(29 days)
Not Found
No
The device description and performance studies focus on mechanical and flow rate characteristics of an elastomeric pump, with no mention of AI or ML.
Yes
The device is indicated for the administration of medications to patients, and the primary purpose of a therapeutic device is to treat or alleviate a medical condition.
No
The device is an infusion pump designed to administer medications, not to diagnose a condition.
No
The device description clearly states it is a "single-use, disposable elastomeric infusion pump" and details physical components like a "plastic tubing flow restrictor, a coupler... and a Luer lock connector." This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "administration of medications" intravenously, intra-arterially, subcutaneously, or epidurally. This describes a device used for delivering substances into the body for therapeutic purposes.
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
- Device Description: The description focuses on the mechanical aspects of delivering a solution at a constant flow rate, not on analyzing any biological samples.
Therefore, the Baxter's Infusor SV Elastomeric Infusion Device is a therapeutic device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module.
Product codes
MEB
Device Description
Baxter's Infusor SV devices are single-use, disposable elastomeric infusion pumps designed to deliver solution at a constant preset flow rate ranging from 0.5mL/hr to 5mL/hr, depending on device configuration. The modifications made to the Infusor SV devices include replacing the glass restrictor tube and housing used in previous versions of the device with a plastic tubing flow restrictor, a coupler to connect the tubing flow restrictor to the tube set and a Luer lock connector.
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
It is suitable for use in the hospital or home setting.
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)
Baxter Healthcare conducts risk analyses using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices." The risk analysis method used to assess the impact of the modification was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the result of risk analysis and design input were performed to verify the modifications. Testing of the device and components included mechanical, biocompatibility, and flow rate testing. All test results meet the acceptance criteria, and prove that the modifications are appropriate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K802820, K905778, K982102, K853881, K842479, K870242, K842905
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
5. 510(K) SUMMARY
SEP 2 1 2006
DATE PREPARED:
August 8, 2006
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Regulatory Affairs Manager 1620 Waukegan Rd. McGaw Park, IL 60085 Telephone: (847) 473-6281 Fax: (847) 785-5116
DEVICE NAME:
Trade name: Infusor SV Elastomeric Infusion Device
- Singleday Infusor
- · Half Day Infusor
- · 2 Day Infusor
- Multiday Infusor
- · Seven Day Infusor
COMMON NAME:
Infusion Pump
CLASSIFICATION NAME:
Infusion Pump (21 CFR 880.5725, Product Code MEB, MEA,
1
PREDICATE DEVICE(S):
| Device | Previous 510(k) | Clearance date |
|---|---|---|
| Single day Infusor | K802820 | |
| K905778 | ||
| K982102 | November 7, 1980 | |
| July 12, 1991 | ||
| September 4, 1998 | ||
| Half Day Infusor | K853881 | |
| K905778 | ||
| K982102 | December 2, 1985 | |
| July 12, 1991 | ||
| September 4, 1998 | ||
| 2 Day Infusor | K802820 | |
| K842479 | ||
| K870242 | ||
| K905778 | ||
| K982102 | November 7, 1980 | |
| November 2, 1984 | ||
| March 13, 1987 | ||
| July 12, 1991 | ||
| September 4, 1998 | ||
| Multiday Infusor | K842905 | |
| K905778 | ||
| K982102 | November 1, 1985 | |
| July 12, 1991 | ||
| September 4, 1998 | ||
| Seven Day Infusor | K842479 | |
| K842905 | ||
| K870242 | ||
| K905778 | ||
| K982102 | November 2, 1984, | |
| November 1, 1985 | ||
| March 13, 1987 | ||
| July 12, 1991 | ||
| September 4, 1998 |
Table 5-1. Previous 510(k)s
DESCRIPTION OF THE DEVICE AND MODIFICATION:
Baxter's Infusor SV devices are single-use, disposable elastomeric infusion pumps designed to deliver solution at a constant preset flow rate ranging from 0.5mL/hr to 5mL/hr, depending on device configuration. The modifications made to the Infusor SV devices include replacing the glass restrictor tube and housing used in previous versions of the device with a plastic tubing flow restrictor, a coupler to connect the tubing flow restrictor to the tube set and a Luer lock connector.
STATEMENT OF INTENDED USE:
Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intraarterial, subcutaneous or epidural administration of medications at a constant flow rate
2
The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.
TECHNOLOGICAL CHARACTERISTICS:
The plastic tubing flow restrictor, Luer lock connector and coupler are replacing the current glass flow restrictor and Luer housing. These components provide the equivalent performance; however the materials differ in that the glass is replaced by plastic tubing and the coupler and Luer together replace the function of the current Luer housing by connecting the restrictor to the device tubing set and providing a Luer lock for connection to the patient's catheter.
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare conducts risk analyses using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices." The risk analysis method used to assess the impact of the modification was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the result of risk analysis and design input were performed to verify the modifications. Testing of the device and components included mechanical, biocompatibility, and flow rate testing. All test results meet the acceptance criteria, and prove that the modifications are appropriate.
CONCLUSION:
The Infusor SV Elastomeric Infusion Device with the modifications is as safe and effective as the predicate device and the performance is substantially equivalent to the predicate device.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2006
Ms. Nanette Hedden Regulatory Affairs Manager Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K062457
Trade/Device Name: Infusor Small Volume (SV) Elastomeric Infusion Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 22, 2006 Received: August 23, 2006
Dear Ms. Hedden:
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. Hedden
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 applicable, 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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):
Device Name: Infusor Small Volume (SV) Elastomeric Infusion Devices
Indications For Use: Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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on Sign-Off)
ion of Anesthesiology, General Hospital,
tion Control, Dental Devices