(430 days)
Not Found
No
The device description and intended use are purely mechanical/physical, and there is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
A therapeutic device is used to treat or cure a disease or condition. This device is used for drainage, which is a supportive function, not a therapeutic one.
No
The device is described as a pigtail drainage catheter set, intended for percutaneous drainage of fluids (abscesses, cysts, gall bladders, and nephrostomies), not for diagnosing conditions.
No
The device description clearly lists multiple hardware components, including a catheter, trocar stylet, trocar needle, and sheath, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies." This involves physically draining fluids from the body.
- Device Description: The components listed (catheter, stylet, needle, sheath, etc.) are all instruments used for a physical procedure (drainage).
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs typically involve reagents, assays, or analytical methods to detect or measure substances.
Therefore, the BIOTEQ® Pigtail Drainage Catheter Set is a medical device used for a therapeutic/interventional procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders, nephrostomies and other fluids.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE, 78 LJE
Device Description
The BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body. It consist of the following major components:
① F.L.L. Adapter
② Screw Cap
③ Catheter
④ Curve Straightener (Sleeve)
⑤ Wire Cap --- (For With Safety String Lock model only)
⑥ Trocar Stylet
⑦ Trocar Needle
⑧ Sheath
⑨ Suture Wire --- (For With Safety String Lock model only)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards----etc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510(K) SUMMARY
K03386
page lofe
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| FEB 1 4 2005 | ||
|---|---|---|
| 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® Pigtail Drainage Catheter Set ( One Step Type) with Safety String Lock , or without Safety String Lock | |
| Common Name: | General Purpose drainage set | |
| Classification name: | Catheter, biliary, diagnostic | |
| Catheter, nephrostomy | ||
| 3. Classification: | Class II | |
| 4. Predicate Device: | URESIL General Purpose Drainage Set (K003753) marketed by | |
| URESIL CORP. | ||
| 5. Device Description: | The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is used for the drainage pathway of patients' fluids through the catheter out of body . It consist of the following major components: | |
| ① F.L.L. Adapter | ||
| ② Screw Cap | ||
| ③ Catheter | ||
| ④ Curve Straightener (Sleeve) | ||
| ⑤ Wire Cap --- (For With Safety String Lock model only) | ||
| ⑥ Trocar Stylet | ||
| ⑦ Trocar Needle | ||
| ⑧ Sheath | ||
| ⑨ Suture Wire --- (For With Safety String Lock model only) | ||
| 6. Intended Use: | BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders, nephrostomies and other fluids. | |
| 7. Performance Summary: | In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards----etc. |
1
୪. Conclusions:
The BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) have the same intended use similar technological characteristics as the URESIL General Purpose Drainage Set (K003753) marketed by URESIL CORP.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety ~ effectiveness. Thus, the BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2005
Bioteque Corporation c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail FLAGSTAFF AZ 86001
K033862 Re:
Trade/Device Name: BIOTEQ® PIGTAIL Drainage Catheter Set (One Step Type) with or without Safety String Lock Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Product Code: 78 FGE Regulation Number: 21 CFR §876.5090 Regulation Name: Suprapubic urological catheter and accessories Product Code: 78 LJE Regulatory Class: II Dated: December 13, 2004 Received: December 17, 2004
Dear Ms. Reich:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreations) it the enactment date of the Medical Device Amendments, or to conimoted provises that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 r ou may, therefore, market of the Act include requirements for annual registration, listing of general concess provisions a ractice, 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 your device is classified (500 a0010) ... Existing major regulations affecting your device can be it may be subject to additions, 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 I Toase of advised that I Dr Crisean that your device complies with other requirements of the Act that I Dri has made a actorned ations administered by other Federal agencies. You must of any I ederal statutes and regaratents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), laborning (21 CFR Part 820); and if applicable, the electronic fordline the quality by stems (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 rr you atte 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 |
| 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
4
Indications for Use
510(k) Number (if known): ___K033862
Device Name: BIOTEQ® Pigtail Drainage Catheter Set ( One Step Type) with Safety String Lock , or without Safety String Lock
BIOTEQUE CORPORATION
Indications For Use:
BIOTEQ® Pigtail Drainage Catheter Set( One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.
V 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)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _
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