(102 days)
Not Found
No
The device is described as a cable that transmits electrical signals from pressure transducers to a monitor. There is no mention of any processing or analysis of this data using AI or ML techniques. The description focuses solely on the physical connection and signal transmission.
No.
The device is described as an adapter cable designed to transmit electrical signals from pressure transducers to a monitor/defibrillator for diagnostic evaluation, not for treating a condition.
Yes
The 'Intended Use / Indications for Use' section states that the device is intended to "aid in diagnostic evaluation by a health care professional."
No
The device is described as a physical electrical cord (trunk cable) with connectors, designed to transmit electrical signals. This description clearly indicates it is a hardware component, not software.
Based on the provided information, the LIFEPAK Invasive Pressure Adapter Cable is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to connect invasive pressure transducers from the patient to a monitor/defibrillator for invasive pressure monitoring and to aid in diagnostic evaluation. This involves measuring a physiological parameter directly from the patient's body (invasive pressure), not analyzing samples taken from the body (in vitro).
- Device Description: The device is described as an electrical cord that transmits an electrical signal from transducers connected to the patient. It facilitates the conversion of fluid pressure from the patient into an electrical signal. This is a direct physiological measurement, not an analysis of a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the device is a cable that enables the measurement of a physiological parameter (invasive pressure) directly from a patient. This falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator. Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator. The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules. The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional / outdoor and indoor emergency care settings.
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)
Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications. Comprehensive testing included the following:
- Biocompatibility Evaluation
- Design Verification Testing
No human or animal clinical studies were submitted as part of this 510(k) Premarket Notification.
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
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 30, 2024
Physio-Control, Inc. Elisha McGaff Staff Regulatory Affairs Specialist 11811 Willows Road NE Redmond, Washington 98052
Re: K240156
Trade/Device Name: LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: January 19, 2024 Received: January 19, 2024
Dear Elisha McGaff:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology,
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021);
LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
Indications for Use (Describe)
The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.
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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4
510(K) SUMMARY
Submitter:
Physio-Control, Inc. 11811 Willows Road Northeast Redmond, Washington 98073-9706 Registration Number: 3015876, 3006703820
Contact:
Elisha McGaff Senior Staff Regulatory Affairs Specialist 425-605-3483 (office) Elisha.McGaff@stryker.com
Date of Preparation: January 19, 2024
Device Trade/Proprietary Name: LIFEPAK® Invasive Pressure Adapter Cable
Device Common Name: Invasive Pressure (IP) Cable
Device Classification:
| Device Classification and CFR Reference | Classification Panel | Product Code |
|---|---|---|
| Patient transducer and electrode cable | ||
| (21 CFR 870.2900) | Cardiovascular Devices | DSA |
Predicate Device(s):
The features and functions of the proposed LIFEPAK Invasive Pressure Adapter Cable accessory are equivalent to the following previously cleared device(s):
| Predicate Device | 510(k) Number(s) / Clearance Date |
|---|---|
| JKH USA, LLC Patient Monitoring Cables | K203635 / |
| Cleared on 02/05/2021 |
LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)
Stryker Emergency Care
11811 Willows Road NE, Redmond, WA 98052
Page 1 of 4
5
Device Description:
The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator.
Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator.
The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules.
The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.
Indications for Use:
The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or to aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.
Summary of Technological Characteristics:
The intended use, features, and functional characteristics of the proposed LIFEPAK Invasive Pressure Adapter Cable are equivalent to the predicate device. A minor difference related to limiting the connection to one type (i.e., patient IP transducers to the monitoring device) was noted. Overall, this difference does not alter the effect or raise new issues for the safety and effectiveness of the invasive pressure adapter cable as compared to the predicate.
LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)
11811 Willows Road NE, Redmond, WA 98052 | P +1 425 867 4000 | stryker.com
6
The proposed changes have not raised any new issues of safety and effectiveness when compared to the existing predicate device.
| Characteristic | Predicate Device:
Patient Monitoring Cables
K203635 | Subject Device:
LIFEPAK Invasive Pressure
Adapter Cable |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | JKH USA, LLC | Physio-Control Inc. |
| Trade Name | Patient Monitoring Cables | LIFEPAK Invasive Pressure
Adapter Cable |
| 510(k) Number | K203635 | K240156 |
| Device
Classification | II | II |
| Product Code | DSA | DSA |
| Regulation Number | 21 CFR 870.2900 | 21 CFR 870.2900 |
| Prescription/ Over-
the-Counter Use | Prescription | Prescription |
| Indications for Use/
Intended Use | The Patient Monitoring Cables
are intended to be used with
ECG, EKG, SpO2 and BP
monitoring devices. The Patient
Monitoring Cables are used to
connect electrodes, catheters,
and/or sensors placed at
appropriate site on the patient to
a monitoring device for general
monitoring and/or diagnostic
evaluation by health care
professional. | The LIFEPAK Invasive Pressure
Adapter Cable is intended to
connect invasive pressure
transducers from the patient to
the LIFEPAK monitor/defibrillator
for invasive pressure monitoring
purposes and/or to aid in
diagnostic evaluation by a health
care professional. The LIFEPAK
Invasive Pressure Adapter Cable
is intended for use in outdoor and
indoor emergency care settings. |
| Contraindications | None known | Same |
| Usage | Reusable | Same |
| Sterile | Non-sterile | Same |
| Design /
Appearance | Connectors on each cable end
and a shielded bulk cable | Same |
| Characteristic | Predicate Device:
Patient Monitoring Cables
K203635 | Subject Device:
LIFEPAK Invasive Pressure
Adapter Cable |
| Material | Shielded and unshielded Copper
with PVC or TPU jacket | Same |
| Cable Length | Various specified standard
lengths | 96 inches (2.44 meters) |
| Patient Connection | Electrodes, catheters, and/or
sensors placed at appropriate site
on the patient. | Invasive Pressure transducers
placed at appropriate site on the
patient. |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-1 |
| Electrical Safety and
Performance | IEC 60601-1
AAMI/ANSI EC53 | IEC 60601-1
IEC 60601-2
IEC 60601-2-34 |
LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)
Stryker Emergency Care
11811 Willows Road NE, Redmond, WA 98052
- P +1 425 867 4000 -stryker.com
Page 3 of 4
7
Performance Data:
Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications. Comprehensive testing included the following:
- Biocompatibility Evaluation ●
- . Design Verification Testing
No human or animal clinical studies were submitted as part of this 510(k) Premarket Notification.
Conclusion:
The information in this 510(k) notification demonstrates that the Physio-Control LIFEPAK Invasive Pressure Adapter Cable is substantially equivalent to the predicate JKH USA, LLC Patient Monitoring Cables with respect to safety, effectiveness, and performance.
LIFEPAK Invasive Pressure Adapter Cable Traditional 510(k)
Stryker Emergency Care
11811 Willows Road NE, Redmond, WA 98052
- | stryker.com
Page 4 of 4