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.

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.

AI/ML Overview

This 510(k) summary describes a submission for an infusion pump, which is a Class II medical device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or specific acceptance criteria with quantifiable performance metrics typically seen in AI/ML device submissions.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be definitively answered from the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in table format. The evaluation focused on non-clinical tests to verify that design modifications met "documented performance and safety requirements."

Acceptance Criteria (Implicit): The device (ambIT® PreSet Ambulatory Infusion Pump) must perform safely and effectively for volumetric delivery of medicines/fluids at preset rates and volumes, similar to its predicate devices, particularly the Palm Pump (K002434), and meet all design requirements following software and PCB modifications.
Reported Device Performance: "All tests will be conducted according to written test protocol, with defined test expectations and documented conclusions." The document claims that "documented verification and validation testing were defined and conducted... to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device." However, no specific performance values (e.g., accuracy of flow rate, battery life, alarm effectiveness) are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to "verification and validation testing" but does not indicate a sample size for any specific clinical or non-clinical test sets.
Data Provenance: Not specified. The testing was conducted by Sorenson Medical, Inc.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. This device is an infusion pump, and its assessment focuses on engineering performance and safety rather than interpretative tasks requiring expert-established ground truth (like in medical imaging or diagnostic algorithms).

4. Adjudication Method for the Test Set:

Not applicable for a device of this nature. The "testing" referred to is performance and safety verification of the pump's mechanical and software functions, not interpretative data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret medical data, and the AI's impact on their performance is evaluated. This is an infusion pump, which does not involve human interpretation of complex medical data during its primary function.

6. If a Standalone Performance Study Was Done:

The document mentions "documented verification and validation testing were defined and conducted" to verify the design modifications met performance and safety requirements. This implies standalone testing related to the device's functional performance (e.g., accuracy of drug delivery, reliability of software). However, the specific methodology or quantitative results of such standalone functional testing are not detailed in this summary. The focus is on demonstrating substantial equivalence via design modifications and non-clinical testing.

7. Type of Ground Truth Used:

For an infusion pump, "ground truth" would relate to its engineering specifications and the accurate delivery of fluids.

Ground Truth (Implicit): The ground truth for this device would be established by:
- Engineering Specifications: Pre-defined standards for flow rate accuracy, pressure limits, alarm thresholds, battery performance, etc.
- Bench Testing/Metrology: Using calibrated equipment to measure pump output, confirm programmed rates, and verify safety features against these specifications.
- Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (e.g., Palm Pump K002434) serve as a de-facto "ground truth" or benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The device is a traditional electro-mechanical infusion pump with software.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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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.

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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:

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.

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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.

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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

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Indications for Use

K 0522 510(k) Number (if known): ___

Device Name: ambIT® "PreSet" Ambulatory Infusion Pump

Indications For Use:

Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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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

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).