(389 days)
Not Found
No
The device description focuses on mechanical features and performance testing, with no mention of AI or ML capabilities.
No
The device is an introducer/guiding sheath, which provides a pathway for other devices; it does not directly treat a medical condition but facilitates the delivery of therapeutic or diagnostic devices.
No
The device description indicates that the FuStar™ Steerable Introducer is designed to facilitate the introduction of other devices into the vasculature, acting as a pathway or guiding sheath, rather than performing any diagnostic function itself.
No
The device description clearly details a physical medical device (introducer sheath) with various hardware components (sheath, tip, knob, connectors, different sizes and lengths). The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, the FuStar™ Steerable 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 a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature." This describes a device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details a physical device (sheath, controller, knob) used for guiding and introducing instruments into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The FuStar™ Steerable Introducer does not perform any such function. It is a tool for accessing and navigating within the body.
Therefore, the FuStar™ Steerable Introducer is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FuStarTM Steerable Introducer is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The FuStarTM Steerable Introducers are designed to perform as a guiding sheath and/or introducer sheath, which provides a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low-profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of catheters and devices.
The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm (Large). In each option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination. Also, the visible knob with scale of controller facilitates the physicians to estimate the deflecting angle of the sheath while intra-operation.
The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French size, 5F, 6F, 7F, 8F, 9F and 10F). The deflectable angle of sheath is from 0 degree to 180 degree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a medical setting.
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)
Performance testing was conducted to validate and verify that the proposed device met all design specifications including:
Performance Test: Primary Dimension Test; Exterior Surface Condition X-Ray Visible Testing; Bending Test, Cycle (Fatigue) Test: Conical Fitting Test: Hub Test; Connection Strength Test: Corrosion Resistance test, Leakage and Aspiration Test,
Biocompatibility Test: Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity Test, Hypersensitivity Test, Hemolysis Test, Complement System Test. Thrombosis Test Sterilization: Sterliization Validation, Package Integrity Test, Pyrogen Test and Endotoxicity Test.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Premarket Notification Section 510(k) Submission
FuStar Steerable Introducers
Exhibit #5 510(k) Summary
Ref No.: A2009-018-075
Image /page/0/Picture/1 description: The image shows the logo for SesrCare Lifetech Scientific. The logo is in black and white, with the word "SesrCare" in a bold, sans-serif font. The letters are connected, giving the logo a sense of unity. The letters "TM" are in superscript to the right of the word "SesrCare". Below the word "SesrCare" is the phrase "Lifetech Scientific" in a smaller, sans-serif font.
1
FEB 1 4 2011
Exhibit #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The 510(k) Number is K100184
| Date of Submission: | 02 SEPT 2010 |
|---|---|
| Sponsor: | Lifetech Scientific (Shenzhen) Co., Ltd |
| Floor 1-3, Cybio Electronic Building, Langshan 2nd Street, North area of High-tech Park, | |
| Nanshan District, Shenzhen, Guangdong, 518057, P. R. China | |
| Contact Person: | |
| Ms. Xiaoli Shi, International Regulatory / Mr. David Zhang, CTO | |
| TEL:86-13418601356 FAX:(86-755)86026251 | |
| Email:stepbystep0326@hotmail.com | |
| Correspondent: | Ms. Diana Hong / Mr. Lee Fu |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Suite 5D, No.19, Lane 999,Zhongshan Road (S-2),Shanghai, 200030, China | |
| TEL: +86-21-22815850 FAX: +86-21-22815850 | |
| Proposed Device | FuStar™ Steerable Introducers |
| Classification: | Class II |
| Product Code: DQY | |
| Classification Name: catheter, percutaneous | |
| Regulation Number: 21 CFR 870.1250 | |
| Review Panel: Cardiovascular | |
| Predicate Device: | Predicate Device 1: |
| 510(k) Number: K072313 | |
| Trade Name: AMPLATZER Torqvue Delivery System | |
| Manufacturer: AGA Medical Corporation |
Predicate Device 2:
510(k) Number: K061119
Trade Name: Enpath Medical Steerable Sheath |
1
Premarket Notification Section 510(k) Submission FuStar Steerable Introducers Exhibit #5 510(k) Summary Ref No .: A2009-018-075
Image /page/1/Picture/1 description: The image shows the logo for "SesrCare Lifetech Scientific". The word "SesrCare" is written in a bold, sans-serif font, with the letters connected. The letters are black. The words "Lifetech Scientific" are written in a smaller, thinner font below "SesrCare".
Intended Use: FuStarTM Steerable Introducer is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Device Description: The FuStarTM Steerable Introducers are designed to perform as a guiding sheath and/or introducer sheath, which provides a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low-profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of catheters and devices.
The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm (Large). In each option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination. Also, the visible knob with scale of controller facilitates the physicians to estimate the deflecting angle of the sheath while intra-operation.
The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French size, 5F, 6F, 7F, 8F, 9F and 10F). The deflectable angle of sheath is from 0 degree to 180 degree.
Testing Conclusion: Performance testing was conducted to validate and verify that the proposed device met all design specifications including:
Performance Test: Primary Dimension Test; Exterior Surface Condition X-Ray Visible Testing; Bending Test, Cycle (Fatigue) Test: Conical Fitting Test: Hub Test; Connection Strength Test: Corrosion Resistance test, Leakage and Aspiration Test,
Biocompatibility Test: Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity Test, Hypersensitivity Test, Hemolysis Test, Complement System Test. Thrombosis Test Sterilization: Sterliization Validation, Package Integrity Test, Pyrogen Test and Endotoxicity Test.
- SE Conclusion: FuStar™ Steerable Introducers, can be claimed to be Substantially Equivalent (SE) to the predicate device, Predicate Device AMPLATZER Torqvue Delivery System K072313 and Enpath Medical Steerable Sheath, K061119.
2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lifetech Scientific (Shenzhen) Co., Ltd C/O Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D. No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China
FEB 1 4 201
K100184 Trade/Device Name: FuStar™ Steerable Introducers Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: January 18, 2011 Received: January 19, 2011
Dear Ms. Hong:
Re:
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
1:00 PM IST STATE
3
Page 2 - Ms. Diana Hong
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/Reportal?rgblem/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,
Dunn P. Viener
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Section 510(k) Submission FuStar Steerable Introducers Section II Indication for Use Statement · Ref No.: A2009-018-075
Image /page/4/Picture/1 description: The image shows the logo for "SesrCare Lifetech Scientific". The word "SesrCare" is in a bold, sans-serif font, with the "TM" symbol in superscript next to it. Below "SesrCare" is the text "Lifetech Scientific" in a smaller, lighter font. The logo appears to be for a company involved in life sciences or scientific research.
Section II Indication for Use Statement
510(k) Number: K106184
Device Name: FuStar
TM
Steerable Introducers
Indications for Use:
FuStar™ Steerable Introducer is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Page 1 of 1
humph R. Vebus
sion Sign-Off) (Division Sign-Oll)
Division of Cardiovascular Devices
510(k) Number K100184
II-1