(81 days)
Not Found
Not Found
No
The summary describes a mechanical infusion device with a design modification for filling and priming. There is no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for the administration of medications to patients, which is a therapeutic purpose.
No
The device is described as an elastomeric infusion pump used for administering medications, not for diagnosing conditions.
No
The device description clearly describes a physical, disposable elastomeric infusion pump with hardware modifications (relocation of fill port, addition of coiled tubing). There is no mention of software as the primary or sole component.
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" to patients via various routes (intravenous, intra-arterial, subcutaneous, epidural). This is a therapeutic function, delivering substances into the body.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such examination of specimens.
- Device Description: The description focuses on the mechanical aspects of the pump for filling and delivering medication.
- Lack of IVD-related terms: There are no mentions of analyzing samples, diagnostic tests, or any other activities associated with IVD devices.
Therefore, the Baxter's Infusor SV Elastomeric Infusion Device is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The modified devices have the same intended use as the comparison devices. They are indicated for slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. They are also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. These devices are suitable for use in the hospital and home setting.
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.
Product codes
MEB
Device Description
A design modification is being made to Baxter's Infusor SV line of Elastomeric Infusion Devices. This modification is being made to facilitate filling and priming the device. The modification involves the relocation of the fill port to the end of the housing and the addition of a piece of coiled tubing to connect the relocated fill port to the volume indicator. Standard flow rate testing was performed to confirm performance characteristics.
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 and 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)
Standard flow rate testing was performed to confirm performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
4 1998 SEP
Section 9.0 Page 1
K 982/62
JUN 1 2 1998
SECTION 9.0
SMDA INFORMATION
SUMMARY OF SAFETY AND EFFECTIVENESS
" Submitted by:
Vicki L. Drews Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073
Date of Submission: June 12, 1998
Proposed Device(s):
Singleday Infusor Infusor SV 2 Day Infusor
Multiday Infusor Seven Day Infusor
Comparison Device(s):
Singleday Infusor Infusor SV 2 Day Infusor
Multiday Infusor Seven Day Infusor
Intended Use:
The modified devices have the same intended use as the comparison devices. They are indicated for slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. They are also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. These devices are suitable for use in the hospital and home setting.
Technological Characteristics:
A design modification is being made to Baxter's Infusor SV line of Elastomeric Infusion Devices. This modification is being made to facilitate filling and priming the device. The modification involves the relocation of the fill port to the end of the housing and the addition of a piece of coiled tubing to connect the relocated fill port to the volume indicator. Standard flow rate testing was performed to confirm performance characteristics.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 4 1998
Ms. Vicki L. Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073
Re : K982102 Trade Name: Baxter Infusor SV-Elastomeric Infusion Device Unclassified Requlatory Class: Product Code: MEB Dated: June 12, 1998 Received: June 15, 1998
Dear Ms. Drews:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨਾ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation-(21-CFR-Part 820) and that; -through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. J Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Ms. Drews
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). 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 (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Autran for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 11.0
INDICATION 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.
Patricia Ciuente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital, Intection and General Hospital Devices
510(k) Number K982102
Prescription Use
(Per 21 CFR 801.109)
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SEP 0 3 1998