(172 days)
No
The summary describes a disposable kit for regional anesthesia with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the administration of regional anesthesia, which is a medical treatment for pain management.
No
The device is described as being used for the "administration of regional anesthesia," which is a treatment, not a diagnostic process.
No
The device description explicitly states it is a "disposable, single patient, single use device" and mentions "componentry within the kit," indicating it is a physical hardware device, not software only.
Based on the provided information, the MedCare Regional Anesthesia Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of regional anesthesia." This is a procedure performed directly on a patient's body, not on a sample taken from the body (which is the hallmark of an in vitro diagnostic).
- Device Description: The description focuses on the components used for administering the anesthesia, again pointing to a device used in a clinical procedure on a patient.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is clearly intended for a therapeutic or procedural use in administering medication to a patient, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.
Product codes
Not Found
Device Description
The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.
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
Not Found
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)
Reference Device(s)
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
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
SEP - 6 1996
510(k) Summary: (D)
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
- (1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446
Contact Person:
Craig J. Bell Director of Research and Development (603)352-3230
- Name of Device: (2)
Regional Anesthesia Kit
Classification Name:
Anesthesia Conduction Kit
-
(3) Identification of Predicate Devices:
Regional Anesthesia Kits: -
- Spinal
-
- Epidural/Caudal
-
- Nerve Block
-
Kendall HealthCare Products Company (a) Mansfield, MA 02048
1
(4) Description of Device Subject to Premarket Notification:
The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.
(ર) Intended Use of the Device:
The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.
(6) Technological Characteristics
The MedCare Regional Anesthesia Kit is similar to the predicate devices in that all of the devices provide a variety of components for the administration of regional anesthesia. All the devices provide flexibility in componentry selection for customization to the user and the particular type of regional anesthesia being performed; spinal, epidural-caudal, or nerve block.