PAIN CARE 4200 by BREG, INC. | FDA 510(k) Summary

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a medical device. The document is an FDA 510(k) clearance letter for a device called "Pain Care 4200," indicating that it has been found substantially equivalent to a predicate device.

The clearance letter primarily states:

Device Name: Pain Care 4200
Regulation Number: 880.5725 (Infusion Kit)
Regulatory Class: II
Product Code: MEB
Indications For Use: To provide continuous infusion for post-operative management of pain.

It does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test set.
Number or qualifications of experts for ground truth.
Adjudication methods.
Information about MRMC comparative effectiveness studies.
Results of standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given input.

Summary

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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.

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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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K020988

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

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_10209

Regulation Number and Section

§ 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).