SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM

K060933 · Apex Medical Technologies, Inc. · MEB · May 9, 2006 · General Hospital

Device Facts

• Record ID: K060933
• Device Name: SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
• Applicant: Apex Medical Technologies, Inc.
• Product Code: MEB · General Hospital
• Decision Date: May 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Solace Infusion System is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care site. The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion. The Solace Infusion System is for single patient use only. The Solace Infusion System is not intended for intravenous, intraarterial or epidural drug delivery. The Solace Infusion System is not intended for the delivery of blood, blood products or lipids or fat emulsions.

Device Story

Single-use, disposable elastomeric infusion pump; delivers medication at constant flow rate (0.5–10 ml/hr) via permanently attached administration set and catheter. Input: medication solution in 65–500 ml reservoir. Operation: elastomeric bladder (synthetic polyisoprene) provides pressure; flow restrictive tubing regulates delivery. Output: continuous infusion to surgical site, subcutaneous, or intramuscular tissue. Used in hospital, home, or alternative care sites; operated by clinicians or patients. Benefits: provides ambulatory post-operative pain management. Healthcare providers use the system to deliver analgesics directly to target sites; output affects pain management protocols.

Clinical Evidence

Bench testing only. Performance data demonstrated flow rate accuracy of +/- 15% over the infusion system, consistent with predicate devices.

Technological Characteristics

Single-use disposable elastomeric infusion pump. Materials: proprietary synthetic polyisoprene (no natural rubber/accelerators). Energy: passive elastomeric bladder pressure. Flow regulation: flow restrictive tubing. Flow rate: 0.5 ml to 10 ml per hour. Fill volume: 65 ml to 500 ml. Form factor: spherical balloon with attached administration set and catheter (standard or multi-hole infusion segments).

Indications for Use

Indicated for continuous infusion of medications for post-operative pain management via intraoperative, subcutaneous, or intramuscular routes. For single patient use in hospital, home, or alternative care settings.

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

• Baxter Infusor (K051253)
• I-Flow Pump (K040337)
• Baxter Pain Management System (K002380)
• I-Flow PainBuster Infusion Kit (K982946)
• I-Flow Nerve Block Infusion Kit (K984502)
• I-Flow Soaker Catheter (K043456)

Submission Summary (Full Text)

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510(k) Premarket Notification STO(R) Premative Pain Management System

Attachment 3 – Summary Page 1 of 3 0977

## 510(k) Summary

.. .

| Date of Submission: | April 20, 2006 |
|---------------------|----------------|
|---------------------|----------------|

MAY - 9 2006

| Submitter: | Apex Medical Technologies, Inc.<br>10064 Mesa Ridge Court, Suite 202<br>San Diego, CA 92121<br>Phone: (858) 535 - 0012<br>Fax: (858) 535 - 9715 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Whitney A. Williams<br>Development Engineer<br>Apex Medical Technologies, Inc. |
| Trade Name: | Solace Post-Operative Pain Relief Infusion System |
| Common Name: | Infusion Pump |
| Classification: | Pump, Infusion, Elastomeric (21CFR 880.5725, Product Code<br>MEB, MRZ) |
| Comparison Device: | Baxter Infusor, K051253<br>I-Flow Pump, K040337<br>Baxter Pain Management System, K002380<br>I-Flow PainBuster Infusion Kit, K982946<br>I-Flow Nerve Block Infusion Kit, K984502<br>I-Flow Soaker Catheter, K043456 |
| Device Description: | Apex's Solace Post-Operative Pain Relief Infusion System is a<br>single use infusion device, which incorporates an elastomeric<br>bladder with a permanently attached fixed flow rate administration <nset a="" at="" constant="" deliver="" designed="" flow="" medication="" rate.="" the<br="" to="">medication enters the body via a catheter, which is inserted near a<br/>surgical wound site then positioned under the skin. The pump<br/>attaches to the catheter at the distal end of the administration set.<br/>The catheter consists of four design options (same as predicate<br/>devices).</nset> |

Confidential Property of Apex Medical Technologies, Inc.

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Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5-inch infusion segment.

Catheter with infusion segment: a modified epidural with multiple holes at the distal end with 2.5 inch, 5.0 inch and 10 inch infusion segments. The holes are arranged so that the flow is evenly distributed along the infusion segment.

The system may also incorporate a dual port site for dual catheter use.

The Solace Infusion System is intended for continuous infusion of Indications for Use: medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.

The Solace Infusion System is for single patient use only. Intended Use:

> The Solace Infusion System is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care site.

The Solace Infusion System is not intended for intravenous, intraarterial or epidural drug delivery.

The Solace Infusion System is not intended for the delivery of blood, blood products or lipids or fat emulsions.

Technological The Solace Infusion System and predicate devices are single-use Characteristics: disposable elastomeric infusion pumps designed to deliver solution at a constant flow rate (0.5 ml to 10 ml per hour) via a permanently attached set. The maximum fill volume range is 65 ml to 500 ml (Baxter maximum volume is 270 ml).

> The Solace pump utilizes flow restrictive tubing to achieve +/-15% flow accuracy over the infusion system.

The I-Flow pump utilizes a glass capillary and/or flow restrictive tubing to achieve +/- 15% flow accuracy over the infusion system.

The Baxter pump utilizes a glass capillary to achieve +/- 10% flow accuracy over the infusion system.

Confidential Property of Apex Medical Technologies, Inc.

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The Solace pump balloon is spherical and is made from a proprietary synthetic polyisoprene formulation that contains no natural rubber or accelerators.

The I-Flow and Baxter pump balloons are cylindrical. The I-Flow pump balloon is made from synthetic polyisoprene and natural rubber. The Baxter pump balloon is made from a proprietary synthetic polyisoprene formulation.

The Solace Post-Operative Pain Relief Infusion System is Conclusion: substantially equivalent to the existing pain management kits.

Confidential Property of Apex Medical Technologies, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Apex Medical Technologies, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K060933

Trade/Device Name: Solace Post-Operative Pain Relief Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: April 21, 2006 Received: April 24, 2006

Dear Mr. Mosenkis:

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. Mosenkis

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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) 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 regulation (21 CFR Part 801), please contact the Office of 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 Division 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,

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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| Applicant: | Apex Medical Technologies, Inc. |
|---------------------------|---------------------------------------------------|
| 510(k) Number (if known): | K464933 |
| Device Name: | Solace Post-Operative Pain Relief Infusion System |
| Indications for Use: | |

- 1. The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.
Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

on of Anesthesiology, General Hospital,

ion Control, Dental Devices

Sunton.

Confidential Property of Apex Medical Technologies, Inc.