(80 days)
Not Found
No
The document describes a standard syringe pump with features related to pressure monitoring and delivery control, but there is no mention of AI or ML technology.
Yes.
The device is intended for the delivery of fluids, medications, blood, and blood products, which categorizes it as a therapeutic device designed to administer treatments or substances for medical purposes.
No
The device is a syringe pump used for the delivery of fluids, medications, blood, and blood products. Its función is to administer substances, not to diagnose medical conditions.
No
The device description explicitly states it is a "Syringe Pump Module" and functions as part of a "Medication Safety System," indicating it is a hardware device designed for fluid delivery.
Based on the provided information, the MEDLEY™ Syringe Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the delivery of fluids, medications, blood, and blood products to patients through various routes of administration. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as a syringe pump that delivers fluids. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition
The MEDLEY™ Syringe Pump is a medical device used for administering substances to a patient, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MEDLEY" Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.
The MEDLEY" Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The MEDLEY Syringe Pump Module functions as part of the MEDLEY™ Medication Safety System. In combination with the MEDLEY™ Programming Module (PM), the Syringe Module will deliver fluids in a manner similar to current syringe pumps on the market. Up to four Syringe Modules may be connected to each PM.
The MEDLEY™ Syringe Pump uses standard, single-use, administration sets (with and without pressure disc) and syringes with luer-lock connectors, of type designed for use on syringe pumps. The MEDLEY™ Syringe Pump may be used with administration sets that contain a pressure disc. If the pressure disc is used, the following features are available:
- Back-off .
- . Fast Start
- Customizable Pressure Alarm Settings ●
- Pressure Tracking Display ●
- Auto Pressure .
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
adults, pediatrics and neonates
Intended User / Care Setting
professional healthcare environment for facilities that utilize syringe pumps
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 DATA - The performance data indicate that the MEDLEY™ System Syringe Pump meets specified requirements, and is substantially equivalent to the predicate devices.
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
K023264 SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® MEDLEY™ Syringe Pump Module
SUBMITTER INFORMATION
| A. | Company Name: | ALARIS Medical Systems, Inc. | |||
|---|---|---|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle | |||
| San Diego, CA 92121-2733 | |||||
| C. | Company Phone: | ||||
| Company Fax: | (858) 458-7563 | ||||
| (858) 458-6114 | |||||
| D. | Contact Person: | Renée L. Fluet | |||
| Principal Regulatory Affairs Specialist | |||||
| ALARIS Medical Systems, Inc. | |||||
| E. | Date Summary Prepared: | September 27, 2002 | |||
| DEVICE IDENTIFICATION | |||||
| A. | Generic Device Name: | Syringe Infusion Pump | |||
| B. | Trade/Proprietary Name: | MEDLEY™ Syringe Pump Module | |||
| C. | Classification: | Class II |
- Product Code: FRN, Infusion Pump D.
DEVICE DESCRIPTION
The MEDLEY Syringe Pump Module functions as part of the MEDLEY™ Medication Safety System. In combination with the MEDLEY™ Programming Module (PM), the Syringe Module will deliver fluids in a manner similar to current syringe pumps on the market. Up to four Syringe Modules may be connected to each PM.
1
SUMMARY OF SAFETY AND EFFECTIVENESS Page 2
DEVICE DESCRIPTION (Continued)
The MEDLEY™ Syringe Pump uses standard, single-use, administration sets (with and without pressure disc) and syringes with luer-lock connectors, of type designed for use on syringe pumps. The MEDLEY™ Syringe Pump may be used with administration sets that contain a pressure disc. If the pressure disc is used, the following features are available:
- Back-off .
- . Fast Start
- Customizable Pressure Alarm Settings ●
- Pressure Tracking Display ●
- Auto Pressure .
SUBSTANTIAL EQUIVALENCE
The ALARIS Medical Systems® MEDLEY™ Syringe Pump is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date
Cleared |
|---------------------------------------------------------|---------------------------------|------------|-----------------|
| Model P7000 Variable Syringe
Pump | ALARIS Medical
Systems, Inc. | K974332 | 12/29/98 |
| Medex 3000 Series Syringe
Infusion Pump, Model 3010a | Medex. Inc. | K982640 | 4/6/99 |
INTENDED USE
The MEDLEY" Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.
The MEDLEY" Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration
2
SUMMARY OF SAFETY AND EFFECTIVENESS Page 3
INTENDED USE (Continued)
such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the MEDLEY™ Syringe Pump and the predicate devices has been performed. The results of this comparison demonstrate that the MEDLEY™ Syringe Pump is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA - The performance data indicate that the MEDLEY™ System Syringe Pump meets specified requirements, and is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Renée L. Fluet Principal Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733
Re: K023264
Trade/Device Name: MEDLEY™ Syringe Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 27, 2002 Received: September 30, 2002
Dear Ms. Fluet:
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 such 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.
4
Page 2 - Ms. Fluet
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if appliedble, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runser
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ALARIS MEDICAL SYSTEMS*, INC.
.
INDICATIONS FOR USE
510(k) Number:
| K 023264 | (To Be Assigned By FDA) |
|---|---|
| ---------- | ------------------------- |
Device Trade Name:
MEDLEY™ Syringe Pump
Indications For Use: The MEDLEY™ Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.
The MEDLEY™ Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Tittina Cucurita
Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Confidential
510(k) Number. _K023264