(46 days)
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No
The summary describes a bioresorbable film for sealing air leaks during surgery and does not mention any AI or ML components or functions.
Yes
The device is used to seal or reduce air leaks during pulmonary surgery by reinforcing lung tissue, which directly contributes to the treatment of a medical condition.
No
The device is a patch designed to seal or reduce air leaks during pulmonary surgery by reinforcing soft tissue. It is a surgical aid for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "bioresorbable film containing gelatin," which is a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reinforce the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery." This is a therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "bioresorbable film containing gelatin" used as a patch. This is a physical device applied during surgery, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, urine, etc.) or providing diagnostic information about a patient's condition. The device's function is purely mechanical/structural reinforcement and sealing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Patch reinforces the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery.
Product codes
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Device Description
The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lung
Indicated Patient Age Range
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Intended User / Care Setting
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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
Twenty six patients were enrolled in a multi-center, open label study in which the Patch was used to seal air leaks that occur during pulmonary surgery.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests: Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1 entitled, "Use of International Standard ISO-10993, Biological Evaluation of Medical Device Part-1: Evaluation and Testing". The product passed all biocompatibility tests including Hemocompatibility, Cytotoxicity (ISO agarose overlay and elution method), Acute Systemic Toxicity, Irritation (Intracutaneous Reactivity), Genotoxicity (Ames mutagenesis, Sister chromatid exchange, Chromosomal aberration), Sensitization (Magnusson and Kligman), and Implantation/Subchronic Toxicity.
Clinical Tests: A multi-center, open label study with 26 patients. Of the 52 leaks treated with the Patch, 96% were deemed to have successful closure. No product related adverse effects were noted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
96% were deemed to have successful closure.
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.
Peri-Strips® Bio-Vascular, Inc.
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.
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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).
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§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
K961440
163
MAY 3 | 1996
510(k) Summary Fusion Medical Technologies, Inc. The Patch
l. Sponsor: Fusion Medical Technologies, Inc. 1615 Plymouth Street Mountain View, CA 94043
Contact Person: Debera Brown Vice President, Regulatory and Clinical Affairs
Date of Summary Preparation: April 10, 1996
2. Device Name:
,一是一
Trade Name: To be determined Common/Usual Name: Surgical Patch , Surgical Membrane, Surgical Mesh Classification Name: Surgical Mesh
3. Identification of the Predicate or Legally Marketed Devices to Which Equivalence is being Claimed:
Peri-Strips® Bio-Vascular, Inc.
4. Device Description
The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package.
ડ. Intended Use
The Patch reinforces the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery.
1
6. A Statement of How the Technological Characteristics of the Device Compare to Those of the Predicate or Legally Marketed Device(s) Cited
Fusion Medical Technologies, Inc. The PATCH Comparison to Predicate Device
| The PATCH | Peri-strip® | |
|---|---|---|
| Intended Use: | • Reinforce soft tissue of | |
| the lung | • Reinforce soft tissue of | |
| the lung under staple | ||
| lines | ||
| Indications for Use: | • Seal or reduce air leaks | |
| in thoracic surgery | • Seal or reduce air leaks | |
| in thoracic surgery | ||
| Product Form: | Thin film | Thin film |
| Materials: | Gelatin | Pericardium |
| Absorbable: | Yes | |
| ( |