(47 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard physiological monitoring parameters (IBP and temperature).
No.
The device is indicated for measuring physiological parameters (arterial, venous, intracranial pressures and temperature), which are diagnostic measurements, not therapeutic interventions.
Yes
The device is indicated for "measuring arterial, venous, and intracranial pressures" and "measuring temperature," which are diagnostic measurements used to assess a patient's condition.
No
The device description explicitly states "ZOLL M Series IBP and Temperature Option," which implies a hardware component (the M Series device) with software options for IBP and Temperature. The intended use also describes measuring pressures and temperatures using "invasive transducers" and "temperature sensors," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device measures:
- IBP (Invasive Blood Pressure): This is a direct measurement of pressure within the body using invasive transducers.
- Temperature: This is a direct measurement of body temperature using sensors.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly measures physiological parameters within or on the body.
Therefore, the ZOLL M Series IBP and Temperature Option falls under the category of a medical device that performs physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IBP
The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial pressures using invasive transducers with 5uV/V/mmHg sensitivity for use with critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only.
Contraindications:
The ZOLL M Series IBP option is not indicated for use on neonatal patients.
TEMPERATURE
The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.
Contraindications:
The ZOLL M Series Temperature option is not indicated for use on neonatal patients.
Product codes
74 DSK
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
Adult and pediatric patients only. Not indicated for use on neonatal patients.
Intended User / Care Setting
Critical care and transport.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 31 2001
Mr. Paul Dias Director, Quality Assurance and Regulatory ZOLL Medical Corporation 32 Second Avenue Burlington, MA 01803-4420
Re: K011865
Trade Name: ZOLL M Series IBP Option ZOLL M Series Temperature Option Regulation Number: 21 CFR 870.1110 Regulatory Class: II (two) Product Code: 74 DSK Dated: June 12, 2001 Received: June 14, 2001
Dear Mr. Dias:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 provision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( fecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish
1
Page 2 - Mr. Paul Dias
further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premarker notheaters the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematket I his letter will anow you to begill marketing your device to a legally marketed nothication. The PDA imania of backan.com 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 and If you desire specific advice to your do rise contact the Office of Compliance at additionally 809.10 for m vitto diagnostions on the promotion and advertising of your device, (301) 394-4040. Addinonally, for questions on are parties of Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, TMIsoranding by relearles to premained from the Division of Small
information on your responsibilities under the Act 12011 412 6507 - at its information on your responsionnes analy under (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Dak Vill
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 6 - Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
ZOLL M Series IBP and Temperature Option Device Name:
Indications for Use:
IBP
The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial Trie ZOLL M Series TD "Option is Indication For resimitivity for resting patients in
pressures using invasive transducers with 5uV/V/mmHg sensitivity for use with and pressures using finasive transducers with our rimming sommercy.
critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only.
Contraindications:
The ZOLL M Series IBP option is not indicated for use on neonatal patients.
TEMPERATURE
The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.
Contraindications:
The ZOLL M Series Temperature option is not indicated for use on neonatal patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ca. Ve. Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K011863
Prescription Use (Per 21 CFR 801.109
or
Over-The-Counter-Use
(Optional Format 1-2-96)