of several standards, and these tests "have indicated passing results." However, it does not provide specific numerical acceptance criteria or performance metrics (e.g., accuracy, precision, sensitivity, specificity) within the text itself for blood pressure, temperature, or SpO2 measurements. The acceptance criteria for these types of devices are typically defined within the cited standards.

Parameter/Characteristic	Acceptance Criteria (from standards)	Reported Device Performance
NIBP Performance	AAMI SP10: 2002 requirements	Passing results
General Safety	IEC 60601-1:1996 requirements	Passing results
Electromagnetic Compatibility	IEC 60601-1-2:2001 requirements	Passing results
Programmable Electrical Medical Systems	IEC 60601-1-4:2000 requirements	Passing results
Pulse Oximetry Performance	ISO 9919:1992 requirements	Passing results
Electronic Thermometer Performance	E1112-00:2006 requirements	Passing results
Functional Specifications	SunTech document # 99-0049-XX-FS requirements	Passing results

Note: "Passing results" indicates that the device met the criteria specified in each standard, but the specific numerical thresholds and the exact performance achieved are not detailed in this summary.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
This type of information is typically found in the detailed test reports that are referenced but not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a measurement device, and its "ground truth" is typically established by comparison to other validated measurement devices or by using physical standards, not by expert consensus in the diagnostic sense.

4. Adjudication method for the test set:

Not applicable. (See answer to #3.)

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a vital signs monitor and does not involve human readers interpreting images or data in the context of an AI-assisted diagnostic workflow.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a "standalone" system in the sense that its algorithms perform the measurements (NIBP, SpO2, temperature) without human intervention in the calculation process. However, a specific "standalone" study comparing algorithm-only performance to a human-in-the-loop scenario is not applicable here as it's a measurement device, not an AI diagnostic tool. Its performance is validated against established measurement standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for this type of measurement device is typically established against reference standards or calibrated instruments as defined by the cited standards (e.g., AAMI SP10 for NIBP, ISO 9919 for Pulse Oximetry, E1112 for thermometers).

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model in the sense of requiring a "training set" for diagnostic pattern recognition. Its underlying algorithms are based on established physiological principles and signal processing.

9. How the ground truth for the training set was established:

Not applicable. (See answer to #8.)

Summary of what can be inferred from the document:

The SunTech Medical 247 device demonstrates its meeting of acceptance criteria by undergoing and passing tests against recognized international and national standards for medical devices and vital signs measurement. These standards define the acceptable performance limits for non-invasive blood pressure, pulse oximetry, and electronic thermometers. The 510(k) summary states that the device has "indicated passing results" for these tests, implying compliance with the performance and safety requirements outlined in the standards. The study mentioned is a series of compliance tests against these standards, not a clinical trial with a detailed statistical analysis of patient data in the context of an AI application.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for SunTech Medical. The logo consists of a stylized sun-like graphic to the left of the text "SunTech Medical". A registered trademark symbol is located to the right of the word "Medical".

K07075D

SunTech Medical, Inc. Abbreviated 510(k) Submission 247 510(k) Summary March 16, 2007

Page :

MAY - 2 2007

(1) Submitter information

Name:	SunTech Medical, Inc
Address:	507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200
Telephone:	919.654.2332
FAX:	919.654.2301
Contact person:	David Gallick (Official Correspondent).
Date prepared:	March 16, 2007

(2) Name of Device

Trade Name:	247
Common Name:	NIBP Monitor
Classification name:	Noninvasive blood pressure measurement system, 870.1130

(3) Legally-marketed predicate devices

Sun Tech Medical has identified Welch Allyn's Spot Vital Signs, K002530, as the predicate device for the 247.

The 247 is substantially equivilent to this device.

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(4) Description

(5) Intended Use

(6) Comparison to Predicate Devices

The 247 has the same basic construction as the predicate device. Both devices are microprocessor controlled and the devices utilize similar circuitry. Both devices measure NIBP, SpO2, and body temperature. Neither device is intended to monitor the patient's vital signs. Both devices utilize the same measurement ranges for the various vital signs parameters being measured. Both devices are intended for adult and pediatric populations.

(7) Testing and Validations

The 247 has been tested to the applicable requirements of the following standards and requirements documents. These tests have indicated passing results.

AAMI SP10: 2002 .
IEC 60601-1:1996 .
IEC 60601-1-2:2001 ●
IEC 60601-1-4:2000 .
ISO 9919:1992 .
E1112-00:2006 .
Functional Specification, (SunTech document # 99-0049-XX-FS) .

(8) Conclusion

The 247 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

MAY - 2 2007

SunTech Medical, Inc. c/o Mr. Chuck Setzer Regulatory Manager 507 Airport Blvd., Suite 117 Morrisville, NC 27560-8200

Re: K070750

Trade Name: 247 BP Device Regulation Number: 21 CFR 870.1130, 21 CFR 870.2700, and 21 CFR 880.2910 Regulation Name: Noninvasive Blood Pressure Measurement System; Oximeter; and, Clinical Electronic Thermometer Regulatory Class: Class II (two) Product Code: DXN, MUD, and FLL Dated: March 16, 2007 Received: March 19, 2007

Dear Mr. Setzer:

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. Chuck Setzer

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), 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,

Blymmumor 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

K070750 510(k) Number (if known):

Device Name: 247

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)

Blummenta
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular 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).