(241 days)
No
The device description details a purely mechanical system with a spring and flow restrictor to control infusion rate. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device delivers enteral fluids, which are supportive rather than therapeutic. Its function is to facilitate fluid delivery, not to treat or cure a disease.
No
This device is designed for the delivery of enteral fluids, functioning as an infusion system, rather than for diagnosing any condition.
No
The device description clearly outlines physical components including a mechanical syringe pump assembly, plastic housings, steel spring, tubing, clamps, and connectors. This indicates it is a hardware device with mechanical components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of enteral fluids through clinically accepted routes of administration." This describes a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a "Syringe Infusion System" consisting of a mechanical pump and administration set. Its function is to physically deliver fluids, not to analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the mechanical function of the device (fluid delivery time, residual volume) and human factors related to its use for enteral feeding. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
-
- The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
-
- The Medi-SIS Administration Extension Set is intended for single patient use only.
-
- The Medi-SIS Syringe Driver can be reused up to 5,000 times
Product codes (comma separated list FDA assigned to the subject device)
FRN, LZH
Device Description
The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.
The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.
The Medi-SIS Syringe Driver is reusable and provided non-sterile.
The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.
The following Administration Extension Sets will be available:
60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate
The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.
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
hospital NICU staff
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)
A human factors study was conducted to assess the clinical risks related to the Medi-SIS Syringe Infusion System for enteral feeding of neonatal patients by the hospital NICU staff. All identified risks have been identified and adequately miligated to ensure the system is safe for use.
The following non-clinical tests were performed to ensure the device is capable of meeting the predicate device's specifications when tested for the addition of enteral fluids to the intended use:
- . Enteral fluid delivery within the specified time
- . Maximum residual volume
Since the addition of enteral fluid delivery was the only difference between the proposed and the predicate device, the significant test to ensure equivalency was to test the delivery time of enteral fluids and to verify they met the predicate device's specifications. The testing concluded that the device met all of the specifications.
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.
Medi-SIS Syringe Infusion System (K953028, K954059, K972173)
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.
B. Braun Perfusor Space Infusion Syringe Pump System (K062699)
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
JAN 1 3 2012
Section 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of safety and effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Acacia, Inc. |
|---|---|
| APPLICANT ADDRESS | 785 Challenger Street |
| Brea, CA 92821 | |
| APPLICANT PHONE | (714) 257-0470 |
| CONTACT PERSON | Fergie Ferguson |
| PREPARATION DATE | 01/11/12 |
| TRADE NAME: | Medi-SIS Syringe Infusion System |
| COMMON NAME: | Infusion Pump |
| CLASSIFICATION NAME: | Infusion Pump |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE | FRN, LZH |
| PREDICATE DEVICES: | Medi-SIS Syringe Infusion System (K953028, K954059, K972173) |
| B. Braun Perfusor Space Infusion Syringe Pump System | |
| (K062699) |
Purpose
The purpose of this submission is to add the delivery of enteral fluids through clinically accepted routed of administration to the intended use. No changes to the design of the device or performance features were made.
Substantially Equivalent To:
The Acacia, Inc. Medi-SIS Syringe Infusion System is substantially equivalent in intended use. principle of operation and technological characteristics to the Medi-SIS Syringe Infusion System (K953028, K954059, K972173), and is substantially equivalent in intended use with the B. Braun Perfusor Space Infusion Syringe Pump System (K062699) for the delivery of enteral fluids.
Description of the Device Subject to Premarket Notification:
The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.
The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The
Page 1 of 3 Premarket Notification
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Section 5
Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.
The Medi-SIS Syringe Driver is reusable and provided non-sterile.
The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.
The following Administration Extension Sets will be available:
60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate
The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.
Indications for Use:
-
- The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
-
- The Medi-SIS Administration Extension Set is intended for single patient use only.
-
- The Medi-SIS Syringe Driver can be reused up to 5,000 times
Technical Characteristics:
Other than differences in connector sizes between the Medi-SIS Administration Sets for IV and Enteral applications (to ensure cross connections do not occur between IV and Enteral infusions), the Medi-SIS Syringe Infusion System is identical to the predicate device (the same Syringe Driver, tubing, and flow restrictor will be used), along with the same compatible syringes. There are no differences in design, material, chemical composition, or any other physical (other than connector sizes) and technical characteristics to the predicate device.
Performance Data:
A human factors study was conducted to assess the clinical risks related to the Medi-SIS Syringe Infusion System for enteral feeding of neonatal patients by the hospital NICU staff. All identified risks have been identified and adequately miligated to ensure the system is safe for use.
The following non-clinical tests were performed to ensure the device is capable of meeting the predicate device's specifications when tested for the addition of enteral fluids to the intended use:
Acacia, Inc. MEDI-SIS Syringe Infusion System
Page 2 of 3 Premarket Notification
2
Section 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- . Enteral fluid delivery within the specified time
- . Maximum residual volume
Since the addition of enteral fluid delivery was the only difference between the proposed and the predicate device, the significant test to ensure equivalency was to test the delivery time of enteral fluids and to verify they met the predicate device's specifications. The testing concluded that the device met all of the specifications.
Since the proposed and predicate devices are the same, it is concluded that the proposed device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.
Basis for Determination of Substantial Equivalence:
Since the only change to the predicate device was to add the delivery of enteral fluids through clinically accepted routes of administration to the intended use, and to differentiate the connectors between the IV and Enteral Medi-SIS Administration Sets, it was concluded that the differences do not affect the performance specifications of the predicate device and do not add new hazards that would pose a safety risk to the patient or clinician. Verification was performed to ensure that the testing with an equivalent enteral fluid standard met all of the predicate device specifications.
Upon reviewing the safety and efficacy information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Medi-SIS Syringe Infusion System is determined by Acacia, Inc., to be substantially equivalent to the existing legally marketed device.
Acacia, Inc. MEDI-SIS Syringe Infusion System
Page 3 of 3 Premarket Notification
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird-like figure, composed of three curved, parallel lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Fergie Ferguson Director of Operations Acacia. Incorporated 785 Challenger Street Brea. California 92821
JAN 1 3 2012
Re: K111381
Trade/Device Name: Medi-SIS Syringe Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZH Dated: January 6, 2012 Received: January 9, 2012
Dear Ms. Ferguson:
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.
4
Page 2 - Ms. Ferguson
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) regulation (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Anton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number (if known): | K111381 |
|---|---|
| --------------------------- | --------- |
Device Name: Medi-SIS Syringe Infusion System
Indications for Use:
1.0 The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
2.0 The Medi-SIS Administration Extension Set is intended for single patient use only.
3.0 The Medi-SIS Syringe Driver can be reused up to 5,000 times
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ri C. Ch 1/13/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K11138