21 CFR 876.1500 — Equipment, Photographic, For Physiologic Function Monitor

Gastroenterology, Urology (GU) · Subpart B—Diagnostic Devices · § 876.1500

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification Rationale

(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Product Codes

Product Code	Device Name	Class	Devices	Attributes
EXZ	Equipment, Photographic, For Physiologic Function Monitor	1	0
FAJ	Cystoscope And Accessories, Flexible/Rigid	2	92
FAK	Panendoscope (Gastroduodenoscope)	2	2
FAL	Panendoscope (Urethroscope)	2	1
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	2	24
FAN	Sigmoidoscope, Rigid, Electrical	2	2
FBI	Rongeur, Cystoscopic	2	0
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	2	89	3rd Party
FBN	Choledochoscope And Accessories, Flexible/Rigid	2	43
FBO	Cystourethroscope	2	19
FBP	Telescope, Rigid, Endoscopic	2	5
FCC	Endoscopic Magnetic Retriever	2	3
FCO	Box, Battery, Rechargeable	1	20
FCP	Box, Battery, Pocket	1	2
FCQ	Light Source, Incandescent, Diagnostic	2	1
FCR	Light Source, Photographic, Fiberoptic	2	3
FCW	Light Source, Fiberoptic, Routine	2	31
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	2	25	3rd Party
FCY	Bulb, Inflation, For Endoscope	1	3
FCZ	Tube, Smoke Removal, Endoscopic	1	0
FDA	Enteroscope And Accessories	2	20
FDC	Resectoscope, Working Element	2	11
FDE	Laparoscopy Kit	2	4
FDF	Colonoscope And Accessories, Flexible/Rigid	2	115
FDP	Apparatus, Pneumoperitoneum, Automatic	2	1
FDR	Sphyncteroscope	2	0
FDS	Gastroscope And Accessories, Flexible/Rigid	2	78
FDT	Duodenoscope And Accessories, Flexible/Rigid	2	35
FDW	Esophagoscope, Rigid, Gastro-Urology	2	0
FDX	Endoscopic Cytology Brush	2	44	3rd Party
FDY	Device, Measuring, For Panendoscope	1	0
FDZ	Attachment, Eyepiece, For Insertion Of Prescription Lens	1	2
FEA	Attachment, Teaching, For Endoscope	1	2
FEB	Accessories, Cleaning, For Endoscope	2	57
FEC	Obturator, For Endoscope	2	3
FED	Endoscopic Access Overtube, Gastroenterology-Urology	2	103
FEI	Instrument, Special Lens, For Endoscope	1	2
FEJ	Attachment, Binocular, For Endoscope	1	1
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	1	4
FEQ	Pump, Air, Non-Manual, For Endoscope	2	21
FER	Anoscope And Accessories	2	27
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	2	101	SaMD
FFS	Image, Illumination, Fiberoptic, For Endoscope	2	26	3rd Party
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	1	2
FFZ	Cord, Electric, For Endoscope	2	3
FGA	Kit, Nephroscope	2	10
FGB	Ureteroscope And Accessories, Flexible/Rigid	2	118
FGC	Urethroscope	2	3
FGS	Carrier, Sponge, Endoscopic	2	4
FHO	Pneumoperitoneum Needle	2	15	3rd Party
FHP	Needle, Pneumoperitoneum, Simple	2	2	3rd Party
FHX	Jelly, Lubricating, For Transurethral Surgical Instrument	2	6	3rd Party
FJL	Resectoscope	2	24
FTI	Lamp, Endoscope, Incandescent	2	2	3rd Party
FTJ	Colonoscope, General & Plastic Surgery	2	0
GCF	Proctoscope	2	2
GCG	Peritoneoscope	2	0
GCH	Mediastinoscope, Diagnostic	2	0
GCI	Laryngoscope, Endoscope	2	14	3rd Party
GCJ	Laparoscope, General & Plastic Surgery	2	1430
GCK	Gastroscope, General & Plastic Surgery	2	0
GCL	Esophagoscope, General & Plastic Surgery	2	4
GCM	Endoscope, Rigid	2	18
GCN	Endoscope, Prism	2	0
GCO	Endoscope, Mirror	2	3
GCP	Endoscope, Ac-Powered And Accessories	2	13
GCQ	Endoscope, Flexible	2	5
GCS	Endoscope, Battery-Powered And Accessories	2	9
GCT	Light Source, Endoscope, Xenon Arc	2	47
GCW	Transformer, Endoscope	2	1
GDB	Endoscope, Fiber Optic	2	7
KDM	Sigmoidoscope, Rigid, Non-Electrical	2	1
KDO	Rongeur, Cystoscopic, Hot	2	1
KGD	Scissors For Cystoscope	2	2
KYH	Endoscope, Ophthalmic	2	1	3rd Party
LYK	Angioscope	2	41
MFJ	Device, Endoscopic Suturing	2	1
MNK	Endoscopic Bite Block	1	6
MNL	Accessories, Cleaning Brushes, For Endoscope	1	4
MPA	Endoilluminator	2	41	3rd Party
NAY	System, Surgical, Computer Controlled Instrument	2	166
NBG	Marker, Colon	2	2
NEQ	Device, Telemedicine, Robotic	2	2
NKZ	Endoilluminator, Reprocessed	2	0
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	2	23
NLX	Needle, Pneumoperitoneum, Spring Loaded, Reprocessed	2	0
NMY	Needle, Endoscopic, Reprocessed	2	0
NTN	Led Light Source	2	9
NVE	Washer, Cleaner, Automated, Endoscope	2	12
NWB	Endoscope, Accessories, Narrow Band Spectrum	2	9
NWS	Kit, Choledochoscope, Flexible And Rigid	2	1
NWT	Endoscopic Cholangiogram Kit	2	0
NWU	Endoscope Introducer Kit	2	3
NZA	Accessories, Germicide, Cleaning, For Endoscopes	2	11
OCS	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	2	1	SaMD
OCT	Anti Fog Solution And Accessories, Endoscopy	2	27	3rd Party
OCU	Endoscopic Storage Cover	2	6
OCV	Endoscope Holder	2	10
OCW	Endoscopic Tissue Approximation Device	2	70
OCX	Endoscopic Irrigation/Suction System	2	93
OCY	Endoscopic Guidewire, Gastroenterology-Urology	2	43
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	2	74	3rd Party
ODA	Endoscopic Central Control Unit	2	18	SaMD
ODB	Endoscopic Contamination Prevention Sheath	2	5
ODC	Endoscope Channel Accessory	2	72
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	2	18
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	2	20	Implant
ODF	Mini Endoscope, Gastroenterology-Urology	2	12
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	2	44
OTJ	Laparoscopic Single Port Access Device	2	11
OWN	Confocal Optical Imaging	2	62
PCV	Endoscopic Leak Tester	2	2
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	2	9
PGU	Spatial Imaging For Display Of Endoscope Position	2	1
PHT	Basin For Endoscope Reprocessing	1	0
PLL	Submucosal Injection Agent	2	10
PPE	Nephroscope Set	2	0
PTQ	Endoscopic Magnetic Retriever, Exempt	2	0
PTR	Scissors For Cytoscope, Exempt	2	0
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	2	0
PUP	Endoscope Maintenance System	2	1
QGY	Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera	2	1	SaMD
QSM	System, Surgical, Computer Controlled Instrument, Remanufactured	2	8
QZB	Software Controlled Endoscope And Instrument Holder	2	4	SaMD
SBX	Software For Endoscopy Procedure Metrics	2	0	SaMD
SFE	Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation	2	2	AI/ML, SaMD
SHU	Appendiceal Scope And Accessories, Flexible	2	1

Special Controls

EXZ — Equipment, Photographic, For Physiologic Function Monitor

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

eCFR

FAJ — Cystoscope And Accessories, Flexible/Rigid

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FAK — Panendoscope (Gastroduodenoscope)

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FAL — Panendoscope (Urethroscope)

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FAM — Sigmoidoscope And Accessories, Flexible/Rigid

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FAN — Sigmoidoscope, Rigid, Electrical

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FBI — Rongeur, Cystoscopic

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FBK — Endoscopic Injection Needle, Gastroenterology-Urology

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FBN — Choledochoscope And Accessories, Flexible/Rigid

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FBO — Cystourethroscope

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FBP — Telescope, Rigid, Endoscopic

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FCC — Endoscopic Magnetic Retriever

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FCO — Box, Battery, Rechargeable

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FCP — Box, Battery, Pocket

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FCQ — Light Source, Incandescent, Diagnostic

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FCR — Light Source, Photographic, Fiberoptic

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FCW — Light Source, Fiberoptic, Routine

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FCX — Insufflator, Automatic Carbon-Dioxide For Endoscope

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FCY — Bulb, Inflation, For Endoscope

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FCZ — Tube, Smoke Removal, Endoscopic

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FDA — Enteroscope And Accessories

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FDC — Resectoscope, Working Element

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FDE — Laparoscopy Kit

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FDF — Colonoscope And Accessories, Flexible/Rigid

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FDP — Apparatus, Pneumoperitoneum, Automatic

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FDR — Sphyncteroscope

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FDS — Gastroscope And Accessories, Flexible/Rigid

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FDT — Duodenoscope And Accessories, Flexible/Rigid

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FDW — Esophagoscope, Rigid, Gastro-Urology

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FDX — Endoscopic Cytology Brush

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FDY — Device, Measuring, For Panendoscope

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FDZ — Attachment, Eyepiece, For Insertion Of Prescription Lens

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FEA — Attachment, Teaching, For Endoscope

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FEB — Accessories, Cleaning, For Endoscope

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FEC — Obturator, For Endoscope

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FED — Endoscopic Access Overtube, Gastroenterology-Urology

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FEI — Instrument, Special Lens, For Endoscope

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FEJ — Attachment, Binocular, For Endoscope

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FEM — Accessories, Photographic, For Endoscope (Exclude Light Sources)

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FEQ — Pump, Air, Non-Manual, For Endoscope

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FER — Anoscope And Accessories

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FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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FFS — Image, Illumination, Fiberoptic, For Endoscope

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FFY — Adaptor, Bulbs, Miscellaneous, For Endoscope

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FFZ — Cord, Electric, For Endoscope

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FGA — Kit, Nephroscope

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FGB — Ureteroscope And Accessories, Flexible/Rigid

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FGC — Urethroscope

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FGS — Carrier, Sponge, Endoscopic

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FHO — Pneumoperitoneum Needle

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FHP — Needle, Pneumoperitoneum, Simple

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FHX — Jelly, Lubricating, For Transurethral Surgical Instrument

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FJL — Resectoscope

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FTI — Lamp, Endoscope, Incandescent

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FTJ — Colonoscope, General & Plastic Surgery

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GCF — Proctoscope

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GCG — Peritoneoscope

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GCH — Mediastinoscope, Diagnostic

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GCI — Laryngoscope, Endoscope

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GCJ — Laparoscope, General & Plastic Surgery

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GCK — Gastroscope, General & Plastic Surgery

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GCL — Esophagoscope, General & Plastic Surgery

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GCM — Endoscope, Rigid

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GCN — Endoscope, Prism

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GCO — Endoscope, Mirror

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GCP — Endoscope, Ac-Powered And Accessories

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GCQ — Endoscope, Flexible

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GCS — Endoscope, Battery-Powered And Accessories

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GCT — Light Source, Endoscope, Xenon Arc

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GCW — Transformer, Endoscope

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GDB — Endoscope, Fiber Optic

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KDM — Sigmoidoscope, Rigid, Non-Electrical

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KDO — Rongeur, Cystoscopic, Hot

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KGD — Scissors For Cystoscope

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KYH — Endoscope, Ophthalmic

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LYK — Angioscope

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LYK — Angioscope

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MFJ — Device, Endoscopic Suturing

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MNK — Endoscopic Bite Block

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MNL — Accessories, Cleaning Brushes, For Endoscope

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MPA — Endoilluminator

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NAY — System, Surgical, Computer Controlled Instrument

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NAY — System, Surgical, Computer Controlled Instrument

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

De Novo Order DEN250068

NBG — Marker, Colon

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NEQ — Device, Telemedicine, Robotic

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NKZ — Endoilluminator, Reprocessed

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NLM — Laparoscope, General & Plastic Surgery, Reprocessed

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NLX — Needle, Pneumoperitoneum, Spring Loaded, Reprocessed

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NMY — Needle, Endoscopic, Reprocessed

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NTN — Led Light Source

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NVE — Washer, Cleaner, Automated, Endoscope

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NWB — Endoscope, Accessories, Narrow Band Spectrum

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NWS — Kit, Choledochoscope, Flexible And Rigid

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NWT — Endoscopic Cholangiogram Kit

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NWU — Endoscope Introducer Kit

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NZA — Accessories, Germicide, Cleaning, For Endoscopes

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OCS — Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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OCT — Anti Fog Solution And Accessories, Endoscopy

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OCU — Endoscopic Storage Cover

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OCV — Endoscope Holder

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OCW — Endoscopic Tissue Approximation Device

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OCX — Endoscopic Irrigation/Suction System

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OCY — Endoscopic Guidewire, Gastroenterology-Urology

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OCZ — Endoscopic Grasping/Cutting Instrument, Non-Powered

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ODA — Endoscopic Central Control Unit

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ODB — Endoscopic Contamination Prevention Sheath

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ODC — Endoscope Channel Accessory

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ODD — Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

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ODE — Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

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ODF — Mini Endoscope, Gastroenterology-Urology

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ODG — Endoscopic Ultrasound System, Gastroenterology-Urology

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OTJ — Laparoscopic Single Port Access Device

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OWN — Confocal Optical Imaging

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PCV — Endoscopic Leak Tester

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PEA — Endoscope, Accessories, Image Post-Processing For Color Enhancement

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PGU — Spatial Imaging For Display Of Endoscope Position

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PHT — Basin For Endoscope Reprocessing

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PLL — Submucosal Injection Agent

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PPE — Nephroscope Set

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PTQ — Endoscopic Magnetic Retriever, Exempt

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PTR — Scissors For Cytoscope, Exempt

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PTS — Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

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PUP — Endoscope Maintenance System

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QGY — Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

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QSM — System, Surgical, Computer Controlled Instrument, Remanufactured

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QZB — Software Controlled Endoscope And Instrument Holder

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SBX — Software For Endoscopy Procedure Metrics

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SFE — Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation

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