BARD ER URETERAL STENT WITH SUTURE

• K Number: K022447
• Device Name: BARD ER URETERAL STENT WITH SUTURE
• Manufacturer: C.R. BARD, INC.
• Date Cleared: 2003-01-23 ( 181 days)
• Product Code: FAD
• Regulation Number: 876.4620

Intended Use

The Bard® Inlay Optima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

Device Description

The Bard® (nLay Optima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtall ureteral stent with a monofilament suture loop attached to aid in stent removal. The stent Is available in two forms: a single size or a customizable multi-length size. The following items are included with each stent: - Ureteral Stont with Suture - Push Catheter with Radiopaque Tip - Pigtail Straightener - 1 Guidewire* (Optional) *Note: a 4.7 Fr stent Is compatible with a .035" guidewire and a 6,7,and 8 Fr stents are compatible with a .038" guidewire.

Predicate Devices

K983498

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (ureteral stent) and its accessories. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on material properties and functional testing, not algorithmic performance.

Therapeutic

Yes
The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter, which directly addresses a medical condition and aims to improve patient health.

Diagnostic

No

The device is a ureteral stent, which is used to relieve obstruction in the ureter, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a ureteral stent, push catheter, pigtail straightener, and guidewire, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
• Device Function: The Bard® Inlay Optima™ Ureteral Stent is a physical device that is implanted into the ureter to relieve obstruction. It is a therapeutic device, not a diagnostic test performed on a sample outside the body.
• Intended Use: The intended use clearly states it is for relieving obstruction in the ureter, which is a treatment function.
• Device Description: The description details a physical stent and associated tools for insertion, not reagents or equipment for analyzing biological samples.
• Performance Studies: The performance studies focus on in vitro testing of calcium salt accumulation on the stent itself, not on diagnostic accuracy metrics like sensitivity or specificity related to identifying a disease.

Therefore, the Bard® Inlay Optima™ Ureteral Stent is a medical device, specifically an implantable therapeutic device, and not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bard® Inlay Optima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent Indwelling device.

Product codes (comma separated list FDA assigned to the subject device)

78 FAD

Device Description

The Bard® (nLay Optima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtall ureteral stent with a monofilament suture loop attached to aid in stent removal. The stent Is available in two forms: a single size or a customizable multi-length size. The following items are included with each stent:
- Ureteral Stont with Suture
- Push Catheter with Radiopaque Tip
- Pigtail Straightener 1
- 1 Guidewire* (Optional)
- *Note: a 4.7 Fr stent Is compatible with a .035" guidewire and a 6,7,and 8 Fr stents are compatible with a .038" guidewire.

In vitro testing conducted on the Bard® InLay Optima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calclum salts as assayed by calcium when compared to a control. Correlation of in vitro data to clinical outcome has not been established.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ureter

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The Bard® Iniay Optima™ Ureteral Stent with Suture referenced in this submission is hald to the same design, manufacture, and performance specifications as those stents curre manufactured by Bard. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K983498

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).

Summary

0

Ko22447

JAN 2 3 2003

C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFOR

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: Address:

Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:

C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Frances E. Harrison, RAC [phone] [phone] January 17, 2003

• B. Device Name:
  Trade Name: Common / Usual Name: Classification Name:

Bard® InLay Optima™ Ureteral Stent with Suture Bard Ureteral Stent Ureteral Stent

• C. Predicate Device Name:
  Trade Name:

Bard® InLay Lubricious Double Pigtail Ureteral Stent with Suture #K983498

• D. Device Description: The Bard® (nLay Optima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtall ureteral stent with a monofilament suture loop attached to aid in stent removal. The stent Is available in two forms: a single size or a customizable multi-length size. The following items are included with each stent:
  • ా Ureteral Stont with Suture
  • Push Catheter with Radiopaque Tip ﻢ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
  • Pigtail Straightener 1
  • 1 Guidewire* (Optional)
  • *Note: a 4.7 Fr stent Is compatible with a .035" guidewire and a 6,7,and 8 Fr stents are compatible with a .038" guidewire.

In vitro testing conducted on the Bard® InLay Optima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calclum salts as assayed by calcium when compared to a control. Correlation of in vitro data to clinical outcome has not been established.

Choong, SKS, Wood, S. Whitfield, HN. "A model to quantify encrustation on ureteric stents, urethral catheters, and polymers intended for urological use," BJU International (2000), 86, 414-421.

• E. Intencied Use: The Bard® Inlay Optima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureferal trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent Indwelling device.

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022447

F. Technological Characteristics Summary:

Table VI-1 provides a tabulated comparison summary of the technological characteristics of the
Bard® Inlay Optima™ Ureteral Stent with Suture versus the predicate device.

Table VI-1 Comparison Summary of Technological Characteriatics

| Product
Characteristics | Bard® Inlay Optima™ Ureteral Stent
(this 510(k)) | Bard InLay Lubricious Double
Pigtail Ureteral Stent with Suture
(Predicate device - #K983498) | Difference |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | Stent | | |
| Indications or
Intended Use | The Bard® Inlay Optima™ Ureteral Stent
is indicated to relieve obstruction in a
variety of benign, malignant and post-
traumatic conditions in the ureter. These
conditions Include stones and/or stone
fragments or other ureteral obstructions
such as those associated with ureteral
stricture, malignancy of abdominal
organs, retroperitoneal fibrosis or
ureteral trauma, or in association with
Extracorporeal Shock Wave Lithotripsy
(ESWL). The stent may be placed using
endoscopic surgical techniques or
percutaneously using standard
radiographic technique. It is
recommended that the indwelling time
not exceed 365 days. The stent is not
intended as a permanent Indwelling
device. | The Bard Lubricious Ureteral Stent
is indicated to relieve obstruction in
a variety of benign, malignant and
post-traumatic conditions in the
urater such as presence of stones
and/or stone fragments or other
ureteral obstructions such as those
associated with ureteral stricture,
carcinoma of abdominal organs,
retroperitoneal fibrosis or ureteral
trauma, or in association with -
Extracorporeal Shock Wave
Lithotriopsy (ESWL). The stent may
be placed using endoscopic surgical
techniques or percutaneously using
standard radiographic technique. | Minimal editorial
changes. |
| Disposable | Yes | Yes | None |
| Sterile | Yes | Yes | None |
| Stent Base Material | Polycarbonate-based Polyurethane" | Polyether-based Polyurethane | Different Material |
| X-Ray Opaque | Yes | Yes | None |
| | | Coating | |
| Double Pigtall | Hydrophobic polymer* | Hydrophilic polymer | Different Coating |
| Multilength | Hydrophobic polymer* | Hydrophilic polymer | Different Coating |
| Models and Sizes | | | |
| Fr. Sizes Available | 4.7 Fr., 6 Fr., 7 Fr., and 8 Fr. | 4.7 Fr., 6 Fr., 7 Fr., and 8 Fr. | None |
| Double Pigtail
Lengths | 14, 20-30 cm | 14, 20-30 cm | None |
| Multilength Lengths | 23-32cm (one overall adjustable length) | 23-32cm (one overall adjustable
length) | None |
| Pigtail Geometry | | | |
| Double Pigtail | 360° curvature + 45° overlap (both ends) | 360° curvature + 45° overlap (both
ends) | None |
| Multilength | 2 ½ Turns | 2 ½ Turns | None |
| Suture Loop | Yes - USP Medical Grade black nylon
monofilament; 3-0 | Yes - USP Medical Grade black
monofilament; 3-0 | None |
| Guidewire Interface | 4.7 Fr. = 0.035" diameter
6, 7, 8 Fr. = 0.038" diameter | 4.7 Fr. = 0.035" diameter
6, 7, 8 Fr. = 0.038" diameter | None |
| Accessories | | | |
| Stent Clamp | No | Yes | Clamp Removed |
| Accessories | Yes* | No | Additional
Component |
| Push Catheter | | | |
| Color | Orange | Orange | None |
| Material | High Density Polyethylene (HDPE) | High Density Polyethylene (HDPE) | None |
| Guidewire Interface | 4.7 Fr. = 0.035" diameter
6, 7, 8 Fr. = 0.038" diameter | 4.7 Fr. = 0.035" diameter
6, 7, 8 Fr. = 0.038" diameter | None |
| Radiopacity | Radiopaque marker band near distal end | Radiopaque marker band near
distal end | None |
| Length | 4.7, 6, 7, 8 Fr. = 17.75" | 4.7, 6, 7, 8 Fr. = 17.75" | None |

New feature(s) or change this 510(k)

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G. Performance Data Summary:

The Bard® Iniay Optima™ Ureteral Stent with Suture referenced in this submission is hald to
the same design, manufacture, and performance specifications as those stents curre manufactured by Bard. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C. R. Bard, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K022447

Trade/Device Name: InLay Optima™ Ureteral Stent and InLay Optima™ Multi-Length Ureteral Stent (ER Ureteral Stent with Suture)

JAN 2 3 2003

Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: January 8, 2003 Received: January 9, 2003

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

X022447

Bard® Inlay Optima™ Ureteral Stent Device Name:

Indications for Use:

The Bard® Inlay Optima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1/2/96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022447