(111 days)
The MD500B Vital Signs Monitor is intended to be used to monitor physiologic parameters including SpO2, Pulse Rate (PR) and Non-Invasive Blood Pressure (NIBP) on adult patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.
The proposed device, MD500B Vital Signs Monitor, is a battery-driven device, which is intended for measuring pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (S) and diastolic pressure (D) on adult.
The provided text describes the 510(k) submission for the MD500B Vital Signs Monitor. It mentions that performance testing, including clinical and laboratory testing, was conducted to validate and verify that the device met all design specifications and was substantially equivalent to the predicate device. However, the document does not contain the specific details required to complete your request for acceptance criteria, study methodologies, and performance metrics.
The text is a regulatory summary (510(k) summary and FDA letter), which often summarizes testing without providing the raw data, specific acceptance criteria values, or detailed study designs.
Therefore, I cannot populate the requested table or answer most of your detailed questions based solely on the provided text. I will indicate where information is missing.
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (e.g., Accuracy, Range) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Not specified in provided text | Not specified in provided text |
| Pulse Rate (PR) Accuracy | Not specified in provided text | Not specified in provided text |
| NIBP Accuracy (Systolic) | Not specified in provided text | Not specified in provided text |
| NIBP Accuracy (Diastolic) | Not specified in provided text | Not specified in provided text |
| Measurement Range (SpO2) | Not specified in provided text | Not specified in provided text |
| Measurement Range (PR) | Not specified in provided text | Not specified in provided text |
| Measurement Range (NIBP) | Not specified in provided text | Not specified in provided text |
| Substantial Equivalence | Met design specifications and substantial equivalence to predicate device | Met design specifications and substantial equivalence to predicate device |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country, retrospective/prospective). The sponsor is based in Beijing, China, but this does not confirm the origin of the clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified within the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified within the provided text.
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. This is a vital signs monitor, not an AI-assisted diagnostic device that involves human reader interpretation. Therefore, an MRMC study with AI assistance is not applicable to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. Vital signs monitors are standalone devices that provide physiological measurements directly. The performance testing (clinical and laboratory) would have evaluated the device's accuracy in producing these measurements directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but for vital signs monitors, the ground truth typically involves reference standards like:
- Direct arterial blood pressure measurement for NIBP accuracy.
- Co-oximetry for SpO2 accuracy.
- Electrocardiogram (ECG) or manual pulse counting for pulse rate accuracy.
- The document only mentions "clinical and laboratory testing," which would have used such reference standards.
8. The sample size for the training set
- Not specified within the provided text. Note: Training sets are typically associated with machine learning or AI models. While the device is electronic, the description does not indicate it uses a machine learning algorithm that would require a separate "training set" in the common sense of AI development. It's more likely validated against established physiological models and clinical data.
9. How the ground truth for the training set was established
- Not applicable as a distinct "training set" in the context of an AI model is not detailed or implied for this device type within the provided text.
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510(k) Submission of MD500B Vital Signs Monitor
Exhibit #B 510(k) Summary
JAN ] 2 2009
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K082787
Sponsor:
Correspondent:
Proposed Device Information
Trade Name Model: Classification Name: Product Code: Subsequent Product Codes: Regulation Number: Device Class:
Intended Use:
Predicate Device:
Beijing Choice Electronic Technology Co., Ltd Bailangyuan Bldg B 1127-1128, Fuxing road, A36 Beijing, 100039, China Establishment Registration Number: 3005569927
Contact Person: Mr. Chen Lei
Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: (760)466-5084 Email: Diana.hong@mid-link.net
Vital Signs Monitor; MD500B; monitor, physiological, patient; MWI; DQA,DXN 870.2300; II
The MD500B Vital Signs Monitor is intended to be used to monitor physiologic parameters including SpO2, Pulse Rate (PR) and Non-Invasive Blood Pressure (NIBP) on adult patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.
VS-800 Vital Signs Monitor K Number: K063055
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Device Description:
The proposed device, MD500B Vital Signs Monitor, is a battery-driven device, which is intended for measuring pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (S) and diastolic pressure (D) on adult.
Testing Conclusion:
Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, MD500B Vital Signs Monitor met all design specifications and was substantially equivalent to the predicate device.
The proposed device, MD50013 Vital Signs Monitor is substantially equivalent (SE) to the predicate device, VS-800 Vital Signs Monitor.
SE Conclusion:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2009
Beijing Choice Electronic Technology Co., Ltd. c/o Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd. Suite 8D, No. 19, Lane 999 Zhongshan No.2 Road(S) Shanghai, 200030, China
Re: K082787
Trade/Device Name: Vital Signs Monitor Model MD500B Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II Product Codes: MWI, DOA, DXN Dated: January 2, 2009 Received: January 2, 2009
Dear Ms. Hong:
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. Iisting 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 -Ms. Diana Hong
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
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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Exhibit #A Indication for Use Statement
510(k) Number: K082787 Device Name: Vital Signs Monitor, MD500B
Indications for Use:
The MD500B Vital Signs Monitor is intended to be used to monitor physiologic parameters including SpO2, Pulse Rate (PR) and Non-Invasive Blood Pressure (NBP) on adult patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.
Prescription Use (Part 21 CFR 801 Subpart D)
श्रीम्
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)
Atteke les Bzu
Division Sian-Off Division of Cardiovascular Devices K082787 510(k) Number
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).