(9 days)
Not Found
No
The summary does not mention any AI or ML terms, image processing, or descriptions of training/test sets, which are common indicators of AI/ML use in medical devices. The device description focuses on mechanical infusion and different volume/flow rate configurations.
No
This device is for pain management and medication delivery, not for treating a disease or medical condition.
No
This device is intended for the continuous infusion of medication for pain management, not for diagnosing a condition or disease.
No
The device description explicitly states the kit consists of a "Personal Infusor" and "medical device components including a catheter set, catheter introducer, 60 mL syringe, dressings and accessories," indicating it is a hardware-based device with physical components for drug delivery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "infusor" intended for "continuous infusion of physician-prescribed local anesthetic medications directly into the intraoperative site of a patient for management of postoperative pain." This is a therapeutic device delivering medication into the body, not a diagnostic device analyzing samples from the body.
- Intended Use: The intended use is for "local pain management," which is a therapeutic application, not a diagnostic one.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications directly into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor's administration line, which is attached to a catheter.
The Personal Infusor is portable and is suitable for use by ambulatory patients.
The Personal Infusor is intended for single use only.
The Personal Infusor is not intended for rapid infusion, intravenous or intra-arterial drug infusion, for the delivery of blood, blood products, lipids, or fat emulsions, or for use by patients with a history of allergic reactions to anesthetics.
Product codes
MEB
Device Description
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit consists of a Personal Infusor provided in a kit with medical device components including a catheter set, catheter introducer, 60 mL syringe, dressings and accessories. Each of the additional medical device components is purchased in finished form and is packaged with the Personal Infusor in the Personal Infusor Local Pain Management Procedural Kit.
The Personal Infusors provided in the Personal Infusor Local Pain Management Procedural Kit will be offered in three volume / flow rate configurations.
Personal Infusor Configurations
| Volume | Delivery Time | Flow Rate |
|---|---|---|
| 50 mL | 96 hours (labeled maximum) | 0.5 mL/hr |
| 100 mL | 96 hours (labeled maximum) | 1.0 mL/hr |
| 100 mL | 50 hours | 2.0 mL/hr |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K020881
7-1
Science Incorporated Personal Infusor Local Pain Management Procedural Kit 510(k)
7.0 510(K) SUMMARY
Submitters name:
Science Incorporated 12150 Nicollet Avenue South Burnsville, MN 55337 (952) 835-1333 (general) (952) 646-2340 (direct) (952) 835-1716 (fax) Contact person: Lynn S. Weist, Vice President, Quality Assurance / Regulatory Affairs
| Device name: | Proprietary name: | To be determined (in this document, the device is referred to as the Science
Incorporated Personal Infusor Local Pain Management Procedural Kit or Express) |
|-------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common name: | Elastomeric pump |
| | Classification name: | Infusion pump |
| Predicate device: | | Science Incorporated Personal Infusor Local Pain Management
Procedural Kit manufactured by Science Incorporated (K010824) |
Device description:
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit consists of a Personal Infusor provided in a kit with medical device components including a catheter set, catheter introducer, 60 mL syringe, dressings and accessories. Each of the additional medical device components is purchased in finished form and is packaged with the Personal Infusor in the Personal Infusor Local Pain Management Procedural Kit.
The Personal Infusors provided in the Personal Infusor Local Pain Management Procedural Kit will be offered in three volume / flow rate configurations.
Personal Infusor Configurations
| Volume | Delivery Time | Flow Rate |
|---|---|---|
| 50 mL | 96 hours (labeled maximum) | 0.5 mL/hr |
| 100 mL | 96 hours (labeled maximum) | 1.0 mL/hr |
| 100 mL | 50 hours | 2.0 mL/hr |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Public Health Service
MAR 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynn Weist Vice President, OA/RA Science Incorporated 12150 Nicollet Avenue South Burnsville, Minnesota 55337-1647
Re: K020881
Trade/Device Name: Personal Infusor Local Pain Management Procedural Set Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 16 ,2002 Received: March 18, 2002
Dear Ms. Weist:
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 vour 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.
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.
2
Page 2 - Ms. Weist
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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,
Timothy A. Ulatowski
Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Science Incorporated Personal Infusor Local Pain Management Procedural Kit 510(k)
Science Incorporated 12150 Nicollet Avenue South Burnsville, MN 55337-1647
Page 1 of 1
510(k) Number: K020881
Device Name: Science Incorporated Personal Infusor Local Pain Management Procedural Kit
Indications for Use:
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications directly into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor's administration line, which is attached to a catheter.
The Personal Infusor is portable and is suitable for use by ambulatory patients.
The Personal Infusor is intended for single use only.
The Personal Infusor is not intended for rapid infusion, intravenous or intra-arterial drug infusion, for the delivery of blood, blood products, lipids, or fat emulsions, or for use by patients with a history of allergic reactions to anesthetics.
(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
(Optional Format 1-2-96
Science Incorporated • 12150 Nicollet Avenue South • Burnsville, MN 55337
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K020881 |
|---|---|
| --------------- | --------- |