(281 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a foam pad for insulation, with no mention of AI or ML technologies.
Yes
The device is described as addressing a medical condition (reducing myocardial re-warming and protecting the phrenic nerve during heart surgery) and providing a therapeutic benefit in clinical studies (preventing diaphragmatic paralysis).
No
The device is described as a "Cardiac Insulation Pad" used to prevent re-warming of the myocardium and protect the left phrenic nerve during heart surgery by isolating the heart from warmer tissues, not to diagnose a condition.
No
The device description clearly states it is a physical foam pad made of crosslinked, closed cell polyolefin foam, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cardiac Insulation Pad is a physical device used during surgery to insulate and protect the heart and a nerve from temperature changes. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a surgical application for temperature management and protection, not laboratory analysis of samples.
Therefore, the Cardiac Insulation Pad falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the myocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Cardiac Insulation Pad is a thin, pliable, foam pad which can be cut to conform to the shape of the heart. The pad covers the posterior cardiac wall or the mvocardium. When the surgeon is finished using the pad, it can be easily removed by pulling the PVC locator tape. The cardiac pad is available in two sizes; adult and infant.
The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium. In addition, it protects the left phrenic nerve from cold injury during local cooling of the heart.
Material: Crosslinked, closed cell polyolefin foam
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, Myocardium, Left Phrenic Nerve
Indicated Patient Age Range
Adult, Infant
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)
In a study conducted by Guinn GA et al in "Phrenic nerve injury during coronary artery bypass" (Texas Heart Institute Journal 1990;17:48-50), it was shown that the cardiac insulation pad prevented left-sided diaphragmatic paralysis in 52 of 58 patients. In a study conducted by Esposito RA, Spencer, FC, in "The effect of pericardial insulation on hypothermic phrenic nerve injury during open heart surgery" (Annals of Thoracic Surgery, 43:3; 1987;303-308), it was shown that a pericardial insulation pad prevented diaphragm paralysis in 83% of the patients. Thus it was concluded that the cardiac insulation pad protects the phrenic nerve from the cold during heart surgery where the heart is cooled.
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
510(k) Summary
- Company: DMC medical limited Unit 9 Distribution Centre Shannon Free Trade Zone Shannon, County Clare, Ireland
- Tradename: Cardiac Insulation Pad
- Classification: Class II
- Description: The Cardiac Insulation Pad is a thin, pliable, foam pad which can be cut to conform to the shape of the heart. The pad covers the posterior cardiac wall or the mvocardium. When the surgeon is finished using the pad, it can be easily removed by pulling the PVC locator tape. The cardiac pad is available in two sizes; adult and infant.
The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium. In addition, it protects the left phrenic nerve from cold injury during local cooling of the heart.
- Material: Crosslinked, closed cell polyolefin foam
- Indications: The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the mvocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.
- Performance Data: In a study conducted by Guinn GA et al in "Phrenic nerve injury during coronary artery bypass" (Texas Heart Institute Journal 1990;17:48-50), it was shown that the cardiac insulation pad prevented left-sided diaphragmatic paralysis in 52 of 58 patients. In a study conducted by Esposito RA, Spencer, FC, in "The effect of pericardial insulation on hypothermic phrenic nerve injury during open heart surgery" (Annals of Thoracic Surgery, 43:3; 1987;303-308), it was shown that a pericardial insulation pad prevented diaphragm paralysis in 83% of the patients. Thus it was concluded that the cardiac insulation pad protects the phrenic nerve from the cold during heart surgery where the heart is cooled.
- Substantial Equivalence: The device is substantially equivalent to the Cardiac Insulation Pad by Shiley, Inc. (currently Sorin Biomedica , Irvine, California), per K781990 cleared on 12/04/78.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2000
Ms. Charmaine Henderson Director of Regulatory Affairs DMC Medical Limited 511 Catalina Road Fullerton, CA 92835
K992932 Re: RJ232 -Pads Regulatory Class: II (two) Product Code: DWF March 31, 2000 Dated: Received: April 10, 2000
Dear Ms. Henderson:
We have reviewed your Section 510(k) notification of intent to market we have reviewed your babove and we have determined the devices are che devices rerorialent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrobare) of regaring to May 28, 1976, the enactment date of the Interstate commerce prior of to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordante aron. You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls co che general of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Please note: this response to your premarket notification Register. submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic
2
Page 2 - Charmaine Henderson
Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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,
sincerely yours,
Ruinn E. Haneym
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
3
INDICATIONS FOR USE ENCLOSURE
K992932 510k:
Cardiac Insulation Pad for Adults Device: Cardiac Insulation Pad for Infants
Indications for Use:
The cardiac insulation pad is indicated for use in patients undergoing heart The cardiac insulation pat is indication indesireble re-warming of the surgery where there is a need to reduce andoclination of the may of the local cooling of the heart.
Prescription use
Burim E. Haveymm
(Division Sign-Off)Over the Counter Use
Division of Cardiovascular, Respiratory,
vascular, Respiratory,
and Neurological Devices
510(k) Number
Division of Cardiov
Division Sign Off)
Hovascular, Respirato
and Neurological Devices
DERA
6/7/00