(19 days)
The Bard® InlayOptima™ 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® InLayOptima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtail 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:
1 Ureteral Stent with Suture
1 Push Catheter with Radiopaque Tip
ー Pigtail Straightener
Guidewire* (Optional) 1
*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® InLayOptima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control. Correlation of in vitro data to clinical outcome has not been established.
Here's an analysis of the provided text regarding the Bard® InlayOptima™ Ureteral Stent, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness Information (K043193) for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a full-scale clinical trial or comparative effectiveness study. As such, many of the requested categories for AI/diagnostic devices (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance with metrics like sensitivity/specificity) are not applicable or not present in a 510(k) for a ureteral stent, which is a physical implant.
The "study" mentioned here is primarily in vitro testing and implicitly, the demonstration of equivalence to an already approved device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Indications/Intended Use | Equivalent to the predicate device's indications: Relieve obstruction in benign, malignant, and post-traumatic ureteral conditions (stones, stricture, malignancy, retroperitoneal fibrosis, trauma, ESWL). Indwelling time not to exceed 365 days; not permanent. | Meets Predicate: Identical indications for use as the predicate device (Bard® InlayOptima™ Ureteral Stent with Suture, K022447). |
| Disposable | Yes | Meets Predicate: Yes |
| Sterile | Yes | Meets Predicate: Yes |
| Stent Base Material | Biocompatible and functionally equivalent to Polyether-based Polyurethane predicate. | Different from Predicate, but deemed equivalent: Polycarbonate-based Polyurethane. This is the primary difference identified and would have required testing to justify equivalence. |
| X-Ray Opaque | Yes | Meets Predicate: Yes |
| Coating (Double Pigtail & Multilength) | Hydrophobic polymer | Meets Predicate: Hydrophobic polymer |
| Fr. Sizes Available | 4.7 Fr., 6 Fr., 7 Fr., 8 Fr. | Meets Predicate: 4.7 Fr., 6 Fr., 7 Fr., 8 Fr. |
| Double Pigtail Lengths | 14, 20-30 cm | Meets Predicate: 14, 20-30 cm |
| Multilength Lengths | 23-32cm (one overall adjustable length) | Meets Predicate: 23-32cm (one overall adjustable length) |
| Pigtail Geometry | Double Pigtail: 360° curvature + 45° overlap (both ends); Multilength: 2 ½ Turns | Meets Predicate: Double Pigtail: 360° curvature + 45° overlap (both ends); Multilength: 2 ½ Turns |
| Suture Loop | Yes - USP Medical Grade black monofilament; 3-0 | Meets Predicate: Yes - USP Medical Grade black nylon monofilament; 3-0 |
| Guidewire Interface | 4.7 Fr. = 0.035" diameter; 6, 7, 8 Fr. = 0.038" diameter | Meets Predicate: 4.7 Fr. = 0.035" diameter; 6, 7, 8 Fr. = 0.038" diameter |
| Stent Clamp | N/A (removed from predicate) | Difference from Predicate: Clamp removed; implies removal was deemed acceptable without negative impact. |
| Push Catheter Color | Orange | Meets Predicate: Orange |
| Push Catheter Material | High Density Polyethylene (HDPE) | Meets Predicate: High Density Polyethylene (HDPE) |
| Push Catheter Guidewire Interface | 4.7 Fr. = 0.035" diameter; 6, 7, 8 Fr. = 0.038" diameter | Meets Predicate: 4.7 Fr. = 0.035" diameter; 6, 7, 8 Fr. = 0.038" diameter |
| Push Catheter Radiopacity | Radiopaque marker band near distal end | Meets Predicate: Radiopaque marker band near distal end |
| Reduced Accumulation of Urine Calcium Salts | Reduced accumulation compared to control (as per predicate device's prior testing and general expectation for "coated" stents). | Reported Performance: In vitro testing indicated "reduced accumulation of urine calcium salts as assayed by calcium when compared to a control." Caveat: "Correlation of in vitro data to clinical outcome has not been established." This is a key disclosure. |
Study Details
Given this is a 510(k) for a ureteral stent, many of the requested points are not applicable as they pertain to AI/diagnostic efficacy studies rather than device substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study. The in vitro testing mentioned would have involved a sample size of stents for calcium accumulation assays. This detail is not provided.
- Data Provenance: The document states "In vitro testing conducted on the Bard® InLayOptima™ Ureteral Stents and Multi-Length Ureteral Stents..." This indicates the testing was done specifically for this device. There's no mention of country of origin for the data or if it was retrospective/prospective in a clinical sense. The reference to Choong et al. (2000) suggests a methodology for quantifying encrustation, not necessarily the specific data provenance for this stent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical ureteral stent, not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" for its performance would be derived from physical and chemical properties and in vitro (and historical in vivo) performance, not expert interpretation of data.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. 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 is a physical medical device, not an AI or imaging diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the in vitro calcium encrustation testing: The ground truth would be the quantitative measurement of calcium accumulation, likely determined by chemical assay or similar laboratory methods (as suggested by "assayed by calcium").
- For the overall device: The ground truth for its safety and effectiveness is largely based on its equivalence to the predicate device, which has a history of safe and effective use. The "truth" is that it performs similarly to, and is as safe as, its predicate.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI or machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study and Acceptance:
The submission K043193 for the Bard® InlayOptima™ Ureteral Stent with Suture demonstrates substantial equivalence to a legally marketed predicate device (Bard® InlayOptima™ Ureteral Stent with Suture, K022447).
The primary "study" components highlighted are:
- Comparison of Technological Characteristics: A detailed tabular comparison demonstrating that the new device is identical to the predicate in most aspects, including intended use, sterility, sizes, geometry, and accessories (with minor acceptable changes like the removal of a clamp).
- Material Change Justification: The key difference identified is the stent base material, changing from Polyether-based Polyurethane to Polycarbonate-based Polyurethane. This change would have been supported by material characterization and biocompatibility testing (not detailed in this summary).
- In Vitro Performance Testing: "In vitro testing conducted... indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control." This directly addresses a performance characteristic important for ureteral stents. While no specific numeric acceptance criterion is provided, the finding of "reduced accumulation" compared to a control is presented as a positive attribute, implying it meets or exceeds expected performance.
- Regulatory Standards Compliance: The device adheres to "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." This indicates that relevant industry and regulatory standards for stent performance were considered and likely met.
The acceptance criteria are implicitly met by demonstrating that the device is substantially equivalent to the predicate, and any differences (like the material change) do not raise new questions of safety or effectiveness and are supported by appropriate testing (e.g., in vitro calcium accumulation tests). The FDA's letter (K043193) confirms this by stating that the device is "substantially equivalent (for the indications for use stated...)" to the predicate.
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DEC - 7 2004
K043193
Page 1 of 3
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., Urological Division |
|---|---|
| Address: | 8195 Industrial Blvd.Covington, Georgia 30014 |
| Contact Person: | Frances E. Harrison, RAC |
| Contact Person's Phone: | (770) 784-6257 |
| Contact Person's Fax: | (770) 784-6419 |
| Date of Preparation: | November 24, 2004 |
- B Device Name:
| Trade Name: | Bard® InLayOptima™ Ureteral Stent with Suture |
|---|---|
| Common / Usual Name: | Bard Ureteral Stent |
| Classification Name: | Ureteral Stent |
- C. Predicate Device Name:
| Trade Name: | Bard ® InLayOptima™ Ureteral Stent with Suture |
|---|---|
| #K022447 |
- D. Device Description: The Bard® InLayOptima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtail 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:
- 1 Ureteral Stent with Suture
- 1 Push Catheter with Radiopaque Tip
- ー Pigtail Straightener
- Guidewire* (Optional) 1
- *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® InLayOptima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calcium 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. Intended Use: The Bard® InlayOptima™ 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.
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Page 2 of 3
- F. Technological Characteristics Summary:
The table below provides a tabulated comparison summary of the technological characteristics of
the Bard* InlayOptima™ Ureteral Stent with Suture versus the predicate device
| ProductCharacteristics | Bard® Inlay Optima ™ Ureteral Stentwith Suture(this 510(k)) | Bard® Inlay Optima™ Ureteral Stentwith Suture(Predicate device - #K022447) | 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® 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. | None |
| Disposable | Yes | Yes | None |
| Sterile | Yes | Yes | None |
| Stent Base Material | Polycarbonate-based Polyurethane* | Polyether-based Polyurethane | Materialchange |
| X-Ray Opaque | Yes | Yes | None |
| Coating | |||
| Double Pigtail | Hydrophobic polymer | Hydrophobic polymer | None |
| Multilength | Hydrophobic polymer | Hydrophobic polymer | None |
| 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 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 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 | No | ClampRemoved |
| 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 near distal end | None |
Comparison Summary of Technological Characteristics
. New feature(s) or change this 510(k)
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X043193
Page 3 of 3
The Bard" InlayOpima" Ureteral Stent with Suture referenced in this submission is held to
the same design, manufacture, and performance specifications as those stents current 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or forms, often interpreted as representing people or the provision of services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 2004
Frances E. Harrison, RAC Director, Regulatory Affairs C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014
Re: K043193
Trade/Device Name: Bard® InlayOptima™ Ureteral Stent with Suture Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: November 10, 2004 Received: November 18, 2004
Dear Ms. Harrison:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becalled by equivalent (for the indications for use stated in above and nave determined the als at redicate devices marketed in interstate commerce prior to the enclosure) to regary manusical Device Amendments, or to devices that have been May 20, 1770, the clademisine acto 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 do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general connois prove, 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 (Premarket If your device is classified (600 above).
Approval), it may be subject to such additional controls. Existing major regulations affecting your Apploval), It they of sabject to antiFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA acvice can be round in the cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Ficast be advised mar PDT o isoual your device complies with other requirements of the Act or any FDA liade a actemination adaministered by other Federal agencies. You must comply with all the Federal statues and regulations administer to registration and listing (21 CFR Part 807); labeling ACL STEQuirements, metading but noing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter notification. The FDA finding of substantial equivalence of your device to a legally promation notificate 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 11 you atter of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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): _K043193
Device Name: Bard® InlayOptima™ Ureteral Stent
Indications for Use:
The Bard® InlayOptima™ 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 1 (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1/2/96)
Daniel A. Suggars
(Division Sign-Of Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number
§ 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).