BARD ER URETERAL STENT WITH SUTURE by C.R. BARD, INC.

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.

AI/ML Overview

The provided document, K022447, is a 510(k) summary for the Bard® InLay Optima™ Ureteral Stent with Suture. This summary primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel device.

The document indicates that the device is "held to the same design, manufacture, and performance specifications as those stents currently manufactured by Bard." It also states that "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."

However, there is no specific table of acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or similar outcomes from a clinical study within the provided text. The performance data summary (Section G) explicitly states that the device is based on existing specifications and industry standards, implying that its performance is presumed to be equivalent to the predicate device and meet these established standards.

The document does mention one in vitro test:

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

Given the nature of a 510(k) submission for substantial equivalence, clinical performance data with detailed acceptance criteria and study results, as might be found for a novel device requiring rigorous clinical validation, are not typically included or required in the summary provided. The primary "study" is the comparison to a legally marketed predicate device (Bard® InLay Lubricious Double Pigtail Ureteral Stent with Suture #K983498) based on technological characteristics and intended use.

Based on the provided text, the following information cannot be extracted:

A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy).
Sample sizes used for a test set (clinical data).
Data provenance (country of origin, retrospective/prospective for clinical data).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
Results from a standalone algorithm performance study.
Type of ground truth used (pathology, outcomes data, etc.) for a clinical study.
Sample size for a training set (as this is not an AI/ML device where a training set is relevant).
How ground truth for a training set was established.

The document focuses on demonstrating technological equivalence and adherence to existing guidance and standards for ureteral stents.

Summary of available information:

Table of Acceptance Criteria and Reported Device Performance: Not explicitly provided in terms of clinical outcomes or performance metrics. The device is asserted to meet design, manufacture, and performance specifications comparable to existing Bard stents, and adhere to FDA and ASTM draft guidance for ureteral stents.
- One in vitro test result is mentioned: Reduced accumulation of urine calcium salts as assayed by calcium, compared to a control. No specific quantitative criteria or success rates are given for this in vitro test, nor is a correlation to clinical outcome established.
Sample sizes used for the test set and the data provenance: Not applicable or not provided, as detailed clinical efficacy or performance studies are not summarized. The comparison is primarily based on technological characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided.
Adjudication method for the test set: Not applicable or not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device (ureteral stent), not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided for clinical outcomes. The in vitro test used "control" for comparison of calcium salt accumulation.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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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 (770) 784-6257 (770) 784-6419 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

ProductCharacteristics	Bard® Inlay Optima™ Ureteral Stent(this 510(k))	Bard InLay Lubricious DoublePigtail Ureteral Stent with Suture(Predicate device - #K983498)	Difference
	Stent
Indications orIntended Use	The Bard® Inlay Optima™ Ureteral Stentis indicated to relieve obstruction in avariety of benign, malignant and post-traumatic conditions in the ureter. Theseconditions Include stones and/or stonefragments or other ureteral obstructionssuch as those associated with ureteralstricture, malignancy of abdominalorgans, retroperitoneal fibrosis orureteral trauma, or in association withExtracorporeal Shock Wave Lithotripsy(ESWL). The stent may be placed usingendoscopic surgical techniques orpercutaneously using standardradiographic technique. It isrecommended that the indwelling timenot exceed 365 days. The stent is notintended as a permanent Indwellingdevice.	The Bard Lubricious Ureteral Stentis indicated to relieve obstruction ina variety of benign, malignant andpost-traumatic conditions in theurater such as presence of stonesand/or stone fragments or otherureteral obstructions such as thoseassociated with ureteral stricture,carcinoma of abdominal organs,retroperitoneal fibrosis or ureteraltrauma, or in association with -Extracorporeal Shock WaveLithotriopsy (ESWL). The stent maybe placed using endoscopic surgicaltechniques or percutaneously usingstandard radiographic technique.	Minimal editorialchanges.
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 PigtailLengths	14, 20-30 cm	14, 20-30 cm	None
Multilength Lengths	23-32cm (one overall adjustable length)	23-32cm (one overall adjustablelength)	None
Pigtail Geometry
Double Pigtail	360° curvature + 45° overlap (both ends)	360° curvature + 45° overlap (bothends)	None
Multilength	2 ½ Turns	2 ½ Turns	None
Suture Loop	Yes - USP Medical Grade black nylonmonofilament; 3-0	Yes - USP Medical Grade blackmonofilament; 3-0	None
Guidewire Interface	4.7 Fr. = 0.035" diameter6, 7, 8 Fr. = 0.038" diameter	4.7 Fr. = 0.035" diameter6, 7, 8 Fr. = 0.038" diameter	None
Accessories
Stent Clamp	No	Yes	Clamp Removed
Accessories	Yes*	No	AdditionalComponent
Push Catheter
Color	Orange	Orange	None
Material	High Density Polyethylene (HDPE)	High Density Polyethylene (HDPE)	None
Guidewire Interface	4.7 Fr. = 0.035" diameter6, 7, 8 Fr. = 0.038" diameter	4.7 Fr. = 0.035" diameter6, 7, 8 Fr. = 0.038" diameter	None
Radiopacity	Radiopaque marker band near distal end	Radiopaque marker band neardistal 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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

X022447

Bard® Inlay Optima™ Ureteral Stent Device Name:

Indications for Use:

(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

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).