(194 days)
No
The device description and intended use focus on the properties of a hydrogel dressing for wound management. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The product is a cream indicated for the dressing and management of various types of dermal ulcers and wounds, and it is intended to cover and protect wounds and burns, which are therapeutic actions.
No
Explanation: The device is a cream indicated for dressing and managing wounds, providing a moist wound environment, and protecting against abrasion and desiccation. It treats wounds rather than diagnosing conditions.
No
The device is described as a cream, which is a physical substance applied to the skin, indicating it is a hardware/physical medical device, not software.
Based on the provided information, BIONECT® Cream is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of BIONECT® Cream is for the dressing and management of various types of wounds and burns on a patient's skin. It acts as a topical dressing to provide a moist wound environment and protection.
- Device Description: The description details the composition and function of the cream as a hydrogel dressing applied to the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. BIONECT® Cream is applied in vivo (on the body) and does not analyze biological specimens.
Therefore, BIONECT® Cream falls under the category of a topical wound dressing or medical device for wound management, not an IVD.
N/A
Intended Use / Indications for Use
BIONECT® Cream is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.
Product codes
Not Found
Device Description
BIONECT® Cream acts to provide a moist wound environment and protect the wound. BIONECT® Cream was designed to provide a soothing, moist environment for easy application to various types of wounds as a hydrogel dressing. BIONECT® Cream is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Cream was designed to provide a moist wound healing environment.
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
Biocompatibility testing has been performed as recommended in the "Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing." These tests all support the safe use of BIONECT® Cream as a hydrogel temporary dressing in contact with breached or compromised skin. Clinical experience in approximately 600 patients with various types of ulcers, burns, and surgical wounds in 21 clinical trials (18 controlled) conducted in Europe indicates that BIONECT® Cream is safe for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
FEB | 2 1997
November 26, 1996
10. 510(k) SUMMARY
10.1 Summary Information
10.1.1 Submitter's name and address
FIDIA Pharmaceutical Corporation 1401 Eye Street, NW, Suite 900 Washington, DC 20005
Contact person and telephone number:
Roberto Fiorentini, M.D., President (202) 371-9898 Telephone: Telefax: (202) 371-1666
Date summary was prepared:
November 26, 1996
10.1.2 Name of the Device
| Trade Name: | BIONECT® Cream |
|---|---|
| Common Name: | Hyaluronic acid sodium salt hydrogel dressing |
| Classification Name: | Hydrogel Wound and Burn Dressing |
1
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
BIONECT® Cream is substantially equivalent in function and intended use to the following commercially available non-interactive wound and burn dressings:
- . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.)
- Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington . Laboratories, Inc.)
- DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.) .
10.1.4 Device description
Explanation of how the device functions: BIONECT® Cream acts to provide a moist wound environment and protect the wound.
Basic scientific concepts that form the basis for the device: BIONECT® Cream was designed to provide a soothing, moist environment for easy application to various types of wounds as a hydrogel dressing.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: BIONECT® Cream is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the
l l
2
1
gel. BIONECT® Cream was designed to provide a moist wound healing environment.
10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended
BIONECT® Cream is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.
These indication statements are not different from the predicate device identified in paragraph (3) of this section.
10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device
The technological characteristics of the device such as form, occlusion, conformability, bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate devices cited.
3
Assessment of performance data 10.2
Biocompatibility testing has been performed as recommended in the "Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing." These tests all support the safe use of BIONECT® Cream as a hydrogel temporary dressing in contact with breached or compromised skin.
Clinical experience in approximately 600 patients with various types of ulcers, burns, and surgical wounds in 21 clinical trials (18 controlled) conducted in Europe indicates that BIONECT® Cream is safe for its intended use.