(266 days)
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.
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.
This submission is for a Class II medical device, the Perifix Pediatric Epidural Kit. The provided text, a 510(k) summary, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance data in the way one would for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable or cannot be extracted from this document.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of objective performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria are implicitly that the device "meets all required release specifications" and performs equivalently to predicate devices in "materials, form, and intended use."
- Reported Device Performance: Not quantified with specific metrics. The reported "performance" is that it "is equivalent in materials, form, and intended use" to the predicate devices.
Acceptance Criteria (Implicit from provided text) Reported Device Performance Materials are suitable for intended use (in accordance with Tripartite Guidance) Materials tested and determined suitable. Equivalent in materials to predicate devices (K813186, K893766, K953467) Device is equivalent in materials to predicate devices. Equivalent in form to predicate devices Device is equivalent in form to predicate devices. Equivalent in intended use to predicate devices Device is equivalent in intended use to predicate devices. Meets all required release specifications (physical testing, visual examination) All finished products are tested and must meet all required release specifications before distribution. Raises no new issues of safety or effectiveness No new issues of safety or effectiveness raised by the Perifix Pediatric Epidural Kit. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission describes testing for manufacturing release (physical testing, visual examination) for its own products, not a clinical study on a "test set" in the context of diagnostic performance.
- Data Provenance: Not applicable. The "testing" refers to internal quality control and release procedures, not data collected from patients or a specific study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. Ground truth as typically understood for a diagnostic algorithm is not relevant here. The ground truth for "meeting specifications" would be defined by the established Quality Control Test Procedure documents and the parameters conforming to product design specifications. These are internal company procedures, not expert-derived ground truth from a clinical setting.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" in the context of diagnostic performance or clinical outcomes requiring expert adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI or software device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's "performance" is conformance to engineering design specifications, material compatibility standards (Tripartite Guidance for Plastics), and established quality control procedures. It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.
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The sample size for the training set
- Not applicable. This is not an AI or software device that undergoes "training."
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How the ground truth for the training set was established
- Not applicable. This is not an AI or software device.
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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 SetforEpidural Anesthesia | Burron Medical |
| K893766 | Lifecare EpiduralCatheter | Abbott |
| K953467 | Spinal AnesthesiaTray | 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.
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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.
§ 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).