(47 days)
The 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 -
- SmartInfuser set with SmartReg flow regulator (regulating set) -
- Compression unit (pump) -
- 100 ml or 250 ml infusion bag (empty) -
- Peel-off introducer -
- -Medication label
- Pump label -
- Carrying pouch made of synthetic cloth -
The empty infusion bag is included as a back-up container. Under normal circumstances, a standard solution bag filled by a pharmacist according to the physician's prescription will be used.
The provided text is a 510(k) summary for a medical device called the SmartInfuser PainPump™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, and ground truth establishment from a study proving criteria is not available in the provided document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The 510(k) summary asserts "equivalent performance characteristics" to the predicate device, but it does not specify what those characteristics are, what the acceptance criteria for those characteristics would be, or the SmartInfuser PainPump™'s reported performance against them.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. The document makes no mention of a specific test set or clinical study. The substantial equivalence claim is based on the device's design and intended use being similar to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided. As no specific test set or study is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable to this device. The SmartInfuser PainPump™ is an infusion pump, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical infusion pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided as no specific study with ground truth establishment is described. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device and the demonstration that the new device shares those characteristics.
8. The sample size for the training set:
This information is not provided. There is no mention of a "training set" as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of available information related to equivalence:
- Acceptance Criteria Implied: The implicit acceptance criterion for this 510(k) submission is that the SmartInfuser PainPump™ is substantially equivalent to the predicate device, the Painbuster Infusion Kit (K982946), in terms of intended use and performance characteristics.
- Study Proving Equivalence: The "study" is the 510(k) submission process itself, where the manufacturer provides information and justification (as presented in the "Substantial Equivalence" section) that the new device has "equivalent performance characteristics" and "the same intended use" as the predicate. The FDA's review and clearance (indicated by the letter) constitute the acceptance that this "study" or review process successfully demonstrated equivalence.
- Reported Device Performance (against equivalence): The document explicitly states: "The SmartInfuser PainPump™ has the same intended use as the Painbuster Infusion Kit, cleared under 510(k) no. K9982946 and has equivalent performance characteristics. It is therefore substantially equivalent to that device." This is the core "performance" reported in the context of a 510(k) – that it performs equivalently to a legally marketed device.
In essence, for a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance metrics through a novel clinical trial. The "study" is the comparison made by the manufacturer and accepted by the FDA based on the provided documentation.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a logo for Precise Medical Products LTD. The logo is in black and white and features the letters PMP in a stylized font. The letters are stacked on top of each other and are slightly angled. The words "PRECISE MEDICAL PRODUCTS LTD." are written below the letters in a smaller font.
SEP 2 2 2004
510(k) Summary: SmartInfuser PainPump™
Company Name: Precise Medical Products Ltd.
Contact Person:
Ofer Shai Managing Director
+972-4-980-9193 Phone: +972-4-980-8356 Fax: E-mail: ofrs@pmp-medical.com
Authorized US Agent:
Mark Dollinger - President Trendlines America 2940 West, 123rd Terrace Leawood, Kansas 66200
Phone: (913) 317-8788 (913) 317-8788 Fax: E-mail: mark@trlines.com
Date prepared: July 30, 2004
Trade Name: SmartInfuser PainPump™
Classification name: Pump, infusion
Common/usual name: Disposable Pain Management System
Product Code: MEB
Regulation No.: 880.5725
{1}------------------------------------------------
2042122 0.2
Image /page/1/Picture/1 description: The image shows the logo for Precise Medical Products LTD. The logo is in black and white and features the letters PMP in a stylized, three-dimensional font. The words "PRECISE MEDICAL PRODUCTS LTD." are written in a smaller font below the letters PMP.
Class: II Panel identification: General Hospital Panel
Predicate Device:
Painbuster Infusion Kit, I-Flow Corp. 20202 Widrow Dr., Lake Forest, CA 92630, cleared under 510(k) no. K982946.
Description of the device:
The device comprises of the following parts:
- SmartCatheter -
- SmartInfuser set with SmartReg flow regulator (regulating set) -
- Compression unit (pump) -
- 100 ml or 250 ml infusion bag (empty) -
- Peel-off introducer -
- -Medication label
- Pump label -
- Carrying pouch made of synthetic cloth -
The empty infusion bag is included as a back-up container. Under normal circumstances, a standard solution bag filled by a pharmacist according to the physician's prescription will be used.
Indications for Use:
The 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 SmartInfuser PainPump™ has the same intended use as the Painbuster Infusion Kit, cleared under 510(k) no. K9982946 and has equivalent performance characteristics. It is therefore substantially equivalent to that device.
Conclusion -
The evaluation of the SmartInfuser PainPump™ does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow together, resembling a human figure or a wave-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2004
Mr. Ofer Shay Managing Director Precise Medical Products Limited P.O. Box 88 Shlomi 22832 ISRAEL
Re: K042122
Trade/Device Name: Smartinfuser PainPump™, Disposable Pain Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: July 30, 2004 Received: August 6, 2004
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 Eederal 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 agencies. 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 vour 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runno
fo Chiu Lin, Ph.D.
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}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: SmartInfuser PainPump™, Disposable Pain Management System
Indications For Use:
The 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.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
Page 1 of __ 1 _______________________________________________________________________________________________________________________________________________________________
§ 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).