ZIO PATCH

K113862 · iRhythm Technologies, Inc. · DSH · Feb 6, 2012 · Cardiovascular

Device Facts

• Record ID: K113862
• Device Name: ZIO PATCH
• Applicant: iRhythm Technologies, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Feb 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The Zio® Patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

Device Story

Zio Patch is a wearable, single-patient use, continuous ECG monitor; worn for up to 14 days. Device records cardiac electrical activity; data retrieved post-wear for analysis. Used in clinical settings or by patients at home under physician prescription. Output consists of recorded ECG data; healthcare providers review data to correlate patient symptoms with cardiac events. Facilitates diagnosis of arrhythmias; benefits patient by providing extended monitoring period compared to traditional Holter monitors.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Single-patient use, wearable ECG monitor. Continuous recording capability for up to 14 days. Form factor designed for patient comfort during extended wear. Technical specifications and materials not detailed in provided text.

Indications for Use

Indicated for patients experiencing transient symptoms including syncope, palpitations, shortness of breath, or chest pains. Prescription only, single-patient use.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 6 2012

iRhythm Technologies, Inc. c/o Michael Righter Manager of Quality Assurance and Regulatory Affairs 650 Townsend Street, Suite 380 San Francisco, CA 94103

Re: K113862

> Trade Name: Zio® Patch Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II Product Code: DSH (Recorder, Magnetic Tape, Medical) Dated: December 23, 2011 Received: December 30, 2011

Dear Mr. Righter:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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## Page 2 - Mr. Michael Righter

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 limpited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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## INDICATIONS FOR USE STATEMENT

510(k) Number:

\$\frac{K11}{3862}\$

Device Names: Zio® Patch

Indications for Use:

The Zio® Patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

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)

(Division Sign-Off)
Division of Cardiovascular Devices

(113862 510(k) Number_