(100 days)
Not Found
Not Found
No
The summary describes a device for local anesthetic infusion and does not mention any AI or ML capabilities.
Yes
The device is intended to provide infusion of a local anesthetic for post-operative pain management, which is a therapeutic purpose.
No
The device is intended for the infusion of a local anesthetic for pain management, which is a treatment rather than a diagnostic function.
No
The intended use describes the infusion of a local anesthetic, which is a physical process requiring hardware (e.g., a pump, catheter). The summary does not mention any software-only function.
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 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) by delivering a substance directly into the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The BREG's e-PAIN CARETM device does not involve the examination of specimens taken from the body. It is a device for delivering medication directly to a patient.
N/A
Intended Use / Indications for Use
BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.
Product codes
FRN
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-operative 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 - 2004
Ms. Kathleen Barber Vice President Quality Assurance/ Regulatory Affairs BREG, Incorporated 2611 Commerce way Vista, California 92081-8309
Re: K041714
Trade/Device Name: E-Pain Care Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 2, 2004 Received: September 7, 2004
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.
1
Page 2 - Ms. Barber
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be actived that 12 a determination that your device complies with other requirements mean that 22 I mar may Federal statutes and regulations administered by other Federal agencies. of the Free of any I vith all the Act's requirements, including, but not limited to: registration 1 od intiles comply was a 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 et read of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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) Frinis for will and in your rinding of substantial equivalence of your device to a premaince notified.com - I 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), rt you dosite spiering and 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 maj South 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,
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
2
Indications for Use
510(k) Number (if known): K041714
Device Name: e-Pain Care
Indications For Use:
BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.
Srene Reveau for ADW 9/30/04
(Division Sign-C Division of Anesthesion Infection Control. Dent
510(k) Number: K041714
escription Use X
AND/OR
Over-The-Counter Use
CFR 801 Subpart D)
(21 CFR 807 Subpart C)
ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE)