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Internal Tissue Marker

Page Type
Product Code
Definition
An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
Physical State
Marker with dye.
Technical Method
A biocompatible dye that is applied to the target tissue using a soft tipped marker.
Target Area
Organs, veins, arteries and other internal tissues.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4670
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4670 Internal tissue marker

§ 878.4670 Internal tissue marker.

(a) Identification. An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

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

(1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.

(2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated.

(3) Performance data must demonstrate the sterility of the device.

(4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life.

(5) Labeling must include:

(i) A warning that the device must not be used on a non-sterile surface prior to use internally.

(ii) An expiration date/shelf life.

(iii) Single use only labeling must be labeled directly on the device.

[80 FR 46486, Aug. 5, 2015]

Internal Tissue Marker

Page Type
Product Code
Definition
An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
Physical State
Marker with dye.
Technical Method
A biocompatible dye that is applied to the target tissue using a soft tipped marker.
Target Area
Organs, veins, arteries and other internal tissues.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4670
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4670 Internal tissue marker

§ 878.4670 Internal tissue marker.

(a) Identification. An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

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

(1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.

(2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated.

(3) Performance data must demonstrate the sterility of the device.

(4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life.

(5) Labeling must include:

(i) A warning that the device must not be used on a non-sterile surface prior to use internally.

(ii) An expiration date/shelf life.

(iii) Single use only labeling must be labeled directly on the device.

[80 FR 46486, Aug. 5, 2015]