(438 days)
Not Found
Not Found
No
The device description focuses on hardware components and a defined calibration process using gas mixtures, with no mention of AI or ML algorithms for data analysis or decision-making.
No
Explanation: The device is described as a calibrator accessory for monitors, used to calibrate sensors and patient data modules. It does not directly treat or diagnose a medical condition.
No
The device is described as a calibrator for TrendCare Monitors and sensors. Its function is to perform a three-point calibration of sensors by bubbling gas mixtures to change partial pressure and pH, which are then used to define values for the sensors. It is an accessory used for calibration, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a microprocessor, LCD display, LEDs, keys, calibration chamber, and connections to gas cylinders. It is a physical device used for calibrating sensors.
Based on the provided text, the TrendCare Calibrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to calibrate sensors and patient data modules for use with TrendCare Monitors. This is a calibration function for a medical device, not a diagnostic test performed on biological samples.
- Device Description: The description details a device that uses gas mixtures to create defined partial pressures and pH values in a tonometer solution to calibrate sensors. It does not describe a device that analyzes biological specimens (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, detecting analytes in biological samples, or providing diagnostic information about a patient's health status based on such analysis.
The device is an accessory used to ensure the accuracy of a medical monitor, which in turn may be used for patient monitoring. However, the calibrator itself does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TrendCare Calibrator is an accessory for use with the TrendCare Monitors. Sensors and Patient Data Modules calibrated with the TrendCare Calibrator may be used with the TrendCare Satellite Monitor (TCM6000) or TrendCare Senior Monitor (TCM7000).
Product codes (comma separated list FDA assigned to the subject device)
73 CCC
Device Description
The TrendCare Calibrator is a microprocessor-based device powered from the mains (line) supply. The device incorporates:
- A LCD display for user prompts.
- A series of LEDs for system status indication.
- Keys for selecting and initiating calibration.
- Calibration chamber.
- Connections to calibration gas cylinders.
- Location fixtures for the multiparameter sensors.
The calibration chamber is located on the front of the Calibrator unit, and is opened by pressing the latch to release the door.
The sensor is calibrated by connecting it to the PDM patient cable, placing the tonometer in the calibration chamber, closing the door and securing the introducer, and pressing the START CAL key.
A three point calibration of the sensor is performed by bubbling three precision mixtures of oxygen, carbon dioxide and nitrogen in sequence through the tonometer solution surrounding the sensor. These gases change the partial pressure of oxygen and carbon dioxide and the pH in the tonometer to defined values.
The calibration gases are contained in cylinders located at the base of the Calibrator. The cylinders are identical to the predicate device. Each cylinder contains a different precision mixture of gases. These gases are automatically passed in sequence through the tonometer when the calibration sequence is initiated.
Each of the cylinders contains sufficient gas for multiple calibrations. The cylinders are disposable, and should be discarded when empty (see the Instructions on the cylinder labels).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1150 Indwelling blood carbon dioxide partial pressure (P
2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
0
Nov 23 1999
Image /page/0/Picture/3 description: The image shows a series of handwritten numbers and a letter. The alphanumeric sequence is K983198. The numbers are written in a dark ink and are slightly distorted.
510(k) Summary Section 10 :
This section satisfies the 510(k) summary as required by 21 CFR 807-92 ©.
Submitter
Miss Jan L Walters Diametrics Medical Limited Short Street High Wycombe Bucks HP112QH UK
+44 1494 471671 Tel: +44 1494 474890 Fax:
Date of Summary : August 1998
Device Name
| Proprietary | TrendCare Calibrator |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Company Comments of Children Comments of Children |
Common : Calibrator
Device Classification
| Panel | : | Anaesthesiology Devices Panel |
|---|---|---|
| Classification | : | Accessory to a Class III device, indwelling pCO2 partial pressure |
| sensor | ||
| FDA CFR | : | 868-1150 |
| Description | : | Calibrator |
| Classification No. | : | 75-JIS 73 CCC |
Statement of Substantial Equivalence
Diametrics Medical Ltd claims substantial equivalence to products which have received FDA clearance by the Premarket Notification process.
The TrendCare Calibrator is a duplication of the calibration function within the TrendCare Senior Monitor to provide a standalone calibration facility.
1
Device Description
The TrendCare Calibrator is a microprocessor-based device powered from the mains (line) supply. The device incorporates:
- A LCD display for user prompts. l
- 트 A series of LEDs for system status indication.
- 이 Kevs for selecting and initiating calibration.
- I Calibration chamber.
- Connections to callbration gas cylinders. ■
- Location fixtures for the multiparameter sensors. ■
The calibration chamber is located on the front of the Calibrator unit, and is opened by pressing the latch to release the door.
The sensor is calibrated by connecting it to the PDM patient cable, placing the tonometer in the calibration chamber, closing the door and securing the introducer, and pressing the START CAL key.
A three point calibration of the sensor is performed by bubbling three precision mixtures of oxygen, carbon dioxide and nitrogen in sequence through the tonometer solution surrounding the sensor. These gases change the partial pressure of oxygen and carbon dioxide and the pH in the tonometer to defined values.
The callbration gases are contained in cylinders located at the base of the Calibrator. The cylinders are identical to the predicate device. Each cylinder contains a different precision mixture of gases. These gases are automatically passed in sequence through the tonometer when the calibration sequence is initiated.
Each of the cylinders contains sufficient gas for multiple calibrations. The cylinders are disposable, and should be discarded when empty (see the Instructions on the cylinder labels).
Intended Use
The TrendCare Calibrator is an accessory for use with the TrendCare Monitors. Sensors and Patient Data Modules calibrated with the TrendCare Calibrator may be used with the TrendCare Satellite Monitor (TCM6000) or TrendCare Senior Monitor (TCM7000),
2
Technological Characteristics
- Mains powered l
- Microprocessor controlled 트
- 동 Digital display
Conclusion
The data presented above satisfies product accuracy claims and shows comparable results for both the TrendCare Calibrator and the TrendCare Senior Monitor.
The device under review is considered substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 2 3 1999
Miss Jan L. Walters Diametrics Medical Ltd. Short Street High Wycombe Bucks HP11 2QH United Kingdom
Re: K983198 TrendCare Calibrator Regulatory Class: III (three) Product Code: 73 CCC Dated: September 11, 1998 September 11, 1998 Received:
Dear Miss Walters:
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 leqally 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 reqistration, 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 regulations 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 Regulation (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 assumptions. Failure to comply with the GMP regulation may result in 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.
4
Page 2 - Miss. Jan L. Walters
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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page I of
K983198 510(k) Number (if Known):
CALIFFATOR Device Name: I RENIVARE
Indications For Use:
alibrator is an accesson 25 The Patien ensar alibrated With the I read Care as itta 770 I fend Care ನ 11endla
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
Prescription dise V 510(k) Number Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96).