(83 days)
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No
The summary describes a device for acquiring, displaying, storing, recording, analyzing, and presenting physiological data. While it performs analysis, there is no mention of AI, ML, or related terms, nor is there any description of training or test sets which are typical for AI/ML-based devices. The analysis described appears to be standard signal processing and data presentation.
No
The device is described as acquiring, displaying, storing, recording, analyzing, and presenting patient data like ECG, heart rate, blood pressure, etc. These are diagnostic and monitoring functions, not therapeutic interventions.
Yes
Explanation: The device acquires, displays, stores, records, and analyzes essential patient data (ECG/Heart Rate, blood pressures, pulse oximetry, EtCO2, respiration, cardiac output, body temperatures), and presents it in various report formats, which are all functions consistent with diagnostic purposes.
No
The device description explicitly states it is a "computerized laboratory, capable of acquiring and displaying essential patient data" and mentions acquiring data from various physiological sensors (ECG, blood pressure, pulse oximetry, etc.). This implies the device includes hardware components for data acquisition, not just software for processing and display.
Based on the provided information, the Horizon SE is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description focuses on acquiring and displaying physiological data directly from the patient (ECG, blood pressure, pulse oximetry, etc.). This is in-vivo measurement, not testing of samples taken from the body.
- Device Description: The description reinforces that the device acquires and displays real-time physiological data from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
The Horizon SE is a patient monitoring system that measures and displays vital signs directly from the patient's body. This falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, EtCO2, respiration, cardiac output and body temperatures.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
Product codes
DQK
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
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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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the text "K070254 page 1/1" in a handwritten style. The text is black against a white background. The numbers and letters are slightly uneven, giving it a casual, handwritten appearance.
| Name: | Mennen Medical Ltd. |
|---|---|
| Registration Number: | 9611022 |
| Operator Number: | 9069173 |
| Address: | 4 Hayarden Street, Yavne, 81228, Israel |
| Postal Address: | PO Box 102, |
| Rehovot, 76100, Israel | |
| Tel: | +972-8-9323333 |
| Fax: | +972-8-9328510 |
| Contact person: | Micha Oestereich, Regulatory Affairs |
| APR 19 2007 |
Traditional 510(k): Device Modification - Horizon SE
Terminology
Horizon SE = Subject of this 510(k). The Horizon SE is a modified device, a system identical to of the Horizon SE Cathlab with the addition of EtCO2 measurement.
Horizon SE = The predicate device. The Horizon SE Cathlab was cleared for marketing by the FDA (K032997)
VitaLogik 5000 = The predicated device for EtCO2 measurement. The VitaLogik 5000 was cleared for marketing by FDA (K052288)
Intended Use of the Horizon SE
The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2007
Mennen Medical Ltd. c/o Mr. Micha Oestereich Regulatory Affairs 4 Hayarden Street, Yavne, 81228, Israel PO Box 102 Rehovot, 76100, Israel
Re: K070254
Trade Name: Horizon SE Cathlab with etCO2 Option Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: January 6, 2007 Received: January 26, 2007
Dear Mr. Oestereich:
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.
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
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Page 2 – Mr. Micha Oestereich
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B. Himmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number : K070254
Device Name: Horizon SE
INDICATIONS FOR USE
The Horizon SE is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, EtCO2, respiration, cardiac output and body temperatures.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
Prescription Use (Part 21 CFR 801 Subpart D)
B.Bimmma
(Division Sign-Off)