(222 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional equivalence to a predicate device, with no mention of AI or ML.
No
The device is described as a "Temperature Probe" used to "monitor myocardial temperature" during surgery, indicating a diagnostic or monitoring function rather than a direct therapeutic intervention.
No
Explanation: The device is described as a "Temperature Probe" used to "monitor myocardial temperature" during "open-heart surgery." This indicates a monitoring function rather than diagnosing a disease or condition. While temperature measurement can be part of a diagnostic process, the device's explicit purpose is monitoring, not diagnosis.
No
The device description explicitly states it is a physical probe with a needle, cable, and connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor myocardial temperature during open-heart surgery." This involves measuring a physiological parameter directly within the body (in vivo).
- Device Description: The device is a probe designed to be inserted into tissue (a needle).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside the body (in vitro) to diagnose a condition or provide information about a physiological state.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This temperature probe is a direct measurement device used during a surgical procedure.
N/A
Intended Use / Indications for Use
The Temperature Probe is indicated for use during open-heart surgery to monitor myocardial temperature.
Product codes
DTN
Device Description
The Chase Temperature Probe consist of a 15mm stainless steel needle connected to 8 ft. of cable with a dual prong plug.
The Chase Temperature Probe consist of a 15mm, .032 O.D. stainless steel needle. The needle is attached to a cable support and eight feet of insulated twin lead cable. The rable ends in a dual prong connector plug.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
myocardial (heart)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
chase temperature probe
| I. | General Information | OCT 28 1997 |
|---|---|---|
| ---- | --------------------- | ------------- |
| A. Generic Name: | Temperature Probe |
|---|---|
| B. Trade Name of Device: | Chase Temperature Probe |
| C. Applicant's Name and Address: | CHASE MEDICAL INC., Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |
| II. | Indication for Use: |
|---|---|
| ----- | --------------------- |
The Temperature Probe is indicated for use during open-heart surgery to monitor myocardial temperature.
| III. | Device Description |
|---|---|
| ------ | -------------------- |
The Chase Temperature Probe consist of a 15mm stainless steel needle connected to 8 ft. of cable with a dual prong plug.
| IV. | Device Classification: | Class I device |
|---|---|---|
| ----- | ------------------------ | ---------------- |
| V. | Safety and Effectiveness: |
|---|---|
| ---- | --------------------------- |
Substantial Equivalence: This device is substantially equivalent to the Webster Labs Temperature Probe (K813271).
| VI. | Other Safety and Effectiveness Data: | |
|---|---|---|
| Materials: | All material are identical to the predicate device. | |
| Sterilization: | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ |
Functional Testing
All functional characteristics of the Chase Temperature Probe are non-differentiable as compared with the predicate because both devices have similar fit, form, and function.
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Package Integrity:
Tyvek/Polymylar passed burst test per ASTM F 1 40-88
Per National Safe Transit Ass. vibration and
Shipping & Distribution Testing:
Accelerated Aging:
: .. .. Two year shelf life
drop tests
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with the head and upper body represented by a series of curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bert Davis President Chase Medical Inc. 1876 Firman Drive Richardson, Texas 75081
OCT 2 8 1997
Re: K971013 Chase Temperature Probe Regulatory Class: II (Two) Product Code: DTN Dated: Auqust 25, 1997 August 25, 1997 Received:
Dear Mr. Davis:
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 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, qood 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 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 requlations.
3
Page 2 - Mr. Bert Davis
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/dsmamain.html."
Sincerely yours,
Thomas J. Callahan, Ph.D.
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Temperature trobe DIN II -
Page
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
CHASE MEDICAL, INC.
TEMPERATURE PROBE
Description:
Clinical:
During open-heart surgery, the patient's heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The pocess of stopping the heart is often achieved by infusing into the heart a solution containing various are propper which act to stop and preserve the heart. This solution is often cooled proof to infusion into the heart. The cooled solution lowers the temperature of the heart. The Chase Temperature Probe monitors the temperature of the heart.
Product:
The Chase Temperature Probe consist of a 15mm, .032 O.D. stainless steel needle. The needle is attached to a cable support and eight feet of insulated twin lead cable. The rable ends in a dual prong connector plug.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ben E. Lempereur
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971013
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)