(316 days)
No
The summary describes a mechanical infusion pump with a material change to the tubing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is strictly for the administration of fluids, blood, and packed red blood cells, and explicitly states it is "not intended to support the delivery of any pharmaceutical or other medications," which differentiates it from a typical therapeutic device that delivers medication.
No
Explanation: The Power Infuser is intended for the administration of fluids, blood, and packed red blood cells, not for diagnosing conditions.
No
The device description clearly outlines a physical, battery-operated infusion pump with cartridges containing tubing. The submission focuses on a material change to the tubing, indicating a hardware component.
Based on the provided text, the ZOLL Power Infuser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells". This describes a device used for delivering substances into the body, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details a "miniature battery-operated infusion pump designed for rapid intravenous fluid delivery". This further reinforces its function as a delivery system.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's condition
- Using reagents or calibrators
The device is an infusion pump, which is a therapeutic device used for administering fluids and blood products directly to a patient.
N/A
Intended Use / Indications for Use
The Power Infuser® is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical and EMT personnel in the field and in pre-hospital and hospital environments.
When used with the Crystalloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.
When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood.
The device is not intended to support the delivery of any pharmaceutical or other medications.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The ZOLL Power Infuser (reviewed and cleared with K090736) is a miniature battery-operated infusion pump designed for rapid intravenous fluid delivery in the field, in pre-hospital transport, or in the hospital. The device supports two types of Power Infuser Cartridges, both of which are sterile and intended for single use:
- · When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.
- · When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. whole blood and packed red blood cells.
The device, along with the cartridges, is not intended to support the delivery of any pharmaceutical or other medications.
Power infuser works on the principle of the shuttle pump mechanism wherein the tubing in the cartridges is squeezed (but not fully occluded) to allow the free flow of the fluid in the forward direction.
As a part of the current application we are proposing a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing (S-40-HL Manufactured by Saint Gobain) has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing (ND 100-40, manufactured by Saint Gobain).
The proposed material change is restricted to the Crystalloid/Colloid Cartridge and Blood Cartridge only. No changes has been made to the Power Infuser Pump as a result of the proposed change. The indications for use of the device, as described in the current application, has not changed as a result of the proposed modification.
No new accessories have been added, as part of the current submission, due to the proposed change. All the accessories offered with the ZOLL Power Infuser have been reviewed and cleared with the K090736.
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 and EMT personnel in the field and in pre-hospital and hospital environments.
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)
The proposed Power Infuser is identical to the currently marketed Power Infuser M100B3-A (K090736) except that there is a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing. The intended use of the proposed Power Infuser device as described in the Indications for Use and labeling has not changed as a result of this submission.
Given the nature of the change, the validation testing in form of the Functional Test and Biocompatibility test was performed. The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-24. Additionally, to evaluate the proposed material change, the device was further tested for accurate functioning of the air alarms, occlusion alarms and flow rate settings. Biocompatibility testing is performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Following bio-compatibility tests were performed to evaluate the new Tygon tubing:
- ISO 10993-5 Test for In Vitro Cytotoxicity -
- ISO 10993-10 Test for Irritation and Skin Sensitization
- ASTM F 756-13 In Vitro Hemolytic Properties of Materials -
- ISO 10993-11 Test for Acute Systemic Toxicity and Pyrogenicity Test -
- ISO 10993-4 Selection of tests for interactions with blood (Complement Activation test, In-vitro Hemocompatibility test, and Partial Thromboplastin test)
The result of the Tygon Tubing Qualification and supplemental testing provide the evidence that the cartridges with the new tygon tubing meet the integrity and performance testing.
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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
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July 18, 2018
ZOLL Medical Corporation Pooja Dalvi Regulatory Affairs Specialist 269 & 271 Mill Road Chelmsford, Massachusetts 01824-4105
Re: K172653
Trade/Device Name: Power Infuser Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: June 4, 2018 Received: June 5, 2018
Dear Pooja Dalvi:
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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Alan M. Stevens -S Alan M. DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130 Stevens - S 0.9.2.2.42.192013.0.1.1.1-150 Date: 2018.07.18 11:17:09 -04'00' Tina Kiang, Ph.D. for Acting Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172653
Device Name Power Infuser
Indications for Use (Describe)
The Power Infuser® is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical and EMT personnel in the field and in pre-hospital and hospital environments.
When used with the Crystalloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.
When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood.
The device is not intended to support the delivery of any pharmaceutical or other medications.
| 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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3
Image /page/3/Picture/0 description: The image shows the word "ZOLL" in blue font. There is a circled R symbol to the right of the second L. The font is sans-serif and the letters are all capitalized. The background is white.
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.
978-421-9655 978-421-0025 Main Fax
510(k) Summary
Sponsor Information:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824
Contact Person: Pooja Dalvi Regulatory Affairs Specialist Phone: (978) 805-6293 Fax: (978) 421-0010 Email: pdalvi@zoll.com
Date of Summary: July 18, 2018
Device Name and Classification:
Device Name: Power Infuser
Common Name: Infusion Pump
Classification Name: Infusion Pump (21 CFR 880.5725)
Product Code: FRN
Predicate Device:
Power Infuser, Model M100B-3A (K090736)
Device Description:
The ZOLL Power Infuser (reviewed and cleared with K090736) is a miniature battery-operated infusion pump designed for rapid intravenous fluid delivery in the field, in pre-hospital transport,
4
or in the hospital. The device supports two types of Power Infuser Cartridges, both of which are sterile and intended for single use:
- · When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products.
- · When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. whole blood and packed red blood cells.
The device, along with the cartridges, is not intended to support the delivery of any pharmaceutical or other medications.
Power infuser works on the principle of the shuttle pump mechanism wherein the tubing in the cartridges is squeezed (but not fully occluded) to allow the free flow of the fluid in the forward direction.
As a part of the current application we are proposing a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing (S-40-HL Manufactured by Saint Gobain) has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing (ND 100-40, manufactured by Saint Gobain).
The proposed material change is restricted to the Crystalloid/Colloid Cartridge and Blood Cartridge only. No changes has been made to the Power Infuser Pump as a result of the proposed change. The indications for use of the device, as described in the current application, has not changed as a result of the proposed modification.
No new accessories have been added, as part of the current submission, due to the proposed change. All the accessories offered with the ZOLL Power Infuser have been reviewed and cleared with the K090736.
Indications for Use:
The Power Infuser® is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points.
The device is intended for use by medical, paramedical and EMT personnel in the field and in prehospital and hospital environments.
When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood products.
When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood.
The device is not intended to support the delivery of any pharmaceutical or other medications.
5
Comparison of Technological Characteristics:
From a technological standpoint, the proposed Power Infuser is substantially equivalent to the predicate device, Power Infuser M100B3-A (K090736). The devices have the same intended use, operating mechanism, and function.
The only minor difference between the proposed Power Infuser and the currently marketed Power Infuser M100B3-A (K090736) is the material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing (S-40-HL Manufactured by Saint Gobain) has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing (ND 100-40, manufactured by Saint Gobain).
Substantial Equivalence - Non-Clinical Evidence:
The proposed Power Infuser is identical to the currently marketed Power Infuser M100B3-A (K090736) except that there is a material change to the tubing used in the Crystalloid/Colloid Cartridge and Blood Cartridge. The cleared DEHP Tygon tubing has reached its end of life and we are proposing to replace it with the non-DEHP Tygon tubing. The intended use of the proposed Power Infuser device as described in the Indications for Use and labeling has not changed as a result of this submission.
Given the nature of the change, the validation testing in form of the Functional Test and Biocompatibility test was performed. The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-24. Additionally, to evaluate the proposed material change, the device was further tested for accurate functioning of the air alarms, occlusion alarms and flow rate settings. Biocompatibility testing is performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Following bio-compatibility tests were performed to evaluate the new Tygon tubing:
- ISO 10993-5 Test for In Vitro Cytotoxicity -
- -ISO 10993-10 Test for Irritation and Skin Sensitization
- ASTM F 756-13 In Vitro Hemolytic Properties of Materials -
- ISO 10993-11 Test for Acute Systemic Toxicity and Pyrogenicity Test -
- -ISO 10993-4 Selection of tests for interactions with blood (Complement Activation test, In-vitro Hemocompatibility test, and Partial Thromboplastin test)
The result of the Tygon Tubing Qualification and supplemental testing provide the evidence that the cartridges with the new tygon tubing meet the integrity and performance testing.
Substantial Equivalence -Clinical Evidence:
Clinical evidence was not necessary to show substantial equivalence.
6
Conclusion:
The information provided in this 510(k) demonstrates that the proposed Power Infuser is substantially equivalent to the predicate device, Power Infuser, Model M100B-3A cleared under K090736.