(5 days)
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No
The summary describes a device for continuous infusion of local anesthetic and does not mention any AI or ML capabilities.
Yes
The device is intended to provide continuous infusion of a local anesthetic for the post-operative management of pain, which clearly indicates a therapeutic purpose.
No
The device delivers medication for pain management and does not appear to diagnose any condition.
No
The description explicitly states the device is a "delivery mechanism" for local anesthetic, implying a physical pump or infusion system, which is hardware. There is no mention of software as the primary or sole component.
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 infusion of a local anesthetic into an intra-operative site for the post-operative management of pain." This describes a device used on a patient for therapeutic purposes (pain management), not a device used to examine specimens from the body to provide diagnostic information.
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions. The description of the BREG Pain Care 3200 does not involve any such testing of biological samples.
Therefore, the BREG Pain Care 3200 is a medical device used for drug delivery and pain management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes
MEB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intra-operative site
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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
2
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