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Hemostatic Device For Endoscopic Gastrointestinal Use

Page Type
Product Code
Definition
Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
Physical State
Hygroscopic hemostatic agent and delivery device.
Technical Method
Proposed hemostatic mechanism of action is absorption of fluid.
Target Area
GI
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4456
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4456 Hemostatic device for intraluminal gastrointestinal use

§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.

(a) Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.

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

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

(2) Performance data must support the sterility and pyrogenicity of the device.

(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:

(i) The ability to deliver the hemostatic material to the bleeding site;

(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and

(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.

(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:

(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.

(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.

(6) Labeling must include:

(i) Information identifying and explaining how to use the device and its components; and

(ii) A shelf life.

[83 FR 52971, Oct. 19, 2018]

Hemostatic Device For Endoscopic Gastrointestinal Use

Page Type
Product Code
Definition
Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
Physical State
Hygroscopic hemostatic agent and delivery device.
Technical Method
Proposed hemostatic mechanism of action is absorption of fluid.
Target Area
GI
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4456
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4456 Hemostatic device for intraluminal gastrointestinal use

§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.

(a) Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.

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

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

(2) Performance data must support the sterility and pyrogenicity of the device.

(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:

(i) The ability to deliver the hemostatic material to the bleeding site;

(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and

(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.

(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:

(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.

(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.

(6) Labeling must include:

(i) Information identifying and explaining how to use the device and its components; and

(ii) A shelf life.

[83 FR 52971, Oct. 19, 2018]