K Number
K970110
Device Name
BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
Manufacturer
Date Cleared
1997-02-19

(37 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation.
Device Description
The Bard® Flexible Endoscopy Injection System consists of an endoscopic injection needle with an endoscopic working channel protector, a stainless steel endoscopic stabilizer sheath and optional medical tape for affixation purposes.
More Information

Not Found

No
The summary describes a mechanical injection system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Yes
The device is used to deliver injectable materials into tissues within the urinary bladder and lower urinary tract, which is a therapeutic action.

No
The device is described as an accessory for delivering injectable materials into tissues, not for diagnosing conditions.

No

The device description explicitly lists physical components such as an endoscopic injection needle, working channel protector, and stabilizer sheath, indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
  • Device Function: The Bard® Flexible Endoscopy Injection System is described as an accessory for endoscopes used to deliver injectable materials into tissues within the urinary bladder and lower urinary tract. This is an in vivo procedure (performed within the living body), not an in vitro test.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or testing for specific markers or conditions in a lab setting, which are hallmarks of IVDs.

Therefore, the device's intended use and description clearly indicate it is a surgical/procedural device used within the body, not an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation.

Product codes

Not Found

Device Description

The Bard® Flexible Endoscopy Injection System consists of an endoscopic injection needle with an endoscopic working channel protector, a stainless steel endoscopic stabilizer sheath and optional medical tape for affixation purposes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

urinary bladder and lower urinary tract

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K933815

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.

0

Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695

K 970 110

SECTION VI

FEB 1 9 1997

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

  • A. Submitter's Information:
Submitter's Name:C. R. Bard, Inc.
Address:8195 Industrial Boulevard
Covington, Georgia 30209
Contact Person:Donna J. Wilson
Phone:(770) 784-6135
FAX:(770) 784-6419
Date of Preparation:January 9, 1997
Device Name:
Trade Name:Bard® Flexible Endoscopy Injection System
Common/Usual Name:Flexible Endoscopy Injection System
Classification Name:Endoscope and Accessories, Class II
Predicate Device Names:

Bard® Endoscopic Injection System Trade Name:

B.

C.

1

D. Device Description:

The Bard® Flexible Endoscopy Injection System consists of an endoscopic injection needle with an endoscopic working channel protector, a stainless steel endoscopic stabilizer sheath and optional medical tape for affixation purposes.

  • E. Intended Use:
    The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation.

  • Technological Characteristics Summary: F.
    Table VI-A provides a tabular comparison of the technological characteristics of the Bard® Flexible Endoscopy Injection System versus the predicate device.

2

K970110

f:093

TABLE VI-A: COMPARISON CHART TO PREDICATE DEVICE

Device FeatureBard® Flexible Endoscopy Injection System#K933815 Bard® Endoscopic Injection System (Predicate Device)
Injection Needle
Luer Lock HubUSP Class VI Polymer*USP Class VI Polymer
Injection Needle
Strain ReliefUSP Class VI Polymer*USP Class VI Polymer
Injection Needle
Catheter Shaft5 Fr., 26" USP Class VI
Polymer5 Fr., 13.14" USF Class VI
Polymer
Injection Needle23 Gauge 0.25" Stainless Steel
(304 grade) Non-Coring
Needle23 Gauge 0.5" Stainless Steel
(304 grade) Non-Coring
Needle
Endoscopic
Stabilizer304 Stainless Steel Tube fitting
over an 18 Fr. (max.) flexible
endoscope and through a
preplaced 20 Fr. percutaneous
introducerUSP Class VI Polymer
tube with positive stop fitting
inside endoscopes
accommodating 7 Fr.
instrumentation
Stabilizer
AffixationMedical tape for securing
stabilizer sheath to flexible
endoscope shaftWorking channel cap fitting
over positive stop of stabilizer
Endoscopic
Working Channel
ProtectorUSP Class VI Polymer tube
used as a protective sheath for
insertion of the injection
needleNone
  • Materials and dimensions identical to predicate device.