(184 days)
The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.
The Stat-Shell SpO2 Disposable Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector.
The photodiode is housed in a textured, rigid shell that is contoured for patient digit placement. The LED's are housed in a foam tape that is positioned over the nail bed and wrapped around the patient's digit.
The sensor cable is 2 feet in length and is terminated in a DB-9 style connector. An adapter cable extends the length and converts the connector to a Hypertronics style.
The provided text describes a 510(k) summary for the Stat-Shell Disposable SpO2 Sensor. Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the Stat-Shell Disposable SpO2 Sensor in terms of specific performance metrics (e.g., accuracy ranges for SpO2 or pulse rate). Instead, it focuses on demonstrating substantial equivalence to a predicate device and meeting certain standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oximeter Compatibility with Smaller Photodiode | "Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode." (Passed) |
| Biocompatibility | "bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility..." (Passed) |
| EMC (Electromagnetic Compatibility) | "...EMC..." (Passed) |
| Safety | "...safety..." (Passed) |
| Pulse Oximeter Standards | "...and pulse oximeter standards." (Passed) |
| Same Theory and Principle of Operation as Predicate Device | "The Stat-Shell SpO2 Disposable Sensor uses the same theory and principle of operation as the predicate device." (Met) |
| No effect on accuracy due to changes (compared to predicate) | "Changes to the predicate device do not affect those aspects of the device related to accuracy." (Met) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative sample size for the "simulated use bench testing" or the other bench testing. It refers to "bench testing" in general terms.
- Data Provenance: The document does not provide details about the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be laboratory/bench testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described is bench testing, not a clinical study involving expert assessment or ground truth derived from human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The testing described is bench testing, not a clinical study involving human judgment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes bench testing to ensure substantial equivalence and adherence to standards, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an SpO2 sensor accessory to a pulse oximeter, which is inherently a sensor that generates a measurement. The "algorithm" or measurement capability resides within the pulse oximeter it connects to. The testing described is for the sensor itself to ensure it functions correctly as an input to the oximeter. Therefore, a standalone algorithm performance study in the sense of AI evaluation is not applicable or described. The performance of the sensor (mechanical, electrical, optical) was assessed.
7. The Type of Ground Truth Used
The ground truth for the bench testing would have been established by engineering specifications, calibration standards, and validated test equipment. For example, for "oximeter compatibility," the ground truth would be successful communication and accurate readings provided by the oximeter when connected to the Stat-Shell sensor, verified against known references or the predicate device's expected performance. For biocompatibility, EMC, and safety, the "ground truth" is adherence to established industry and regulatory standards.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Stat-Shell Disposable SpO2 Sensor is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. The Stat-Shell Disposable SpO2 Sensor is not an AI/ML device that requires a training set.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be "K992092". The characters are written in black ink on a white background. The bottom of the image has a thick black line.
Image /page/0/Picture/2 description: The image shows three black lines that are angled upwards from left to right. The lines are not straight, but rather have a wave-like pattern. The lines are thick and solid, and there is white space between them.
Epic Medical Equipment Services
1800 10TH STREET, SUITE 300, PLANO, TEXAS 75074
DEC 22 1999
510(k) Summary
Submitter Information:
Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074
Providina Solutions Throp
Contact:
Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: (972) 801-9854 Fax: (972) 801-9859
Date Prepared:
June 18, 1999
Product Name:
Common Name: SpO2 Sensor (accessory to pulse oximeter) Trade Name(s): Stat-Shell Disposable SpO2 Sensor
Predicate Device:
This product is a modification to the Epic 100 Series SpO2 sensor marketed under 510(k) # K970098.
Description:
The Stat-Shell SpO2 Disposable Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector.
The photodiode is housed in a textured, rigid shell that is contoured for patient digit placement. The LED's are housed in a foam tape that is positioned over the nail bed and wrapped around the patient's digit.
The sensor cable is 2 feet in length and is terminated in a DB-9 style connector. An adapter cable extends the length and converts the connector to a Hypertronics style.
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Intended Use:
The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.
Comparison to Predicate Device:
The Stat-Shell SpO2 Disposable Sensor uses the same theory and principle of operation as the predicate device. The Stat-Shell SpO2 Disposable Sensor differs from the predicate device in essentially three ways:
-
- it uses a different method of attachment to the patient (foam tape vs. clip/finger pad);
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- it is intended for limited, single patient reuse (predicate device is multi-patient durable reusable);
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- it uses a smaller photodiode (1.7mm2 vs. 8.23mm2)
The LED specifications, as well as the electrical/optical specifications of the photodiode, are identical to the predicate device.
Performance Data & Conclusions:
Changes to the predicate device do not affect those aspects of the device related to accuracy. Changes to the photodiode's mechanical size affects the device's ability to be recognized by the compatible oximeter. Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode.
Other bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility, EMC, safety, and pulse oximeter standards.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1999
Ms. Krista Oakes Epic Medical Equipment Services, Inc. 1800 10th Street, Suite 300 Plano, TX 75074
Re: K992092 Stat-Shell Disposable Spo2 Sensor, Model E502-02 Regulatory Class: II (two) Product Code: 74 DQA Dated: October 1, 1999 Received: October 4, 1999
Dear Ms. Oakes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Krista Oakes
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Jeanne A Westerhener for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX B
Page 1 of 1
Statement of Indications For Use
K992092 510(k) # Device Name: Stat-Shell Disposable SpO2 Sensor
Indications for Use:
The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
L. A. Weitershan
n Sign-Off) (Division Sign-Oir)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
§ 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).