SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

K023083 · Mettler Electronics Corp. · FRN · Feb 28, 2003 · General Hospital

Device Facts

• Record ID: K023083
• Device Name: SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
• Applicant: Mettler Electronics Corp.
• Product Code: FRN · General Hospital
• Decision Date: Feb 28, 2003
• Decision: ST
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Ultrasonic dispersion of infused subcutaneous fluid prior to saphenous vein harvesting for coronary artery bypass graft surgery. The one megahertz ultrasound/peristaltic irrigation pump combination system, trade name Silberg T.P.S. (Tissue Preparation System), provides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any life-sustaining purpose.

Device Story

Silberg Tissue Preparation System (ME 800) combines 1 MHz ultrasonic generator, 10 cm2 applicator, and peristaltic irrigation pump. Used in clinical settings by medical professionals to prepare tissues for saphenous vein harvesting. Device infuses and disperses tumescent fluid subcutaneously via hollow cannula; ultrasound energy facilitates dispersion. System includes foot switch, IV pole, and irrigation tubing. Output is controlled via front panel potentiometer. Facilitates tissue hydration and preparation for vein removal; benefits patient by optimizing surgical site conditions for graft harvesting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and functional comparison to legally marketed predicate devices.

Technological Characteristics

System comprises 1 MHz ultrasonic generator, 10 cm2 applicator, and peristaltic irrigation pump. Components housed in non-conductive plastic. Energy source: electrical (ultrasound and pump). Connectivity: manual control via front panel potentiometer and foot switch. No software-based automation or digital connectivity described.

Indications for Use

Indicated for subcutaneous infusion and ultrasonic dispersion of tumescent fluid prior to saphenous vein harvesting for coronary artery bypass graft surgery. Not for parenteral fluid administration, drug infusion, or life-sustaining purposes.

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

• Sonicator 716, Model ME 716 (K934846)
• Irrigation or Infusion Pump 'K' Pump (K991203)

Submission Summary (Full Text)

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## K023083

FEB 2 8 2003

# SILBERG'S VEIN PREPARATION SYSTEM MODEL ME 800 510(K) SUMMARY STATEMENT (KXXXXX)

| Submitter's Name: | Mettler Electronics Corp. |
|-------------------|----------------------------|
| Address: | 1333 South Claudina Street |
| | Anaheim, CA 92805 |

Telephone: [phone]

Contact: Robert E. Fleming Director, QA/RA

Date Prepared: September 16, 2002

#### Proposed Device Name:

| a. | TRADE NAME: |
|----|-------------|
| | |

| b. CLASSIFICATION NAME: | |
|-------------------------|--|
| c. COMMON NAME: | |

Silberg T.P.S., Model ME 800 Ultrasonic Physiotherapy Ultrasonic Physiotherapy

### Predicate Devices:

| TRADE NAME: | 510(k) Number |
|--------------------------------------|---------------|
| Sonicator 716, Model ME 716 | K934846 |
| Irrigation or Infusion Pump "K" Pump | K991203 |

### Description of Proposed Device:

The Silberg Tissue Preparation System, Model ME 800, consists of a 1 MHz ultrasonic generator, 10 cm2 ultrasonic applicator, peristaltic pump irrigation unit. foot switch, hollow cannula, system cart, IV pole with saline solution bag and irrigation tubing set.

### Proposed Device Intended Use Statement:

510(k) Number: TBD

Device Name: Silberg Tissue Preparation System, Model ME 800

Indication for use:

- 1. Ultrasonic dispersion of infused subcutaneous fluid prior to saphenous vein harvesting for coronary artery bypass graft surgery.

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# K023083

# SILBERG'S VEIN PREPARATION SYSTEM MODEL ME 800 510(K) SUMMARY STATEMENT (KXXXXXX)

### Comparison of Technological Characteristics Between Proposed and Predicate Devices:

The ultrasound portion of the Tissue Preparation System is functionally and electrically the same as the Sonicator 716, ME 716, ultrasound therapy device (K934846). The only difference is the housing in which the ME 716 is installed. It is a non-conductive plastic housing containing the ultrasound component and subassemblies along with the pump and controller electronics for the saline delivery system that complements use of ultrasound to prepare tissues for vein removal.

The peristaltic irrigation pump and controller system is the same as the Barnant pump system used by the KMI Kolster Methods, Inc. "Irrigation or Infusion Pump 'K' Pump" (K991203). It is driven by a foot switch with relative flow rate controlled by front panel potentiometer and provides the saline solution for hydration of tissues in preparation for vein removal.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 2 8 2003

Mettler Electronics Corporation Robert E. Fleming Director, QA/RA 1333 South Claudina Street Anaheim, California 92805

Re: K023083

Trade/Device Name: Silberg T.P.S., Model ME 800 Regulation Number: 880.5725; 890.5860 Regulation Name: Infusion pump; Ultrasound and muscle stimulator for use in applying therapeutic deep heat Regulatory Class: Class II Product Code: FRN; IMG Dated: November 26, 2002 Received: December 2, 2002

Dear Mr. Fleming:

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.

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

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Page 2 – Mr. Robert E. Fleming

(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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Muth N. Mullener

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4023083

# INDICATIONS FOR USE STATEMENT

SILBERG T.P.S. (Tissue Preparation System), ME 800

Indication for use:

The one megahertz ultrasound/peristaltic irrigation pump combination system, trade name Silberg T.P.S. (Tissue Preparation System), nrovides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any life-sustaining purpose.

Marlu N Millkum
Division Sign Off

Division of Coneral, Restorative and Neurological Devices

ೆ ೧(k) Number _______________________________________________________________________________________________________________________________________________________________