(183 days)
Not Found
No
The summary describes a physical device that delivers RF energy and does not mention any software or algorithms that would incorporate AI/ML.
Yes
The device is described as creating an atrial septal defect in the heart to treat a medical condition, which is a therapeutic intervention.
No
The device is described as creating a septal defect and accessing the heart, infusing solutions, and sampling blood, which are interventional and therapeutic actions, not primarily diagnostic. While it can monitor pressures and sample blood, its core intended use is not solely for diagnosis.
No
The device description explicitly states it is a "sterile, single-use device that delivers radiofrequency (RF) energy," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create an atrial septal defect in the heart and for other procedures directly within the heart (transseptal access, monitoring pressures, sampling blood, infusing solutions). This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The device delivers radiofrequency energy to create a defect in the heart. This is a therapeutic or procedural device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) outside of the body for diagnostic information. The device's function is to perform a physical action within the heart.
IVD devices are used to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose diseases or conditions. This device operates directly on the patient's heart.
N/A
Intended Use / Indications for Use
Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.
Product codes
DXF
Device Description
The NRG Transseptal Needle is a sterile, single-use device that delivers radiofrequency (RF) energy to create an atrial septal defect in the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The NRG Transseptal Needle has been subjected to mechanical, electrical and simulated use bench testing to verify compliance with safety and performance requirements. The device will be validated for biocompatibility, sterilization and packaging.
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
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).
0
1. 510(k) Summary
Submitter Information
MAY 2 8 2008
- A. Company Name: Baylis Medical Company Inc.
- B. Company Address: 2645 Matheson Blvd. East
Mississauga, Ontario L4W 5S4
Canada
- C. Company Phone: (905) 602-4875; ext: 252
- D. Company Facsimile: (905) 602-5671
- E. Contact Person: Meghal Khakhar
- F. Summary Prepared: 13-December-2007
Device Identification
- A. Device Trade Name: NRG Transseptal Needle
- B. Device Common Name: Catheter, Septostomy
- C. Classification Name: Septostomy catheter, 21 CFR 870.5175
- D. Device Class: Class II
- E. Device Code: DXF
Identification of Predicate Device
Predicate devices are the Toronto RF Septostomy Catheter (Baylis Medical Company, Inc.), which is cleared under 510(k) Premarket Notification Number K031949 and the Transseptal Needle/Trocar (Thomas Medical Products, Inc), which is cleared under the 510(k) Premarket Notification number K011727.
Device Description
The NRG Transseptal Needle is a sterile, single-use device that delivers radiofrequency (RF) energy to create an atrial septal defect in the heart.
Intended Use
Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.
1
Substantial Equivalence
The indications for use of the NRG Transseptal Needle are identical to the Toronto RF Septostomy Catheter. Both the devices are used in conjunction with the BMC Radio Frequency Perforation Generator (510(k) #: K013904) to create an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions. The fundamental scientific technology of both these devices is also the same.
The indication for use of the NRG Transseptal Needle is substantially equivalent to the indication for use of the predicate Transseptal Needle/Trocar.
Device Testing
The NRG Transseptal Needle has been subjected to mechanical, electrical and simulated use bench testing to verify compliance with safety and performance requirements. The device will be validated for biocompatibility, sterilization and packaging.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 2008
Baylis Medical Company Inc. c/o Ms. Meghal Khakar Manager, Regulatory and Scientific Affairs 2645 Matheson Blvd. East Mississauga, Ontario, Canada, L4W 5S4
Rc: K073326
Trade/Device Name: NRG Transseptal Needle Regulation Number: 21 CFR 870.5175 Regulation Name: Catheter, Septostomy Regulatory Class: Class II Product Code: DXF Dated: April 28, 2008 Received: April 30, 2008
Dear Ms. Khakar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Meghal Khakar
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerelv vours.
R. Wachner
Bram D. Zuckerman, MD 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): K 07 3326
Device Name: NRG Transseptal Needle
Indications For Use:
Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.
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)
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Number K033326