(8 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use is for continuous infusion for pain management, which is a standard function for medical devices and does not inherently require AI/ML.
Yes
The device is indicated to provide continuous infusion for the post-operative management of pain, which is a therapeutic function.
No
The device is indicated for continuous infusion for pain management, which is a treatment, not a diagnostic function.
No
The intended use describes a device that provides continuous infusion, which inherently requires hardware (a pump or similar mechanism) to deliver the infusion. The summary does not mention any software-only functionality.
Based on the provided information, the Pain Care™ 4200 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide continuous infusion for the post-operative management of pain." This describes a device that delivers medication or fluid directly to a patient's body, which is a therapeutic function, not a diagnostic one performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Using reagents or assays
Therefore, the Pain Care™ 4200 is a medical device used for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pain Care™ 4200 is indicated to provide continuous infusion for the post-operative management of pain.
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Barber Vice President of Regulatory Affairs Breg. Incorporated 2611 Commerce Way Vista, California 92083
APR 0 4 2002
Re: K020988
Trade/Device Name: Pain Care 4200 Regulation Number: 880.5725 Regulation Name: Infusion Kit Regulatory Class: II Product Code: MEB Dated: March 27, 2002 Received: March 27, 2002
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.
1
Page 2 - Ms. Barber
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply William and 807); labeling (21 CFR Part 801); good manufacturing practice continue allu lisung (21 CFR Part 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality in 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 This letter will anow you to begin marketing your of substantial equivalence of your device to J ro(k) premarket nouricate 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 II you desire specific at rice 10. your for in vitro diagnostic devices), please contact the and additionally 21 CFR Far 80710 108 in 100 milly, for questions on the promotion and
Office of Compliance at (301) 594-4618. Additionally, for questions on the 100 Office of Colliphiance at (3 ) 1) 5 advertibing or your aregulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nonicallor (210) It I dr 0071).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained its toll-free number (800) 638-2041 or (301) 443-6597 or at its Consumer risonstance :: //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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
1
Pain Care (PNC) 4200 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Pain Care™ 4200 is indicated to provide continuous infusion moreations For Use. "The post-operative management of pain.
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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 DFR 801.109) Over-The-Counter Use __
(Optional Format 1-2-96)
Patricia Cusenite
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_10209