(87 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest any AI/ML functionality.
Yes
The device is described as an "Infusion System" intended to provide "continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management" and to "deliver pain medication percutaneously via a catheter attached to the pump." These uses directly address pain management, which is a therapeutic intervention.
No
Explanation: The device is an infusion pump intended to deliver local anesthetic or pain medication for postoperative pain management, not to diagnose a condition.
No
The device description explicitly refers to a "pump" and "catheter," which are hardware components, indicating it is not a software-only device.
Based on the provided information, the Freedom™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering local anesthetic directly into the intraoperative site for pain management. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on an "Infusion System pump" for delivering medication.
- Lack of Diagnostic Elements: 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 based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Freedom™ device's function is to deliver medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
-
- Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management.
-
- Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump.
-
- Freedom™is a single use only device.
-
- Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment.
-
- Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery.
-
- Freedom™is not intended for use with chemotherapy drugs.
-
- Freedom™is not intended for use with blood, blood products, or TPN.
Product codes
MEB
Device Description
The Freedom™ Infusion System pump. The silicone balloons are 100% tested to an internal pressure of 110+5 mmhg. Normal clinical operating pressure has been measured at approximately 70 mmhg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site (for postoperative pain management)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment (ambulatory device)
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) Performance data and test protocols for burst testing of the DIB infusors are included as FDA file no's. K930404, K941766, and K955849. Bench test protocols and study results for flow rate, flow profile, and accuracy are also reported in the above referenced FDA filings
B) Clinical Experience: legally marketed DIB pumps have been used clinically in the USA for obstetrical analgesia, post operative pain, chronic pain and intravenous infusions. (See attached Anesthesiology News)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PainBuster system
Reference Device(s)
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
SEP 1 0 1999
ATTACHMENT G
SUMMARY of SAFETY and EFFECTIVENESS for the DIB-RA INFUSOR
I. Standards and Intended Use
The Freedom™ Infusion System pump will conform to the AMMI Draft Infusion Device Standard. The intended use of the Freedom™ Infusion System is identical to the legally marketed PainBuster system.
II. Manufacturing and Testing Procedures
All manufacturing operations are performed in a class 10,000 clean room in accordance with GMP regulations. The silicone balloons are 100% tested to an internal pressure of 110+5 mmhg. Normal clinical operating pressure has been measured at approximately 70 mmhg. Full traceability of production lots will be maintained.
Prior In-Vitro Tests and Clinical Experience III.
A) Performance data and test protocols for burst testing of the DIB infusors are included as FDA file no's. K930404, K941766, and K955849. Bench test protocols and study results for flow rate, flow profile, and accuracy are also reported in the above referenced FDA filings
B) Clinical Experience: legally marketed DIB pumps have been used clinically in the USA for obstetrical analgesia, post operative pain, chronic pain and intravenous infusions. (See attached Anesthesiology News)
- Contact Address: Inquiries related to the Freedom™ Infusion System should be IV. directed to:
NOVACON Corporation 5451 Hilltop Avenue Lake Elmo. MN 55042-9539 Tel: (651) 704-9160 Fax: (651) 704-9161
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1999
Mr. David P. Lanq NOVACON Corporation 5451 Hilltop Avenue North Lake Elmo, Minnesota 55042-9539
K992015 Re: Freedom™ Infusion System Trade Name: Regulatory Class: II Product Code: MEB Dated: June 11, 1999 Received: June 15, 1999
Dear Mr. Lang:
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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
2
Page 2 - Mr. Lang
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 one regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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,
Citrus
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
사용량 및
: 上海:
| ATTACHMENT A | |
|---|---|
| -- | -------------- |
F=============================================================================================================================================================================
510(k) Number (if known): Freedom™ Infusion System Device Name: –
Indications For Use:
-
- Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management.
-
- Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump.
-
- Freedom™is a single use only device.
-
- Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment.
-
- Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery.
-
- Freedom™is not intended for use with chemotherapy drugs.
-
- Freedom™is not intended for use with blood, blood products, or TPN.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K992015 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |