(300 days)
Not Found
Not Found
No
The description focuses on the device being a "passive connector" and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is described as a "passive connector" that allows connection to two defibrillators and a physiological monitor. It does not actively deliver therapy or perform a diagnostic function itself, but rather facilitates the use of other therapeutic (defibrillator) and diagnostic (monitor) devices.
No
The device is described as a passive connector for defibrillators and for unipolar recording, primarily facilitating the delivery of electrical energy or recording electrical signals, not for diagnosing medical conditions.
No
The device description explicitly states it is a "passive connector" and allows "connection to two defibrillators," indicating it is a hardware device designed to physically connect to other medical equipment.
Based on the provided information, the Booker Box is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Booker Box Function: The Booker Box is a passive connector used during a medical procedure (defibrillation) to connect external devices (defibrillators and a monitor) to the patient's body via electrodes. It facilitates the delivery of energy to the patient and the recording of physiological signals from the patient.
- No Specimen Testing: The description of the Booker Box's intended use and device description does not involve the testing of any biological specimens.
Therefore, the Booker Box falls under the category of a medical device used for direct patient intervention and monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.
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- Provides simultaneous connection to two defibrillators, which allows placement of a set of backup electrodes
- Provides connection to generic physiologic monitor recorder cable for unipolar recording from 2. using a back electrode.
-
- Used in Hospitals/EP Laboratories
-
- Used with manual defibrillators and has been tested with the following devices:
Hewlett Packard CodeMaster Hewlett Packard 7600, 7800 Zoll PD1200, PD1400, "M" Series Siemans 410 PhysioControl LifePak LP5, LP6, LP8, LP9, LP10 and LP 12
Product codes
74 LDD, DSA
Device Description
The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals/EP Laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center is a stylized emblem of an eagle, which is a common symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2000
Mr. Byron Zahler TZ Medical Inc. 15858 SW Upper Boones Ferry Road Lake Oswego, OR 97035
K993205 Re: Booker Box Defibrillation Cable Adapter, Model Pad 5001 Regulatory Class: II (two) Product Code: 74 LDD, DSA March 18, 2000 Dated: Received: April 21, 2000
Dear Mr. Zahler:
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 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. 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 further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Bryon Zahler
This letter will allow you to begin marketing your device as described in inzo feecer wire are area. The FDA finding of substantial your brokk, premains a legally marketed predicate device results equivalence of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation 11 you debiro opend additionally 809.10 for in vitro diagnostic (zi circ our over and add the Office of Compliance at (301) 594-4586. acviceb// produce on the promotion and advertising of your Additionally) to questions the office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premained insibilities under the Act may be obtained from the Division of your responsibirers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Buim E. Auseyom
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
993205 510(k) Number (if known)
Device Name:
Booker Box Defibrillation Cable Adapter and Adapter/Connectors
Indications For Use:
The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.
-
- Provides simultaneous connection to two defibrillators, which allows placement of a set of backup electrodes
- Provides connection to generic physiologic monitor recorder cable for unipolar recording from 2. using a back electrode.
- ડે. Used in Hospitals/EP Laboratories
-
- Used with manual defibrillators and has been tested with the following devices:
Hewlett Packard CodeMaster Hewlett Packard 7600, 7800 Zoll PD1200, PD1400, "M" Series Siemans 410 PhysioControl LifePak LP5, LP6, LP8, LP9, LP10 and LP 12
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office OF Device Evaluation (ODE)
E. D. Hanson
Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)