(281 days)
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.
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
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.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Prevention of Left-Sided Diaphragmatic Paralysis (Phrenic Nerve Protection) | Guinn GA et al. study (1990): The cardiac insulation pad "prevented left-sided diaphragmatic paralysis in 52 of 58 patients" (89.7%). Esposito RA, Spencer, FC study (1987): A pericardial insulation pad "prevented diaphragm paralysis in 83% of the patients." Conclusion: "Thus it was concluded that the cardiac insulation pad protects the phrenic nerve from the cold during heart surgery where the heart is cooled." |
| Reduction of Undesirable Myocardial Re-warming | The predicate device description (Cardiac Insulation Pad by Shiley, Inc.) also cites this indication. The submitted device states: "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." No explicit separate performance metric is provided for this aspect in the 510(k) summary, but its effect is generally implied through the mechanism of insulation. The clinical studies focus on the phrenic nerve, but the overall function of insulation would inherently contribute to reduced re-warming. |
2. Sample Size Used for the Test Set and the Data Provenance
- Guinn GA et al. study: 58 patients. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the 510(k) summary. Given the journal (Texas Heart Institute Journal), it is likely to be US-based, and clinical studies of this nature are typically prospective, but this is an assumption.
- Esposito RA, Spencer, FC study: The number of patients is not explicitly stated in the provided abstract, only "83% of patients." The journal (Annals of Thoracic Surgery) suggests it is a clinical study, likely prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. These were clinical studies (likely medical professionals, surgeons, or cardiologists), but the specific number of experts or their qualifications for establishing the outcome (diaphragmatic paralysis) are not detailed.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary. For clinical outcomes like diaphragmatic paralysis, the assessment would typically be made clinically by the treating physicians, but no specific adjudication method (e.g., 2+1, 3+1 consensus) is described.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a physical medical device (an insulation pad), not an AI/software device that would involve human readers interpreting images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an AI/software device. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was clinical outcomes data, specifically whether left-sided diaphragmatic paralysis occurred or was prevented, as determined by medical professionals in the context of a clinical study.
8. The sample size for the training set
This is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set. The studies cited are clinical performance studies, not dataset training.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.
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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.
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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
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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
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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
§ 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).