(123 days)
Not Found
No
The device description and performance studies focus on the physical properties and functional performance of the introducer sheath, dilator, and guidewire. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is intended for the introduction of diagnostic and interventional devices into the human vasculature, acting as an accessory rather than performing a therapeutic function itself.
No
Explanation: The device is an Introducer Sheath, which is intended for use in the introduction of diagnostic and interventional devices, rather than performing a diagnostic function itself.
No
The device description clearly details physical components made of materials like polyamide, Ethylene, Teflon, Polypropylene, FEP, and stainless steel, and describes functional testing of these physical components. There is no mention of software as a component of this device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the introduction of diagnostic and interventional devices into the human vasculature." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body.
- Device Description: The description details physical components like sheaths, dilators, and guidewires, all designed for insertion into blood vessels. There is no mention of reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly an invasive medical device used for accessing the vascular system.
N/A
Intended Use / Indications for Use
Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.
Product codes
DYB, DRE
Device Description
The Super Sheath Introducer Sheaths are available in-4F-Device Description 9F diameters and available in lengths ranging from 7 to 25 cm. Some sheaths may be ordered with a suture wing and some sheaths have radiopaque markers. The devices are provided sterile and are intended for one procedure use only.
The Medikit Super Sheath Introducer Sheath is packaged with a dilator. The Super Introducer Sheath Sets consists of a sheath, a dilator and a mini guidewire, with Inserter, as described in this submission or a US commercially available mini guidewire meeting Medikit specifications. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and Ethylene shart and mac mac the (Teflon). Some sheaths have radiopaque markers that are embedded into the shaft 1.5 mm from the distal tip. The hubs, color-coded by French size, contain a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The sidetube extension is used for site management.
The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. It is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. There are two different dilators, 0.038" and a 0.035" guidewire compatible. The 4-8F-dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are pressed into the dilator hub with a bushing. The sheath hub and the dilator hub lock using a rotating motion.
Super Sheaths can be ordered with a Polypropylene suture wing color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures.
The uncoated mini guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The mini guidewire (with Inserter) is available in 45cm and 80cm lengths. The Inserter does not contact blood and is used strictly for guiding the guidewire into a cannula or introducer. A US commercially available mini guidewire (meeting Medikit specifications) may be used in the sets or the mini guidewire that is described in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature
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)
Functional testing for the Super Sheath consisted of sheath shaft tensile, sheath kink, sheath hub to shaft tensile, hemostatic valve integrity/sheath pressure, valve integrity of sheath, sheath lubricity, sheath radiopacity, and sheath/dilator corrosion resistance testing. Dilator functional testing consisted of dilator shaft tensile and dilator hub to shaft tensile testing. Mini Guidewire functional testing included tensile, combined load, torqueability, radiopacity and corrosion resistance. Biocompatibility, packaging and product shelf life testing has also been conducted. Test results verified that the Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are adequate for their intended use. Based on a comparison of intended use, design and the results of bench testing, Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets have been shown to be substantially equivalent to the predicate Terumo Pinnacle Introducer Sheaths (K954234) and are therefore deemed suitable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Terumo Pinnacle Introducer Sheaths K954234
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 7 2006
Image /page/0/Picture/1 description: The image shows a black and white logo of a person standing in front of a globe. The globe is represented by a grid of lines, and the person is standing with their arms outstretched. The logo is simple and iconic, and it could be used to represent a variety of concepts, such as global unity, human connection, or international cooperation. The person is centered in the image.
TOGO MEDIKIT CO., LTD.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
57
510(k) Summary per 21 CFR §807.92
| Submitter's Name
and Address | Togo Medikit Co. Ltd.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062
Japan | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|
| Contact Name and
Information | Toshimitsu Hayashi
Quality Assurance Assistant Manager
Phone: 81-982-53-8027
Fax: 81-982-53-8008
e-mail: toshimitsu.hayashi@togomedikit.co.jp | | |
| Applicant | Heidi M. Erickson
Specialist, Regulatory Affairs
Phone: 763-694-3028
Fax: 763-694-6966
e-mail: ericksoh@bsci.com | | |
| Date Prepared | September 15, 2005 | | |
| Proprietary
Name(s) | Super Sheath Introducer Sheath | | |
| Common Name | Catheter Introducer | | |
| Product Code | DYB | | |
| Classification of
Device | Class II, 21 CFR Part 870.1340 | | |
| Predicate Device | Terumo Pinnacle
Introducer
Sheaths | K954234 | November 27, 1995 |
1
The Super Sheath Introducer Sheaths are available in-4F-Device Description 9F diameters and available in lengths ranging from 7 to 25 cm. Some sheaths may be ordered with a suture wing and some sheaths have radiopaque markers. The devices are provided sterile and are intended for one procedure use only.
The Medikit Super Sheath Introducer Sheath is packaged with a dilator. The Super Introducer Sheath Sets consists of a sheath, a dilator and a mini guidewire, with Inserter, as described in this submission or a US commercially available mini guidewire meeting Medikit specifications. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and Ethylene shart and mac mac the (Teflon). Some sheaths have radiopaque markers that are embedded into the shaft 1.5 mm from the distal tip. The hubs, color-coded by French size, contain a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The sidetube extension is used for site management
The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. It is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. There are two different dilators, 0.038" and a 0.035" guidewire compatible. The 4-8F-dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are pressed into the dilator hub with a bushing. The sheath hub and the dilator hub lock using a rotating motion.
Super Sheaths can be ordered with a Polypropylene suture wing color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures.
2
| Device Description
continued | The uncoated mini guidewire is made of a stainless steel
coil wrapped tightly around an inner mandrel that tapers at
the distal tip. The flexible tip is J-shaped available in
diameters of 0.035" and 0.038". The mini guidewire (with
Inserter) is available in 45cm and 80cm lengths. The
Inserter does not contact blood and is used strictly for
guiding the guidewire into a cannula or introducer. A US
commercially available mini guidewire (meeting Medikit
specifications) may be used in the sets or the mini
guidewire that is described in this submission. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of
Device | Super Sheath Introducer Sheaths and Super Sheath
Introducer Sheath Sets are intended for the introduction of
diagnostic and interventional devices into the human
vasculature. |
| Non-Clinical Test
Summary | Functional testing for the Super Sheath consisted of sheath
shaft tensile, sheath kink, sheath hub to shaft tensile,
hemostatic valve integrity/sheath pressure, valve integrity
of sheath, sheath lubricity, sheath radiopacity, and
sheath/dilator corrosion resistance testing. Dilator
functional testing consisted of dilator shaft tensile and
dilator hub to shaft tensile testing. Mini Guidewire
functional testing included tensile, combined load,
torqueability, radiopacity and corrosion resistance.
Biocompatibility, packaging and product shelf life testing
has also been conducted. Test results verified that the
Super Sheath Introducer Sheaths and Super Sheath
Introducer Sheath Sets are adequate for their intended use.
Based on a comparison of intended use, design and the
results of bench testing, Medikit Super Sheath Introducer
Sheaths and Super Sheath Introducer Sheath Sets have
been shown to be substantially equivalent to the predicate
Terumo Pinnacle Introducer Sheaths (K954234) and are
therefore deemed suitable for their intended use. |
·
3
Technological Characteristics The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets and the Terumo Pinnacle Introducer Sheaths (K954234) are operated manually or by a manual process. The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets use similar product design, packaging, sterilization methods and labeling when compared to Terumo Pinnacle Sheaths (the predicate device). The similar indications for use and technological characteristics support a determination of substantial equivalence. Differences in materials or manufacturing methods do not raise any new issues of safety and effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 17 2006
Togo Medikit Co., Ltd. c/o Boston Scientific Corporation Ms. Heidi M. Erickson Specialist, Regulatory Affairs 5905 Nathan Lane P-25 Plymouth, MN 55442
K052557 Re: Super Sheath Introducer Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: December 27, 2005 Received: December 29, 2005
Dear Ms. Erickson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessed in the encreated of to trg. 25 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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
5
Page 2 -- Ms. Heidi M. Erickson
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. 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/industry/support/index.html.
Sincerely vours.
Dulla R. Vines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Traditional 510(k) Notification
Togo Medikit Co. LTD. Introducer Sheaths and Introducer Sheath Sets
、・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Section 4: Indications for Use Statement
Indications for Use
のお気になる。
2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
K052557 510(k) Number (if known):
Device Name: Super Sheath Introducer Sheath
Indications for Use: Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dina R. Vidiner
(Division Sign-Off) Division of Cardiovascular Devices
10(k) Number_K052557
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