(91 days)
Not Found
Hermitage Combine II Dressing
No
The 510(k) summary describes a simple wound dressing and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device description indicates it is a topical dressing to cover a wound, which is a supportive rather than therapeutic function.
No
The device is described as a topical dressing to cover wounds and provide absorbency, which are therapeutic and protective functions, not diagnostic ones.
No
The device description clearly states it is a "pad" and a "topical dressing," indicating a physical, 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 described as a "topical dressing to cover a wound or operative site while providing absorbency." This is a physical function applied externally to the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The Dukal Sterile, ABD Combine pad does not perform any such testing.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with IVDs.
Therefore, the Dukal Sterile, ABD Combine pad is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Dukal Sterile, ABD Combine pad
is used as a topical dressing to cover a
wound or operative site while providing
absorbency.
Product codes
Not Found
Device Description
The Dukal Sterile, ABD Combine pad
is used as a topical dressing to cover a
wound or operative site while providing
absorbency.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Hermitage Combine II Dressing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
510(K) SUMMARY (as required by 807.92(c))
MAY - 8 1997
Requiatory & Marketing Services, Inc. (RMS) Submitter of 510(k): 40178 U.S. 19 North Tarpon Springs, FL 34689
813-942-3908 Phone: 813-942-3828 Fax:
Contact Person:
Ed Ransom
February 3, 1997 Date of Summary:
Trade Name: Dukal, ABD Combine pad
Dressing Classification Name:
Hermitage Combine II Dressing Predicate Device:
Device Description/
| Comparison: | ||
|---|---|---|
| Material | Dukal | Hermitage Hospital |
| Thickness | 47 mil | same |
| Delnet Fracture | 5lb/in | same |
| T-Peel | 700 lb/in | same |
| Absorptive Capacity | 38 oz/yd² | same |
| MD Tensile | 6lb/in | same |
| Basis weight | 5.0 oz/yd² | same |
| Intended Use | The Dukal Sterile, ABD Combine pad | |
| is used as a topical dressing to cover a | ||
| wound or operative site while providing | ||
| absorbency. | same |
The Dukal Sterile, ABD Combine pad is used as a topical dressing Intended Use: to cover a wound or operative site while providing absorbency.