AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP

K052221 · Sorenson Medical, Inc. · FRN · Dec 8, 2005 · General Hospital

Device Facts

• Record ID: K052221
• Device Name: AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
• Applicant: Sorenson Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Compact, lightweight, microcomputer-controlled ambulatory infusion pump; utilizes rotary peristaltic pumping technology. Operated by surgeons and anesthesiologists in perioperative and post-operative settings. Delivers local anesthetics and narcotics via intravenous, subcutaneous, intramuscular, perineural, or epidural routes. Device features modified printed circuit board and software revision to facilitate user programming. Provides volumetric delivery of fluids at preset rates and volumes. Clinical benefit includes reduced narcotic consumption and improved pain management compared to narcotic-only regimens.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per Sorenson Medical quality system requirements to confirm design modifications met performance and safety specifications.

Technological Characteristics

Rotary peristaltic infusion pump; microcomputer-controlled. Features modified printed circuit board and software. Compact, lightweight form factor. Powered by internal electronics. Sterilization method not specified.

Indications for Use

Indicated for surgeons and anesthesiologists for perioperative and post-operative infusion of local anesthetics and narcotics for pain management and regional anesthesia. Routes include intravenous, subcutaneous, intramuscular, perineural, and epidural. Intended to decrease narcotic use and pain when delivering local anesthetics to surgical wound sites or near nerves.

Regulatory Classification

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.

Predicate Devices

• The MicroJect PCA Pump (K965222)
• The Palm Pump (K002434)
• The amblT® Continuous Ambulatory Infusion Pump (K033325)
• Stryker Pain Pumps 1 & 2 (K042405)

Submission Summary (Full Text)

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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:

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.

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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 [phone]. 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 [phone] or [phone] 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:

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 _____________________________________________________________________________________________________________________________________________________________

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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