(363 days)
Esophageal / Rectal temperature probe (4009-ER and 40012-ER):
The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum.
Esophageal Stethoscope with temperature sensor (4009-ES, 40012-ES, 40018-ES, and 40024-ES):
The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.
The Starboard Medical temperature probes are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The probes are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature probes or equivalent.
This 510(k) includes the following probes:
4009-ER (Esophageal / Rectal temperature probe - 9FR) 40012-ER (Esophageal / Rectal temperature probe - 12FR) 4009-ES (Esophageal Stethoscope with temperature sensor - 9FR) 40012-ES (Esophageal Stethoscope with temperature sensor - 12FR) 40018-ES (Esophageal Stethoscope with temperature sensor - 18FR) 40024-ES (Esophageal Stethoscope with temperature sensor - 24FR)
The probes are single use, and they are sterile.
This is a 510(k) summary for a set of disposable temperature probes/sensors, not an AI device. Therefore, the typical acceptance criteria and study mechanisms for AI-driven devices (like those involving test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies) are not applicable here.
The provided text describes a medical device clearance process for temperature probes, which relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific AI-related metrics.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the way an AI device would have accuracy or F1 scores. Instead, the "acceptance criteria" are based on the device's characteristics being "substantially equivalent" to predicate devices.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Substantial Equivalence to Predicate Devices | The devices are considered "as safe and effective as the predicate devices" based on material, technology, manufacturing processes, and performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a physical temperature probe, not a software algorithm that processes dataset inputs. Performance was assessed through engineering tests, not a clinical trial with a "test set" in the AI sense.
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)
This is not applicable. Ground truth, in the context of AI, refers to annotated data. For a temperature probe, performance is verified through metrological accuracy testing, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There was no "test set" in the AI sense that required adjudication.
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
This is not applicable. An MRMC study is relevant for AI assistance to human readers, which is not the nature of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a standalone physical medical device (temperature probe), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the AI sense. The performance of the temperature probes would be validated against calibrated temperature standards, which serves as the "ground truth" for temperature measurement accuracy.
8. The sample size for the training set
This is not applicable. There is no AI training set for this device.
9. How the ground truth for the training set was established
This is not applicable. There is no AI training set for this device.
Summary of Device Performance Testing from the Document:
The document mentions that the devices underwent:
- Raw materials bio-compatibility testing: To ensure the materials are safe for patient contact.
- Accuracy testing: To verify that the temperature measurements are accurate. This would involve comparing the probe's readings against a known, accurate temperature source (the "ground truth" for a physical sensor).
- Electrical testing and comparison: To ensure electrical safety and performance, often compared against established standards or predicate devices.
The conclusion is that these tests support the claim that the differences between the new devices and the predicate devices are minor, establishing substantial equivalence.
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ട്. 510(k) Summarv
Date prepared: March 2, 2011
This 510(k) is being submitted by Anthony Beran on behalf of Starboard Medical, LLC.
Contact:
Anthony Beran President Starboard Medical, LLC 22845-H Savi Ranch Parkway Yorba Linda, CA 92887 Tel: 714 283 3099 Fax: 714 283 3033 Email: aberan@cox.net FDA Establishment Registration #: 3006845683
Contract Manufacturer:
Starboard Medical Jiangsu Tel: 86-515-82306811 FDA Establishment Registration#: 3006845687
Trade Name:
The device trade name is Disposable Temperature probes/ sensors.
Device common, usual, or classification names:
Esophageal / Rectal temperature probe Esophageal Stethoscope with temperature sensor
Classification:
Class II, product code BZT Classification Panel: Anesthesiology, Reg# 21CFR 868.1920
Predicate Device:
The following devices have been identified as predicate devices: SMITHS LEVEL 1 Esophageal / Rectal temperature probe - K863646
SMITHS LEVEL 1 Esophageal Stethoscope with temperature sensor - K854212
Description of device:
The Starboard Medical temperature probes are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The probes are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature probes or equivalent.
This 510(k) includes the following probes:
4009-ER (Esophageal / Rectal temperature probe - 9FR) 40012-ER (Esophageal / Rectal temperature probe - 12FR) 4009-ES (Esophageal Stethoscope with temperature sensor - 9FR)
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40012-ES (Esophageal Stethoscope with temperature sensor - 12FR) 40018-ES (Esophageal Stethoscope with temperature sensor - 18FR) 40024-ES (Esophageal Stethoscope with temperature sensor - 24FR)
The probes are single use, and they are sterile.
Intended Use:
The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The sensor is designed for insertion into the esophaqus, nasopharynx, or rectum.
The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds.
Technology Characteristics:
Both devices are substantially equivalent to the predicate devices based on material, technology, manufacturing processes, and performance.
Performance Data:
Both devices have been subjected to raw materials bio-compatibility testing, accuracy testing, and electrical testing and comparison.
Conclusion:
We believe the differences between the Starboard Medical devices and the predicate devices are minor, and conclude that the subject devices are as safe and effective as the predicate devices.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Anthony Beran President Starboard Medical, LLC 22845 Savi Ranch Parkway, Suite H Yorda Linda, California 92887
APR 1 2 2012
Re: K111050
Trade/Device Name: Esophageal/ Rectal Temperature Probe, Catalog Numbers 4009-ER and 40012-ER. Esophageal Stethoscope with Temperature Sensor, Catalog
Numbers 4009-ES, 40012-ES, 40018-ES, and 40024-ES.
Regulation Number: 21 CFR 868.1920
Regulation Name: Esophageal stethoscope with electrical conductors
Regulatory Class: II
Product Code: BZT
Dated: March 30, 2012
Received: April 5, 2012
Dear Mr. Beran:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Eederal Register.
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Page 2- Mr. Beran
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Antony B. nratin
Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use Statement 4.
510(k) Number (if known): Unknown.
Device Name(s):
Esophageal / Rectal Temperature Probe, Catalog Numbers 4009-ER and 40012-ER. Esophageal Stethoscope with Temperature Sensor, Catalog Numbers 4009-ES, 40012-ES, 40018-ES, and 40024-ES.
Indications for Use:
Esophageal / Rectal temperature probe (4009-ER and 40012-ER):
The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum.
Esophageal Stethoscope with temperature sensor (4009-ES, 40012-ES, 40018-ES, and 40024-ES):
The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for oontinuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.
Prescription Use: XXXXX (Part 21CFR801 Subpart D) and/or
Over-the-Counter Use: (Part 21CFR801 Subpart C)
111050
Hild C. Chapman 4/12/12
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).