(508 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a reprocessed medical device and does not mention any AI or ML components or functionalities.
Yes
The device is used to create an atrial septal defect in the heart, which is a therapeutic intervention, and also mentions monitoring and infusing solutions, which are part of medical treatment.
No
The device is primarily used to create an atrial septal defect, which is a therapeutic intervention, not a diagnostic one. While it can monitor intracardiac pressures and sample blood, these functions are secondary and support the primary therapeutic use, rather than being its sole or primary diagnostic purpose.
No
The device description clearly outlines a physical medical device (a needle) that delivers radiofrequency power and has physical connections for other hardware components (generator, cable, pressure monitoring system). It also details bench and laboratory testing related to the physical characteristics and performance of the needle.
No, 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 examine these samples outside of the living body.
- Device Function: The description clearly states that the Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. It is an invasive surgical device used within the body.
- Intended Use: The intended use is to perform a procedure directly on the heart, not to analyze samples taken from the body.
- Device Description: The description details how the device interacts with the heart tissue and delivers RF energy, which is consistent with an in-vivo (within the living body) procedure.
The secondary indications (monitoring intracardiac pressures, sampling blood, and infusing solutions) are also performed in vivo during the procedure, not as part of an in vitro diagnostic test.
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
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, which is in compliance with IEC 60601-2-2. 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 dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, 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
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) 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 (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
Image /page/0/Picture/0 description: The image contains 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.
April 4, 2023
Innovative Health, LLC. Christina Fleming VP, Compliance and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K213584
Trade/Device Name: Reprocessed NRG Transseptal Needle Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy catheter Regulatory Class: Class II Product Code: OLZ Dated: March 3, 2023 Received: March 6, 2023
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,
Rachel E. Neubrander -S
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
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Enclosure
The Reprocessed NRG Transseptal Needle model numbers in the scope of this clearance are as follows: NRG-E-HF-71-C0, NRG-E-HF-89-C0, NRG-E-HF-89-C0, NRG-E-HF-98-C0, NRG-E-HF-71-C1, NRG-EHF-89-C1, NRG-E-HF-98-C1.
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Indications for Use
510(k) Number (if known) K213584
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) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | . |
__ Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY K213584
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 Requlatory Affairs Innovative Health, LLC. (480) 252-4731 (cell) (480) 525-5972 (office) (888) 965-7705 (fax) tfleming@innovative-health.com
Date prepared:
November 10, 2021
Device Information:
Trade/Proprietary Name: Common Name: Classification Name: Classification Number: Product Code:
Reprocessed NRG Transseptal Needle Catheter, Septostomy Septostomy catheter, 21 CFR 870.5175 Class II QLZ
Predicate Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K200060 | Reprocessed NRG | |
| Transseptal Needle | Innovative Health | |
| 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, which is in compliance with IEC 60601-2-2. 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 dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, 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
5
Radiofrequency Puncture Generator Instructions for Use"). Please refer to the applicable user manual for recommended settings for the compatible generators.
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.
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.
| Description | Item Number | Curve
Type | Shaft OD
(mm) | Usable
Length
(cm) |
|---------------------------------------------|----------------|---------------|------------------|--------------------------|
| Reprocessed
NRG
Transseptal
Needle | 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:
Technoloqical 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 was conducted to demonstrate performance (safety and effectiveness) 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 ●
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The Reprocessed NRG Transseptal Needle is reprocessed no more than three (3) times. Each device is marked, serialized and tracked. After the device has reached the maximum number of 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 devices described herein.