(174 days)
No
The device description and performance studies focus on the material properties and mechanical function of a surgical buttress, with no mention of AI or ML technologies.
No
The device aids in surgical procedures by reinforcing staple lines but does not directly cure, treat, or prevent disease.
No
Explanation: The device is described as a buttressing material for reinforcing staple lines during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a sterile, single patient use device consisting of a cartridge and an anvil carrier with a strip of buttressing material, which are physical components. It is integrated into physical staplers.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures involving soft tissue transection or resection with staple line reinforcement. This is a surgical device used directly on the patient's tissue.
- Device Description: The device is a buttressing material integrated into surgical staplers. It reinforces the staple line during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.
Product codes
FTL
Device Description
The AFB (Absorbable Foam Buttress) Reload is a sterile, single patient use device which consists of two components: a cartridge and an anvil carrier. A strip of buttressing material is attached to both the cartridge and anvil carrier. AFB reinforces the staple line in soft tissue while it is simultaneously being cut and stapled. AFB is prepared from a synthetic, bioabsorbable copolymer similar to that used in synthetic absorbable sutures.
The AFB is integrated into endoscopic and open linear cutting/transecting staplers and reload cartridges. The two product reload cartridge configurations are suitable for the Endopath™ Endoscopic Linear Cutter used for VATS cases and the Linear Cutter used for OPEN cases.
The dimensions of AFB with a 0.03" (0.75 mm) thickness, accommodates the above-cited Ethicon-Endosurgery devices:
| Device | Dimensions of AFB (Attached to Staple Cartridge) (inches) | Dimensions of AFB (Attached to Staple Anvil Carrier) (inches) |
|---|---|---|
| Endoscopic Linear Cutter 45mm Application | 1.83 × 0.34 | 1.83 × 0.59 |
| Linear Cutter 75 mm Application | 3.19 x 0.44 | 3.30 x 0.63 |
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
surgical procedures
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)
Non-clinical testing was conducted on AFB to characterize the product. This testing included polymer composition by NMR, inherent viscosity, foam thickness, pore size, tensile strength, moisture content, residuals, force to fire and tear resistance.
Preclinical testing on the copolymer was conducted in multiple species to establish pharmacokinetics, toxicology, biocompatibility, and absorbability. AFB, although bioabsorbed in
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
A.
SUMMARY OF SAFETY AND EFFECTIVENESS JUN 1 2 2002
I. GENERAL INFORMATION
| Submitted By: | J&J Corporate Biomaterials Center, a
division of Ethicon
Rt. 22 West, P.O. Box 151
Somerville, NJ 08876-0151 |
|---------------|-----------------------------------------------------------------------------------------------------------------------|
| Tel: | (908) 218-2041 |
| Fax: | (908) 218-3679 |
Contact Person: David A. Dalessandro At address above
- Device Trade Name: B. AFB Common Name: Staple Line Reinforcement Material Classification Name: Mesh, Surgical, Polymeric
- C. Predicate Devices:
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| Bio-Vascular, Inc. | Peri-Strips Dry® | K921895 |
| K923657 | ||
| K940205 | ||
| K942583 | ||
| K971048 | ||
| K992537 | ||
| W.L. Gore | Seamguard™ | K955364 |
| K001789 | ||
| Ethicon, Inc. | Coated Vicryl II | K915835 |
| Ethicon, Inc. | Monocryl (poliglecaprone 25) | |
| suture, dyed | K960653 | |
| K964072 |
D. Device Description:
The AFB (Absorbable Foam Buttress) Reload is a sterile, single patient use device which consists of two components: a cartridge and an anvil carrier. A strip of buttressing material is attached to both the cartridge and anvil carrier. AFB reinforces the staple line in soft tissue while it is simultaneously being cut and stapled. AFB is prepared from a synthetic,
1
bioabsorbable copolymer similar to that used in synthetic absorbable sutures.
The AFB is integrated into endoscopic and open linear cutting/transecting staplers and reload cartridges. The two product reload cartridge configurations are suitable for the Endopath™ Endoscopic Linear Cutter used for VATS cases and the Linear Cutter used for OPEN cases.
The dimensions of AFB with a 0.03" (0.75 mm) thickness, accommodates the above-cited Ethicon-Endosurgery devices:
| Device | Dimensions of AFB
(Attached to Staple
Cartridge) (inches) | Dimensions of AFB
(Attached to Staple Anvil
Carrier) (inches) |
|----------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------|
| Endoscopic Linear Cutter
45mm Application | 1.83 × 0.34 | 1.83 × 0.59 |
| Linear Cutter 75 mm
Application | 3.19 x 0.44 | 3.30 x 0.63 |
-
E. Indications for Use:
AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. -
F. Technological Comparison:
Substantial equivalence for AFB is based upon two separate categories of predicate devices. The first category contains predicate devices that address the intended use, mechanism of use, and application (i.e., two marketed buttress materials, namely Peri-Strips Dry® manufactured by Bio-Vascular, Inc. and Seamguard™ manufactured by W. L. Gore).
The second category of predicate devices addresses the composition of AFB in regard to its biocompatibility, safety data, absorption, and biodegradability (i.e., Coated Vicryl II and Monocryl sutures).
2
II. TESTING
A. Non-Clinical Testing
Non-clinical testing was conducted on AFB to characterize the product. This testing included polymer composition by NMR, inherent viscosity, foam thickness, pore size, tensile strength, moisture content, residuals, force to fire and tear resistance.
- Preclinical Testing B.
Preclinical testing on the copolymer was conducted in multiple species to establish pharmacokinetics, toxicology, biocompatibility, and absorbability. AFB, although bioabsorbed in