ZIO PATCH

K121319 · iRhythm Technologies, Inc. · DSH · Jul 18, 2012 · Cardiovascular

Device Facts

• Record ID: K121319
• Device Name: ZIO PATCH
• Applicant: iRhythm Technologies, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The Zio Patch is a prescription-only, single-patient-use, continuously recording ECG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.

Device Story

Zio Patch is a single-patient-use, wearable, continuous ECG monitor; worn on chest for up to 14 days. Device records cardiac electrical activity; patient returns patch to iRhythm for data analysis. iRhythm processes data; generates report for physician review. Physician uses report to diagnose cardiac arrhythmias; facilitates clinical decision-making regarding patient treatment. Benefits include extended monitoring duration compared to traditional Holter monitors, increasing probability of capturing transient cardiac events.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological characteristics and intended use comparison to predicate.

Technological Characteristics

Wearable, single-patient-use ECG monitor; adhesive patch form factor. Continuous recording capability up to 14 days. Solid-state memory for data storage. Non-invasive; battery-powered. Analysis performed via external processing facility.

Indications for Use

Indicated for patients, asymptomatic or symptomatic (palpitations, dyspnea, dizziness, light-headedness, pre-syncope, syncope, fatigue, anxiety), requiring continuous ECG monitoring for up to 14 days. Prescription-only.

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.

Predicate Devices

• SEER Light Holter Monitor (K052639)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

JUL 18 2012

Re: K121319

Trade/Device Name: Zio® Patch Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Codes: DSH Dated: May 1, 2012 Received: May 2, 2012

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.

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 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

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Page 2 - Mr. Michael S. Righter

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/Safety/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

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for iRhythm. The logo consists of the word "iRhythm" in a serif font, with the "i" in lowercase and the "R" in uppercase. Above the word "iRhythm" are five stylized leaf-like shapes arranged in a diagonal line. The first three shapes are solid black, while the last two are outlined.

## INDICATIONS FOR USE STATEMENT

K121319 510(k) Number:

Zio® Patch Device Names:

Indications for Use:

The Zio Patch is a prescription-only, single-patient-use, continuously recording ECG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR .

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)

VDrikius Sius Om

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** R/21319