(199 days)
Not Found
No
The summary describes a reprocessed medical device that uses radiofrequency energy and mechanical components. There is no mention of AI, ML, or any computational processing that would suggest the use of these technologies. The performance studies listed are standard for a device of this type and do not indicate AI/ML evaluation.
Yes
The device is used to "create an atrial septal defect in the heart," which is a treatment for a medical condition. While it also performs diagnostic functions (monitoring pressures, sampling blood), its primary stated purpose involves treatment.
No
The device is used to create an atrial septal defect and for monitoring pressures, sampling blood, and infusing solutions, which are interventional or measurement functions, not diagnostic ones.
No
The device is a physical needle used for creating an atrial septal defect and other procedures, requiring extensive hardware testing and validation. It is 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, monitor intracardiac pressures, sample blood, and infuse solutions. These are all procedures performed in vivo (within the living body).
- Device Description: The device is a needle used to deliver RF power and is inserted into the heart. This is a surgical/interventional device, not a device used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) in vitro to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used on specimens derived from the human body to provide diagnostic information. This device is used directly on the patient's heart for a therapeutic and monitoring purpose.
N/A
Intended Use / Indications for Use
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
Product codes
OLZ, QLZ
Device Description
The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and, optionally, to an external pressure monitoring system via a luer connection.
The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. The active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
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
Bench and laboratory testing were conducted to demonstrate performance of the Reprocessed NRG Transseptal Needle. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- Visual Inspection
- Dimensional Verification
- Simulated Use
- Electrical Continuity
- Leak Testing
- Corrosion Resistance
- Mechanical Characteristics
- Electrical Safety Testing
- Dielectric and Current Leakage
- Packaging Validation
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2020
Innovative Health, LLC. Ms. Christina Fleming VP, Quality and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K200060
Trade/Device Name: Reprocessed NRG Transseptal Needle Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy catheter, reprocessed Regulatory Class: Class II Product Code: OLZ Dated: June 19, 2020 Received: June 22, 2020
Dear Christina Fleming:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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The Reprocessed NRG Transseptal Needle model numbers in the scope of this clearance are as follows: NRG-E-56-32-C0, NRG-E-HF-71-C0, NRG-E-HF-89-C0, NRG-E-HF-98-C0, NRG-E-HF-71-C1, NRG-E-HF-89-C1, NRG-E-HF-98-C1.
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Indications for Use
510(k) Number (if known) K200060
Device Name Reprocessed NRG Transseptal Needle
Indications for Use (Describe)
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
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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510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Christina Fleming VP, Quality and Regulatory Affairs Innovative Health, LLC. (480) 252-4731 (cell) (480) 525-5972 (office) (888) 965-7705 (fax) tfleming@innovative-health.com
Date prepared:
July 29, 2020
Device Information:
| Trade/Proprietary Name: | Reprocessed NRG Transseptal Needle |
|---|---|
| Common Name: | Catheter, Septostomy |
| Classification Name: | Septostomy catheter, reprocessed |
| Classification Number: | Class II, 21 CFR §870.5175 |
| Product Code: | QLZ |
Predicate Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K073326 | NRG Transseptal Needle | Baylis Medical Company Inc. |
Device Description:
The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and, optionally, to an external pressure monitoring system via a luer connection.
The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. The active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
Note: Detailed information concerning the BMC Radiofrequency Puncture Generator is contained in a separate manual that accompanies the Generator (entitled "BMC Radiofrequency Puncture Generator Instructions for Use"). Please refer to the applicable user manual for recommended settings for the compatible generators.
Innovative Health Reprocessed Transseptal Needle
Page 1 Traditional 510(k) K200060
5
Note: Only the reprocessed NRG Transseptal Needle is the subject of this submission. Any other related equipment is not included in the scope of this submission.
| Description | Item Number | Curve Type | Shaft OD (mm) | Usable Length (cm) |
|---|---|---|---|---|
| NRG | ||||
| Transseptal | ||||
| Needle | NRG-E-56-32-C0 | C0 | 19Ga/1.1mm | 56 |
| NRG-E-HF-71-C0 | C0 | 18Ga/1.3mm | 71 | |
| NRG-E-HF-89-C0 | C0 | 18Ga/1.3mm | 89 | |
| NRG-E-HF-98-C0 | C0 | 18Ga/1.3mm | 98 | |
| NRG-E-HF-71-C1 | C1 | 18Ga/1.3mm | 71 | |
| NRG-E-HF-89-C1 | C1 | 18Ga/1.3mm | 89 | |
| NRG-E-HF-98-C1 | C1 | 18Ga/1.3mm | 98 |
The item numbers in scope of this submission are as follows:
Indications for Use:
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed NRG Transseptal Needle is identical to the predicate device. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of this device includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling,
Functional and Safety Testing:
Bench and laboratory testing were conducted to demonstrate performance of the Reprocessed NRG Transseptal Needle. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation
- Functional Testing
- Visual Inspection o
- Dimensional Verification o
- Simulated Use o
- Electrical Continuity O
- Leak Testing o
- Corrosion Resistance o
- Mechanical Characteristics o
- Electrical Safety Testing ●
- Dielectric and Current Leakage o
- . Packaging Validation
The Reprocessed NRG Transseptal Needle is reprocessed no more than one (1) time. Each device is serialized and tracked. After the device has reached the maximum number of
Innovative Health Reprocessed Transseptal Needle
Page 2 Traditional 510(k) K200060
6
reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed NRG Transseptal Needle is as safe and effective as the predicate device described herein.