SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000

K023713 · Sontra Medical, Inc. · KRC · Jan 28, 2004 · Cardiovascular

Device Facts

• Record ID: K023713
• Device Name: SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
• Applicant: Sontra Medical, Inc.
• Product Code: KRC · Cardiovascular
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2370
• Device Class: Class 2

Indications for Use

The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG Impedance. The Supplied Stock onstrated that the SonoPrep IDx reduced skin monitoring. Olimour rooms when used in conjunction with the supplied ECG impediation for 21 how patients developing skin irritation. However, any skin irritation resolved within a 24 hour period.

Device Story

SonoPrep IDx system prepares skin for ECG monitoring by lowering skin impedance. System components include microprocessor-controlled ultrasonic skin prep generator, reusable handpiece, reusable handheld contact electrode, coupling media, and ECG electrodes. Device uses low-level ultrasonic energy to induce cavitation in coupling solution; cavitation acts on stratum corneum to increase skin conductance. Used in physician offices or hospital/institutional environments. Healthcare providers use device to improve signal-to-noise ratio for ECG monitoring. Benefits include improved signal quality for cardiac monitoring. Clinical studies showed no difference in ECG waveform morphology compared to predicate; minor skin redness resolved within 24 hours.

Clinical Evidence

Clinical studies compared SonoPrep IDx to predicate device. Results showed no difference in ECG waveform morphology or long-term impedance. Safety data indicated some patients developed redness at treated sites, which resolved within 24 hours without follow-up treatment. Bench testing and biocompatibility data also provided.

Technological Characteristics

System utilizes low-level ultrasonic energy to induce cavitation for stratum corneum modification. Components include microprocessor-controlled generator, reusable handpiece, and contact electrode. Designed for adult patients (>30kg).

Indications for Use

Indicated for preparation of intact skin to lower skin impedance for ECG monitoring in adult patients (>30kg).

Regulatory Classification

Identification

An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.

Predicate Devices

• Quinton, Inc. QuikPrep Electrode System (K782079)

Submission Summary (Full Text)

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## JAN 2 8 2004

## 510(k) Summary of Safety and Effectiveness

| Submitter: | Sontra Medical Corporation<br>10 Forge Parkway<br>Franklin, MA 02038 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Albert Farinha<br>Director of Clinical and Regulatory Affairs<br>Telephone: [phone] x224<br>Fax: [phone]<br>[e-mail] |
| Date: | January 11, 2004 |
| Trade Name: | SonoPrep™ Impedance Diagnostics (IDx) |
| Common Name: | Electrocardiograph (ECG) Electrode |
| Classification Names<br>and References: | Cardiovascular Monitoring Devices, 21 CFR<br>870.2360, Electrocardiograph Electrode. |
| Predicate Device: | Quinton, Inc. QuikPrep Electrode System,<br>K782079 |
| Device Description: | The Sontra Medical Corporation<br>SonoPrep™ Impedance Diagnostics (IDx)<br>System consists of a microprocessor<br>controlled ultrasonic skin prep generator, a<br>reusable handpiece, a reusable handheld<br>contact electrode, coupling media and ECG<br>electrodes used for ultrasonically treating<br>intact skin in order to lower the skin<br>impedance for the application of ECG<br>electrodes for monitoring heart rates. |
| Intended Use: | Use of these products is indicated for the<br>preparation of intact skin to lower skin<br>impedance. The supplied electrodes are<br>intended to be used for ECG monitoring. |
| Technological Characteristics: | The SonoPrep IDx system uses low level<br>ultrasonic energy to create cavitation in a<br>coupling solution which results in the<br>cavitation in the handpiece that causes the<br>outermost layer of skin, the stratum<br>corneum, to become increasingly |

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conductive. The increased conductance or lower impedance improves the signal to noise ratio which is important in ECG monitoring.

Bench testing, clinical testing and biocompatibility data demonstrate that the device is comparable to previous cleared devices. Clinical studies showed no difference in ECG waveform morphology or long term impedance as compared to the predicate device. Some patients developed redness at the treated sites which resolved within 24 hours and required no further follow-up treatment.

Performance Data:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 2 8 2004

Sontra Medical, Inc. c/o Mr. Albert Farinha Director of Regulatory and Clinical Affairs 58 Charles Street Cambridge, MA 02141

Re: K023713

Trade Name: SonoPrep™ Impedance Diagnostics (IDx) System Regulation Number: 21 CFR 870.2370 Regulation Name: Electrocardiograph Surface Electrode Tester Regulatory Class: Class II (two) Product Code: KRC Dated: November 4, 2003 Received: November 7, 2003

Dear Mr. Farinha:

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. Albert Farinha

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/dsma/dsmamain.html

Sincerely yours,

Donna R. Vachner

J. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 3 – Statement of Indications for Use

510(k) Number: Ko23913

Device Name: Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System

Intended Use / Indications for Use:

The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG Impedance. The Supplied Stock onstrated that the SonoPrep IDx reduced skin monitoring. Olimour rooms when used in conjunction with the supplied ECG impediation for 21 how patients developing skin irritation. However, any skin irritation resolved within a 24 hour period.

## Environment of Use / Patient Population:

- Handpiece: For multiple patient use in physician's office or hospital/institutional environment.
- Electrodes: For single patient use on adult patients (>30kg).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vichnes
Division of Cardiovascular & Respiratory Devices
510(k) Number K023713

Prescription Use
(per 21 CFR 801.109)

OR

Over the Counter Use _ Optional Format 1-2-96