(266 days)
Not Found
No
The summary describes a physical kit for epidural anesthesia and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used to administer regional anesthesia, which is part of a surgical procedure, but the device itself is not providing therapy.
No
The device is described as an epidural kit for regional anesthesia during surgery, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "Kit" composed of "materials" and undergoes "physical testing," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide regional anesthesia during surgery. This is a therapeutic procedure performed directly on a patient, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description focuses on the materials and testing for suitability for direct patient contact and use in a surgical setting.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, diagnosing conditions based on biological markers, or any other activity typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a tool used for a medical procedure on a patient.
N/A
Intended Use / Indications for Use
The Perifix Pediatric Epidural Kit is designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.
Product codes
73 CAZ
Device Description
In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Perifix Pediatric The Perifix Pediatric Epidural Kit is Epidural Kit. designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.
The Perifix Pediatric Epidural Kit is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the level of the tenth thoracic vertebrae
Indicated Patient Age Range
pediatric patients
Intended User / Care Setting
Not Found
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
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
APR - 3 1997
July 9, 1996 B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
CONTACT: Mark S. Alsberge, Regulatory Affairs Manager
Perifix Pediatric Epidural Kit PRODUCT NAME:
Conduction Anesthesia Kit TRADE NAME :
CLASSIFICATION NAME:
Anesthesiology Class II, 73 CAZ, Conduction Anesthesia Kit 21 CFR 868.5140
SUBSTANTIAL EQUIVALENCE, TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K813186 | Perifix Set | |
| for | ||
| Epidural Anesthesia | Burron Medical | |
| K893766 | Lifecare Epidural | |
| Catheter | Abbott | |
| K953467 | Spinal Anesthesia | |
| Tray | Becton Dickinson |
DEVICE DESCRIPTION:
In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Perifix Pediatric The Perifix Pediatric Epidural Kit is Epidural Kit. designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.
- The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
1
MATERIAL:
The Perifix Pediatric Epidural Kit is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
SUBSTANTIAL EQUIVALENCE:
The Perifix Pediatric Epidural Kit is equivalent in materials, form, and intended use to the Perifx Set for Epidural Anesthesia with Tuohy Needle and Catheter K813186 currently marketed by B. Braum Medical (formerly Burron It is also equivalent to Abbott's Epidural Medical. Catheter K893766 and Becton Dickinson's K953467 Spinal Anesthesia Tray. There are no new issues of safety or effectiveness raised by the Perifix Pediatric Epidural Kit.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.