(84 days)
The Zio TM 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.
The Zio TM patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days.
This document is a 510(k) clearance letter for the Zio™ patch Model Z100 from the U.S. FDA, dated May 8, 2009. It primarily grants market clearance and defines the indications for use. It does not contain detailed information about acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information based on the provided text. The document is for regulatory clearance and states that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study details.
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Image /page/0/Picture/0 description: The image shows a black and white logo for the U.S. Department of Health and Human Services. The logo features the text "U.S. HEALTH & HUMAN SERVICES. USA" arranged in an arc. To the right of the text is a stylized graphic with three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
iRhythm Technologies, Inc. c/o Mr. William H. Righter Director of Product Development 650 Townsend Street, Suite 380 San Francisco, CA 94103
Re: K090363
Trade/Device Name: Zio™ patch Model Z100 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Codes: DSH Dated: February 6, 2009 Received: February 13, 2009
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 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. William H. Righter
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
37 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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| Page 1 of 1 | |
|---|---|
| INDICATIONS FOR USE STATEMENT | |
| 510(k) Number: | K090363 |
| Device Names: | Zio TM patch |
| Indications for Use:. | |
| The Zio TM 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) | X |
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K090363 |
| 650 Townsend Street, Suite 380 San Francisco, CA 94103 (415) 632-5700 (415) 632-5701 www.irhythmtech.com |
દર્ભાગના પાક
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).