(5 days)
BREG's Pain Care 3200 has the same intended use as BREG's Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain.
The purpose of BREG's Pain Care 3000 and 3200 is to provide a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
Not Found
Here is an analysis of the provided text regarding the Pain Care 3200 device, focusing on acceptance criteria and a study to prove its performance:
Based on the provided FDA 510(k) clearance letter (K013928) for the Breg Pain Care 3200, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The FDA letter is a substantial equivalence determination, meaning the device (Pain Care 3200) was deemed substantially equivalent to a legally marketed predicate device (Pain Care 3000) for its stated intended use. This type of clearance typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often without requiring new standalone clinical studies against specific performance metrics outlined in your request.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not a detailed technical study report.
To directly answer your prompt based on the absence of this information in the provided text:
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A table of acceptance criteria and the reported device performance:
- Not Available: The provided document does not specify quantitative acceptance criteria or report performance metrics from a study for the Pain Care 3200. The clearance is based on substantial equivalence to the Pain Care 3000.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available: The document does not describe a test set, sample size, or data provenance for performance evaluation.
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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):
- Not Available: No ground truth establishment is described in relation to performance testing in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available: No test set or adjudication method is described.
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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:
- Not Applicable: This device is an infusion pump, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Available/Not Applicable: The Pain Care 3200 is an infusion pump, a medical device with mechanical and electronic components; it is not an algorithm, so standalone algorithm performance is not relevant. The substantial equivalence determination implies that its performance is equivalent to the predicate without requiring a new "standalone" study in the sense of an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available: As no performance study with a test set is described, no ground truth type is mentioned.
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The sample size for the training set:
- Not Applicable: This is an infusion pump, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable: There is no training set for this device.
In summary, the provided FDA communication is a regulatory clearance document. While it indicates that the device has been cleared for market based on substantial equivalence, it does not include the detailed technical study information that your questions are looking for regarding acceptance criteria and performance studies. Such information would typically be found in a separate design validation report or a clinical investigation report, which are not part of this 510(k) summary letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular seal.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Kathleen Barber Vice President of Regulatory Affairs Breg, Incorporated 2611 Commerce Way Vista, California 92083
Re: K013928
Trade/Device Name: Pain Care 3200 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: November 26, 2001 Received: November 28, 2001
Dear Ms. Barber:
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.
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.
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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) 594-4618. 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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C
STATEMENT OF INDICATIONS FOR USE
Intended Use
BREG's Pain Care 3200 has the same intended use as BREG's Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain.
The purpose of BREG's Pain Care 3000 and 3200 is to provide a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
Pulazzo Cucenate
§ 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).