(70 days)
Not Found
No
The device description and performance studies focus on the physical design, electrical safety, biocompatibility, and usability of internal defibrillation paddles, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device is used for defibrillation, which is a therapeutic intervention to treat cardiac arrhythmias by delivering an electrical shock to the heart.
No
Explanation: The device is a set of paddles used with defibrillators to deliver electrical shocks for defibrillation, which is a therapeutic treatment. It is not described as performing any diagnostic function.
No
The device is described as physical paddles with a shock button and undergoes hardware testing, biocompatibility testing, and sterilization validation, 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 "defibrillate the heart during open-chest surgical procedures." This is a direct therapeutic intervention on a living patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a device used to deliver an electrical shock to the heart, which is a treatment, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Switched Internal Paddles are in the treatment of ventricular fibrillation by manual defibrillation being provided directly to the heart during open-chest surgical procedures.
The Switched Internal Paddles are intended for use with HeartStart defibrillators to defibrillate the heart during open-chest surgical procedures.
The Switched Internal Paddles are indicated for use in the treatment of ventricular fibrillation by manual defibrillation being provided directly to the heart during open-chest surgical procedures.
Product codes
LDD
Device Description
The Switched Internal Paddles are used for defibrillation during open-chest (intrathoracic) procedures. These paddles have a shock button located on the right-hand paddle shown in Figure 5-1. This shock button allows the user to deliver a defibrillation shock holding the paddles to discharge the defibrillator remotely.
The reusable switched internal paddles are shipped non-sterilized by the health care provider prior to each patient use. These switched internal paddles are accessories to compatible Philips HeartStart Defibrillators as detailed in Table 5-1, and are identified by the M47xxA series model numbers (where "xx" is a variable integer), as listed below in Table 5-1. These paddles can be used on adult and pediatric populations per the indications for use of the compatible defibrillators.
The switched internal paddles are compatible with the HeartStart MRx and HeartStart XL+. The switched internal paddles are used with the HeartStart Defibrillators in Manual Mode only and cannot be used with the defibrillators in the AED Mode. The compatible defibrillators have a built-in maximum limit of 50 Joules when used with switched internal paddles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
adult and pediatric populations
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)
Bench testing was performed to re-verify system level device specifications including hardware testing, biocompatibility, cleaning and sterilization validation, and labeling verification testing. The test result confirmed that the Switched Internal Paddles meets the specifications and complies with the requirements of IEC 60601-1:2005/(R)2012+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-4:2010/AMD1:2018, Medical Electrical Equipment: Particular Requirements for Basic Safety and essential performance of cardiac defibrillators, and ISO 17665-1:2013, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
Biocompatibility: Switched Internal Paddles were re-tested for biocompatibility. Extra Large Switched Internal Paddles with the largest surface area (Model No. M4741A) were used to maximize patient contact region in biocompatibility tests to simulate a worstcase scenario. Test results confirmed that the Switched Internal Paddles met acceptance criteria for cytotoxicity, sensitization, irritation or intra-cutaneous reactivity, acute systemic toxicity, and material mediated pyrogenicity and are in compliance with the requirements of ISO 10993-1, Biological evaluation of medical devices.
Electrical Safety: Electrical safety testing was conducted for the proposed modifications made to Switched Internal Paddles. Test results confirmed that the subject device complies with the ES60601-1:2005/(R)2012+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-2-4:2010, Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators. Modifications made to the Switched Internal Paddles did not impact the electromagnetic compatibility of the device.
Performance Testing-Usability: Switched Internal Paddles were tested for usability per the narrowed instructions for cleaning and sterilization to ensure the subject device is as safe and effective as the predicate. This test was conducted with fifteen (15) participants (eleven (11) sterile processing technicians and four (4) surgical technicians in an operating room and a central processing/sterilization room in a hospital (intended use environment). The test results confirmed that the subject device is substantially equivalent when used per the modified instructions for use and complies with the requirements of ANSI AAMI HE75:2009/(R) 2018, Human Factors Engineering - Design of Medical Devices and Guidance for Industry and Food Drug Administration Staff-Applying Human Factors and Usability Engineering to Medical Devices (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 11, 2021
Philips North America LLC Neha Hardiya Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, Washington 98021
Re: K203231
Trade/Device Name: Switched Internal Paddles Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator (Including Paddles) Regulatory Class: Class II Product Code: LDD Dated: December 17, 2020 Received: December 18, 2020
Dear Neha Hardiya:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203231
Device Name Switched Internal Paddles
Indications for Use (Describe)
The Switched Internal Paddles are in the treatment of ventricular fibrillation by manual defibrillation being provided directly to the heart during open-chest surgical procedures.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
510(k) Summary
This 510(k) summary was prepared in accordance with the requirements of 21 CFR 807.92.
| I. | Contact Information |
|---|---|
| ---- | --------------------- |
| Submitter | |
|---|---|
| Name | Philips North America LLC (dba Philips Medical |
| Systems) | |
| Address | 22100 Bothell Everett Hwy |
| Bothell, WA 98021 | |
| Phone No. | 425-908-2569 |
| Fax No. | 425-402-8526 |
| Correspondent | |
| Name | Neha Hardiya |
| Phone No. | 425-908-2569 |
| neha.hardiya@philips.com | |
| Date Prepared | January 07, 2021 |
II. Device Information
| Trade Name | Switched Internal Paddles |
|---|---|
| Common Name | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Classification | Class II |
| 21 CFR 870.5300, DC-defibrillator (including paddles) | |
| Product Code | LDD |
III. Predicate Device Information
| Primary Predicate Name | HeartStream XL Defibrillator/Monitor |
|---|---|
| 510(k) Submission No. | K021453 |
| Classification | Class II (for LDD product code) |
| 21 CFR 870.5300, DC-defibrillator (including paddles) | |
| Product Code | LDD (Class II features); MKJ (Class III features 1) |
| Secondary Predicate Name | Sterilizable Internal Defibrillation Paddles for use with |
| LIFEPAK defibrillators/monitors | |
| 510(k) Submission No. | K182503 |
| Classification | Class II |
| 21 CFR 870.5300, DC-defibrillator (including paddles) | |
| Product Code | LDD |
1 There are no Class III features in this submission; the primary predicate referenced is only for the Switched Internal Paddles (LDD) that were included in the overall submission; this is the reason for multiple product codes in K021453.
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Prior Submissions
This is an original submission. There has been no prior submission for the subject device.
IV. Device Description
The Switched Internal Paddles are used for defibrillation during open-chest (intrathoracic) procedures. These paddles have a shock button located on the right-hand paddle shown in Figure 5-1. This shock button allows the user to deliver a defibrillation shock holding the paddles to discharge the defibrillator remotely.
Figure 5-1. Shock Button on Switched Internal Paddles
Image /page/4/Figure/8 description: The image shows a medical device with two paddles and a cable. The paddles are connected to the cable via a gray handle with a red button labeled "Shock Button". The cable connects to a gray plug that can be inserted into a wall-mounted socket.
The reusable switched internal paddles are shipped non-sterilized by the health care provider prior to each patient use. These switched internal paddles are accessories to compatible Philips HeartStart Defibrillators as detailed in Table 5-1, and are identified by the M47xxA series model numbers (where "xx" is a variable integer), as listed below in Table 5-1. These paddles can be used on adult and pediatric populations per the indications for use of the compatible defibrillators.
| Model No. | Product Name | Compatible Devices |
|---|---|---|
| M4741A | Extra Large Switched Internal Paddles, 7.5 cm | HeartStart MRx and HeartStart XL+ |
| M4742A | Large Switched Internal Paddles, 6.0 cm | |
| M4743A | Medium Switched Internal Paddles, 4.5 cm | |
| M4744A | Small Switched Internal Paddles, 2.8 cm |
| Table 5-1. Switched Internal Paddles Model Numbers | |||
|---|---|---|---|
| -- | ---------------------------------------------------- | -- | -- |
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The switched internal paddles are compatible with the HeartStart MRx and HeartStart XL+. The switched internal paddles are used with the HeartStart Defibrillators in Manual Mode only and cannot be used with the defibrillators in the AED Mode. The compatible defibrillators have a built-in maximum limit of 50 Joules when used with switched internal paddles.
Reason for Change
This submission is to notify the FDA of our intent to market the Switched Internal Paddles with the modified Instructions for Use (IFU) that includes narrowed reprocessing instructions for switched internal paddles. The modified IFU includes the maximum number of allowable reprocessing cycles. A comprehensive list of updates made to the Switched Internal Paddles, including updates that did not specifically require submission of a premarket notification, is provided below in Table 5-2.
| Change | Description | ||
|---|---|---|---|
| Reprocessing | Instructions for reprocessing Switched Internal Paddles | ||
| Instructions | have been narrowed to include maximum number of | ||
| reprocessing cycles (100) and have narrowed the preferred | |||
| cleaning agent (quaternary ammonium based detergent) | |||
| and sterilization method (steam sterilization) per user | |||
| preference. These changes to the instructions have been | |||
| re-verified and re-validated; results are summarized in | |||
| Section 13. | |||
| Material Change | The resin is a non-patient contacting material used as an | ||
| assembly aid. Resin material used in the switched internal | |||
| paddles' handle at the switch termination has been | |||
| replaced to support the end of life resin material. | |||
| Engineering | Engineering specification for the switched internal paddles | ||
| Specification Update | has been made more detailed to include more | ||
| comprehensive requirements including clarification and | |||
| modification in accordance with the state-of-the-art | |||
| standards, since switched internal paddles were last | |||
| cleared in 2002. | |||
| Assembly Drawing | Assembly drawing has been made more detailed to | ||
| Update | include the related information from the engineering | ||
| specification, assembly aid material change, and minor | |||
| modifications for clarity. | |||
| Fastener Change | fastener used to secure the high voltage lead wires to the | ||
| base of the electrode has been changed to resolve potential | |||
| over-molding process issues. | |||
| Device labeling | Labeling for switched internal paddles has been updated to | ||
| updates | include in the correct legal manufacturer's address, | ||
| addition of UDI (Unique Device Identifier) Tag and UDI |
| Table 5-2. List of Changes Made to Switched Internal Paddles | |||||
|---|---|---|---|---|---|
| -------------------------------------------------------------- | -- | -- | -- | -- | -- |
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Special 510(k) Switched Internal Paddles
| Change | Description |
|---|---|
| attachment wire for assisting users in tracking the | |
| reprocessing cycles. | |
| Biocompatibility | |
| Testing | Biocompatibility testing was repeated for confirmatory |
| purposes to ensure any unanticipated material drift since | |
| the last product iteration, as described in Table 10-4 and | |
| Table 13-2 , to ensure that the switched internal paddles | |
| remain in compliance with the requirements of ISO | |
| 10993-1:2009, Biological evaluation of medical devices | |
| – Part 1: Evaluation and testing within a risk | |
| management process. |
While previous premarket submissions included Switched Internal Paddles, Switchless Internal Paddles, and External Paddles, this Special 510(k) submission only includes Switched Internal Paddles and therefore, the updated IFU only includes instructions for using and reprocessing Switched Internal Paddles.
V. Intended Use
Note that the intended use statement has been narrowed to include the specific compatible HeartStart Defibrillators, but the intended use for switched internal paddle remains functionally unchanged.
The Switched Internal Paddles are intended for use with HeartStart defibrillators to defibrillate the heart during open-chest surgical procedures.
Indications for Use:
The Switched Internal Paddles are indicated for use in the treatment of ventricular fibrillation by manual defibrillation being provided directly to the heart during open-chest surgical procedures.
VI. Comparison of Technological Characteristics with the Predicate Device
The intended use and technology used with the Switched Internal Paddles remains unchanged by the labeling modifications for reprocessing internal paddles. Table 5-3 below provides a summary of comparison between the Switched Internal Paddles that is the subject of this 510(k) and the primary predicate device Switched Internal Paddles included with HeartStart XL Defibrillator/Monitor cleared per K021453.
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| Similarities | |
|---|---|
| Intended User | No change. |
| Environmental Specification | No change. |
| Physical Dimensions | No change. |
| User Interface | No change to the physical device user interface. |
| Differences | |
| Intended use | The intended use statement has been narrowed to include the specific compatible HeartStart Defibrillators, but the intended use for switched internal paddle remains functionally unchanged. |
| Scope of Devices | Narrowed to only include Switched Internal Paddles (Switchless and External paddles removed). |
| Internal Paddle Checks | Continuity Check |
| In comparison with the primary predicate device, Converted the frequency of checks from 3 months (current labeling) to every 25 reprocessing cycles, to ensure checks are usage based and not only time based. | |
| Reprocessing Instructions | Narrowed to allow a maximum of 100 reprocessing cycles. |
| Material | Resin material used in the switched internal paddles' handle at the switch termination has been replaced with a similar resin to support the end of life resin material. The resin is a non-patient contacting material used as an assembly aid. |
| Cleaning Instructions | Narrowed to only quaternary ammonium detergent as the cleaning agent. To reduce ambiguity, recommendations on rinsing time, air drying, and performing a post-cleaning visual inspection as part of the cleaning process were added. |
| Sterilization Instructions | To reduce ambiguity, recommendations on dry time and updated exposure time for gravity steam were added. All sterilization options other than steam sterilization were removed. |
| Transport and Storage | To reduce ambiguity, recommendations added to the IFU. |
| Warning and Cautions | Cautions for paddle health checks and handling switched internal paddles during use added and also limited rewording for clarity. |
Table 5-3. Comparison of Technological Features with the Primary Predicate Device
VII. Performance Data
The following performance data were provided in support of substantial equivalence determination.
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Bench Testing
Bench testing was performed to re-verify system level device specifications including hardware testing, biocompatibility, cleaning and sterilization validation, and labeling verification testing. The test result confirmed that the Switched Internal Paddles meets the specifications and complies with the requirements of IEC 60601-1:2005/(R)2012+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-4:2010/AMD1:2018, Medical Electrical Equipment: Particular Requirements for Basic Safety and essential performance of cardiac defibrillators, and ISO 17665-1:2013, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
Biocompatibilitv
Switched Internal Paddles were re-tested for biocompatibility, as these paddles are used for defibrillation during open-chest procedures. In accordance with Guidance for Industry and FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2020), the classification of the switched internal paddles is 'Contact Duration' - A limited (