(24 days)
Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.
The SensAid sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate Disposable Positioning Tape (DPT) accessory.
The SensAid SpO2 Sensors measure oxygen saturation (SpO2), pulse rate, and plethysmographic pulse wave. The self-adhesive, latex free Disposable Positioning Tape (DPT) accessories quickly, comfortably, and securely attach to a patient. When a DPT is properly positioned on the patient and the SpO2 Multi-Site Reusable sensor is connected to the DPT, the sensor light emitting diodes and detector are aligned to ensure proper sensor performance.
The provided text is a 510(k) summary for a pulse oximeter accessory (sensors), not a standalone AI/device or clinical study report for software/AI. Therefore, much of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC study, standalone performance) is not applicable or not present in the document.
The document describes the SensAid SpO2 Sensors and their similarity to a predicate device. The primary "study" mentioned is a "desaturation study" to demonstrate substantial equivalence to the predicate device, not to prove specific performance against acceptance criteria in the way a novel AI device would.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent or not relevant for this type of medical device submission:
1. Table of acceptance criteria and reported device performance
No explicit acceptance criteria (e.g., specific accuracy thresholds with upper/lower bounds) nor direct reported performance metrics (e.g., SpO2 accuracy, bias, precision) are provided for the SensAid sensors within this 510(k) summary. The study's conclusion is qualitative: "no significant deviation exists between the SensAid SpO2 sensors and the respective predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: The study was conducted by an "independent research laboratory." No information on country of origin or whether it was retrospective or prospective is given, though clinical desaturation studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a pulse oximeter, ground truth for oxygen saturation is typically established by direct arterial blood gas analysis, not expert consensus interpreting images or data. No information on experts is provided.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert interpretations (e.g., in imaging studies). This study compares device measurements to a reference standard (likely co-oximetry).
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
Not applicable. This is not an AI device or a study involving human readers or interpretation. It's a physiological monitoring device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a standalone medical device (the SensAid sensors) operating to measure physiological parameters. It does not contain an "algorithm only without human-in-the-loop" in the AI sense, as it performs its measurement function directly when applied to a patient. The "standalone performance" is implicitly what the desaturation study assesses by comparing it to the predicate device.
7. The type of ground truth used
While not explicitly stated, for a pulse oximeter desaturation study, the ground truth for oxygen saturation (SpO2) is typically established using arterial blood gas analysis (co-oximetry).
8. The sample size for the training set
Not applicable. These are physical sensors, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
MAY 13 2002
K02/246
510(k) SUMMARY (as required by 807.92( c )
| Submitter of 510(k): |
|---|
| ---------------------- |
Sensidyne, Inc. 16333 Bay Vista Drive Clearwater, Florida, 33760
George Mason
Contact Person:
Date of Summary: 4/17/02
Trade Name: SensAid
Oximeter (Accessory) Classification Name:
Predicate Device:
The Sensors listed below are similar in design, composition and function to the Sensaid sensor cleared by the FDA on Sensidyne's submission 510(k) K011974 and will be used as the predicate device for this submission. All sensors are used in conjunction with Disposable Positioning Tape (DPT Tape) which was cleared for sale by the FDA on Sensidyne's submission 510(k) K011974.
| Predicate Device | New Sensor Model | Modification |
|---|---|---|
| RC-OHM20-10 | RC-NVA30-10 | Connector change9 pin Hypertronix to7 pin Hypertronix |
| RC-OHM20-10 | RC-CSI40-10 | Connector change9 pin Hypertronix to5 pin Limo |
| RC-OHM20-10 | RC-BCI50-3 | Connector change9 Pin Hypertronix toDB9 |
{1}------------------------------------------------
Device Description:
The SensAid SpO2 Sensors measure oxygen saturation (SpO2), pulse rate, and plethysmographic pulse wave. The self-adhesive, latex free Disposable Positioning Tape (DPT) accessories quickly, comfortably, and securely attach to a patient. When a DPT is properly positioned on the patient and the SpO2 Multi-Site Reusable sensor is connected to the DPT, the sensor light emitting diodes and detector are aligned to ensure proper sensor performance.
Indications For Use:
The intended use for the SensAid SpO2 sensors is the same as the predicate sensors, i.e. compatible oximeter sensors are indicated for non-invasive monitoring of patient oxygen saturation (SpO2), pulse rate, and plethysmographic pulse wave.
The SensAid sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate DPT accessory.
Technological Characteristics:
The SensAid and predicate oximeter sensors use two LED's (light emitting diodes) as light sources: a red LED typically 660nm peak emission (a wavelength of maximum discrimination between oxyhemogloben and reduced hemoglobin), and an infrared LED (typically in the peak emission range of 880nm to 940nm, varying by manufacturer). These light sources are sequentially pulsed into the tissue, and the light passing through the tissue for each wavelength is received by the photodiode, which converts the light intensity to a measurable electrical current.
Clinical Testing:
A desaturation study was completed by an independent research laboratory. The study provided a comparison between the SensAid System and the predicated devices. The data obtained from the study indicated that no significant deviation exists between the SensAid SpO2 sensors and the respective predicate devices.
Conclusion:
Comparison of the data obtained from performance and clinical testing prove that the SensAid System is substantially equivalent to the predicate devices.
G. Mar=
George Mason QA and Regulatory Affairs Manager
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with three profiles of human faces incorporated into its body. 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.
JUN 2 7 2002
Sensidyne, Inc. c/o Mr. George Mason 16333 Bay Vista Drive Clearwater, FL 33760
Re: K021246
Sensaid Pulse Oximeter Sensors, Models #RC-NVA30-10, #RC-CSI40-10, and #RC-BCI50-3 Regulation Number: 870.2700 Regulation Name: Oximeter
Regulatory Class: II (two) Product Code: 74 DOA Dated: April 18, 2002
Received: April 19, 2002
Dear Mr. Mason:
This letter corrects our substantially equivalent letter of May 13, 2002 regarding the indications for use of your device. Our letter incorrectly limited your device to use in military environments.
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 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). 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
{3}------------------------------------------------
Page 2 - Mr. George Mason
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll freenumber (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Page 1 of 1
K021246 510(k) Number:
Device Name: SENSAID
Indications For Use:
Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.
plethySmographic pulse wave:
The SensAid sensors can be used for Adult, Pediatric and/or Neonate/Infant The Sellsons with the appropriate Disposable Positioning Tape (DPT) accessory.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K001846
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).