(2 days)
The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
The device is a photoelectric plethysmograph with is used to estimate blood flow in a region of the body using photoelectric measurement techniques
The provided text is a 510(k) summary for the SA3000P System, a photoelectric plethysmograph. It does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the comprehensive study that proves the device meets them.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functions substantially equivalent to the predicate | "The functions are substantially equivalent to the predicate" |
| Meets "the same safety and performance Standards as the predicate" | "the device meets the same safety and performance Standards as the predicate." |
Missing Information: The specific quantitative acceptance criteria for parameters like accuracy of pulse waveform, heart rate measurement, safety, or specific performance standards are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: This information is not provided in the 510(k) summary. The summary mentions "performance testing showing that The functions are substantially equivalent to the predicate," but no details about the test set, sample size, or data provenance are included.
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)
Missing Information: This information is not provided. The summary does not describe how ground truth was established or if any experts were involved in a blinded assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No adjudication method is mentioned in 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
Missing Information: The device described is a photoelectric plethysmograph, which measures physiological parameters like pulse waveform and heart rate. It is not an AI-assisted diagnostic imaging device that would typically involve human readers or MRMC studies for comparative effectiveness of AI vs. human performance. Therefore, an MRMC study is highly unlikely to have been conducted for this type of device. The document does not mention any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: As this device is a plethysmograph (a measurement device), its performance would inherently be "standalone" in terms of its ability to measure pulse waveform and heart rate. However, the details of how this "standalone performance" was assessed (e.g., against a gold standard reference device) are not provided. The document focuses on equivalence to a predicate, not necessarily absolute accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: The type of ground truth used for performance validation is not specified. For a plethysmograph, ground truth would typically be established by a reference method or a gold standard device for pulse waveform and heart rate measurement.
8. The sample size for the training set
Missing Information: This device does not appear to involve machine learning, therefore, there would not be a "training set" in the context of AI/ML models. The summary focuses on hardware performance and equivalence.
9. How the ground truth for the training set was established
Missing Information: Not applicable, as there is no indication of a machine learning component requiring a training set.
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510(k) Summary
Prepared November 23, 2007
| Submitted by: | Medicore Co. Ltd.4F, Luna B/D, 72 3, Chungdam dongGangnam guSeoul Korea |
|---|---|
| NOV 2 9 2007 | |
| Contact Person: | Yoo Byung kukManagerTelephone: |
| 83-2-2056-2650 | |
| FAX: | |
| 83-2-2056-2688 | |
| e-mail: | |
| bkyoo@medi-core.com | |
| Product Name: | SA3000P System |
| Common Name: | Pneumatic Plethysmography |
| Classification: | JOM; Class II; CFR 21 870.2780 |
| Predicate Devices: | McPulse by Meridian Co. Ltd. |
| Description of Device: | The device is a photoelectric plethysmograph with isused to estimate blood flow in a region of the body usingphotoelectric measurement techniques |
| Intended Use: | The device provides noninvasive measurement of pulse waveformand heart rate by photoelectric plethysmography. The anatomicalsite for taking the measurement is the left index finger. The deviceis intended for use with patients age 18 years and older and with aweight of 100 lbs or greater. The device is indicated for use inhospitals, health care clinics and physicians' offices |
| Comparison withPredicate Devices: | The SA-3000P is substantially equivalent to the indication forUse and the technological characteristics of the predicate device,the Meridian McPulse device (K023238) |
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Performance: The device has completed performance testing showing that The functions are substantially equivalent to the predicate In addition the device meets the same safety and performance Standards as the predicate.
Page 2 of 2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2007
Medicore Co., Ltd c/o Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K073323
SA-3000P Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic or Photoelectric Plethysmograph Regulatory Class: Class II (two) Product Code: JOM Dated: November 26, 2007 Received: November 27, 2007
Dear Mr. Job:
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. Mark Job
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,
Blzimuma 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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1073323 510(k) Number (if known):
Device Name: SA3000P
Indications For Use:
The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
x OR Over-The-Counter Use __ Prescription Use (Per 21CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office Of Device Evaluation (ODE)
B/Amma
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).