(74 days)
BMI Surgical Staple Marker, Ethicon Surgical Staplers (Titanium Staples, Multifeed Stapler, LIGACLIP)
Not Found
No
The summary describes a physical marker device and its deployment mechanism, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a marker to radiographically mark a surgical location, not to treat a disease or condition.
No
The device is a surgical staple marker used to radiographically mark a surgical location, not to diagnose a condition or disease.
No
The device description clearly states it consists of a "non absorbable material compatible with X-ray" and is "deployed with manual appliers or surgical instruments," indicating it is a physical hardware device, not software.
Based on the provided information, 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 Function: The Surgical Staple Marker is a physical device applied to soft tissue during a surgical procedure to provide a radiographic marker. It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it's for marking a surgical location radiographically, not for diagnosing a condition based on a biological sample.
The device is a surgical implant/marker, not a diagnostic test performed outside the body on a sample.
N/A
Intended Use / Indications for Use
The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.
Product codes
Not Found
Device Description
The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
BMI Surgical Staple Marker, Ethicon Surgical Staplers (Titanium Staples, Multifeed Stapler, LIGACLIP)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
OCT - 7 1996
APPENDIX V
Summary of Safety and Effectiveness
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The BMI Surgical Staple Marker is substantially equivalent to many staple/marker devices including the BMI Surgical Staple Marker and Ethicons' Titanium Staple, Stapler (Endopath EMS), and LIGACLIP. The BMI device has the same intended use as the marketed predicate devices; these devices' intended use are to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location. The BMI Surgical Staple Marker has technologic characteristics which are substantially equivalent to the BMI and Ethicon predicate devices.
COMPANY AND CONTACT PERSON
Biopsys Medical, Inc. (BMI) 3 Morgan Irvine, CA 92618
Mark A. Cole, Ph.D. 714-460-7800
DEVICE NAME
Surgical Staple Marker
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
-
- BMI Surgical Staple Marker
-
- Ethicon Surgical Staplers (Titanium Staples, Multifeed Stapler, LIGACLIP)
STATEMENT OF INTENDED USE
The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.
STATEMENT OF INTENDED USE OF PREDICATEMARKETED DEVICES
-
- The BMI Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location.
-
- The Ethicon Staple/Clip's intended use is to be applied to soft tissue during open or percutaneous procedures; the staple may be used to radiographically mark the surgical location.
1
K963015 (P.2 of 2)
STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The design, construction, materials, nominal specifications are either identical or substantially equivalent to the marketed predicate devices. The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.
510(k) Notification Biopsys Medical, Inc.
CONFIDENTIAL Page 35