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Wound Retraction And Protection System

Page Type
Product Code
Definition
A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
Physical State
The device is comprised of a flexible, double-walled sheath with an impermeable inner layer. The retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom of the device. The sheath also includes an integrated fluid delivery and removal component.
Technical Method
The device is sterile, single-use surgical wound retraction that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. Fluid is delivered via gravitational feed from an external sterile irrigation solution bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through a separate chamber within the sheath via a connection with the hospital’s standard vacuum suction mechanism.
Target Area
Abdomen
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4371
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4371 Irrigating wound retractor device

§ 878.4371 Irrigating wound retractor device.

(a) Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

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

(1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.

(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.

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

(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:

(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;

(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;

(iii) Characterize the forces required to deploy the device;

(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;

(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and

(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.

(5) The labeling must include or state the following information:

(i) Device size or incision length range;

(ii) Method of sterilization;

(iii) Flammability classification;

(iv) Non-pyrogenic;

(v) Shelf life; and

(vi) Maximum flow rate and suction pressure.

[83 FR 24, Jan. 2, 2018]

Wound Retraction And Protection System

Page Type
Product Code
Definition
A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
Physical State
The device is comprised of a flexible, double-walled sheath with an impermeable inner layer. The retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom of the device. The sheath also includes an integrated fluid delivery and removal component.
Technical Method
The device is sterile, single-use surgical wound retraction that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. Fluid is delivered via gravitational feed from an external sterile irrigation solution bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through a separate chamber within the sheath via a connection with the hospital’s standard vacuum suction mechanism.
Target Area
Abdomen
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4371
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4371 Irrigating wound retractor device

§ 878.4371 Irrigating wound retractor device.

(a) Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

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

(1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.

(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.

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

(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:

(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;

(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;

(iii) Characterize the forces required to deploy the device;

(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;

(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and

(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.

(5) The labeling must include or state the following information:

(i) Device size or incision length range;

(ii) Method of sterilization;

(iii) Flammability classification;

(iv) Non-pyrogenic;

(v) Shelf life; and

(vi) Maximum flow rate and suction pressure.

[83 FR 24, Jan. 2, 2018]