MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
Device Facts
| Record ID | K972678 |
|---|---|
| Device Name | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS |
| Applicant | Mcgaw, Inc. |
| Product Code | FRN · General Hospital |
| Decision Date | Oct 7, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, nitroglycerin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, I.V. drugs such as paclitaxel and other chemotherapeutic agents, and epidural administration of anesthetic and analgesic drugs. The pump is capable of drawing fluid from containers or syringes and administering the fluid to a patient through the administration set. The Millennium CRT™ Infusion Pump Administration Sets can also be used as stand-alone devices without the Millennium CRT™ Infusion Pump. When used without the Millennium CRT™ Infusion Pump, the Millennium CRT™ Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, lipids, nitroglycerin, TPN, I.V. drugs including paciltaxel and other chemotherapeutic agents, and enteral fluids. The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRT™ Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician's order.
Device Story
Millennium CRT™ Infusion Pump is an electrical, external, linear peristaltic, volumetric infusion pump; uses dedicated administration sets with a free-flow clip. System inputs: parenteral/enteral fluids from containers or syringes. Operation: software-controlled linear peristaltic crushing action against tubing; detects downstream occlusions. Output: accurate, continuous fluid delivery. Used in hospitals, home care, and nursing homes by trained healthcare providers; data entry/validation performed per physician order. Benefits: provides controlled, accurate delivery of critical fluids and medications. Administration sets can function independently for gravity infusion.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including system and software hazard analysis, requirements, test plans, protocols, and test matrices.
Technological Characteristics
Linear peristaltic volumetric infusion pump; electrical power via AC or dual NiMH batteries. Components include air-in-line detector, free-flow receptacle, and downstream occlusion detection. Administration sets are sterile, single-use, featuring free-flow clips, various injection sites (needle/needle-free), filters, and check valves. Software-controlled operation.
Indications for Use
Indicated for parenteral and enteral fluid administration, including IV fluids, blood/components, TPN, lipids, chemotherapeutic agents, and epidural anesthetics/analgesics. Intended for use in hospital, home care, and nursing home settings by trained healthcare providers.
Regulatory Classification
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.
Predicate Devices
- Flo-Gard® 6201 Volumetric Infusion Pump (K915522)
- Flo-Gard® 6200 Volumetric Infusion Pump (K860162, K870801, K913895)
- Baxter solution administration sets (K924721, K921703)
- McGaw standard gravity and pump I.V. administration sets (K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212, K820133)
Submission Summary (Full Text)
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Oct. 7, 1997
P.O. Box 19791
#### 510(k) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in summary of Stories of SMDA 1990 and 21 CFR § 807.92."
"The assigned 510(k) number is: H972678
### 1. Submitter Information
McGaw, Inc. 2525 McGaw Avenue P.O. Box 19791 Irvine, California 92623-9791
Contact Person: John G. D'Angelo, M.S., R.Ph. Director Regulatory Affairs Phone: (714) 660-2517 FAX: (714) 660-3292
2. Name of Device
Trade/Proprietary Names: Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets Common/Usual Names: External Infusion Pump I.V. Administration Sets Blood Administration Sets Enteral Administration Sets Classification Names: Pump. Infusion Set. Administration, Intravascular Set, Blood Transfusion Set. Enteral Administration
#### 3. Predicate Device
The predicate pump device that McGaw is claiming substantial equivalence to is the Flo-Gard® 6201 Volumetric Infusion Pump marketed by Baxter Healthcare Corporation. The Flo-Gard@ 6201 Pump is an electrical, external, single channel, linear peristaltic, volumetric infusion pump. The predicate set devices that McGaw is claiming substantial equivalence to are standard Baxter solution administration sets intended for use with the Flo-Gard@ 6201 Pump. McGaw is also using our currently marketed 510(k) cleared standard gravity and pump I.V. administration sets as additional predicate set devices.
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**McGraw, Inc.**
· California 92623-9791 Fax: 714,660,2700 510fld Summary
## McGaw
The Flo-Gard® 6201 Volumetric Infusion Pump is marketed by Baxter under their cleared 510(k) K915522. The Flo-Gard® 6201 was introduced by Baxter as an upgrade to their Flo-Gard® 6200 Volumetric Infusion Pump. The following 510(k)s covered the Flo-Gard® 6200 pump: K860162, K870801 and K913895. The standard Baxter solution administration sets are marketed under many Baxter cleared 510(k)s, including K924721 and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133.
#### 4. Description of the Subject Device
The subject devices include an electrical, external, linear peristaltic, volumetric infusion pump called the Millennium CRT™ Infusion Pump and administration sets called the Millennium CRT™ Infusion Pump Administration Sets. The Millennium CRT™ Infusion Pump can only be used with the Millennium CRT™ Infusion Pump Administration Sets. The Millennium CRTM Infusion Pump Administration Sets do not contain a dedicated cassette. However, these sets do contain a free-flow clip that is a special slide clamp that interfaces with the pump. The Millennium CRTTM pump will not function as intended without the Millennium CRT™ sets. The Millennium CRT™ sets can be used either with the pump for pump infusion or without the pump for gravity infusion.
The system created by using the Millennium CRT™ Infusion Pump Administration Set with the Millennium CRT™ Infusion Pump is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The pump is software controlled and operates using linear peristaltic crushing action against a straight piece of plastic tubing threaded through the pump mechanism. The system detects occlusions in the patient line downstream.
The Millennium CRT™ Infusion Pump Administration Sets are sterile single use devices. The sets are composed of a straight piece of standard tubing, a free-flow clip and various combinations of other standard I.V. set components including filters, check valves, spikes, drip chambers, injection sites (standard needle injection sites and needle free injection sites such as the SafeLine® pre-slit septum injection site and the Clave® Connector luer activated injection site), clamps, measured volume burets, caps or protectors, and luer connectors. All of these standard set components are used in McGaw's currently marketed 510(k) cleared standard gravity and pump I.V. administration sets. The administration set components are welded or bonded and assembled using current McGaw manufacturing procedures to form the completed sets.
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McGraw, Inc.
P.O. Box 19791 a. California 92623-9791 one: 714 660 2000 x: 714,660,2700 510 (k) Summary
# Ac.Gaw
The Millennium CRT™ Infusion Pump Enteral Administration Set is a non-sterile single use device. This enteral administration set is composed of standard administration set components including a straight piece of standard tubing, a free-flow clip, luers, and a drip chamber. The enteral set also includes a pre-attached enteral fluid bag.
The infusion pump contains the following hardware subassemblies: linear peristaltic mechanism assembly, power supply assembly, pole clamp assembly, air-in-line detector assembly, free-flow receptacle assembly, display assembly, and electronics assembly. The linear peristaltic mechanism assembly contains additional subassemblies for downstream occlusion detection. The power supply assembly includes two identical NiMH (Nickel Metal Hydride) batteries. One battery is permanently mounted inside the pump: whereas, the other battery is optional and can be inserted or removed by the user as required to provide additional battery capacity.
#### 5. Intended Use of the Subject Device
The Millennium CRTM Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, nitroglycerin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, I.V. drugs such as paclitaxel and other chemotherapeutic agents, and epidural administration of anesthetic and analgesic drugs. The pump is capable of drawing fluid from containers or syringes and administering the fluid to a patient through the administration set.
The Millennium CRT™ Infusion Pump Administration Sets can also be used as stand-alone devices without the Millennium CRT™ Infusion Pump. When used without the Millennium CRT™ Infusion Pump, the Millennium CRT™ Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, lipids, nitroglycerin, TPN, I.V. drugs including paciltaxel and other chemotherapeutic agents, and enteral fluids.
The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRT™ Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and
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Mr.Gsw. Inc.
2525 McGaw Avenue P.O. Box 19791 vine. Californi a 92623-979 Telephone: 714,660.2000
> validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician's order.
### 6. Technological Characteristics of the Subject Device
The subject devices, the Millennium CRT™ Infusion Pump and the Millennium CRT™ Infusion Pump Administration Sets, are substantially equivalent to the predicate devices, Baxter's currently marketed Flo-Gard® 6201 Volumetric Infusion Pump, standard Baxter solution administration sets intended for use with the Flo-Gard® 6201 Pump, and McGaw's currently marketed 510(k) cleared standard gravity and pump I.V. administration sets. The subject and predicate devices are similar in design, material composition, components, manufacturing process, intended use and labeling. There are technological differences between the subject devices and the predicate devices. However, these differences do not raise new issues of safety and effectiveness. The substantial equivalence claim between the subject devices and the prodicate devices is supported by the information and data contained in this 510(k) submission. This includes the following items:
- Description of the subject devices and predicate devices.
- Intended use of the subject devices and predicate devices.
- Material composition of the subject devices and predicate devices.
- Labels and labeling for the subject dévices and predicate devices.
- Comparison tables of attributes and specifications for the subject devices and predicate devices.
- Subject device customer functional specification.
- Subject device system and software hazard analysis.
- Subject device system and software requirements.
- Subject device system and software test plans.
- Subject device system and software test protocols.
- Subject device system and software test matrix.
#### 7. Signature of Applicant:
McGaw. Inc. John D'Angelo, M.S., R.Ph. Director Regulatory Affairs
John S. Rogers
Signature
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Date
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Rebecca Stolarick Section Manager Regulatory Affairs McGaw, Incorporated 2525 McGaw Avenue Irvine, California 92714-5895
OCT - 7 1997
Re : K972678 Millennium CRT™ Infusion Pump and Trade Name: Millennium CRT™ Infusion Pump Administration Sets Regulatory Class: II Product Code: FRN Dated: July 14, 1997 Received: July 16, 1997
Dear Ms. Stolarick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the " device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices : General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. In Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Stolarick
obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device: " "" Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If vou desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general ....... information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours
Timoth y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Notification July 14, 1997
### Indications For Use Statement
#### 510(k) Number (if known):
#### Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Device Name: Pump Administration Sets
#### Indications For Use:
The Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard I.V. fluids (large volume parenterals and small volume parenterals). blood components, nitroglycorin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, I.V. drugs such as pacifiaxel and other chemotherapeutic agents, and epidural administration of anesthetic and analgesic drugs. The nump is capable of drawing fluid from containers or syringes and administering the fluid to a patient through the administration set.
The Millennium CRT™ Infusion Pump Administration Sets can also be used as standalone devices without the Millennium CRTM Infusion Pump. When used without the Millennium CRTM Infusion Pump, the Millennium CRTTM Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard I.V. fluids (large volume parenterals and small volume parenterals). blood, blood components, lipids, nitroglycerin, TPN. I.V. drugs including paciltaxel and other chemotherapeutic agents, and enteral fluids.
The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRTM Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician's order.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
| D | Danial, Infection Control, |
|---------------|-----------------------------------------------------------|
| F | Hospiaroumenge of CDRH, Office of Device Evaluation (ODE) |
| 510(k) number | K072678 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
| Over-The-Counter Use | 3 |
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