(267 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is "Tape and Bandage, Adhesive," which are not typically associated with AI/ML.
Yes
A "Cutaneous Compression Device" used for medical purposes, such as in a hospital setting for hemodialysis (as indicated by the predicate device), is considered a therapeutic device as it applies physical force to a part of the body for treatment or prevention of a condition.
No
This device is described as a "Cutaneous Compression Device" for "General Hospital Use" and "Tape and Bandage, Adhesive." Its intended use is for compression, not for diagnosing conditions or diseases. Diagnostic devices typically gather information about health status, such as imaging devices, lab tests, or monitors that provide diagnostic data.
No
The device description explicitly states "Tape and Bandage, Adhesive," which are physical hardware components. The intended use also describes a "Cutaneous Compression Device," which typically involves physical materials for compression. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cutaneous Compression Device for General Hospital Use." This describes a physical device applied to the skin for compression, not a test performed on biological samples in vitro (outside the body).
- Device Description: The description "Tape and Bandage, Adhesive" further reinforces that this is a physical, external device.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
Therefore, this device falls under the category of a physical medical device used for compression, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
AUG
Summary of Safety and Effectiveness X.
| Classification Name: | Tape and Bandage, Adhesive
21 C.F.R. § 880.5240 (1994). |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Cutaneous Compression Device for General Hospital
Use. |
| Proprietary Name: | At present, no proprietary name has been chosen for this device. |
| Establishment Registration: | Mr. Robert R. Stevens has not yet engaged in activities requiring establishment registration. Upon engaging in such activities, an establishment registration will be filed in accordance with the requirements set forth at 21 C.F.R. § 807.20 (1994). |
| Classification: | Under Section 513 of the Federal Food, Drug, and Cosmetic Act, this device is classified into Class I. |
| Performance Standards: | As of the date of this Premarket Notification submission, no Performance Standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act. As such, no actions have been taken to comply with Section 514 Performance Standards. |
| Labeling/Promotional Materials: | Proposed labeling is included in this submission. |
| Substantial Equivalence: | This device is substantially equivalent to the following legally-marketed device ("Predicate Device") in terms of safety, effectiveness, and intended use:
Product: Cutaneous Compression Device for Hemodialysis
Manufacturer: Mr. Robert R. Stevens
510(k) Number: K951973
Substantial Equivalence Date: Class I exempt. |