(102 days)
Not Found
No
The description focuses on the device being a pre-packaged collection of existing, legally marketed disposable devices for anesthesia procedures, with no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is described as a collection of legally marketed, typically and repeatedly used disposable devices for the setup, performance, transport, and recovery phases of anesthesia procedures, not for treating a disease or condition.
No
The text describes the Vital Pak as a convenience package of disposable devices used during anesthesia procedures, transport, and recovery. It simply groups together "legally marketed" devices typically used by anesthesia clinicians and does not mention any function for diagnosis or the output of diagnostic information.
No
The device description explicitly states that the Vital Pak is a "customizable, convenience packaged group of sterile and non-sterile disposable devices," indicating it is a collection of physical medical devices, not software.
Based on the provided information, the Vital Pak is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the Vital Pak as a collection of disposable devices used during the setup and performance of anesthesia procedures. This involves direct interaction with the patient and the delivery of care, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces that the devices are used during anesthesia procedures and potentially transport and recovery. This aligns with devices used in a clinical setting for patient care, not laboratory testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The Vital Pak appears to be a convenience kit containing standard medical devices used in anesthesia, similar to its predicate device, the General Anesthesia System (GAS). These types of devices are generally classified as medical devices, but not specifically as IVDs.
N/A
Intended Use / Indications for Use
The Vital Pak is an expansion of the currently marketed General Anesthesia System (GAS). It is, like the GAS, a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the setup and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure.
Product codes
74KFN
Device Description
The Vital Pak is an expansion of the currently marketed General Anesthesia System (GAS). It is, like the GAS, a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the setup and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.
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
anesthesia clinicians
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
- 8 1996 ATTACHMENT 2
510(k) Summary
MAID
VITAL PAK
Prepared February 29, 1996
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and Sec. 801.92(c).
- Submitter's Name and Address:
Vital Signs, Inc. 20 Campus Road Totowa, NJ 07512
- Contact Person:
Ms. Whitney Torning Telephone: (201) 790-1330, Extension 392 Fax: (201) 790-7585
-
- Name of Device:
Classification Name: Common Name: Proprietary Name:
- Name of Device:
Accessory to Monitor, Cardiac Output, Thermal Anesthesia Kit Vital Pak
-
- Classification:
C.F.R. Section: Panel: Product Code: Device Class:
- Classification:
21 CFR 870.1435 Cardiovascular 74KFN Class II
-
ડ. Performance Standards:
No performance standard(s) applicable to this device have been promulgated under Section 514 of the Food, Drug and Cosmetic Act. -
ર. Device Description and Indicated Use:
The Vital Pak is an expansion of the currently marketed General Anesthesia System (GAS). It is, like the GAS, a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the setup and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.
1
Substantial Equivalence:
The Vital Pak is an expansion of the General Anesthesia System (GAS). The GAS was described in the 510(k) K945455 and received FDA clearance on December 23, 1994. Since, the addition of legally marketed devices to the GAS does not either change the intended use of the kit, nor does it affect the safety or efficacy of the kit, the Vital Pak is substantially equivalent to the GAS.
The Vital Pak is "convenience packaging" of devices legally marketed and commercially available. The packaging of this convenience kit does not alter the intended use of any of its individual devices. The Vital Pak is as safe and effective as the devices included. Therefore, the Vital Pak is also substantially equivalent to the devices included in it.
[END OF SUMMARY]