(144 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a stainless steel cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate a medical procedure (transseptal catheterization) to gain left heart access, which is a therapeutic intervention.
No
The device is described as providing structural support for a guidewire during a transseptal catheterization procedure to gain left heart access, which is an interventional or procedural function, not a diagnostic one.
No
The device description clearly states it is a stainless steel device with physical components (cannula, packaging, labeling) and undergoes performance testing related to its physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical device (stainless steel cannula) used for mechanical support and access within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) for the purpose of providing information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze samples.
The device is a surgical tool used in vivo (within the body) for a procedural purpose, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Transseptal Cannula is used in conjunction with a transseptal guidewire to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.
Product codes
DRC
Device Description
The Transseptal Cannula is a stainless steel device that comes in three lengths equivalent to the body of a transseptal needle, 69.7cm for the 71cm cannula, 87.7cm for the 89cm cannula, and 96.7cm for the 98cm cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .033" at the tip. The components of the Transseptal Cannula include the transseptal cannula, sterile packaging and labeling. There are six model numbers for the cannula: TSC071, TSC089, TSC171, TSC189, and TSC198. The Transseptal Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Cannula is used in a healthcare facility/hospital.
The Transseptal Cannula is used in transseptal procedures to provide structural support to a transseptal guidewire to gain access to the left atrium through the right side of the heart. The device is used by a physician by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The transseptal quidewire is then advanced to the fossa ovalis with the support of the Transseptal Cannula and dilator. This allows physicians to use a transseptal guidewire in difficult cases where there is a particularly tough septum as the Transseptal Cannula provides the extra support needed. The cannula's duration in the body is less than 24 hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, left heart, femoral vein, fossa ovalis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, healthcare facility/hospital
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 data provided in support of substantial equivalence to the predicate include:
- Visual and dimensional inspection
- Particulate testing (USP, Light Obscuration Method)
- Mating Joint Pull test (Handle to Hub)
- Guidewire Restriction Inspection
- Strength of Union Cannula Hub and Cannula
- Needle Point Inspection
- Hub Female Luer Taper
- Water Leak Testing
- Air Leak Testing
- Packaging Testing
Biocompatibility evaluation was conducted in accordance with FDA 510/k) Memorandum- #G95-1 and International Standard ISO 10993-1. Tests performed:
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Sensitization
- ISO 10993-10 Irritation/Intracutaneous Reactivity
- ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogenicity
- ISO 10993-3 Genotoxicity
- ISO 10993-4 Hemocompatibility – ASTM Hemolysis Complete
- ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9
The Transseptal Cannula met the requirements set forth in ISO-10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 16, 2018
Pressure Products Medical Device Manufacturing LLC Andrew Armour Managing Director 1 School Street Morton, Pennsylvania 19070
Re: K172934
Trade/Device Name: Needle Free Transseptal Cannula Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC Dated: January 16, 2018 Received: January 17, 2018
Dear Mr. Armour:
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 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);
1
Page 2 - Andrew Armour
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -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) K172934
Device Name Needle Free Transseptal Cannula
Indications for Use (Describe)
The Transseptal Cannula is used in conjunction with a transseptal guidewire to puncture the interatival septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter
Pressure Products Medical Device Manufacturing LLC. 1 School Street Morton, PA 19070 Phone: 610-285-9858 Fax: 610-285-9859
Contact Person: Andrew Armour Prepared: February 14, 2018
Identification of the Device
Proprietary-Trade Name: Needle Free™ Transseptal Cannula Device Class: Class II Classification Name: Trocar (CFR 870.1390) Common/Usual Name: Transseptal Cannula Product Code: DRC
Equivalent Legally Marketed Devices
St. Jude Medical, BRK Transseptal Needle, K122587
Description of the Devices
The Transseptal Cannula is a stainless steel device that comes in three lengths equivalent to the body of a transseptal needle, 69.7cm for the 71cm cannula, 87.7cm for the 89cm cannula, and 96.7cm for the 98cm cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .033" at the tip. The components of the Transseptal Cannula include the transseptal cannula, sterile packaging and labeling. There are six model numbers for the cannula: TSC071, TSC089, TSC171, TSC189, and TSC198. The Transseptal Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Cannula is used in a healthcare facility/hospital.
The Transseptal Cannula is used in transseptal procedures to provide structural support to a transseptal guidewire to gain access to the left atrium through the right side of the heart. The device is used by a physician by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The transseptal quidewire is then advanced to the fossa ovalis with the support of the Transseptal Cannula and dilator. This allows physicians to use a transseptal guidewire in difficult cases where there is a particularly tough septum as the Transseptal Cannula provides the extra support needed. The cannula's duration in the body is less than 24 hours.
Indications for Use
The Transseptal Cannula is used in conjunction with a transseptal quidewire to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.
The BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Both the Transseptal Cannula and the transseptal needle are used in transseptal catheterization procedures to gain left heart access. The difference between the two indications for use is that the Transseptal Cannula is used with a transseptal guidewire to puncture the septum, while the
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transseptal needle has a needle point and it is used on its own to puncture the septum. Because the two devices are made of stainless steel, the Transseptal Cannula, when used in conjunction with a transseptal guidewire, mimics the same structural support as a procedure with the transseptal needle. Because of these similarities, the BRK transseptal needle is the predicate device for the Transseptal Cannula.
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of this device are similar to the predicate device. The difference between the two indications for use is that the Transseptal Cannula is used with a transseptal guidewire to puncture the septum, while the transseptal needle point and it is used on its own to puncture the septum. The subject and predicate device are based on the follow technological elements:
- Stainless steel that provides structural support in the transseptal procedure ●
- Smooth inner diameter so devices can pass through the body of the devices smoothly .
- Devices are inserted through the transseptal dilator and sheath assembly so that it can . be used in the transseptal procedure
- . Devices come in 71, 89, and 98cm lengths (actual lengths: 69.7cm, 87.7cm, and 96.7cm)
- Devices come in two curves. Curve0 and Curve1 ●
- Devices assembled through the transseptal introducer system match curve shapes .
- . Cannula used with transseptal guidewire in the introducer assembly feels equivalent to the transseptal needle with the introducer assembly
The following are technological modifications to the predicate device:
- Needle point on predicate device to create the primary puncture of the fossa while ● Transseptal Cannula is used with a transseptal guidewire to create the primary puncture of the fossa
- The tip of the cannula is a blunt radius edge so it is stopped in the transseptal dilator . while transseptal needle has a needle point
- . Hub is clear instead of metal so that it is lighter and allows visualization of the introduction of devices
- . Transseptal Cannula is a non-skiving device when inserted into the transseptal dilator
Performance Testing
The following performance data were provided in support of the substantial equivalence to the predicate:
- Visual and dimensional inspection ●
- Particulate testing (USP, Light Obscuration Method) ●
- Mating Joint Pull test (Handle to Hub) ●
- Guidewire Restriction Inspection
- Strength of Union Cannula Hub and Cannula ●
- Needle Point Inspection ●
- Hub Female Luer Taper ●
- Water Leak Testing
- Air Leak Testing ●
- Packaging Testing ●
Biocompatibility Data
The biocompatibility evaluation for the Transseptal Cannula was conducted in accordance with FDA 510/k) Memorandum- #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The following tests were performed:
- ISO 10993-5 Cytotoxicity
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- ISO 10993-10 Sensitization .
- ISO 10993-10 Irritation/Intracutaneous Reactivity ●
- ISO 10993-11 Acute Systemic Toxicity ●
- ISO 10993-11 Pyrogenicity .
- ISO 10993-3 Genotoxicity .
- . ISO 10993-4 Hemocompatibility – ASTM Hemolysis Complete
- ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9 .
The Needle Free™ Transseptal Cannula is considered an external communicating device with an indirect blood path, and limited exposure (less than 24 hours). The Transseptal Cannula met the requirements set forth in ISO-10993.
Conclusion
When compared to the predicate device, the Transseptal Cannula is substantially equivalent in design, technological characteristics, materials and performance testing.