(77 days)
Not Found
Not Found
No
The description focuses on a mechanical device (titanium tack) for stabilizing membranes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's purpose is to stabilize membranes during healing, not to directly treat a disease or condition. While it aids in a healing process, it's a fixation device rather than one with direct therapeutic action.
No
Explanation: The device, a miniature nail made of titanium, is designed to stabilize guided tissue regeneration membranes during healing by providing an attachment mechanism to bone. Its purpose is mechanical stabilization, not diagnosis.
No
The device description explicitly states the device is a "titanium alloy, machined, miniature nail" and part of a "System consists of components and instruments," indicating it is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stabilize guided tissue regeneration membranes during the healing process by attaching them to bone. This is a surgical/implantable function, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical tack made of titanium alloy designed for mechanical attachment. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The description 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 samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for a surgical procedure to aid in tissue regeneration, which falls under the category of medical devices used in vivo (within the body).
N/A
Intended Use / Indications for Use
The Membrane Tack is a titanium alloy, machined, miniature nail designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The guided tissue regeneration membranes are intended for use in wrapping bone or cartilage, or in soft tissue defects when bony or soft tissue ingrowth and attachment is required Guided tissue regeneration membranes are also appropriate for augmentation of slight tissue deficiencies. These are medical devices currently cleared by FDA and commercially available for sale in the United States. While not yet classified by FDA, the FDA Dental Advisory Panel has recommended a Class II Classification for guided tissue regeneration devices, both resorbable and non-resorbable. The Membrane Tack is designed for implantation during the healing period during which tissue regeneration takes place. It is not intended for long-term implantation, but should be removed upon completion of the healing process.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The IMZ Membrane Tack System consists of components and instruments designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The Membrane Tack is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone or cartilage, or in soft tissue defects
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)
Pull Force testing of the IMZ Membrane Tack was performed using membrane material tacked into cortical and cancellous bone. Results showed that the membrane material does not possess the strength to pull the implanted Tack out of the bone without compromising itself in the process.
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.
Straumann, USA MemFix™ Mini-Screw Kits
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
MAY 2 4 1996
510(k) SUMMARY
SUBMITTED BY
Lynn Rodarti Manager, Regulatory Affairs INTERPORE International 181 Technology Drive Irvine, California 92718 (714) 453-3200
Date Submitted: March 7, 1996
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Smooth or threaded metallic bone fixation fastener (ref: 21 CFR
888.3040) |
|----------------------|------------------------------------------------------------------------------|
| Common/Usual Name: | Bone Tack, Bone Screw or Bone Fixation Device |
| Proprietary Names: | IMZ Membrane Tack System |
PREDICATE DEVICES
Straumann, USA MemFix™ Mini-Screw Kits
DEVICE DESCRIPTION
The IMZ Membrane Tack System consists of components and instruments designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The Membrane Tack is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization.
INDICATIONS FOR USE
The Membrane Tack is a titanium alloy, machined, miniature nail designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The guided tissue regeneration membranes are intended for use in wrapping bone or cartilage, or in soft tissue defects when bony or soft tissue ingrowth and attachment is required Guided tissue regeneration membranes are also appropriate for augmentation of slight tissue deficiencies. These are medical devices currently cleared by FDA and commercially available for sale in the United States. While not yet classified by FDA, the FDA Dental Advisory Panel has recommended a Class II Classification for guided tissue regeneration devices, both resorbable and non-resorbable.
1
The Membrane Tack is designed for implantation during the healing period during which tissue regeneration takes place. It is not intended for long-term implantation, but should be removed upon completion of the healing process.
PRINCIPLES OF OPERATION
The Membrane Tack System is used in conjunction with commercially available guided tissue regeneration membranes. Surgically, the implantation site for the membrane is prepared following the membrane manufacturer's Directions-for-Use. At the point in surgery where the membrane is properly located at the surgical site and sufficient space is left under the material for tissue regeneration, the Membrane Tack vial is opened and the sterile contents of one or more vials are delivered to the sterile operative field. The Membrane Tacks are then aseptically transferred to a pre-sterilized Tack Holder where they may be picked up by either a straight or curved Tack Seating Instrument. The Tack is engaged by the Tack Seating Instrument by firmly pressing the tip of the instrument onto the head of the Tack. The Tack is then delivered to the desired position over the membrane.
The Tack may be seated by one of two methods:
-
- In cancellous or "soft" bone, the Tack may be seated by gently tapping the end of the Tack Seating Instrument with a Surgical Mallet; or alternatively,
-
- In cortico-cancellous, cortical or "hard" bone, the Tack may be placed by pre-drilling a small guide hole in the desired bone location which is designed to facilitate Tack placement. This is accomplished by placing the Tack Drill Guide immediately over the membrane at the desired Tack attachment site and using a pre-sterilized 0.4 mm Twist Drill connected to a dental hand-piece to drill through the Drill Guide opening and bone to create a guide hole in the dense bone approximately perpendicular to the plane of the membrane. There are "teeth" on the Tack Drill Guide designed to hold the membrane to the underlying bone during the drilling process. Care must be exercised in use of the Twist Drill since it is delicate. Abnormal forces may cause the drill to fracture at the hub. Following preparation of the guide hole, the knob on the Tack Drill Guide is pulled back to the open position and, using the pre-sterilized Tack Seating Instrument to deliver the Tack into the guide hole, the Tack is seated by gently tapping the Seating Instrument with a Surgical Mallet.
Please note that the Tack Seating Instrument is designed to disengage from the Tack atter it is securely seated into the bone by rolling the Instrument tip to one side (away from perpendicular to the bone). Because the design of the Tack Seating Instrument is such that it requires a spring action on the tip of the device to retain the Tack, there is a special tip protector which must remain in place over the tip when the Seating Instrument is not in use.
It is recommended that both written and radiographic documentation of the number and location of the Tacks be obtained for later removal.
When the tissue regeneration procedure is complete, the Tacks may be removed by exposing the surgical site and using a scalpel blade, periosteal elevator or other similar thin,
2
flat surface, to pry the head of the Tack away from the underlying bone. The removed Tacks should be accounted for and discarded. If the membrane is non-resorbable, it should be removed in accordance with the manufacturer's Directions-for-Use. The surgical site would then be resutured.
CONTRAINDICATIONS
Contraindications customary to the use of bone grafts and membrane techniques should be observed. These include, but are not limited to, current local infection, vascular impairment at the implant site, uncontrolled diabetes, chromic high dose steroid therapy, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which affect bone or wound healing.
COMPLICATIONS
Possible complications with any oral reconstructive surgery include infection, flap sloughing, perforation, abscess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with the use of dental implants or anesthesia.
In addition to these complications, augmentation naterial perforation or exfoliation may occur. Depending on the type and severity of the cornplication(s), augmentation material and Tack removal may be indicated.
MATERIALS OF CONSTRUCTION
| Membrane Tack - | Titanium Alloy |
|---|---|
| Tack Dispenser (holds Tacks | |
| inside dispensing vial) - | Polysulfone Resin |
| Tack Dispenser Cover - | Polycarbonate |
| Silicone Stopper - | Medical Grade Silicone Tubing |
| Tack Holder - | Stainless Steel |
| Tack Seating Instrument (straight)1 - | Stainless Steel |
| Tack Seating Instrument (curved)1 - | Stainless Steel |
| Tack Seating Instrument, straight, tip only - | Stainless Steel |
| Tack Seating Instrument, curved, tip only - | Stainless Steel |
| Tack Seating Instrument Protective Cap - | Stainless Steel |
1 Includes protective cap.
3
Handle, Tack Seating Instrument or Drill Stainless Steel Guide -
| Surgical Mallet - | |
|---|---|
| Handle and Head - | Stainless Steel |
| Twist Drill, 0.4 mm diameter | Tool Steel with an aluminum alloy shank |
| Twist Drill Inserts - | Polymer |
| Twist Drill Case - | Vendor material number 90191 |
| Tack Drill Guide, | |
| Handle - | Stainless Steel |
| Drill Guide, Tip - | Stainless Steel |
| Sliding Drill Guide, | |
| Tack Positioner - | Stainless Steel |
| Anchor Pins - | Stainless Steel |
| Screw - | Stainless Steel |
| Nut - | Stainless Steel |
| Tack Drill Guide, Tip only - | Stainless Steel |
| Bone Tack System Sterilization Tray | |
| Lid - | Aluminum Alloy |
| Base - | Aluminum |
| Shelf - | Aluminum Alloy |
| Stud - | Stainless Steel |
| Pick-up Posts (2) - | Stainless Steel |
| Legs - | Stainless Steel |
| Inserts - | Virgin Teflon |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The design, material, configuration, method of sterilization and other technological characteristics are similar to the currently marketed predicate device.
NONCLINICAL TEST CONCLUSIONS
Pull Force testing of the IMZ Membrane Tack was performed using membrane material tacked into cortical and cancellous bone. Results showed that the membrane material does not possess the strength to pull the implanted Tack out of the bone without compromising itself in the process.