(129 days)
No
The device description and performance studies focus solely on the physical and functional characteristics of a medical introducer sheath and its components. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is indicated for the introduction of diagnostic and interventional devices, not for therapeutic treatment itself.
No
Explanation: The device is an introducer sheath and sheath set, intended to facilitate the introduction of diagnostic and interventional devices into the human vasculature. It does not perform diagnostic functions itself.
No
The device description clearly details physical components made of materials like polyamide, ethylene tetrafluoro ethylene, and polypropylene, and the performance studies focus on physical properties and sterilization, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of diagnostic and interventional devices inserted into the human vasculature." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical device (sheath, dilator, guidewire) designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are considered medical devices used for interventional and diagnostic procedures within the human body, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
Product codes
DYB
Device Description
The Super Sheath Introducer Sheaths and Super Sheath Sets are similar to the 4F-9F with the addition of the 3.3 French sheath, compatible dilator and guidewire to the sheath line. The Super Sheath Introducer Sheath is available in 3.3F and lengths of 5 cm and 7 cm. The device is provided sterile and intended for one procedure use only.
The Super Sheath Introducer Sheath is packaged with one dilator. The Super Sheath Introducer Sheath Set consists of one sheath, one dilator, and one guidewire with inserter. The sheath shaft and hub are manufactured of polyamide and ethylene tetrafluoro ethylene; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains 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 side tube extension may be used for fluid and medication administration, as well as blood sampling.
The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The 3.3F Super Sheath Introducer Sheaths and provided dilator are compatible with a maximum recommended 0.025" guidewire. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.
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
adult and pediatric patients of all ages.
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 was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification. Testing was conducted according to protocols based on international standards and in-house requirements, and included:
- Sheath Shaft Tensile Test
- Sheath Kink Test
- Connection Strength Test
- Hemostatic Valve Pressure Test
- Sheath Valve Integrity / Sheath Pressure Test
- Sheath Lubricity Test
- Sheath Radiopacity Test
- Sheath / Dilator Corrosion Resistance Test
- Dilator Tensile Test
- Dilator Connection Strength Test
- Guidewire Tensile Test
- Guidewire Radiopacity Test
- Guidewire Corrosion Resistance Test
- Guidewire Torque Load Test
- Guidewire Torqueability Test
Additionally the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets were adopted into the existing ethylene oxide sterilization cycle for sheath products, which was validated in accordance with ISO 11135-1:2007.
Biocompatibility, packaging and product shelf life testing was provided in K052557. The devices tested included materials and packaging used in the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets included in this Special 510(k) premarket notification. Additional testing was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Page 1 of 5
Section 5. 510(k) Summary
Submission Correspondent Emergo Group, Inc.
Address
611 West Fifth Street Third Floor Austin, TX 78701
Phone
(512) 327-9997
Fax
(512) 327-9998
Contact
Ms. Heather Crawford, RAC heather@emergogroup.com
Submission Sponsor
Togo Medikit Co. Ltd. 17148-6 Aza Kamekawa Oaza Hichiya Hyuga City, Miyazaki, Japan 883-0062 +81-982-53-8027 (Voice) +81-982-53-8008 (Fax)
Date Prepared
20 June 2012
Trade Name
Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Set
Classification Name
Catheter Introducer
Regulation Number
870.1340
Product Code
DYB
Classification Panel Cardiovascular
SEP 27 2012
1
Device Class
Class II
Predicate Device
- K052557: Super Sheath Introducer Sheath and Introducer Sheath Sets, 4F-9F
Togo Medikit Co., Ltd. previously submitted Special 510(k) K060190 Super Sheath XL Introducer Sheath to add sizes 10F, 11F, 12F and 14F to the range previously cleared under predicate device premarket notification number K052557. Special 510(k) K060190 was determined substantially equivalent on 04 April 2006 and added sizes 10F, 11F, 12F and 14F.
Indications for Use
The Super Sheath Introducer Sheaths and Super Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
Device Description
The Super Sheath Introducer Sheaths and Super Sheath Sets are similar to the 4F-9F with the addition of the 3.3 French sheath, compatible dilator and guidewire to the sheath line. The Super Sheath Introducer Sheath is available in 3.3F and lengths of 5 cm and 7 cm. The device is provided sterile and intended for one procedure use only.
The Super Sheath Introducer Sheath is packaged with one dilator. The Super Sheath Introducer Sheath Set consists of one sheath, one dilator, and one guidewire with inserter. The sheath shaft and hub are manufactured of polyamide and ethylene tetrafluoro ethylene; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains 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 side tube extension may be used for fluid and medication administration, as well as blood sampling.
The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The 3.3F Super Sheath Introducer Sheaths and provided dilator are compatible with a maximum recommended 0.025" guidewire. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.
2
Technological Characteristics and Substantial Equivalence
The following table compares the Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets to the predicate device with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Parameter | Super Sheath (3.3F)
Additional Size | Super Sheath (4F-9F)
Predicate Device |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | To be assigned | K052557 |
| Device Trade Name | Super Sheath Introducer
Sheaths and Super Sheath
Introducer Sheath Sets | Super Sheath Introducer
Sheaths and Super Sheath
Introducer Sheath Sets |
| Indications for Use | The Super Sheath Introducer
Sheaths and Super Sheath
Introducer Sheath Sets are
indicated for use in the
introduction of diagnostic and
interventional devices inserted
into the human vasculature of
adult and pediatric patients of
all ages. | Introducer Sheaths and
Introducer Sheath Sets are
intended for use in the
introduction of diagnostic and
interventional devices
inserted into the human
vasculature. |
| Regulation Number | 870.1340 | 870.1310 |
| FDA Product Code | DYB | DRE |
| Prescription / OTC Use | Prescription | Prescription |
| Single-Use / Reusable | Single-Use | Single-Use |
| Sheath | | |
| French Sizes Available | 3.3F | 4F - 9F |
| Effective Length | 5 cm – 7 cm
(50 mm – 70 mm) | 7 cm – 25 cm
(70 mm – 250 mm) |
| Radiopaque Marker | Not applicable | Tantalum |
| Guidewire and Inserter | | |
| Guidewire Tip Shape | Straight type | J-tip |
| Guidewire Recommended
Maximum OD (Outer
Diameter) | 0.025" | 0.035", 0.038" |
| Inserter | Available | Available |
| Sterilization and Shelf Life | | |
| Sterilization Method | Ethylene oxide | Ethylene oxide |
| Sterile Package | Pouch | Pouch |
| Shelf Life (Use By Date) | Three (3) years | Three (3) years |
Table 5-1. Device Comparison Table
3
Summary of Non-Clinical Data Submitted
Functional testing was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification. Testing was conducted according to protocols based on international standards and in-house requirements, and included:
- -Sheath Shaft Tensile Test
- -Sheath Kink Test
- Connection Strength Test י
- Hemostatic Valve Pressure Test -
- Sheath Valve Integrity / Sheath Pressure Test ー
- Sheath Lubricity Test -
- -Sheath Radiopacity Test
- Sheath / Dilator Corrosion Resistance Test
- Dilator Tensile Test -
- Dilator Connection Strength Test -
- ﮯ Guidewire Tensile Test
- Guidewire Radiopacity Test
- -Guidewire Corrosion Resistance Test
- -Guidewire Torque Load Test
- -Guidewire Torqueability Test
Additionally the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets were adopted into the existing ethylene oxide sterilization cycle for sheath products, which was validated in accordance with ISO 11135-1:2007.
Biocompatibility, packaging and product shelf life testing was provided in K052557. The devices tested included materials and packaging used in the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets included in this Special 510(k) premarket notification. Additional testing was not conducted.
Safety and Effectiveness
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
lt has been shown in this 510(k) submission that the differences between the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets and predicate devices do not raise any questions regarding its safety and effectiveness. The 3.3F Super Sheath Introducer Sheaths
4
and Super Sheath Introducer Sheath Sets, as designed and manufactured, therefore are determined to be substantially equivalent to the referenced predicate devices.
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5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 27 2012
Togo Medikit Co., Ltd. c/o Ms. Heather Crawford, RAC Sr. Quality and Regulatory Consultant, Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701
Re: K121504
Trade/Device Name: Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets
Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: August 14, 2012 Received: August 16, 2012
Dear Ms. Crawford:
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.
6
Page 2 - Ms. Heather Crawford
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Brain D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name:
Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets
Indications for Use:
The Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
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 IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | Page 1 of 1 |
K 12,504
510(k) Number