Last synced on 25 November 2022 at 11:04 pm

Parathyroid Autofluorescence Imaging Device

Page Type
Product Code
Definition
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Physical State
The device has a non-contact image head that emits a coherent excitation light in the near-infrared spectrum and captures an autofluorescence image of the target tissues. Imaging contrast agents are not required for autofluorescence imaging.
Technical Method
The imaging device is a non-contact medical device that captures autofluorescence images using a coherent excitation light source in the near-infrared spectrum.
Target Area
Parathyroid glands.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4550
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4550 Autofluorescence detection device for general surgery and dermatological use

§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.

(a) Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

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

(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.

(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.

(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.

(8) Labeling must include the following:

(i) Instructions for use;

(ii) The detection performance characteristics of the device when used as intended; and

(iii) A shelf life for any sterile components.

[87 FR 24273, Apr. 25, 2022]

Parathyroid Autofluorescence Imaging Device

Page Type
Product Code
Definition
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Physical State
The device has a non-contact image head that emits a coherent excitation light in the near-infrared spectrum and captures an autofluorescence image of the target tissues. Imaging contrast agents are not required for autofluorescence imaging.
Technical Method
The imaging device is a non-contact medical device that captures autofluorescence images using a coherent excitation light source in the near-infrared spectrum.
Target Area
Parathyroid glands.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4550
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4550 Autofluorescence detection device for general surgery and dermatological use

§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.

(a) Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

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

(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.

(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.

(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.

(8) Labeling must include the following:

(i) Instructions for use;

(ii) The detection performance characteristics of the device when used as intended; and

(iii) A shelf life for any sterile components.

[87 FR 24273, Apr. 25, 2022]