(454 days)
Not Found
No
The device description and intended use describe a physical medical device (a ureteral stent set) and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device facilitates the temporary internal drainage of urine, which is a therapeutic function aimed at alleviating a medical condition.
No
The device is a ureteral stent set intended to facilitate the temporary internal drainage of urine, not to diagnose a condition.
No
The device description clearly outlines physical components such as a ureter stent, pusher catheter, guide wire, plastic dispenser, and plastic clips, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician." This describes a device used within the body for a therapeutic or drainage purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical device (stent, pusher catheter, guide wire) used for insertion and drainage. It does not mention any reagents, assays, or components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Diagnostic claims or interpretation of results
Therefore, the BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.
Product codes
78 FAD
Device Description
The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The Pusher Catheter (Introducer sheath) is approximately 45cm long. The Guide Wire (Spiral stylet) is made of stainless steel with PTFE coating and a flexible safety tip and a marked rigid tip and is approximately 120 cm long. The plastic dispenser is used to protect the Guide Wire (Spiral stylet). There are also plastic clips in the set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
In terms of Physical specification, Chemical specification 7. Performance Summary: specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards-----etc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 3 0 2004
510(K) SUMMARY
Image /page/0/Picture/2 description: The image shows the text "K033210" in a handwritten style. The text is slightly slanted and has a somewhat rough appearance. There is some additional illegible text below the main text, which appears to be handwritten as well. The background is plain white.
" " is summary of 510(k) safety and effectiveness information is being submitted in accordance with
the requirements of SMDA and 21 CFR $807.92
| 1. | Submitter's Name: | BIOTEQUE CORPORATION |
|---|---|---|
| Address: | 8 F-3, No. 136, Sec.3,Jen-Ai Road, Taipei, Taiwan, R.O.C. | |
| Phone: | 886-2-2708-3188 | |
| Fax: | 886-2-2707-6610 | |
| Contact: | Mr. William Lee (General Manager) | |
| 2. | Device Name | |
| Trade Name: | BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET, or | |
| BIOTEQ® URETERAL STENT SET(Double J Type) | ||
| Common Name: | Ureteral Stent | |
| Classification name: | Ureteral Stent | |
| 3. | Classification: | Class II |
| Predicate Device: | Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets | |
| (K982974) marketed by RUSCH INTL. | ||
| 5. | Device Description: | The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist of |
| a ureter stent that is completely radiopaque, coiled cylindrical or open | ||
| tip with drainage holes at intervals of 5-20 mm, centimeter | ||
| graduations, continuous black positioning line to indicate the direction | ||
| in which the catheter tip coils, and black marking at the catheter end. | ||
| The Pusher Catheter (Introducer sheath) is approximately 45cm long. | ||
| The Guide Wire (Spiral stylet) is made of stainless steel with PTFE | ||
| coating and a flexible safety tip and a marked rigid tip and is | ||
| approximately 120 cm long. The plastic dispenser is used to protect | ||
| the Guide Wire (Spiral stylet). There are also plastic clips in the set. | ||
| 6. | Intended Use: | INDICATION FOR USE |
| BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to | ||
| facilitate the temporary internal drainage of urine from the kidney to | ||
| the bladder via placement endoscopically by a trained physician. |
1
- In terms of Physical specification, Chemical specification 7. Performance Summary: specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards-----etc.
Conclusions: 8.
The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET have the same intended use and similar technological characteristics as the Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets (K982974) marketed by RUSCH INTL.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2004
Bioteque Corporation c/o Ms. Jennifer Reich 3892 South America West Trail FLAGGSTAFF, AZ 86001
RE: K033210
Trade/Device Name: Bioteq Double Pigtail Ureteral Stent Set Regulation Number: 21 CFR§876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: 78 FAD Dated: December 13, 2004 Received: December 16, 2004
Dear Ms. Reich:
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 (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 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/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
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET BIOTEQUE CORPORATION
INDICATIONS FOR USE:
BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.
Nancy C hogdon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0 332/0
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
See above.
Wbrogdon
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