(88 days)
CodeMaster XL+ Defibrillator/Monitor, Philips Medical Systems (formally HP) with the following internal paddle model numbers: M1742A, M1743A, M1744A, M1785A, M1786A, M1787A
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No
The summary describes a physical medical device (defibrillation paddles) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or any data sets typically associated with AI/ML development or validation.
Yes
The device is used for manual defibrillation during an intra-thoracic procedure, which is a therapeutic intervention to treat cardiac arrhythmias.
No
The device is described as "defibrillation paddles" used for "manual defibrillation" during a procedure, which is a treatment not a diagnostic function.
No
The device description explicitly states it is a physical device ("Disposable Sterile Internal Defibrillation Paddles") and describes physical characteristics (sizes, switched/switch-less versions).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for manual defibrillation during an intra-thoracic procedure. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical paddle used to deliver an electrical shock. It is not designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components of IVD devices.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to provide information about a person's health status. This device is a therapeutic tool used during surgery.
N/A
Intended Use / Indications for Use
The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
LDD
Device Description
The Disposable Sterile Internal Defibrillation Paddles are used primarily by physicians in the operating room during intra-thoracic surgical procedures. These paddles are available in both switched and switch-less versions where both versions are available in three different sizes. The paddles are packaged sterile and are single-use only. These paddles will be used in the manner and application as is currently available.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
intra-thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians in the operating room
Description of the training set, sample size, data source, and annotation protocol
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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)
Bench testing, demonstrating the performance of the Philips Disposable Sterile Internal Defibrillation Paddles to the current re-useable internal paddles. Based on the results of the testing described above, it is concluded that the Philips Disposable Sterile Internal Defibrillation Paddles perform in the same manner as the current internal defibrillation paddles. The Philips Disposable Sterile Internal Defibrillation Paddles application does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
CodeMaster XL+ Defibrillator/Monitor, Philips Medical Systems (formally HP) with the following internal paddle model numbers: M1742A, M1743A, M1744A, M1785A, M1786A, M1787A
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
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Figure/1 description: The image shows a document with the title "510(k) Summary" and the number "16." written on it. The number "K030417" is written in large font next to the title. The document appears to be a summary of some kind, possibly related to a medical device or product.
Date Summary Prepared
January 31, 2003
Submitter's Name and Address
Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Contact Person
Peter Ohanian Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099 Telephone: (978) 659-3397 Facsimile: (978) 659-7360
Device Name
| Proprietary Name: | Disposable Sterile Internal Defibrillation Paddles |
|---|---|
| Common Name: | Internal Defibrillation Paddles |
| Classification Names: | Low-Energy Internal Defibrillator Paddles |
Predicate Devices
The legally marketed devices to which Philips Medical Systems claims equivalence for the Disposable Sterile Internal Defibrillation Paddles are as follows:
- CodeMaster XL+ Defibrillator/Monitor, Philips Medical Systems (formally HP) with ● the following internal paddle model numbers:
-
- M1742A
-
- M1743A
-
- M1744A
-
- M1785A
-
- M1786A
-
- M1787A
-
The design of the proposed Disposable Sterile Internal Defibrillation Paddles is substantially equivalent in safety and performance to the device listed above.
Device Description
1
The Disposable Sterile Internal Defibrillation Paddles are used primarily by physicians in the operating room during intra-thoracic surgical procedures. These paddles are available in both switched and switch-less versions where both versions are available in three different sizes. The paddles are packaged sterile and are single-use only. These paddles will be used in the manner and application as is currently available.
Intended Use
The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.
Comparison of Technology Characteristics
The Philips Disposable Sterile Internal Defibrillation Paddles are used for internal defibrillation in the same manner as the internal paddles currently used with the CodeMaster Defibrillator/Monitors.
Nonclinical Tests Used in Determination of Substantial Equivalence
The testing performed to show substantial equivalence to the CodeMaster internal defibrillation paddles included:
- Bench testing, demonstrating the performance of the Philips Disposable Sterile . Internal Defibrillation Paddles to the current re-useable internal paddles.
Conclusion from Testing
Based on the results of the testing described above, it is concluded that the Philips Disposable Sterile Internal Defibrillation Paddles perform in the same manner as the current internal defibrillation paddles. The Philips Disposable Sterile Internal Defibrillation Paddles application does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
MAY - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Ohanian Director, Quality and Regulatory Affairs Philips Medical Systems 3000 Minuteman Road, M/S 0222 Andover, MA 01810-1099
Re: K030417
Trade/Device Name: Disposable Sterile Internal Defibrillation Paddles Regulation Number: 21 CFR 870.5300 Regulation Name: DC-defibrillator (including paddles). Regulatory Class: II Product Code: LDD Dated: February 3, 2003 Received: February 10, 2003
Dear Mr. Ohanian:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Peter Ohanian
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,
K. D. Zuker, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 2.
510(k) Number (if known): K030417
Device Name: Disposable Sterile Internal Defibrillation Paddles
Indications For Use: The Philips Disposable Sterile Internal Defibrillation Paddles are for use in manual defibrillation during an intra-thoracic procedure. The device is sterile and single-use only. It must be used by or on the order of a physician.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
DeaVTU
510(k) Numbe