(25 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is intended to deliver local anesthetic for postoperative pain management, directly treating a medical condition.
No
The device is intended to provide continuous delivery of a local anesthetic, which is a therapeutic function, not a diagnostic one.
No
The device description lists multiple hardware components including a pump, infusion bag, syringe, and catheter, indicating it is 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 to "provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management." This describes a device used for delivering medication directly to a patient's body, which is a therapeutic or drug delivery function.
- Device Description: The components listed are all related to delivering fluid (anesthetic) to a patient (infusion bag, pump, catheter, flow regulator, etc.). There are no components or descriptions related to analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
IVD devices are specifically designed to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The modified SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
The device comprises of the following parts:
- SmartCatheter (optional) -
- SmartInfuser set with SmartReg flow regulator, T Check Valve and Multi -Bolus (regulating set)
- Compression unit (pump) -
- 500 ml infusion bag (empty) -
- Peel-off introducer(optional) -
- Wound Dressing (Medical adhesive bandage) -
- 50/60cc luer lock syringe -
- -Medication label
- Pump label
- Instructions for use
- Carrying pouch
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical 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): 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.
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.
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
KOBI409 (
JUN 16 2006
Image /page/0/Picture/2 description: The image shows a logo for "PRECISE MEDICAL PRODUCTS LTD." The logo consists of the letters "PMP" in a bold, sans-serif font, with the letters slightly overlapping each other. The words "PRECISE MEDICAL PRODUCTS LTD." are written in a smaller font below the letters "PMP". The logo is in black and white and has a slightly angled perspective.
510(k) Summary: SmartInfuser PainPump™
Company Name: Precise Medical Products Ltd.
Contact Person:
Ofer Shay Managing Director
Phone: +972-4-980-9193 +972-4-980-8356 Fax: E-mail: ofers@pmp-medical.com
Authorized US Agent:
Mark Dollinger - President Trendlines America 2940 West, 123rd Terrace Leawood, Kansas 66200
Phone: (913) 317-8788 Fax: (913) 317-8788 E-mail: mark@trlines.com
Date prepared: May 15, 2006
Trade Name: SmartInfuser PainPump™
Classification name: Pump, infusion
Common/usual name: Disposable Pain Management System
Product Code: MEB
Regulation No.: 880.5725
1
10061409
2 of 2
Image /page/1/Picture/1 description: The image shows a logo for "PMP Precise Medical Products LTD." The logo consists of the letters "PMP" stacked on top of each other in a bold, sans-serif font. The words "PRECISE MEDICAL PRODUCTS LTD." are written in a smaller font below the letters "PMP". The logo is in black and white and has a slightly angled perspective.
Class: II Panel identification: General Hospital Panel
Predicate Device:
SmartInfuser PainPump™, Precise Medical Products Ltd, Shlomi, Israel, cleared under 510(k) no. K042122.
Description of the device:
The device comprises of the following parts:
- SmartCatheter (optional) -
- SmartInfuser set with SmartReg flow regulator, T Check Valve and Multi -Bolus (regulating set)
- Compression unit (pump) -
- 500 ml infusion bag (empty) -
- Peel-off introducer(optional) -
- Wound Dressing (Medical adhesive bandage) -
- 50/60cc luer lock syringe -
- -Medication label
- Pump label ﺳﺘ
- Instructions for use ﻪ
- Carrying pouch ﮩ
Indications for Use:
The modified SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
Substantial Equivalence:
The modified SmartInfuser PainPump™ has the same intended use as the original SmartInfuser PainPump™, cleared under 510(k) no. K042122 and has equivalent performance characteristics. It is therefore substantially equivalent to that device.
Conclusion:
The evaluation of the modified SmartInfuser PainPump™ does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate device.
11-3
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 16 2006
Mr. Ofer Shay Managing Director Precise Medical Products, Limited Dora Street (Industrial Zone) Shlomi 22832 ISRAEL
Re: K061409
Trade/Device Name: SmartInfuser PainPump™, Disposable Pain Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: May 15, 2006 Received: May 22, 2006
Dear Mr. Shay:
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.
3
Page 2 - Mr. Shay
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 squarences. 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 prectice 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.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K041409
1 of 1
Indications for Use
510(k) Number (if known):
Device Name: SmartInfuser PainPump™, Disposable Pain Management System
The SmartInfuser PainPump™ is intended to provide continuous delivery of a local I he United through a catheter inserted directly into the surgical site for postoperative pain management.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Anthony D. newton
on of Anesthesiology, General Hospital. con Control, Denta
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) Number:
12-2