(25 days)
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.
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
The provided text is a 510(k) summary for the SmartInfuser PainPump™, a disposable pain management system. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed studies on AI performance or specific acceptance criteria met through rigorous clinical trials for a new, innovative device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to a device's performance measured against specific metrics, nor does it describe a study proving the device meets such criteria in the context of an AI-powered system.
Specifically:
- Table of acceptance criteria and reported device performance: Not present. The document focuses on showing substantial equivalence to a predicate device.
- Sample size for test set and data provenance: No test sets are described in the context of performance metrics.
- Number of experts used to establish ground truth and qualifications: Not applicable as there is no mention of ground truth establishment for an AI system.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. The device is a physical pump, not an AI-assisted diagnostic tool.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document states that the modified SmartInfuser PainPump™ "has equivalent performance characteristics" to its predicate device (K042122) and "does not raise any additional concerns regarding safety and effectivity." This indicates that the acceptance criteria are implicitly tied to the performance and safety demonstrated by the predicate device, but these specific criteria and their measured outcomes are not explicitly detailed in this summary. The "study" here is a regulatory review for substantial equivalence, not a performance trial for an AI system.
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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
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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
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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.
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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
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K041409
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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
§ 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).