Last synced on 30 September 2022 at 11:05 pm

Absorbable Lung Biopsy Plug

Page Type
Product Code
Definition
A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.
Physical State
Polymerized hydrogel plug, cylindrical in shape and placed by a deployment system following lung biopsy by smaller biopsy needle/instrument.
Technical Method
Upon deployment into a lung biopsy tract, the plug expands to fill the biopsy void provide closure of the biopsy void.
Target Area
to be used in the lung, specifically in punctures left by percutenous, transthoracic needles
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4755
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4755 Absorbable lung biopsy plug

§ 878.4755 Absorbable lung biopsy plug.

(a) Identification. A preformed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.

(2) Performance testing must demonstrate deployment as indicated in the accompanying labeling, including the indicated introducer needles, and demonstrate expansion and resorption characteristics in a clinically relevant environment.

(3) In vivo evaluation must demonstrate performance characteristics of the device, including the ability of the plug to not prematurely resorb or migrate and the rate of pneumothorax.

(4) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the plug.

(5) Shelf-life testing must demonstrate the shelf-life of the device including the physical characteristics of the plug.

(6) The device must be demonstrated to be biocompatible.

(7) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device and appropriate warnings. Labeling must include identification of compatible introducer needles.

[79 FR 13219, Mar. 10, 2014]

Absorbable Lung Biopsy Plug

Page Type
Product Code
Definition
A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.
Physical State
Polymerized hydrogel plug, cylindrical in shape and placed by a deployment system following lung biopsy by smaller biopsy needle/instrument.
Technical Method
Upon deployment into a lung biopsy tract, the plug expands to fill the biopsy void provide closure of the biopsy void.
Target Area
to be used in the lung, specifically in punctures left by percutenous, transthoracic needles
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4755
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4755 Absorbable lung biopsy plug

§ 878.4755 Absorbable lung biopsy plug.

(a) Identification. A preformed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.

(2) Performance testing must demonstrate deployment as indicated in the accompanying labeling, including the indicated introducer needles, and demonstrate expansion and resorption characteristics in a clinically relevant environment.

(3) In vivo evaluation must demonstrate performance characteristics of the device, including the ability of the plug to not prematurely resorb or migrate and the rate of pneumothorax.

(4) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the plug.

(5) Shelf-life testing must demonstrate the shelf-life of the device including the physical characteristics of the plug.

(6) The device must be demonstrated to be biocompatible.

(7) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device and appropriate warnings. Labeling must include identification of compatible introducer needles.

[79 FR 13219, Mar. 10, 2014]