(66 days)
No
The device description explicitly states it is identical in design to a predicate device from 1989 (K896422) and mentions no changes in design, materials, or method of manufacture. There is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery, which is a therapeutic purpose.
No
The device is an infusion pump designed to deliver medication for pain management, not to diagnose a condition.
No
The device description explicitly states it is an "Infusion Pump," which is a hardware device used for delivering medication. It also mentions a "catheter" for percutaneous delivery. The description focuses on the physical device and its equivalence to a predicate hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to deliver medication (local anesthetic) directly into a surgical site for pain management. This is a therapeutic function, not a diagnostic one.
- Mechanism: It's an infusion pump, which is a device used to administer substances into the body. IVD devices are used to examine specimens from the body to provide information for diagnosis.
- No mention of in vitro testing: The description focuses on drug delivery and pain control, with no indication of testing samples outside of the body.
Therefore, the Pain Control Infusion Pump falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.
The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.
Product codes
FRN
Device Description
The proposed device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc. The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System. There is no change in design, materials, method of manufacture, or intended use and only minor name changes in the labeling from the Burron device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
3/19/99
19. 510(k) Summary
510(k) SUMMARY - Safety and Effectiveness
Pain Control Infusion Pump
The proposed device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc. The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System. There is no change in design, materials, method of manufacture, or intended use and only minor name changes in the labeling from the Burron device.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1999
Thomas Sgarlato, DPM Sgarlato Laboratories, Incorporated 250 Almendra Avenue Los Gatos, California 95030
Re : K990101 Pain Control Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN February 8, 1999 Dated: January 12, 1999 Received:
Dear Mr. Sgarlato
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Sgarlato
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to ene regaration Choroson" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
3
Statement of Indications for Use 20.
INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________ Pain Control Infusion Pump ...................................................................................................................................................
Indications for Use:
The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.
The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paloux Cassente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
2 99101 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________