(62 days)
No
The document describes a standard infusion pump with no mention of AI/ML capabilities, image processing, or data sets for training/testing. The submission focuses on a change to the intended use statement of a previously cleared device.
No.
The device is an infusion pump designed to administer fluids, blood, and packed red blood cells, which are supportive care but not therapeutic interventions in themselves. The text explicitly states it is "not intended to support the delivery of any pharmaceutical or other medications," which are typically considered therapeutic.
No
The device is described as an "infusion pump designed to deliver IV fluids and blood products," which is a therapeutic function, not a diagnostic one. It administers substances rather than analyzing or identifying medical conditions.
No
The device description explicitly states it is a "miniature battery-operated infusion pump," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Power Infuser Model M100B-3A is an infusion pump designed to administer fluids (IV fluids, blood, packed red blood cells) into the patient's body. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states the device is for "continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells". This describes a treatment or support function, not a diagnostic test.
- Device Description: The description reinforces that it's a "miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients".
The device's purpose is to deliver substances to the patient, not to analyze samples from the patient. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Power Infuser® Model M100B-3A 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 pre-hospital 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 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
FRN
Device Description
The Power Infuser model M100B-3A, reviewed and cleared under (K030739) is a miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients in the field, in pre-hospital transport, or in the hospital. When used with the Crystalloid/Colloid Cartridge, the device infuses crystalloid and colloid IV fluids, the most common initial therapy used to restore a patient's blood pressure and intravascular volume in both pre-hospital and hospital settings. When the device is used with the Blood Cartridge, it is intended to deliver crystalloid and colloid resuscitative fluids as well as whole blood and packed red blood cells. The device is not intended to support the delivery of any pharmaceutical or other medications.
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, paramedical 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)
Since the design and functionality of the Power Infuser M100B-3A has not changed, performance testing was not conducted. This submission is focused on the change to the Intended Use Statement.
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
§ 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
K0907BL
Image /page/0/Picture/1 description: The image shows the logo for ZOLL Medical Corporation. The logo features the word "ZOLL" in large, bold, black letters. Below the company name is the tagline "Advancing Resuscitation. Today." in a smaller, italicized font. There is a curved line below the tagline.
MAY 20 2009
ZOLL Medical Corporation Worldwide Headguarters 269 Mill Road Chelmsford, MA 01824 U.S.A
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person: Eileen M. Boyle (978) 421-9171
| Date Summary Prepared: | March 10, 2009 |
|---|---|
| Device: | Power Infuser |
| Classification: | Infusion Pump: Class II (21 CFR 880.5725) |
| Reason for submission: | Change in the Intended Use |
Description:
The Power Infuser model M100B-3A, reviewed and cleared under (K030739) is a miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients in the field, in pre-hospital transport, or in the hospital. When used with the Crystalloid/Colloid Cartridge, the device infuses crystalloid and colloid IV fluids, the most common initial therapy used to restore a patient's blood pressure and intravascular volume in both pre-hospital and hospital settings. When the device is used with the Blood Cartridge, it is intended to deliver crystalloid and colloid resuscitative fluids as well as whole blood and packed red blood cells. The device is not intended to support the delivery of any pharmaceutical or other medications.
The current indication for use is to restore volume and blood pressure to patients experiencing clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock and septic shock. The indication is being expanded to administer fluids to any patient requiring continuous or intermittent delivery of IV fluids, whole blood, or packed red blood cells. The device is intended for use by medical, paramedical and EMT personnel in the field and in pre-hospital and hospital environments. The device is not intended to support the delivery of any pharmaceutical or other medications.
1
A previous 510(k) submissions demonstrated substancial equivalence to the David Clark Pressure Infuser for an I.V. bag (K820159 as required by 21 CFR Part 880.5420). The purpose of this submission is to more closely align the Intended Use of the Power Infuser to the predicate device as described below.
Intended Use:
The Power Infuser® Model M100B-3A 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 pre-hospital 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 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.
Substantial Equivalence:
The features and functions of the Power Infuser M100B-3A are substantially equivalent to the current features and functions of the Power Infuser.
Comparison of Technological Characteristics
The Power Infuser design characteristics have not been changed from the original design, which was reviewed and cleared by FDA as a result of this update.
Performance Testing:
Since the design and functionality of the Power Infuser M100B-3A has not changed, performance testing was not conducted. This submission is focused on the change to the Intended Use Statement.
Conclusion
Performance of the Power Infuser M100B-3A has not changed and remains substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness. No software or hardware changes have been implemented into the device since the predicate (K030739) as a result of this update.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in a bold, dark color.
Public Health Service
MAY 2 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Eileen M. Boyle Regulatory Affairs Specialist Zoll Medical Corporation 269 Mill Road Chelmsford, Massachusetts 01824
Re: K090736
Trade/Device Name: Power Infuser Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 10, 2009 Received: March 19, 2009
Dear Ms. Boyle:
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.
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.
3
Page 2- Ms. Boyle
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) régulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Susan Runner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 - Indications for Use
510(k) Number (if known): _ KO90 736
Device Name: Power Infuser
Intended Use:
The Power Infuser® Model M100B-3A 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 pre-hospital 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 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.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1090736 510(k) Number:
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)