(145 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a foam pad, with no mention of AI or ML.
No.
The device's intended use is to insulate the heart, which is a supportive function during surgery, not a direct therapeutic intervention to treat a disease or condition. While it aids in a medical procedure, it doesn't have a therapeutic effect itself.
No
Justification: The device's intended use is to insulate the heart during surgery, not to diagnose any condition. Its description as a "foam pad" further supports its non-diagnostic nature.
No
The device description clearly states it is a physical object made of foam and silicone, not software.
Based on the provided information, the CHASE Phrenic Nerve Pad is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "insulate the heart from the warmer organs and tissues of the body during open-heart surgery." This is a physical function performed in vivo (within the living body) during a surgical procedure.
- Device Description: The device is a physical pad made of foam and silicone. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes.
- Lack of Diagnostic Information: The device's function is purely mechanical/insulative. It does not provide any diagnostic information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The CHASE Phrenic Nerve Pad does not fit this description.
N/A
Intended Use / Indications for Use
The CHASE Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.
Product codes (comma separated list FDA assigned to the subject device)
74 DWF
Device Description
The CHASE Phrenic Nerve Pad consists of a heart shaped, 1/8 inch, closed cell piece of foam with an 18 inch silicone tail.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial Equivalence: This device is substantially equivalent to the Medtronic/DLP Phrenic Nerve Pad (K890707).
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 Phrenic Nerve Pad are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
Package Integrity: Tyvek/Polymylar passed burst test per ASTM F 1 40-88
Shipping & Distribution Testing: Per National Safe Transit Ass. vibration and drop tests
Accelerated Aging: Two year shelf life
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.
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
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
AUG | 2 |997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE PHRENIC NERVE PAD
| I. | General Information | |
|---|---|---|
| A. | Generic Name: | Phrenic Nerve Pad |
| B. | Trade Name of Device: | CHASE Phrenic Nerve Pad |
| C. | Applicant's Name and Address: | CHASE MEDICAL INC., Richardson, TX |
| D. | Pre-market Notification Number: | Not assigned |
II. Indication for Use:
The CHASE Phrenic Nerve Pad is indicated for use during open-heart surgery to insulate the heart from the warmer organs and tissues of the body.
III. Device Description
The CHASE Phrenic Nerve Pad consists of a heart shaped, 1/8 inch, closed cell piece of foam with an 18 inch silicone tail.
IV. Device Classification: Class I device
V. Safety and Effectiveness:
Substantial Equivalence: This device is substantially equivalent to the Medtronic/DLP Phrenic Nerve Pad (K890707).
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 Phrenic Nerve Pad are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
Tyvek/Polymylar passed burst test per ASTM F 1 40-88
Per National Safe Transit Ass. vibration and drop tests
Two year shelf life
2
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 stylized eagle with three stripes forming its wing and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Bert Davis President Chase Medical, Inc. 1876 Firman Drive Richardson, Texas 75081
AUG 1 2 1997
K971021 Re: Chase Phrenic Nerve Pad Regulatory Class: II (Two) Product Code: 74 DWF Dated: June 30, 1997 Received: June 30, 1997
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, 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, 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.
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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 requlation (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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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