K Number
K042877
Device Name
MICROVERTER URETERAL ACCESS SHEATH
Date Cleared
2004-11-16

(29 days)

Product Code
Regulation Number
876.5130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.
Device Description
The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.
More Information

78 KNY

Not Found

No
The summary describes a mechanical device for accessing the urinary tract and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.

No.
The device facilitates the introduction of instruments and forms a lubricious barrier, but does not provide therapy itself.

No
The device is described as an access sheath to facilitate the introduction of instruments for endoscopic procedures and fluid injection, not to diagnose a condition.

No

The device description clearly describes a physical device consisting of a film membrane, outer tube, and pusher tube, which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device used to facilitate the introduction of instruments into the urinary tract for endoscopic procedures and fluid injection. This is an in vivo application, meaning it's used within a living organism.
  • Device Description: The description details a physical device (sheath, tubes, membrane) designed for insertion into the body.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any analysis of biological samples.

Therefore, the MICROVERTER Ureteral Access Device is a medical device used for surgical/interventional procedures, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

Product codes

78 KNY

Device Description

The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

urinary tract, ureteral tissue

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)

Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath and the predicate device.

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

Not Found

Predicate Device(s)

PSI SLIP Urology Introducer Sheath, Cook Flexor Ureteral Access Sheath, Boston Scientific Navigator Ureteral Access Sheath

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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NOV 1 6 2004

K042877
Payeldz

510(k) SUMMARY

Percutaneous Systems, Inc.'s MICROVERTER Ureteral Access Sheath

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Percutaneous Systems, Inc. 1300 Crittenden Lane, #301 Mountain View, CA 94043-1359

(650) 969-8800 x 204 Phone: Facsimile: (650) 969-8801

Contact Person: Thomas Lawson

September 25, 2004 Date Prepared:

Common or Usual Name

Urology Introducer Sheath

Classification Name

Accessories, Catheter, G-U

Predicate Device

PSI SLIP Urology Introducer Sheath Cook Flexor Ureteral Access Sheath Boston Scientific Navigator Ureteral Access Sheath

Intended Use / Indications for Use

The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the

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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of numbers and words. The numbers "1042877" are written on the top line. Below that, the word "page" is written, followed by the number "202".

urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

Technological Characteristics

The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.

Performance Data

Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath and the predicate device.

Substantial Equivalence

The MICROVERTER Ureteral Access Sheath has the same intended use, indications for use, and principles of operation and very similar technological characteristics as the predicate devices. Thus, the MICROVERTER Ureteral Access Sheath is substantially equivalent to the cleared predicate devices.

Image /page/1/Picture/8 description: The image shows a hand-drawn figure of a rounded shape, possibly resembling a cell or a blob. Inside the shape, the number 122 is written in a simple, handwritten style. The number is centered within the shape, and the overall image has a casual, informal appearance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Thomas Lawson, Ph.D. Director, Clinical Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, #301 MOUNTAIN VIEW CA 94043-1359

Re: K042877

Trade/Device Name: MICROVERTER Ureteral Access Sheath Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: September 25, 2004 Received: October 18, 2004

Dear Dr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one 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 the enated of the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1710, 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 do not require 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 (Premarket Approval), it may be subject to such 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.

3

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 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
Other240-276-0100

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/dsmaldsmamain.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):_ K 042 877

Device Name: MICROVERTER Ureteral Access Sheath

Indications for Use:

The MICROVERTER Ureteral Access Sheath is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract.

The MICROVERTER Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

Prescription Use x Use (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

Nancy C. Brogdon

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