Sheath Introducer

K150932 · Bioteque Corp. · DRE · Jul 22, 2016 · Cardiovascular

Device Facts

• Record ID: K150932
• Device Name: Sheath Introducer
• Applicant: Bioteque Corp.
• Product Code: DRE · Cardiovascular
• Decision Date: Jul 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended 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.

Device Story

Sheath introducer system facilitates percutaneous access to veins/arteries for diagnostic/therapeutic procedures; maintains hemostasis during device introduction. Components include sheath with side port, hemostasis valve, suture ring, 4-way stopcock, vessel dilator, and guidewire. Used in clinical settings by physicians; provides access point for secondary devices. Benefits include controlled vascular entry and reduced blood loss. Device assembly involves rotating dilator into sheath hub. Output is a secured vascular access port. No electronic or software components.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

Materials: ETFE (sheath), Polypropylene (dilator), Stainless steel (guidewire), PVC (side tube). Features: 6% Luer taper, hemostasis valve, 4-way stopcock. Sizes: 5F-7F, lengths 11cm/23cm. Sterilization: Ethylene Oxide (EO). Mechanical device; no electrical or software components.

Indications for Use

Indicated for patients requiring percutaneous vascular access for diagnostic or therapeutic procedures. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Merit Prelude™ Sheath Introducer (K050962)

Reference Devices

• Guidewire (K920884)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: underline;"><b></b></span> <span style="font-size: 20px;"><b> <div style="text-align: left;"> <input checked="true" type="checkbox"/> </div></b></span> | Commercial and/or Industrial USE (Subject to Local Sewer Charges) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b></b></span> <span style="font-size: 20px;"><b> <div> <input type="checkbox"/> </div></b></span> | 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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K150932

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.<br>Rd., Taipei 104, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| Correspondent: | Stella Hsu |
| Registration number: | 9615118 |
| 5.4 Identification of the Device: | |
| Proprietary/Trade name: | Sheath Introducer |
| Classification Name: | Vessel Dilator for Percutaneous<br>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 |

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### 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

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#### 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.

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### 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<br>product | Proposed device | Predicate device |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sheath Introducer | Merit PreludeTM Sheath<br>Introducer |
| Manufacturer | Bioteque Corporation | Merit Medical Systems, Inc. |
| Indication for Use | The Bioteq Sheath Introducer<br>is intended to provide access<br>and facilitate the percutaneous<br>introduction of various devices<br>into veins and/or arteries while<br>maintaining hemostasis for a<br>variety of diagnostic and<br>therapeutic procedures. | The Merit PreludeTM Sheath<br>Introducer is intended to<br>provide access and facilitate the<br>percutaneous introduction of<br>various devices into veins<br>and/or arteries while<br>maintaining hemostasis for a<br>variety of diagnostic and<br>therapeutic procedures. |
| Regulation Number | 870.1310 | 870.1310 |
| FDA 510(k) No. | N/A | K050962 |

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BIOTEQUE CORP. 510(k) Notification, K150932/S002 Sheath Introducer

| Classification | Class II | Class II | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Device Description | Bioteq Sheath Introducer<br>consists of a sheath introducer<br>with side port extension and<br>stopcock. The sheath hub<br>includes a hemostasis valve<br>and a suture ring. A 4-way<br>stopcock is affixed to the<br>proximal end of the side port<br>extension. The Bioteq Sheath<br>Introducer assembly includes a<br>vessel dilator that rotates<br>securely with the sheath<br>introducer hub and guidewire. | Merit's Prelude consists of a<br>sheath introducer with side port<br>extension and stopcock.<br>The sheath hub includes a<br>hemostasis valve and a suture<br>ring. A 3-way stopcock is<br>affixed to the proximal end of<br>the side port extension. The<br>Prelude assembly includes a<br>vessel dilator that snaps<br>securely into the sheath<br>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,<br>Guidewire | Sheath Introducer, Dilator,<br>Guidewire |
| | | Sterilization method | Ethylene Oxide Gas<br>Sterilization |
| | Materials | | |
| | Sheath tube | ETFE | HDPE |
| Dilator tube | Polypropylene | Polypropylene | |
| Guide wire | Stainless steel | Stainless steel | |
| Side tube | PVC | polyurethane | |

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### 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.