(228 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No.
The device is a medical guidewire used for navigating within the heart during transseptal procedures to facilitate access, not to treat a disease or condition itself.
No.
The device description indicates that the SafeSept Transseptal Guidewire is used to gain access to the left atrium through the right side of the heart by perforating the fossa ovalis. This is a procedural, not a diagnostic, function. Its purpose is to facilitate a procedure, not to identify or monitor a medical condition.
No
The device description clearly outlines physical components made of nitinol, including a guidewire, dispenser, and straightener, and describes physical performance testing. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the SafeSept device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SafeSept is a physical device inserted into the body to facilitate a medical procedure (transseptal access). It does not analyze blood, tissue, or other bodily fluids.
- The intended use describes a surgical/interventional procedure. The description clearly states the device is used to gain access to the left atrium through the right side of the heart by perforating the fossa ovalis. This is a procedural function, not a diagnostic test performed on a sample.
- The device description details a physical guidewire. The components and materials described are those of a medical device used for navigation and access within the body.
- The performance studies focus on physical and biological compatibility. The tests performed (tensile strength, fracture testing, biocompatibility, etc.) are relevant to the safety and function of an implantable or interventional medical device, not an IVD.
In summary, the SafeSept is a medical device used during a procedure, not a diagnostic tool used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The SafeSept is indicated for use in procedures where access to the transseptal technique is desired. The SafeSept Transseptal Guidewire is intended for single use only.
Product codes
DRC
Device Description
The SafeSept® Transseptal Guidewire is 0.014″ in diameter and 135cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept include the 0.014″ transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept, SS-135. The SafeSept is sterilized by 100% ethylene oxide cycle and is for single-use only. The SafeSept is used in a healthcare facility/hospital. Dose Not apply The SafeSept is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through the femoral vein. The SafeSept is then advanced to the fossa ovalis with the support of the needle and dilator. The SafeSept's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as a typical 0.014″ diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the guidewire tip in relation to the tip of the needle. The guidewire'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
left atrium, right side of the heart, femoral vein, fossa ovalis, interatrial septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
The following performance tests were performed in support of substantial equivalence to the predicate:
- Visual and dimensional inspection
- Particulate testing (USP , Light Obscuration Method) ●
- Surface finish assessment
- Corrosion resistance
- Guidewire tensile strength
- Fracture and Flex testing
- Curve Integrity testing
- Torque Testing
- Packaging testing
- Radiopacity assessment
In addition, the sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical device is sterilized to a SAL of 10-6. The results of the testing demonstrated the subject device performed equivalently to the predicate device.
Biocompatibility Testing:
The biocompatibility evaluation for the SafeSept 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-"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
- 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 - In-vivo Dog Thromboresistance
- ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9 ●
The SafeSept transseptal guidewire is considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours). The SafeSept met the requirements set forth in ISO-10993.
Key Metrics
Not Found
Predicate Device(s)
Oscor, SafeSept® Transseptal Trocar Guidewire, K081986
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 20, 2017
Pressure Products Medical Device Manufacturing LLC Andrew Armour Managing Director 1 School Street Morton, Pennsylvania 19070
Re: K170671
Trade/Device Name: Safesept Transseptal Guidewire Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC Dated: September 20, 2017 Received: September 21, 2017
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education (DICE) 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,
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
2
Indications for Use
510(k) Number (if known) K170671
Device Name SafeSept Transseptal Guidewire
Indications for Use (Describe)
The SafeSept is indicated for use in procedures where access to the transseptal technique is desired. The SafeSept Transseptal Guidewire is intended for single use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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: October 19, 2017
Identification of the Device
Proprietary-Trade Name: SafeSept® Transseptal Guidewire Device Class: Class II Classification Name: Trocar (CFR 870.1390) Common/Usual Name: Transseptal Guidewire Product Code: DRC
Equivalent Legally Marketed Devices
Oscor, SafeSept® Transseptal Trocar Guidewire, K081986
Description of the Devices
The SafeSept® Transseptal Guidewire is 0.014″ in diameter and 135cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept include the 0.014″ transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept, SS-135. The SafeSept is sterilized by 100% ethylene oxide cycle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.
The SafeSept is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through the femoral vein. The SafeSept is then advanced to the fossa ovalis with the support of the needle and dilator. The SafeSept's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as a typical 0.014″ diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the guidewire tip in relation to the tip of the needle. The guidewire's duration in the body is less than 24 hours.
Indications for Use
The SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept Transseptal Guidewire is intended for single use only.
The Indications for Use statement for the SafeSept transseptal guidewire device is identical to the predicate device. Both devices have the same intended use and are used in conjunction with a transseptal needle to create the primary puncture in the interatrial septum. The devices guide the needle, dilator, and introducer through the septum from the right side of the heart to the left side.
4
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of this device are the predicate device. The main difference between the subject device and the predicate device is the length of the guidewire. The predicate SafeSept device is 120cm in length and the currently marketed SafeSept is 135cm. The subject and predicate device are based on the follow technological elements:
- The guidewire is manufactured from nitinol wire that is super-elastic so that it can have a 'J' curve with a sharp tip
- Radiopaque coil used by the physician to locate SafeSept and to guide supporting devices like the transseptal needle, dilator, and sheath across the fossa
- . Device inserted through the transseptal needle so that it can be used in the transseptal procedure
- . Creates the primary puncture of the fossa with the sharp tip
- . Coil is used to dilate the fossa further so that the needle can then be inserted through the fossa rather then used as the primary puncture
- . Printed markers are along the body for the physician to use as a guide to understand how far the SafeSept is in relation to the supporting devices
Performance Testing
The following performance tests were performed in support of substantial equivalence to the predicate:
- Visual and dimensional inspection
- Particulate testing (USP , Light Obscuration Method) ●
- Surface finish assessment
- Corrosion resistance
- Guidewire tensile strength
- Fracture and Flex testing
- Curve Integrity testing
- Torque Testing
- Packaging testing
- Radiopacity assessment
In addition, the sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical device is sterilized to a SAL of 10-6. The results of the testing demonstrated the subject device performed equivalently to the predicate device.
Biocompatibility Testing
The biocompatibility evaluation for the SafeSept 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-"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
- ISO 10993-10 Sensitization
- ISO 10993-10 Irritation/Intracutaneous Reactivity .
5
- 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 - In-vivo Dog Thromboresistance
- ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9 ●
The SafeSept transseptal guidewire is considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours). The SafeSept met the requirements set forth in ISO-10993.
Conclusion
When compared to the predicate device, the SafeSept transseptal guidewire is substantially equivalent in design, technological characteristics, materials and performance testing.