(22 days)
Not Found
Not Found
No
The description details a physical compression system with bandages and a dressing, and there is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of venous leg ulcers and related conditions, which are therapeutic applications.
No
The DYNA-FLEX Multi-Layer Compression System is a treatment device, specifically a compression system for managing venous leg ulcers. It does not perform any diagnostic functions; rather, it applies compression to aid in healing. The text explicitly states that Doppler ultrasound is recommended to rule out arterial disease, indicating that this device itself is not used for diagnosis.
No
The device description clearly outlines multiple physical components including wound dressings and various bandage layers.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The DYNA-FLEX* Multi-Layer Compression System is a physical kit comprised of dressings and bandages applied externally to the leg for the management of venous leg ulcers. It does not involve testing samples taken from the body.
The device is a therapeutic device used for external compression, not a diagnostic test.
N/A
Intended Use / Indications for Use
DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions.
The DYNA-FLEX Multi-Layer Compression System should not be used on diabetic patients with advanced small vessel disease, patients with lymphadema as a result of cancer, or on patients with an ankle:brachial index (ABI) of less than 0.8 . Doppler ultrasound is recommended to rule out arterial disease.
Product codes
MCY
Device Description
The DYNA-FLEX* Multi-Layer Compression System is a kit that is comprised of one wound dressing component and three bandage layers for the management of venous leg ulcers and related conditions and is packaged in a polyethylene resealable bag. The description of each of these components/bandage layers is as follows:
- The wound dressing component is the ADAPTIC* Non-Adhering Dressing (Sterile). . This non-adherent 5" x 9 " pad is impregnated with a petrolatum emulsion and is packaged in a polyester polyethylene film that is heat sealed prior to sterilization.
- The first bandage layer is the DYNA-FLEX* Layer One (Padding/Absorption Layer). . This polyurethane stretch foam/cotton wrap (non-sterile) is packaged in a polyurethane shrink wrap. Layer One is supplied in a 4" x 156" roll. (unstretched).
- . The second bandage layer is the DYNA-FLEX* Layer Two (Compression Bandage). This non-sterile compression wrap is comprised of absorbent yarns knitted with elastomeric and nylon yarns and is packaged in a polyurethane shrink wrap. Layer Two is supplied in a 4" x 90" roll (unstretched). To assist the healthcare professional in wrapping, this bandage layer is knitted with a rectangle design, such that as the bandage is extended it will change to a square design thus indicating a satisfactory compression range.
- . The third bandage layer is the DYNA-FLEX* Layer Three (Cohesive Compression Bandage). This non-sterile cohesive compression bandage is comprised of a nonwoven . fabric with spandex elastic yarns bonded with a natural rubber cohesive latex based system. Layer Three is supplied in a 4" x 216" roll (stretched).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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)
Safety tests conducted in accordance with ISO 10993 Part-1 "Biological Evaluation Of Medical Devices" demonstrate the DYNA-FLEX* Multi-Layer Compression System is non-sensitizing, non-cytotoxic, non-systemic toxic, non-irritating and is suitable for its intended use. In addition, testing was done to demonstrate that sustained compression for up to seven days at both the ankle and below the knee was maintained, when used according to package insert directions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Wound Care Compression System (WCCS) marketed by Suncoast Medical Products.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
510(k) - DYNA-FLEX* Multi-Layer Compression System
MAR 2 1 1997
510(k) SUMMARY
DATE PREPARED 1.
February 27, 1997
2. SUBMITTER
Johnson & Johnson Medical, Inc. 2500 Arbrook Blvd. P.O. Box 90130 Arlington, TX 76004-3130
CONTACT PERSON 3.
Wm. P. Robb Senior Regulatory Affairs Project Manager Phone: 817-784-5210 817-784-5462 Fax:
4. NAME OF THE MEDICAL DEVICE
Classification Name: Common/Usual Name: Proprietary Name:
Bandage, Compression Compression Bandaging System DYNA-FLEX* Multi-Layer Compression System
ત્ત્વ DEVICE CLASSIFICATION
Regulatory Class: Unclassified Product Code: MCY
STATEMENT OF SUBSTANTIAL EQUIVALENCE ર્.
The DYNA-FLEX* Multi Layer Compression System is substantially equivalent and identical in function to the Wound Care Compression System (WCCS) marketed by Suncoast Medical Products.
- Trademark
0052
1
7. INDICATIONS FOR USE
DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions.
The DYNA-FLEX Multi-Layer Compression System should not be used on diabetic patients with advanced small vessel disease, patients with lymphadema as a result of cancer, or on patients with an ankle:brachial index (ABI) of less than 0.8 . Doppler ultrasound is recommended to rule out arterial disease.
8. PHYSICAL DESCRIPTION
The DYNA-FLEX* Multi-Layer Compression System is a kit that is comprised of one wound dressing component and three bandage layers for the management of venous leg ulcers and related conditions and is packaged in a polyethylene resealable bag. The description of each of these components/bandage layers is as follows:
- The wound dressing component is the ADAPTIC* Non-Adhering Dressing (Sterile). . This non-adherent 5" x 9 " pad is impregnated with a petrolatum emulsion and is packaged in a polyester polyethylene film that is heat sealed prior to sterilization.
- The first bandage layer is the DYNA-FLEX* Layer One (Padding/Absorption Layer). . This polyurethane stretch foam/cotton wrap (non-sterile) is packaged in a polyurethane shrink wrap. Layer One is supplied in a 4" x 156" roll. (unstretched).
- . The second bandage layer is the DYNA-FLEX* Layer Two (Compression Bandage). This non-sterile compression wrap is comprised of absorbent yarns knitted with elastomeric and nylon yarns and is packaged in a polyurethane shrink wrap. Layer Two is supplied in a 4" x 90" roll (unstretched). To assist the healthcare professional in wrapping, this bandage layer is knitted with a rectangle design, such that as the bandage is extended it will change to a square design thus indicating a satisfactory compression range.
- . The third bandage layer is the DYNA-FLEX* Layer Three (Cohesive Compression Bandage). This non-sterile cohesive compression bandage is comprised of a nonwoven . fabric with spandex elastic yarns bonded with a natural rubber cohesive latex based system. Layer Three is supplied in a 4" x 216" roll (stretched).
9. BIOCOMPATIBILITY
Safety tests conducted in accordance with ISO 10993 Part-1 "Biological Evaluation Of Medical Devices" demonstrate the DYNA-FLEX* Multi-Layer Compression System is non-sensitizing, non-cytotoxic, non-systemic toxic, non-irritating and is suitable for its intended use. In addition, testing was done to demonstrate that sustained compression for up to seven days at both the ankle and below the knee was maintained, when used according to package insert directions.
- Trademark