(84 days)
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No
The provided text does not mention AI, ML, or any related terms, and the device description focuses solely on its function as a continuous ECG monitor.
No
The Zio TM patch is an ECG monitor used for diagnosis, not for treating or providing therapy for a medical condition.
Yes
The device is indicated for use on patients experiencing symptoms like syncope, palpitations, shortness of breath, or chest pains, and functions as a continuous recording ECG monitor. This suggests its purpose is to collect data that can aid in identifying or characterizing a medical condition, which is the definition of a diagnostic device.
No
The device description explicitly states it is a "patch" and an "ECG monitor," which are hardware components.
Based on the provided information, the Zio TM patch is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Zio TM patch is an ECG monitor that records electrical activity of the heart directly from the patient's skin. It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use describes monitoring the patient's heart activity. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Zio TM patch falls under the category of a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes
DSH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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 |
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