(37 days)
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)
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
f:093
TABLE VI-A: COMPARISON CHART TO PREDICATE DEVICE
Device Feature | Bard® Flexible Endoscopy Injection System | #K933815 Bard® Endoscopic Injection System (Predicate Device) |
---|---|---|
Injection Needle | ||
Luer Lock Hub | USP Class VI Polymer* | USP Class VI Polymer |
Injection Needle | ||
Strain Relief | USP Class VI Polymer* | USP Class VI Polymer |
Injection Needle | ||
Catheter Shaft | 5 Fr., 26" USP Class VI | |
Polymer | 5 Fr., 13.14" USF Class VI | |
Polymer | ||
Injection Needle | 23 Gauge 0.25" Stainless Steel | |
(304 grade) Non-Coring | ||
Needle | 23 Gauge 0.5" Stainless Steel | |
(304 grade) Non-Coring | ||
Needle | ||
Endoscopic | ||
Stabilizer | 304 Stainless Steel Tube fitting | |
over an 18 Fr. (max.) flexible | ||
endoscope and through a | ||
preplaced 20 Fr. percutaneous | ||
introducer | USP Class VI Polymer | |
tube with positive stop fitting | ||
inside endoscopes | ||
accommodating 7 Fr. | ||
instrumentation | ||
Stabilizer | ||
Affixation | Medical tape for securing | |
stabilizer sheath to flexible | ||
endoscope shaft | Working channel cap fitting | |
over positive stop of stabilizer | ||
Endoscopic | ||
Working Channel | ||
Protector | USP Class VI Polymer tube | |
used as a protective sheath for | ||
insertion of the injection | ||
needle | None |
- Materials and dimensions identical to predicate device.