(115 days)
No
The description mentions a "microcomputer-controlled pump" and a "software revision," but there is no mention of AI, ML, or related concepts. The changes are described as providing "ease of pump programming by the user," which suggests standard software functionality rather than AI/ML.
Yes.
The device is intended for the infusion of local anesthetics and narcotics for pain management and regional anesthesia, which are therapeutic interventions.
No
The device is an infusion pump intended to deliver medication, not to diagnose a condition or disease.
No
The device description explicitly states it is a "microcomputer-controlled pump that uses rotary peristaltic pumping technology," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "infusion of local anesthetics and narcotics for pain management and regional anesthesia" and for delivering these substances to "surgical wound sites or close proximity to nerves." This describes a device used for delivering substances into the body for therapeutic purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body to analyze biological samples.
- Device Description: The description details a "microcomputer-controlled pump that use rotary peristaltic pumping technology." This is consistent with a device designed to deliver fluids, not analyze biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVD devices.
Therefore, the ambIT® "PreSet" Ambulatory Infusion Pump is a therapeutic device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ambIT® PreSet Ambulatory Infusion Pump is intended for the volumetric delivery of medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.
The ambIT® "EZ-PRO" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.
Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.
The ambIT® "EZ-PRO" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.
Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.
The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Product codes
FRN
Device Description
Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons and anesthesiologists
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
The requirements and results of documented verification and validation testing were defined and conducted according to Sorenson Medical quality system requirements to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device. All tests will be conducted according to written test protocol. with defined test expectations and documented conclusions. All test data is attached to the verification and validation test protocols performed and a permanent record of Sorenson Medical's Design History File.
Key Metrics
Not Found
Predicate Device(s)
K965222, K002434, K033325, K042405
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
12 510(k) SUMMARY
DEC 8 2005
510(k) Summary
Kosazal
Submitted by:
Douglas Bueschel Vice President of Regulatory Affairs and Quality Assurance Sorenson Medical, Inc. 1375 West 8040 South West Jordan, Utah 84088-1888
Name/Classification of the Device:
Infusion Pump/Class II, 80FRN - 21 CFR 880.5725
Trade Names:
ambIT® PreSet Ambulatory Infusion Pump, or amblT® Pump
Predicate Devices:
- · The MicroJect PCA Pump K965222
- · The Palm Pump, K002434
- · The amblT® Continuous Ambulatory Infusion Pump K033325.
Note: These predicate devices are manufactured by Sorenson Medical, Inc.
- · Stryker Pain Pumps 1 & 2 K042405.
Note: These pumps are manufactured by Stryker Instruments.
Statement of Intended Use:
The ambIT® PreSet Ambulatory Infusion Pump is intended for the volumetric delivery of medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.
Indications For Use
The ambIT® "EZ-PRO" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.
1
Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.
The ambIT® "EZ-PRO" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Device Description:
Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.
Summary of Technological Characteristics of New Device to Predicate Device:
The technological features of the ambIT® EZ-PRO Ambulatory Infusion Pump are identical to the predicate Palm Pump except for several software modifications required to allow for ease of programming, and a modified PCB. The subject and predicate devices are the same in intended use. The technological differences between the subject and predicate devices are minor and they do not raise issues of safety and effectiveness.
Discussion of Non-Clinical Tests; Conclusions Drawn from Non-Clinical Tests:
The requirements and results of documented verification and validation testing were defined and conducted according to Sorenson Medical quality system requirements to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device. All tests will be conducted according to written test protocol. with defined test expectations and documented conclusions. All test data is attached to the verification and validation test protocols performed and a permanent record of Sorenson Medical's Design History File.
Labels and Labeling:
Labels and labeling, including the User's Manual are similar to the predicate Palm Pump and meet all FDA and E.U. requirements for a medical device product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
2005 DEC 8
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douglas Bueschel Vice President of Regulatory Affairs and Quality Assurance Sorenson Medical, Incorporated 1375 West 8040 South West Jordan, Utah 84088-1888
Re: K052221
Trade/Device Name: amblT® "PreSet" Ambulatory Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 22, 2005 Received: November 23, 2005
Dear Mr. Bueschel:
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.
3
Page 2 - Mr. Bueschel
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be advised that 12 a determination that your device complies with other requirements mount that I Driving and regulations administered by other Federal agencies. or the rece of any vith all the Act's requirements, including, but not limited to: registration 1 ou Inust compry with areast to the Part 801); good manufacturing practice alle nisting (21 OF Far and 007), moslity systems (QS) regulation (21 CFR Part 820); and if requirements as bettern in arouv a 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) rins reter notification. The FDA finding of substantial equivalence of your device to a premaired notification - 11 device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), r you desire specific ace for 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 obtain 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/industry/support/index.html.
Sincerely yours,
Ove
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
4
Indications for Use
K 0522 510(k) Number (if known): ___
Device Name: ambIT® "PreSet" Ambulatory Infusion Pump
Indications For Use:
The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.
Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.
The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
()R
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William M. Burdell
for Anthony D. Watson 12/8/05