(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of polyethylene covers, with no mention of AI or ML.
No
Explanation: The device is described as equipment covers used to maintain a sterile field and aid in equipment cleanup, with no mention of direct patient contact or therapeutic benefit.
No
The document states that the device's intended use is to cover equipment to maintain a sterile field and aid in cleanup, not to diagnose a medical condition.
No
The device description explicitly states it consists of "various sizes and shapes of polyethylene covers," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the covers are "intended to cover equipment and are not intended to be as patient drapes or have patient contact." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. This device does not interact with patient specimens.
- Device Description: The description focuses on the physical characteristics and function of the covers for maintaining a sterile field and aiding in cleanup. This is consistent with a medical device used in a surgical setting, but not an IVD.
- Lack of IVD-related information: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device is a medical device used in a surgical setting, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Both the Auto Suture* Equipment Covers™ and the Sterile INTENDED USE: Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Both the Auto Suture* Equipment Covers™ and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of various sizes and shapes of polyethylene covers which are positioned on surgical equipment. The covers are used to maintain the surgeons sterile field and as an aid in the clean up of equipment after surgery.
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)
A study was done to test the performance of the Auto Suture® Equipment Covers**. Testing consisted of an evaluation of tear resistance, puncture resistance, fluid penetration resistance and material thickness. Testing results, demonstrate that the Auto Suture* Equipment Covers** provides an acceptable fluid barrier which is resistant to puncturing, tearing and fluid penetration under normal use conditions.
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
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
AUG 23 1996
Attachment I
510(k) SUMMARY OF INFORMATION:
| SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT. 06856
(203) 845-1000 |
| ------------ | ------------------------------------------------------------------------------------------------- |
|---|
CONTACT PERSON: Janet G. Johnson
DATE PREPARED: June 28, 1996
CLASSIFICATION NAME: Equipment Covers
COMMON NAME: Equipment Covers
PROPRIETARY NAME: Auto Suture* ABBI* System Equipment Cover
PREDICATE DEVICE: Sterille Equipment Covers by Custom Medical Products (K931417)
DEVICE DESCRIPTION: Both the Auto Suture* Equipment Covers™ and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of various sizes and shapes of polyethylene covers which are positioned on surgical equipment. The covers are used to maintain the surgeons sterile field and as an aid in the clean up of equipment after surgery.
Both the Auto Suture* Equipment Covers™ and the Sterile INTENDED USE: Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.
All component materials of the Auto Suture* Equipment MATERIALS: Covers** are comprised of materials which are in accordance with ISO Standard #10993-1.
normal use conditions.
PERFORMANCE:
A study was done to test the performance of the Auto Suture® Equipment Covers**. Testing consisted of an evaluation of tear resistance, puncture resistance, fluid penetration resistance and material thickness. Testing results, demonstrate that the Auto Suture* Equipment Covers** provides an acceptable fluid barrier which is resistant to puncturing, tearing and fluid penetration under