(344 days)
Not Found
No
The device description focuses on mechanical components (sheath introducer, dilator, guidewire, needle, stylet) and their physical functions. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are based on non-clinical mechanical and material testing, not algorithmic performance.
No.
The device is used to introduce other catheters and to puncture the interatrial septum, which are procedural steps rather than direct therapeutic actions themselves.
No
The device is an introducer kit designed to facilitate the insertion of other cardiovascular catheters into the heart and to puncture the interatrial septum. Its function is to provide access for treatment or further diagnostic tools, not to diagnose a condition itself.
No
The device description explicitly details physical components like a sheath introducer, dilator, guidewire, needle, and stylet, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an Intracardiac Catheter Introducer Kit and Transseptal Needle. These are instruments used to physically access and navigate within the heart. They are used in vivo (within the living body) to facilitate procedures, not to analyze samples in vitro (outside the living body).
- Intended Use: The intended use is for "introducing various cardiovascular catheters into heart" and "puncture the interatrial septum." This is a procedural function, not a diagnostic test performed on a sample.
The device is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
Product codes (comma separated list FDA assigned to the subject device)
DYB, NKQ, DRC
Device Description
The proposed device includes Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration; Dilator is assembled with the sheath introducer and introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.
The transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, interatrial septum, body vessel
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 11070-1998 Sterile single-use intravascular catheter introducer
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
- ASTM F88/F88M-09. Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
In addition to the following standards, the following test items have also been performed to evaluate the proposed device:
- Simulated Use Testing
- Anti-kink Testing
- Torque Strength Testing
- Torqueability Testing
- Tip Flexibility Testing
- A Flow Rate Testing
- Coating Integrity
- Particulate Evaluation.
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
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and continuity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
Synaptic Medical Limited % Diana Hong General Manager Mid-Link Consulting P.O. Box 120-119 Shanghai, 200120 CH
Re: K132943
Trade/Device Name: Intracardiac Catheter Introducer Kit and Transseptal Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, NKQ, DRC Dated: July 24, 2014 Received: July 28, 2014
Dear Diana Hong:
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.
1
Page 2 - Diana Hong
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
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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Tab # 6 Indications for Use Statement
510(k) Number: K132943
Device Name: Intracardiac Catheter Introducer Kit and Transseptal Needle
Indications for Use:
Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
| ☑PRESCRIPTION USE | OR | □OVER-THE-COUNTER USE |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
3
Tab # 7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K132943
-
7.1 Date of Preparation
8/29/2014 -
7.2 Sponsor
Synaptic Medical Limited
Building C, 100 Kechuang 6th Street Beijing Economic-Technological Development Area Beijing, 100176, PR China
Establishment Registration Number: Not yet registered
Contact Person: Mr. Yang, Tiecheng Position: Quality Director Tel: +86-10-51297209-813 Fax: +86-10-51297209-802 Email: tiecheng.yang@synapticmed.com.cn
- 7.3 Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
7.4 Identification of Proposed Device
Trade Name: Intracardiac Catheter Introducer Kit and Transseptal Needle Common Name: Catheter Introducer and Trocar
Regulatory Information: Classification Name: Introducer, Catheter Classification: II; Product Code: DYB: Regulation Number: 21 CFR 870.1340; Review Panel: Cardiovascular;
Regulatory Information: Classification Name: Trocar Classification: II; Product Code: DRC; Regulation Number: 21 CFR 870.1390; Review Panel: Cardiovascular;
Regulatory Information: Classification Name: Guidewire, Catheter, Reprocessed Classification: II; Product Code: NKQ: Regulation Number: 21 CFR 870.1330; Review Panel: Cardiovascular;
Intended Use Statement:
Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
7.5 Device Description
The proposed device includes Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration; Dilator is assembled with the sheath introducer and introduced into a body vessel over the guidewire. It is
5
used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.
The transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.
- 7.6 Identification of Predicate Device
510(k) Number: K070417 Product Name: ACross™ Transseptal Access System Manufacturer: St. Jude Medical
7.7 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 11070-1998 Sterile single-use intravascular catheter introducer;
-
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity:
- ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic > toxicity;
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
-
ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood;
-
ASTM F88/F88M-09. Standard Test Method for Seal Strength of Flexible Barrier Materials:
-
ASTM F1140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
In addition to the following standards, the following test items have also been performed to evaluate the proposed device:
-
Simulated Use Testing
-
Anti-kink Testing;
-
Torque Strength Testing;
-
Torqueability Testing:
-
Tip Flexibility Testing;
- A Flow Rate Testing;
-
Coating Integrity;
-
Particulate Evaluation.
6
7.8 Clinical Test Conclusion
No clinical study is included in this submission.
- 7.9 Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | DYB | DYB |
| Regulation Number | 21 CFR 870.1340 | 21 CFR 870.1340 |
| Intended Use | Intracardiac Catheter Introducer Kit | |
| is intended for introducing various | ||
| cardiovascular catheters into heart. | ||
| Transseptal Needle is intended for | ||
| puncture the interatrial septum | ||
| during a transseptal catheterization | ||
| procedure. | The St. Jude Medical ACross™ | |
| Transseptal Access System is | ||
| used both to puncture the | ||
| interatrial septum during a | ||
| transseptal catheterization | ||
| procedure and to introduce | ||
| various cardiovascular catheters | ||
| into the left side of the heart. | ||
| Sterile | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Shelf Life | 3 years | 3 years |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Performance | Comply with ISO 11070-1998 | Comply with ISO 11070-1998 |
| Features | Curve at sheath introducer tip | |
| Radiopaque | ||
| Curve at needle Transseptal Needle tip | ||
| J Shape Guidewire | Curve at sheath introducer tip | |
| Radiopaque | ||
| Curve at needle Transseptal Needle tip | ||
| J Shape Guidewire |
Table 6-1 Comparison of Technology Characteristics
7.10 Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.