SMARTBLOCK PAIN PUMP

K072053 · Medical Flow Systems, Ltd. · MEB · Nov 6, 2007 · General Hospital

Device Facts

• Record ID: K072053
• Device Name: SMARTBLOCK PAIN PUMP
• Applicant: Medical Flow Systems, Ltd.
• Product Code: MEB · General Hospital
• Decision Date: Nov 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.

Device Story

SmartBlock™ Pain Pump is a disposable infusion system for regional anesthesia and pain management. Device components include a compression unit with a solution reservoir (up to 500 ml), a SmartInfuser regulating set, a 50/60 cc disposable syringe, wound dressing, and optional FlowSpliter™. The system delivers medication continuously or intermittently to surgical wound sites or near nerves. It is used in clinical settings for preoperative, perioperative, and postoperative care. The device provides specific flow rate ranges (1-6 ml/hr or 5-15 ml/hr) and optional bolus functionality to assist clinicians in managing patient pain. The system is designed for intraoperative, perineural, percutaneous, and epidural administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable infusion pump system. Components: compression unit, solution reservoir (up to 500 ml), SmartInfuser regulating set, 50/60 cc syringe. Flow rate options: 1-6 ml/hr or 5-15 ml/hr. Includes optional bolus feature and FlowSpliter™. Mechanical flow regulation.

Indications for Use

Indicated for patients requiring regional anesthesia and pain management via continuous or intermittent medication delivery to surgical wound sites or near nerves; applicable for preoperative, perioperative, and postoperative use; routes include intraoperative, perineural, percutaneous, and epidural.

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

• On-Q Pump (K063530)

Submission Summary (Full Text)

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K072053

Image /page/0/Picture/1 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' in a stylized font, with a teardrop shape incorporated into the 'f'. The text 'Medical Flow Systems Ltd.' is written below the letters.

P.O.Box 26, Shlomi 22832, Israel ● Tel: [phone] ● Fax: [phone] E-mail: [e-mail] ● www.mfs-medical.com

## 510(k) Summary:

## SmartBlock™ Pain Pump

Company Name: Medical Flow Systems Ltd.

NOV 0 6 2007

### Contact Person:

Ofer Shai Managing Director

Phone: [phone] [phone] Fax: E-mail: [e-mail]

### Authorized US Agent:

Mark Dollinger - President Trendlines America 2940 West, 123rd Terrace Leawood, Kansas 66200

Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date prepared: July 20, 2007

Trade Name: SmartBlock™ Pain Pump

Classification name: Pump, infusion

Common/usual name: Disposable Pain Management System

Product Code: MEB

Regulation No .: 880.5725

Class: II Panel identification: General Hospital Panel

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Image /page/1/Picture/0 description: The image shows a logo with the letters 'mfs' in a stylized font. The 'm' is in lowercase, while the 'f' and 's' are in uppercase. A teardrop shape is positioned below the 'f', creating a unique design element. Below the logo, the text 'Medical Flow Systems Ltd' is printed in a smaller font, indicating the name of the company or organization associated with the logo.

P.O.Box 26, Shlomi 22832, Israel ● Tel: [phone] ● Fax: [phone] E-mail: [e-mail] ● www.mfs-medical.com

### Predicate Device:

On-Q Pump, I-Flow Corp. 20202 Widrow Dr., Lake Forest, CA 92630, cleared under 510(k) no. K063530.

### Description of the device:

The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.

The SmartBlock™ device comprises of the following components:

- Compression unit including solution reservoir (up to 500 ml)
- SmartInfuser regulating set (several versions of flow rate ranges, with or without MultiBolus™)

- 50/60 cc disposable svringe
- Wound dressing
- Medication labes
- Pump lables
- Carry pouch
- FlowSpliter™ (optional)

The SmartBlock™ Pain Pump is designed for the following flow rate options:

| Reference # | Flow Rate Range | Bolus Feature | |
|-------------|-----------------|---------------|--------------|
| 1 | P49520 | 1-6 ml/hr | Included |
| 2 | P49524 | 5-15 ml/hr | Included |
| 3 | P49530 | 1-6 ml/hr | Not included |
| 4 | P49534 | 5-15 ml/hr | Not included |

### Indications for Use:

The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.

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Image /page/2/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' in a stylized font, with a water droplet replacing the dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written below the logo in a smaller font.

P.O.Box 26, Shlomi 22832, Israel ● Tel: [phone] ● Fax: [phone] E-mail: [e-mail] ● www.mfs-medical.com

### Substantial Equivalence:

The SmartInfuser PainPump™ has the same intended use as the On-Q Pump, cleared under 510(k) no. K063530and has equivalent performance characteristics. It is therefore substantially equivalent to that device.

### Conclusion -

The evaluation of the SmartBlock™ Pain Pump does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and a serpent winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2007

Medical Flow Systems, Limited C/O Mr. Mark Dollinger President Treadlines America 2940 West 123rd Terrace Leawood, Kansas 66200

Re: K072053

Trade/Device Name: SmartBlock™ Pain Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: September 23, 2007 Received: September 25, 2007

Dear Mr. Dollinger:

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. Dollinger

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Neil R. P. Ogden

Chiu Lin, Ph.D. Ja 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

| 510(k) Number (if known): | K072053 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SmartBlock™ Pain Pump |
| Indications for Use: | The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. |

Prescription Use X OR (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

( Infection Control Anosthesionogy, Gene

510(k) Number: _______________________________________________________________________________________________________________________________________________________________