(473 days)
No
The device description and performance studies focus on the physical components and basic functionality of a sheath introducer, with no mention of AI or ML.
No
The device is described as an introducer sheath intended to facilitate the percutaneous introduction of other devices for both diagnostic and therapeutic procedures. It does not perform the therapeutic action itself.
No
The device is a sheath introducer, used to facilitate the percutaneous introduction of other devices for diagnostic and therapeutic procedures, rather than performing diagnosis itself.
No
The device description clearly outlines physical components such as a sheath introducer, side port extension, stopcock, hemostasis valve, suture ring, vessel dilator, and guidewire, indicating it is a hardware device.
Based on the provided information, the Bioteq Sheath Introducer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries". This describes a device used in vivo (within the body) for diagnostic and therapeutic procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical device designed for insertion into blood vessels, including a sheath, dilator, and guidewire. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, the Bioteq Sheath Introducer is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884).
The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and/or arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
A series of tests were performed to assess the substantial equivalence of the Sheath Introducer.
- Sterilization Validation
- Bioburden test
- Bioburden recovery test
- Endotoxin test
- Sterility test
- Biological Indicator test
- Bacteriostatic/Fungistatic test
- EO residual test
- Pyrogen test
- Batch release report
- A Packaging validation test
- Biocompatibility
- Cytotoxicity Test
- Intracutaneous Reactivity Test
- Acute Systemic Injection Test
- Sensitization Test
- The Salmonella typhimurium Reverse Mutation Assay
- Hemolysis Test
- Thromboresistance Test
- Complement Activation
- Material-Mediated Pyrogenicity
- Performance
- Force at Break Testing
- Conical Fittings with 6% (Luer) Taper
- Size Designation
- Liquid Leakage of Sheath Introducer & Liquid Leakage through Hemostasis Valve
- Chemical characterization
- Radiopacity Test
- Insertion force Test
- Guidewire compatibility Test
- Inspection the external surface
- Comparison Performance Testing
- Force at Break Testing
- Size Designation
- Liquid Leakage
- Insertion force
- Kink Resistance and Recovery
- Minimum Tensile Force Required to Remove the Dilator From the Sheath Hub
- Stiffness
All the test results demonstrate the substantial equivalence of Sheath Introducer, which meets the related requirements and its intended use.
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.
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
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2016
Bioteque Corp. Stella Hsu 5F-6. No. 23. Sec. 1 Chang-an E. Road Taipei 104, Taiwan
Re: K150932
Trade/Device Name: Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: May 30, 2016 Received: June 2, 2016
Dear Stella Hsu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150932
Device Name Sheath Introducer
Indications for Use (Describe)
The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Commercial and/or Industrial USE (Subject to Local Sewer Charges) | |
|---|---|
| Fire Suppression and/or Hydrant Use |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
BIOTEQUE CORP. 510(k) Notification, K150932/S002 Sheath Introducer
510(k) Summary
| 5.1 Type of Submission: | Traditional |
|---|---|
| 5.2 Date of Summary: | 07/15/2016 |
| 5.3 Submitter: | BIOTEQUE CORP. |
| Address: | 5F-6, No.23 Sec.1, Chang-An E. |
| Rd., Taipei 104, Taiwan | |
| Phone: | +886-2-2571-0269 |
| Fax: | +886-2-2536-1967 |
| Correspondent: | Stella Hsu |
| Registration number: | 9615118 |
| 5.4 Identification of the Device: | |
| Proprietary/Trade name: | Sheath Introducer |
| Classification Name: | Vessel Dilator for Percutaneous |
| Catheterization | |
| Device Classification: | II |
| Regulation Number: | 870.1310 |
| Panel: | Cardiovascular |
| Product Code: | DRE |
| 5.5 Identification of the Predicate Device: | |
| Predicate Device Name: | Merit Prelude TM Sheath Introducer |
| Predicate Device Name: | Merit Prelude TM Sheath Introducer |
|---|---|
| Manufacturer: | Merit Medical Systems, Inc. |
| Regulation Number: | 870.1310 |
| Panel: | Cardiovascular |
| Product Code: | DRE |
| 510(k) Number: | K050962 |
4
5.6 Intended Use and Indications for Use of the subject device.
The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
5.7 Device Description
Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884).
The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.
5.8 Non-clinical Testing
A series of tests were performed to assess the substantial equivalence of the Sheath Introducer.
-
Sterilization Validation
- Bioburden test -
- -Bioburden recovery test
- -Endotoxin test
- Sterility test -
- -Biological Indicator test
- Bacteriostatic/Fungistatic test -
- EO residual test -
- । Pyrogen test
- Batch release report -
- A Packaging validation test
5
Sheath Introducer
BIOTEQUE CORP. 510(k) Notification, K150932/S002
-
Biocompatibility
- Cytotoxicity Test -
- -Intracutaneous Reactivity Test
- Acute Systemic Injection Test -
- -Sensitization Test
- The Salmonella typhimurium Reverse Mutation Assay -
- Hemolysis Test -
- Thromboresistance Test -
- Complement Activation -
- Material-Mediated Pyrogenicity -
- Performance A
- Force at Break Testing -
- Conical Fittings with 6% (Luer) Taper -
- -Size Designation
- Liquid Leakage of Sheath Introducer & Liquid Leakage through -Hemostasis Valve
- Chemical characterization -
- Radiopacity Test -
- Insertion force Test -
- Guidewire compatibility Test -
- -Inspection the external surface
- Comparison Performance Testing A
- Force at Break Testing -
- Size Designation -
- Liquid Leakage -
- Insertion force -
- Kink Resistance and Recovery -
- Minimum Tensile Force Required to Remove the Dilator From the -Sheath Hub
- Stiffness -
All the test results demonstrate the substantial equivalence of Sheath Introducer, which meets the related requirements and its intended use.
6
5.9 Clinical Testing
No clinical test data was used to support the decision of the substantial equivalence.
5.10 EMC and Electrical safety
The devices do not require EMC/Electrical Safety evaluation.
5.11 Substantial Equivalence Determination
The Sheath Introducer submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation and performance to the cleared Merit Prelude™ Sheath Introducer which is the subject of K050962. Differences between the devices do not raise any new issues of substantial equivalence.
| Items
| product | Proposed device | Predicate device |
|---|---|---|
| Sheath Introducer | Merit PreludeTM Sheath | |
| Introducer | ||
| Manufacturer | Bioteque Corporation | Merit Medical Systems, Inc. |
| Indication for Use | The Bioteq Sheath Introducer | |
| is intended to provide access | ||
| and facilitate the percutaneous | ||
| introduction of various devices | ||
| into veins and/or arteries while | ||
| maintaining hemostasis for a | ||
| variety of diagnostic and | ||
| therapeutic procedures. | The Merit PreludeTM Sheath | |
| Introducer is intended to | ||
| provide access and facilitate the | ||
| percutaneous introduction of | ||
| various devices into veins | ||
| and/or arteries while | ||
| maintaining hemostasis for a | ||
| variety of diagnostic and | ||
| therapeutic procedures. | ||
| Regulation Number | 870.1310 | 870.1310 |
| FDA 510(k) No. | N/A | K050962 |
7
BIOTEQUE CORP. 510(k) Notification, K150932/S002 Sheath Introducer
| Classification | Class II | Class II | |
|---|---|---|---|
| Device Description | Bioteq Sheath Introducer | ||
| consists of a sheath introducer | |||
| with side port extension and | |||
| stopcock. The sheath hub | |||
| includes a hemostasis valve | |||
| and a suture ring. A 4-way | |||
| stopcock is affixed to the | |||
| proximal end of the side port | |||
| extension. The Bioteq Sheath | |||
| Introducer assembly includes a | |||
| vessel dilator that rotates | |||
| securely with the sheath | |||
| introducer hub and guidewire. | Merit's Prelude consists of a | ||
| sheath introducer with side port | |||
| extension and stopcock. | |||
| The sheath hub includes a | |||
| hemostasis valve and a suture | |||
| ring. A 3-way stopcock is | |||
| affixed to the proximal end of | |||
| the side port extension. The | |||
| Prelude assembly includes a | |||
| vessel dilator that snaps | |||
| securely into the sheath | |||
| introducer hub. | |||
| Product specifications | |||
| Sheath length | 11/23 cm | 11/23 cm | |
| Sheath French Size | 5~7 Fr | 4~8 Fr | |
| Guidewire Diameter | 0.038" & 0.035" | 0.038" & 0.035" | |
| Guidewire Length | 45/80 cm | 80 cm | |
| Contents | Sheath Introducer, Dilator, | ||
| Guidewire | Sheath Introducer, Dilator, | ||
| Guidewire | |||
| Sterilization method | Ethylene Oxide Gas | ||
| Sterilization | |||
| Materials | |||
| Sheath tube | ETFE | HDPE | |
| Dilator tube | Polypropylene | Polypropylene | |
| Guide wire | Stainless steel | Stainless steel | |
| Side tube | PVC | polyurethane |
8
5.12 Similarity and differences
The proposed device has the same technological characteristics as the predicate device. The differences between the proposed device and the predicate device are Sheath French Size, Guidewire Length and the materials of Sheath tube and Side tube. ETFE and HDPE are commonly used materials in sheath introducer. We have evaluated and reviewed these materials, and the proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the differences of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in design, operation, intended use, method of preparation, and performance claims.
5.13 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that Sheath Introducer is substantially equivalent to the predicate device.