(84 days)
The Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidney.
The Deflecting Ureteral Access Sheath consists of a tapered dilator and a sheath, which are both coated with a hydrophilic coating, which is activated when wet. The tip of the sheath is designed such that it may be deflected in order to position the tip of the sheath to a desired site within the kidney to allow better access to surgical site. The deflecting feature also aids in positioning/maneuvering instruments such as endoscopes positioned inside the sheath.
The Deflecting Ureteral Access Sheath consists of two components, the sheath and the dilator, The sheath consists of an elongated body attached to a lever and handle assembly. Activation of the handle/lever mechanism results in desired deflection of the sheath. The dilator is assembled into the sheath during placement. The tapered tip of the dilator is designed for easy placement. The Deflecting Ureteral Access Sheath can be placed over a guidewire or by itself, The female luer fitting on the dilator is securely attached to the sheath handle during placement. Devices such as syringes and suction and irrigation equipment with luer port connectors may be attached to the dilator when irrigation and/or aspiration of the surgical site is desired. The dilator may also be used by itself in similar procedures.
The Deflecting Ureteral Access Sheaths will be made available as disposable, single use, sterile devices in two sizes (35cm and 60 cm).
The provided text describes a 510(k) summary for the "Deflecting Ureteral Access Sheath." This is a medical device, and the information presented focuses on regulatory approval rather than a detailed study comparing its performance against specific acceptance criteria in a quantitative sense as might be seen for an AI/CADe device.
Therefore, many of the requested categories for AI/CADe studies (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.
However, I can extract the acceptance criteria and the "reported device performance" in terms of what the performance data summary claims to demonstrate.
Here's a breakdown derived from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Surface Friction and Hydrophilic Coating Adhesion Test | Performance and functional testing demonstrates substantial equivalence to predicate devices. |
| Kink Free Test | Performance and functional testing demonstrates substantial equivalence to predicate devices. |
| Tip Deflection Test | Performance and functional testing demonstrates substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device, and the "performance data" refers to engineering and functional tests, not clinical data sets in the AI/CADe sense. The text does not specify sample sizes for these functional tests, nor their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood for AI/CADe studies (e.g., expert consensus on medical images or pathology) is not relevant here. The "ground truth" for the functional tests would be established by engineering specifications and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human expert evaluation, which is not described for this device's performance data.
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 not an AI/CADe device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The device's performance is inherently standalone in that its physical properties are tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's assessment would be engineering specifications and physical testing standards. The text asserts that the device meets these standards and is "substantially equivalent" to predicate devices, which implies it performs comparably in these physical tests according to established benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See above.
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MAY 2 3 2003
K030 642
pg 1 of 2
510(k) SUMMAR Y
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713-8327 |
| CONTACT PERSON: | Anil BhalaniVice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | February 20, 2003 |
| NAME OF DEVICE: | Deflecting Ureteral Access Sheath |
| CLASSIFICATION NAME: | Sheath, for EndoscopeEndoscope and Accessories, 21 CFR 876.1500 |
| TRADE NAME: | Not Determined |
| PREDICATE DEVICES: | Forte Ureteral Access Sheath Set (K993650 and K990775)Applied Medical Resources CorporationRancho Santa Margarita, CA |
INTENDED USE: The Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidnev.
DEVICE DESCRIPTION: The Deflecting Ureteral Access Sheath consists of a tapered dilator and a sheath, which are both coated with a hydrophilic coating, which is activated when wet. The tip of the sheath is designed such that it may be deflected in order to position the tip of the sheath to a desired site within the kidney to allow better access to surgical site. The deflecting feature also aids in positioning/maneuvering instruments such as endoscopes positioned inside the sheath.
The Deflecting Ureteral Access Sheath consists of two components, the sheath and the dilator, The sheath consists of an elongated body attached to a lever and handle assembly. Activation of the handle/lever mechanism results in desired deflection of the sheath. The dilator is assembled into the sheath during placement. The tapered tip of the dilator is designed for easy placement. The Deflecting Ureteral Access Sheath can be placed over a guidewire or by itself, The female luer fitting on the dilator is securely attached to the sheath handle during placement. Devices such as syringes and suction and irrigation equipment with luer port connectors may be
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1030642
attached to the dilator when irrigation and/or aspiration of the surgical site is desired. The dilator may also be used by itself in similar procedures.
The Deflecting Ureteral Access Sheaths will be made available as disposable, single use, sterile devices in two sizes (35cm and 60 cm).
PERFORMANCE DATA SUMMARY: The performance and functional testing of the Deflecting Ureteral Access Sheath included tests to verify Surface Friction and Hydrophilic Coating Adhesion, Kink Free Test, Tip Deflection Test. The performance and functional testing demonstrates that the Deflecting Ureteral Access Sheath is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
MAY 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688
Re: K030642
Trade/Device Name: Deflecting Ureteral Access Sheath Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FED Dated: February 20, 2003 Received: February 28, 2003
Dear Mr. Bhalani:
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. Iisting 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 (QS) 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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This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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 Chrogdon
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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030 642
INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Ureteral Access Sheath Set "Indications for Use" as required.
510(k) Number:
K030642 Not assigned
Device Name: Deflecting Ureteral Access Sheath
The Deflecting Ureteral Access Sheath is indicated for use in endoscopic Indications for Use: urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidney.
Signature:
Title: V.P., RA/Clinical Programs Date: 2-20-03
(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
David A. Symmon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic
510(k) Number K030642
(Optional Format -2-96)
§ 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.